the march2012 digital edition of general surgery news

®

GeneralSurGerynewS.com

The Independent Monthly Newspaper for the General SurgeonMarch 2012 • Volume 39 • Number 3

opinion Large Variation Found In Payment for Nine Common

Surgical Procedures

Team Approach Reduces Central-

Line InfectionsBy Kate O’ROuRKe

Houston—Can hospitals drive their rates of central-line bloodstream infec-tions to zero? Although it sounds like a pipe dream, multidisciplinary team approaches are making great strides in dramatically reducing rates, new research has found.

At the Universi-ty of Massachusetts Memorial Medical Center in Worcester, for example, a team of clinicians dedicated to preventing central-line infections in eight of the hospital’s inten-sive care units (ICUs) cut the rate by almost 90% over a seven-year period. Similarly, a team effort at the Ohio State University Medical Center in Columbus, decreased infection rates in a 25-bed ICU by roughly 33% in one year. Researchers presented details of the two approaches at the 2012 annual meeting of the Soci-ety of Critical Care Medicine (abstracts

Study of Accelerated Partial Breast Irradiation Sparks Debate

By Kate O’ROuRKe

A new study has spurred some doctors to urge caution in

selecting patients for accelerated par-tial breast irradiation (APBI) and angered others who say the study is flawed and could derail a Phase III clinical trial testing APBI. The

retrospective study, presented at the recent San Antonio Breast Can-cer Symposium (SABCS), conclud-ed that APBI with brachytherapy is associated with inferior effectiveness and increased toxicity compared with

Spam in a Can II: Another Perspective

By edwaRd M. COpeland III, Md

I always enjoy the opinion col-umns written by David Coss-

man, MD. His opinions usually reflect the constructive criticisms that I would get from the pri-vate sector as I traveled around

the country in my various capacities as a representative of the leadership of the American College of Surgeons (ACS). Often these criticisms took the form of “what have you done for me lately?” or were made with minimal background information. I have been gone from a leadership role in the ACS now for more than five years and cannot com-ment on the views of the members of the current Board of Regents.

What I can say is that I am a mem-ber of the “then” generation and Tom Russell, MD, became a member of the “now” generation. These views put us into conflict. From Dr. Russell’s posi-tion as the executive director of the ACS, he was able to see the “now” generation of surgeons and health care

Major Flaws in Reimbursement Formulas, Researchers Say

By ChRIstIna FRangOu

san Francisco—A new study reveals vast discrepancies in surgeons’ hour-ly payment for some common gener-al surgery procedures—a finding that demonstrates significant failings in the current reimbursement formula.

Researchers compared the total care time and payment per unit of time for nine common inpatient and outpatient procedures using Cur-rent Procedural Terminology (CPT)

Procedureestimated payment per hour

Lap gastric bypass $707

Thyroidectomy $693

Lap gallbladder with cholangiogram $541

Lap Nissen fundoplication $481

Partial mastectomy $453

Lap appendectomy $443

Inguinal hernia repair $326

Umbilical hernia repair $321

Partial colectomy with anastomosis $188

see Spam II page 39

see ReImbuRSement page 36

see paRtIal bReaSt IRRadIatIon page 50

see CentRal-lIne page 22

In the NewsStatewide Data Initiative Reveals Clues To Improving Outcomes..........................................4

INSIDEClinical Review Catheter-related

Bloodstream Infections .......................7

Obesity CareStudy Shows Plateauing of Obesity, Conflicting With Earlier Studies ............ 26

CliniCal ExpEriEnCE

Endo GIA™ Reloads With Tri-Staple™ Technology and Endo GIA™ Ultra Universal Staplers in Minimally Invasive Liver and Pancreatic Resections

see page 12

SpECial rEportProGripTM Mesh: Self-Gripping Mesh for Hernia Repair

see InSeRt at page 6

nEw produCt announCEmEnt

see page 38

SpECial rEportAddressing Current Challenges in Managing Postsurgical Pain With EXPAREL®, a New DepoFoam® Formulation of Bupivacaine


MCGSN1126.indd 1 2/17/12 4:32 PM

Frederick L. Greene, MDChairman, Department of General Surgery Carolinas Medical Center Charlotte, N.C.

The Proliferation of Gowns and Gloves

The other day while making rounds on a patient who was in her fourth postoperative day after a

colectomy for diverticular disease, I was struck by a new collection of gowns and gloves on her door, along with multiple other signs indicating an infection con-trol issue. As I looked up and down the hall, I noticed that almost every door on the surgical unit had the same collection of yellow gowns and blue gloves with signage indicating some form of isolation. Although I didn’t know anything about the other patients on the unit, I did know that my own patient had no particular bacterial issues when admitted and there were certain-ly no intra- or postoperative infection control stigmata that would warrant new signage and the proliferation of gowns and gloves.

I asked a nursing student who was in the throes of putting on a gown and gloves in front of my patient’s door if she knew anything about the infection control issue. She mentioned that there was a reference some-where in the electronic medical record that in 2008 my patient “may have had” a culture of methicillin-resis-tant Staphylococcus aureus (MRSA). I then proceeded to

go into my patient’s room, donning all of the appropri-ate accoutrements of the infection control guidelines, and asked my patient whether she had any recollection of any infectious issues. She assured me that she had never had any involvement with MRSA and said she was rather surprised that the gowns and gloves all of a sudden appeared on her fourth postoperative day.

I use this little scenario to highlight a potential prob-lem that seems to be proliferating throughout my hos-pital and perhaps yours as well. Although I am certainly not against appropriate infection control measures and have always supported the guidelines as to when these measures should be deployed, I feel that we are seeing an increase in patient isolation that may be inappro-priate and that may actually foster poor infection con-trol because of the ubiquitous nature of these protective measures. I think this is representative of the “boy who cried wolf ” syndrome. If we employ this process too fre-quently and potentially indiscriminately, then appropri-ate infection control measures may be ignored.

It amazes me to see the number of doors in the inpatient unit covered with signs indicating a variety of infection control measures and I wonder whether these types of measures are well founded or potential-ly placed at the whim of a well-meaning ID [infectious disease] nurse without appropriate information to justi-fy these actions. Again, before any readers accuse me of not wanting to follow appropriate guidelines, I feel that we are now in some ways overusing these measures with

the resultant unintended consequences.The overall cost of having multiple gowns, gloves,

masks and other infection control methods instituted without appropriate indicators to warrant their use also must be eschewed. I cringe sometimes to see how much waste is collected each day as a consequence of using these expensive disposable items, and I believe that in our culture we tend to give little thought to the waste that is generated and the overall cost that is engendered.

Another possible byproduct of indiscriminate use of infection control guidelines is worse patient care:

3GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012 GSn editorial

McMahon Publishing is a family-owned

medical publishing and medical educa-tion company. McMahon publishes seven clinical news papers and nine annual or semiannual Special Editions.

mcmahonmed.com © 2012 by McMahon Publishing, new york, ny 10036. all rights reserved. General Surgery News (ISSn 1099-4122) is published monthly by McMahon Publishing. Periodicals postage paid at new york, ny, and at additional mailing offices. POSTMaSTER: Please send address changes to General Surgery News, 545 W. 45th St., 8th Floor, new york, ny 10036.

Senior Medical AdviserFrederick L. Greene, MD Charlotte, NCGeneral Surgery, laparoscopy, Surgical Oncology

Editorial Advisory BoardMaurice E. Arregui, MD Indianapolis, INGeneral Surgery, laparoscopy, Surgical Oncology, ultrasound, Endoscopy

Kay Ball, RN, CNOR, FAAN Lewis Center, OHnursing

Philip S. Barie, MD, MBANew York, NYCritical Care/Trauma, Surgical Infection

L.D. Britt, MD, MPHNorfolk, VAGeneral Surgery, Trauma/Critical Care

David Earle, MDSpringfield, MAGeneral Surgery, laparoscopy

James Forrest Calland, MDPhiladelphia, PAGeneral Surgery, Trauma Surgery

Edward Felix, MD Fresno, CAGeneral Surgery, laparoscopy

Robert J. Fitzgibbons Jr., MD Omaha, NEGeneral Surgery, laparoscopy, Surgical Oncology

David R. Flum, MD, MPHSeattle, WAGeneral Surgery, Outcomes Research

Michael Goldfarb, MD Long Branch, NJlaparoscopy, Telemedicine

Leo A. Gordon, MD Los Angeles, CAGeneral Surgery, laparoscopy, Surgical Education

Gary Hoffman, MD Los Angeles, CAColorectal Surgery

Namir Katkhouda, MD Los Angeles, CAlaparoscopy

Michael Kavic, MD Youngstown, OHGeneral Surgery, laparoscopy

Peter K. Kim, MDBronx, NYEmergency General Surgery

Raymond J. Lanzafame, MDRochester, NYGeneral Surgery, laparoscopy, Surgical Oncology, laser Surgery, new Technology

John Maa, MDSan Francisco, CASurgical hospitalist

Gerald Marks, MD Wynnewood, PAColon and Rectal Surgery, Colonoscopy

J. Barry McKernan, MD Marietta, GAlaparoscopy

Joseph B. Petelin, MD Shawnee Mission, KSlaparoscopy

Richard Peterson, MDSan Antonio, TXGeneral Surgery, Bariatric Surgery

Joseph J. Pietrafitta, MD Minneapolis, MNGeneral Surgery, laparoscopy, Colon and Rectal Surgery, laser Surgery

David M. Reed, MD New Canaan, CTGeneral Surgery, laparoscopy, Medical Technology Development/assessment

Barry A. Salky, MD New York, NYlaparoscopy

Paul Alan Wetter, MD Miami, FLOb/Gyn, laparoscopy

Editorial Staff

Kevin HortyGroup Publication Editor ([email protected])

Victoria Sternassociate Editor ([email protected])

James PruddenGroup Editorial Director

Robin B. WeisbergManager, Editorial Services

Elizabeth Zhongassociate Copy Chief

SalesMichael EnrightGroup Publication Director (212) 957-5300, ext. [email protected]

Kate CarmodyManager of Publication Sales (212) 957-5300, ext. 278 [email protected]

Alina Dasgupta Classified advertising (212) 957-5300, ext. 338 [email protected]

Art/MAX Graphics & Production Staff

Michele McMahon VelleCreative Director

Deanna Cosmeart Director

James O’NeillSenior Systems Manager

Dan RadebaughDirector of Production and Technical Operations

Brandy WilsonCirculation Coordinator

McMahon Group

Raymond E. McMahon, Publisher & CEO,

Managing Partner

Van Velle, President, Partner

Matthew McMahon, General Manager, Partner

Lauren Smith, Michael McMahon, Michele McMahon Velle, Rosanne C. McMahon, Partners

change of address Procedure

All U.S. general surgeons, colorectal sur-geons, vascular surgeons, surgical oncolo-gists and trauma/critical care surgeons should receive General Surgery News free of charge. If you are changing your address or name, you must notify the AMA at (800) 262-3211 or the AOA (if appropriate) at (800) 621-1773 to continue receiving GSN. You need not be a member; however, they maintain the ultimate source of our mailing addresses.

If you are not a general surgeon or other specialist listed above and would like to sub-scribe, please send a check payable to Gener-al Surgery News. Please allow 8-12 weeks for the first issue. Subscription — $70 per year (outside U.S.A. — $90). Single copies — $7 (outside U.S.A. — $10).

Send checks and queries to: Circulation Coordinator, General Surgery News, 545 West 45th Street, 8th Floor, New York, NY 10036. Fax: (212) 664-1242.

INFECTIOUS DISEASE SPECIAL EDITION

� +We would like your opinion.Please send letters to:[email protected].

mission StatementIt is the mission of General Surgery News

to be an independent and reliable source of news and analysis about the current state of surgery. It strives to provide a venue for dis-cussion and opinions, from all viewpoints, on the issues most important to surgeons.

DisclaimerOpinions and statements published in

General Surgery News are those of the individual author or speaker and do not necessarily represent the views of the editorial advisory board, editorial staff or reporters.

see GownS and GloveS page 51

Statewide Data Initiative Reveals Clues To Improving OutcomesnSQIP in Tennessee; a First Step

in Improving Outcomes

By VICtORIa steRn

Joseph Cofer, MD, listened with rapt attention as Skip Campbell, MD,

shared his first data from the National Surgical Quality Improvement Program (NSQIP) at the 2004 American College of Surgeons (ACS) meeting, in Boston.

Dr. Campbell, Henry King Ransom Professor of Surgery, and chief of staff and senior associate director of the Uni-versity of Michigan Hospitals and Health Centers, in Ann Arbor, said that a sig-nificant barrier to process improvement was the lack of reliable data for identify-ing problems and changing procedures. That is why Dr. Campbell and his col-leagues developed NSQIP to understand how best to develop quality initiatives that would enhance surgical care in Michigan. Before this project, validated prospective data with 30-day outcomes did not exist.

“Hearing this talk was an epiphany,” said Dr. Cofer, professor of surgery and surgery residency program director in the Department of Surgery, University of Tennessee College of Medicine, Chatta-nooga. “It was clear to me this is what sur-geons needed to be doing to improve care and cut costs. We had never had anything like this before.”

Dr. Cofer went home and spoke with the CEO of Erlanger Hospital, in Chat-tanooga, about immediately enrolling Erlanger in NSQIP to collect data on surgical processes and outcomes and the CEO agreed. By 2005, Erlanger Hospital as well as St. Francis Hospital in Mem-phis and Vanderbilt Hospital in Nashville had joined NSQIP. Based on the expe-rience of Dr. Campbell and the NSQIP statewide collaborative, the Tennessee State Chapter of the ACS decided to form a Tennessee statewide collaborative.

By 2008, Dr. Cofer had spearheaded a three-way collaboration between Blue Cross/Blue Shield in Tennessee, The Tennessee Hospital Association and the Tennessee ACS. Blue Cross/Blue Shield

agreed to fund this initiative. In the sum-mer of 2009, seven more hospitals in Ten-nessee enrolled, for a total of 10. Blue Cross/Blue Shield agreed to increase their funding to about $3 million over three years and the Tennessee Surgical Quality Collaborative (TSQC) was formed.

“If you have no data, you can’t change anything,” Dr. Cofer noted. “Once you get your data, you can see where the warts are and can change your hospital’s prac-tices. Data drives process change.”

Dr. Cofer’s initial goal was to track surgical outcomes from the 10 participating hos-pitals and identi-fy trends so that he could ultimate-ly determine best practices among these hospitals. The results of this initia-tive, published online Jan. 19 in the Journal of the American College of Surgeons, examined postoperative complications in 20 catego-ries and 30-day mortality rates, and hos-pital costs associated with postoperative complications in 14,205 surgical cases in 2009 and 14,901 surgical cases in 2010. The investigators compared complica-tions and hospital costs associated with complications per 10,000 procedures.

The investigators saw significant decreases in postoperative complications from 2009 to 2010 in several categories: acute renal failure (–25.1%; P=0.023), graft/prosthesis/flap failure (–60.5%; P<0.0001), ventilator use longer than 48 hours (–14.7%; P=0.012), surgical site infection (–18.9%; P=0.0005) and wound disruption (–34.3%; P=0.011).

They also tracked significant increas-es in complications in three categories: deep venous thrombosis (DVT)/throm-bophlebitis (34.9%; P=0.05), pneumo-nia (23.1%; P=0.05) and urinary tract infections (41.8%; P=0.001). Mortality also went up slightly (2.3%) from 2009 to 2010, despite the overall reduction in postoperative complications.

The improvements led to a net savings

of over $4 million per 10,000 general and vascular procedures. But, when tak-ing into account the costs associated with the increased complications, the net sav-ings—costs avoided minus costs from increased complications—was just over $2.2 million per 10,000 general and vas-cular surgery cases. If applied to all gen-eral and vascular surgery cases in the 10 hospitals, the total estimated costs avoid-ed would rise to more than $8 million in 2010 compared with 2009, Dr. Cofer

estimated.

“We were surprised to see how much improvement

we had,” Dr. Cofer said. “We met four times a year to identify

problems and discuss them, but we’re not really sure why certain outcomes improved [and others did not].”

Dr. Cofer noted that better outcomes for skin and soft tissue/wound disruption and ventilator management may have occurred because surgeons and staff iden-tified and solved problems rapidly. It’s also possible, he added, that some of the improvements could have been due to the Hawthorne effect—surgeons may have performed better simply because they knew they were being evaluated.

Although the mortality rate increased from 2009 to 2010, from a statistical standpoint there was no difference. “If you look at all our cases over the last three years in our TSQC, the mortality rate has actually dropped,” Dr. Cofer said.

Hiram C. Polk Jr., MD, Ben A. Reid Senior Professor of Surgery at the Uni-versity of Louisville Department of Sur-gery, in Kentucky, complimented Dr. Cofer’s efforts, but isn’t celebrating yet. “Dr. Cofer understands surgery inside out and saw many improvements [over time], but the fact that postoperative complica-tions with pneumonia, DVT and urinary

tract infection were up significantly shows how hard this business is,” he said.

Dr. Polk added, “The real question is why did they succeed on some mea-sures and fail on others? How did they get things right? Without knowing the answers to these questions, it’s difficult to make lasting improvements.”

Going forward, the investigators want to address the gaps in postoperative care. “Now we’re in the process of identifying exemplars—hospitals that are statistical-ly better than any other—and we’re going to these hospitals to export best practices,” said Dr. Cofer. “We’re trying to make this up as we go along.” Next year, TSQC will include 21 hospitals. “We have put into place a system that improves the care of surgical outcomes. Our driving force is to do a better job of treating patients."

David Flum, MD, MPH, professor in the Schools of Medicine and Public Health, and director of the Surgical Out-comes Research Center at the University of Washington, in Seattle, would like to take this type of initiative to the next level.

“[Universal surveillance] is what the surgical community should be doing,” said Dr. Flum, also medical director of the Surgical Care and Outcomes Assessment Program, a program providing hospital-specific data feedback and best practices regarding processes of care and outcomes across the Pacific Northwest. “We need to do a better job of determining what’s working and what’s not working. Cur-rently, only 5% of hospitals nationwide are using clinical registries to monitor perfor-mance—that needs to change.”

Dr. Flum believes that surgeons and sur-gical systems need surveillance to improve performance. For example, knowing that mortality is too high isn’t very helpful, he said, but “if I’m told my patients with diabetes aren’t being managed well, that becomes the focus of my efforts to deliv-er better care. “When it comes to the sci-ence about what works and what’s worth investing in, we’re far away from under-standing that,” Dr. Flum added. “There’s not going to be one answer or one size that fits all.” It’s more of an evolution, he said.

New Book To Call Attention to Women Surgeons’ StoriesBy ChRIstIna FRangOu

Female surgeons are now being called on to write and submit stories for a new book that will highlight the

experiences of women surgeons.Preeti John, MD, project organizer and critical care

surgeon in Baltimore, said there are remarkably few books written by women in the surgical field. As a result, she decided to compile an anthology of stories and articles

from female surgeons.The goal is to collect about 50 contributions from sur-

geons across the United States who are in private practice or academic surgery as well as from surgical residents-in-training. Selected contributions will be compiled into a book and published sometime next year.

Dr. John is seeking contributions from women in the form of anecdotes, essays, biographies and even poems. The stories can recount experiences during training and

work as well as from life outside surgery. Women also can choose to be interviewed about their story if they do not have time to devote to writing an original article.

“These stories deserve to be shared to encourage and inspire young women, and to sensitize and educate a broader public, not just in the United States, but across the globe,” she said.

Dr. John asks anyone interested to contact her by email at [email protected]. Original contributions have no specific guidelines and there is no word limit. The dead-line for draft submissions is April 30, 2012.

4 In the news GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012

’If you have no data, you can’t change

anything.’—Joseph Cofer, MD

For challenging hernias, choose Strattice™

Not convinced? To learn how other brands compare contact your

LifeCell™ sales representative at www.lifecell.com/rep10

1. Nov. 2010 Ventral Hernia Market Tracking Study, Millennium Research Group (n=200), based on evaluation of 10 brands. Study commissioned by LifeCell Corporation

2. IMS Data Jan-Dec 2010 3. Data on file: LifeCell™ study (Feb. 2010) compared out of package tensile strength of nine biological brands

demonstrating superior strength for the Firm version of Strattice™ Reconstructive Tissue Matrix

© 2011 LifeCell Corporation. All rights reserved. LifeCell™ and Strattice™ are trademarks of LifeCell Corporation. MLC1583-R3/1335/8-2011

The most trusted biologic mesh1

The most used biologic mesh2

The strongest biologic mesh3

logicalNow that’s

Before use, physicians should review essential prescribing information, including all risk information, which can be found in the Instructions for Use attached to the packaging of each LifeCell™ Tissue Matrix.

Untitled-16 1 9/9/11 4:14 PM

Overall Cancer Deaths Down, Incidence of Some Cancers UpBy geORge OChOa

In the past two decades, the over-all death rate from cancer decreased

by 22.9% in men and 15.3% in women, according to the most recent annu-al report on cancer incidence from the American Cancer Society (ACS; CA Cancer J Clin 2012;62:10-29). More than 1 million cancer deaths were avoided between 1990 and 2008, the report said.

For 10 years with available data (1998-2008), death rates continued to decrease for all four major cancer sites—lung, colorectum, breast and prostate—with colorectal cancer accounting for much of the decline in both men and women.

“Among men, 78% of the [overall] decline is due to decreases in the top three cancer sites (lung, prostate and colorectal cancers); while among women, 56% of the decline is due to decreases in death rates

for breast and colorectal cancers,” said lead author Rebecca Siegel, MPH, an ACS epidemiologist based in Atlanta. “Lung cancer death rates have been declining among men since 1990, due to the reduc-tion in tobacco use over the past 50 years,” she said, noting that the mortality decline has been smaller for women than for men because of the lag in decline in the lung cancer death rate among women. Smok-ing prevalence among women peaked 20

years later than among men.“Decreases in prostate, female breast

and colorectal cancer death rates large-ly reflect improvements in early detection and/or treatment,” Ms. Siegel added.

Howard Sandler, MD, MS, chair of radiation oncology and Ronald H. Bloom Family Chair in Cancer Therapeutics at Cedars-Sinai Medical Center, in Los Angeles, attributed the long decline in cancer death rates to a “combination of factors,” including a declining number of smokers, effective methods of early cancer detection and better treatments.

Dr. Sandler did not believe the novel, targeted cancer therapies had a great effect on cancer mortality rates, in part because those therapies are usually administered to patients who have “fatal cancer.” Such drugs are more important for increasing survival time than for changing the death rate, said Dr. Sandler, executive editor of CancerProgress.net, the American Soci-ety of Clinical Oncology Web site.

Despite the decline in overall cancer mortality, incidence of some less common cancers have been increasing, according to a second article from the ACS (CA Cancer J Clin 2012 Jan 4. [Epub ahead of print]). Authors of that study docu-mented increases in cancers of the pan-creas, liver, thyroid and kidney, as well as esophageal adenocarcinoma, melanoma and some throat cancers associated with human papillomavirus infection.

“The reason for the increasing rates is unknown, but the obesity epidemic is probably associated with increases for some of these cancers,” Ms. Siegel said. “Increases in early detection practices are a likely contributor as well.”

Dr. Sandler described several fac-tors that may account for the observed increases in cancer incidence rates: gastro-esophageal reflux associated with obesity for esophageal adenocarcinoma, hepatitis C and B virus infections for liver cancer, and increased sun exposure for melano-ma of the skin. The increase in melanoma incidence was particularly sharp, he noted.

Ms. Siegel added that the increase in thyroid cancer incidence was the largest, and the increase in kidney cancer inci-dence was unexpected. “Although most of the increases were confined to whites, rates of kidney cancer increased among men and women of every racial/ethnic group, except it was not statistically sig-nificant among American Indian/Alaska Native men.”

Regarding mortality rates, Dr. Sandler expressed hope that the downward trend in deaths from cancer will continue.

Dr. Sandler and Ms. Siegel reported no relevant conflicts of interest.


‘Decreases in prostate, female breast and colorectal cancer death rates largely

reflect improvements in early detection and/or

treatment.’—Rebecca Siegel, MPH

‘To survive [as oncologists], we have

to be optimistic. yes, the trend [in cancer mortality rates] is going to continue

to go down.’—Howard Sandler, MD, MS

Safety isn’t just a matter of compliance, it’s a matter of trust. At Aspen Surgical, we produce many products to safeguard

everyone in your facility including patients, doctors, nurses, and housekeeping staff. To see all of our innovative safety

products, from WriteSite Plus™ Skin Markers to Bard-Parker® Safety Scalpels to Colby Fluid Management products,

visit aspensurgical.com.

Rev 1 ©2012 Aspen Surgical Products, Inc. All Rights Reserved.

Oxboro™ Bard-Parker® Sterion® Colby™ WriteSite® WriteSiteg® SafeClean™ Oxboro™ Bard-Parker® Sterion® Colby™ WriteSd-Allan™ Dr. Fog® SafeClean™ Oxboro™ Bard-Parker® Sterion®

ite Plus™ Richard-Allan™ Dr. Fog® SafeClean™ Oxboro™ Bard™ WriteSite® WriteSite Plus™ Richard-Allan™ Dr. Fog® SafeCleaarker® Sterion® WriteSite Plus™ Richard-Allan™ Dr. Fog® arker® Sterion® Colby™ WriteSite® WriteSite Plus™ Richard-Al Oxboro™ Bard-Parker® Sterion® Colby™ WriteSite® WriteSog® SafeClean™ Oxboro™ Bard-Parker® Sterion® Colby™ Writd-Allan™ Dr. Fog® SafeClean™ Oxboro™ Bard-Parker® Steite® WriteSite Plus™ Richard-Allan™ Dr. Fog® SafeClean™ Oxb

nColby™ WriteSite® WriteSite Plus™ Richard-Allan™ Dr. Fog® Sarker® Sterion® Colby™ WriteSite® WriteSite Plus™ Richard-A Oxboro™ Bard-Parker® Sterion® Colby™ WriteSite® WriteSit

g® SafeClean™ Oxboro™ Bard-Parker® Sterion® Colby™ WriteSd-Allan™ Dr. Fog® SafeClean™ Oxboro™ Bard-Parker® Sterionite Plus™ Richard-Allan™ Colby™ SafeC Bard-Parker® Steite® WriteSite Plus™ Richard-Allan™ Dr. Fog® SafeClean™ Ox

n® Colby™ WriteSite® WriteSite Plus™ Richard-Allan™ Dr. Foarker® Sterion® Colby™ WriteSite® WriteSite Plus™ Richard-A Oxboro™ Bard-Parker® Sterion® Colby™ WriteSite® WrDr. Fog® SafeClean™ Oxboro™ Bard-Parker® Sterion® Colby™

Richard-Allan™ Dr. Fog® SafeClean™ Oxboro™ Bard-Parkeite® WriteSite Plus™ Richard-Allan™ Dr. Fog® SafeClean™ Oxb

Aspen Surgical. The brand behind the brands you trust.

Catheter-related Bloodstream InfectionsCybele l. abad, Md

Section of Infectious DiseasesUniversity of Wisconsin

Madison, Wisconsin

Nasia safdar, Md, phdAssistant Professor

Section of Infectious DiseasesDepartment of MedicineUniversity of Wisconsin

Madison, Wisconsin

Health care–associated infections (haIs) are an important cause of morbidity and mortality and place a significant economic burden on the health care system.1-3

an estimated 1.7 million haIs (4.5 infections per 100 hospital admissions) occurred in the united States in 2002, resulting in nearly 100,000 deaths.4

Catheter-related bloodstream infec-tions (CRBSIs), most of which are asso-ciated with central venous catheters (CVCs), account for 11% of all HAIs.4-6

Agencies such as the National Health-care Safety Network (NHSN; former-ly the National Nosocomial Infections Surveillance System) of the Centers for Disease Control and Prevention (CDC) were formed in response to the grow-ing awareness that HAIs are urgent public health and patient safety issues.1

The recent action plan proposed by the Department of Health and Human Ser-vices identified CRBSIs as a priority area for prevention.7

In 2002, the National Quality Forum created and endorsed a list of Serious Reportable Events (SREs) to increase public accountability and consum-er access to critical information about health care performance. These SREs soon became known as “never events.” Following this lead, in 2007 the Cen-ters for Medicare & Medicaid Services

(CMS) declared it would no lon-ger reimburse HAIs such as CRB-SIs, increasing the urgency for rational and effective prevention and treatment strategies to reduce the morbidity, mortality, and costs associated with them.8 The poli-cy, which went into effect in late 2008, was created to help improve the care of patients by incentivizing hos-pitals to prevent serious hospital-associated adverse events. Beginning in January 2011, CMS mandated that hospitals report CRBSI rates through the NHSN. This new CMS regula-tion makes CRBSI reporting a nation-al requirement to receive full Medicare inpatient payments; facilities that fail to report will not receive the annual 2% Medicare payment increase.

Intravascular catheters play a cen-tral role in the care of critically and chronically ill patients; an estimat-ed 5 million CVCs are inserted in patients each year. However, more than

250,000 central line–associated blood-stream infections (CLABSIs) also occur annually, with an estimated mortali-ty rate of 12% to 25%.3 A recent meta-analysis of patients in the intensive care unit (ICU) found that mortality rates were significantly higher when a CRBSI occurred (random effects model: odds ratio [OR], 1.96; 95% confidence inter-val [CI], 1.25-3.09).9 Each episode sig-nificantly increases hospital length of

stay, with additional health care costs ranging from $4,000 to $56,000 per epi-sode.6,10,11 The NHSN has published surveillance criteria for defining CRB-SIs. The criteria for patients older than 1 year of age are the following: isolation of a recognized pathogen from blood culture(s), the presence of clinical signs of sepsis and/or shock (eg, fever, chills, or hypotension), a determination that the infection is not from other sources, and confirmation that the organism is not a contaminant.1

Intravascular devices (IVDs) include peripheral vascular catheters (venous and arterial), pulmonary artery catheters, midline catheters, peripherally inserted central catheters (PICCs), and various CVCs, including tunneled (usually long-term devices) and nontunneled catheters(percutaneously placed CVCs common-ly used in ICUs).3,5,6,12 This review cov-ers the pathogenesis, microbiology, and treatment of CRBSIs, highlighting advances in the areas of prevention and government policy.

microbiologyAntimicrobial resistance, now consid-

ered a global crisis, continues to loom large, and the organisms that cause CRBSIs are no exception. In the past 2 decades, the proportion of CRB-SIs caused by antimicrobial-resistant organisms, such as methicillin-resis-tant Staphylococcus aureus (MRSA), mul-tidrug-resistant gram-negative bacilli, and fluconazole-resistant Candida spe-cies, has been increasing at an alarming rate.3,13-15 Overall, the organisms most frequently responsible for nosocomial

Table 1. Diagnosis of crBSIs

met

hods

not

requ

irin

g cV

c re

mov

al

Diagnostic method Description criteria for Positivity Sensitivity, % Specificity, %

Qualitative blood culture through device

One or more blood cultures drawn through CVC

Any growth 87 83

Quantitative blood culture through device

Blood culture drawn through CVC, processed by pour-plate methods or a lysis-centrifugation technique

≥100 CFU/mL 77 90

Paired quantitative blood cultures

Simultaneous cultures drawn through CVC and percutaneously

Both cultures positive with CVC culture yielding 5-fold higher or more than peripherally drawn culture

87 98

Differential time to positivity

Simultaneous blood cultures drawn, through CVC and percutaneously, and monitored continuously

Both cultures positive with CVC positive ≥2 h earlier than peripherally drawn culture

85 81

met

hods

requ

irin

g cV

c re

mov

al

Qualitative catheter segment culture

Segment from removed CVC is immersed in broth media and incubated for 24-72 h

Any growth 90 72

Semiquantitative catheter segment culture

A 5-cm segment from removed CVC is rolled 4 times across a blood agar plate and incubated

≥15 CFU 85 82

Quantitative catheter segment culture

Segment from removed CVC is flushed or sonicated with broth, serially diluted, plated on blood agar, and incubated

≥1,000 CFU 83 87

CFU, colony-forming units; CRBSI, catheter-related bloodstream infection; CVC, central venous catheter

Adapted from reference 22.

7GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012 clinical review

see bloodStReam InfeCtIonS page 8

CLABSIs are coagulase-negative staph-ylococci (CoNS) (31%), S. aureus (20%), enterococci (9%), Escherichia coli (6%), Klebsiella species (5%), and Candida spe-cies (9%). A large prospective surveillance study using data from SCOPE (Surveil-lance and Control of Pathogens of Epi-demiological Importance) that included 24,179 cases of CRBSIs from a 7-year period at 49 hospitals found that the rates of MRSA isolates increased from 22% in 1995 to 57% in 2001 (P<0.001). Rates of ceftazidime-resistant Pseudo-monas aeruginosa isolates increased from 12% in 1995 to 29% in 2001 (P<0.001), and 60% of isolates contained vancomy-cin-resistant Enterococcus faecium.15

PathogenesisThe pathogenesis of CRBSIs can be

attributed to 2 primary causes: bacterial colonization of the device and contami-nation of the fluid being administered.16

Contaminated infusate leads to the major-ity of epidemic IVD-related BSIs, but it is rare.16,17 Colonization of the device may be either extraluminal (from surround-ing skin or hematogenous seeding of the catheter tip) or intraluminal (caused by an organism adhering to the device

followed by the creation of a biofilm, a process responsible for persistent infec-tions and hematogenous spread).3,16,17 In short-term devices, the extraluminal route

is more frequent, whereas the intralumi-nal route is more common in long-term devices (≥10 days) or short-term devices left in longer than 4 to 7 days.16,18

DiagnosisThe clinical diagnosis of CRBSIs

is difficult because both the sensitivi-ty for clinical signs of inflammation at

8 clinical review GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012

bloodstreaM iNfeCtioNsContinued from page 7

figure. MaNageMeNt of Crbsis.AC, arterial catheter; ALT, antibiotic lock therapy; CRBSIs, catheter-related bloodstream infections; CVC, central venous catheter; SAT, systemic antimicrobial therapya Choose most appropriate systemic antimicrobial therapy based on current published guidelines.b Remove retained catheter if there is clinical worsening, relapsing, or persisting infection.c Current guidelines recommend considering catheter salvage therapy; however, outcomes may be poor.

Adapted from reference 19.

Endocarditis, septic thrombosis, osteomy-elitis, etc.

Staphylococcus aureus

Complicated

Short-term CVC/AC and long-termCVC/port:Remove, SATª for 4-6 wk or 6-8 wk for osteomyelitisTunnel infection or port abscess:Remove, SAT for 7-10 d

Coagulase-negative Staphylococcus

Short term CVC/AC:Remove, SAT for 5-7 dORRetain,b SAT + ALT for 10-14 dLong-term CVC/port:Retain,b SAT + ALT for 10-14 d

Short-termCVC/AC:Remove, SAT for minimum of 14 dLong-term CVC/port:Remove,c SAT for4-6 wk

Enterococci

Short-term CVC/AC:Remove, SAT for 7-14 dLong-term CVC/port:Remove, SAT for 10-14 dORRetain, SAT + ALT for10-14 d, remove if no response

Short-term CVC/AC:Remove, SATfor 7-14 dTunneled CVC/port:Retain,b SAT + ALT for 7-14 d

Gram-negative bacilli

Uncomplicated

Short-term CVC/AC and long-term CVC/port:Remove, SAT for14 d after first negative blood culture

Candida species

the catheter site and the specificity for signs of systemic infection are low.19,20

Blood culture specimens from the cath-eter should be drawn from all available lumens to avoid missed infections. In a recent retrospective analysis of CRB-SIs at a single institution, 27.2% would have been missed if only one lumen of the double-lumen catheter had been sampled.21

A number of techniques for the diag-nosis of CRBSIs have been studied, including catheter-sparing and non–cath-eter-sparing methods (Table 1, page 7).

A recent meta-analysis found that paired quantitative blood cultures were the most accurate diagnostic test, fol-lowed by quantitative blood cultures through the CVC and quantitative or semiquantitative catheter segment cultures.22

Paired quantitative blood cultures are labor-intensive and cost almost twice as much as standard blood cultures. The widespread availability of radiometric blood culture systems (eg, BACTEC, Becton Dickinson)—in which blood cultures are continuously monitored for microbial growth (approximately every 20 minutes)—has led to their use in detecting CRBSIs.23 The differential time to positivity (the detection of posi-tivity in a culture of blood drawn from an IVD 2 hours or more before the detec-tion of positivity in a culture of blood drawn simultaneously from a peripheral site) was an accurate predictor for CRB-SIs in studies of short- and long-term devices.12,23-25 Newer diagnostic tech-niques, including acridine orange leu-cocyte cytospin and endoluminal brush, are currently being investigated and have shown promise.12,26-30

managementThe management of CRBSIs relies on

2 major clinical decisions: 1) the appro-priate and timely administration of sys-temic antimicrobial treatment (SAT) and 2) catheter removal or catheter sal-vage treatment. SAT should be selected based on the suspected or proven pres-ence of causative agents in accordance with published guidelines and resourc-es.19 The decision to remove the cath-eter is based on the type of catheter being used and the organism in ques-tion. This decision becomes more com-plex when specific patient characteristics are considered, such as the type of device required (tunneled or implanted) and the ease of venous access. Guidelines from the Infectious Diseases Society of Amer-ica (IDSA) recommend the removal of nontunneled catheters in all complicat-ed infections (eg, thrombosis, endocar-ditis, osteomyelitis) and in all infections caused by S. aureus, gram-negative bacil-li, Enterococcus species, and Candida spe-cies. The catheter may be retained with

CoNS if systemic antibiotics are given in conjunction with antibiotic lock ther-apy (ALT).19 In CRBSIs associated with tunneled or implantable devices, the catheters also require removal for any complicated infections (eg, thrombo-sis, endocarditis, osteomyelitis), tunnel or pocket infections and port abscesses, and all infections caused by S. aureus and Candida species.

According to the recent guidelines, catheter salvage regimens—includ-ing the use of ALT—may be attempt-ed when necessary for infections caused by organisms other than S. aureus, fungi,

P. aeruginosa, Bacillus species, Micrococcus species, propionibacteria, and mycobac-teria.19 Although device-sparing regi-mens with longer treatment durations and using antibiotic lock solutions have been attempted for uncomplicated S. aureus, gram-negative bacilli, and even fungal pathogens, the data supporting its efficacy are scant—we do not recom-mend catheter salvage for S. aureus and other virulent organisms.12,19,31-42

The duration of therapy varies based on the organism and whether or not the device has been removed.

Systemic therapy for CoNS infections

ranges from 5 to 7 days when the cath-eter is removed and from 10 to 14 days when it is retained in conjunction with ALT. With catheter removal and uncom-plicated infections, the duration of sys-temic therapy for CRBSIs caused by S. aureus is greater than 14 days, 7 to 14 days for gram-negative bacilli infec-tions, and 14 days from the first nega-tive blood culture for Candida infections (Figure).12,19

Transesophageal echocardiography (TEE) should be performed in all patients with a CRBSI caused by S. aureus because



W. L. Gore & Associates, Inc. • Flagstaff, AZ 86004 • goremedical.com

Products listed may not be available in all markets. GORE®, BIO-A®, PERFORMANCE THROUGH INNOVATION, and designs are trademarks of W. L. Gore & Associates.©2011 W. L. Gore & Associates, Inc. AQ3165-EN1 NOVEMBER 2011

A Valuable Alternative to Biologics

New choice for complexsoft tissue reinforcement.Finally – a cost-effective alternative to biologics! GORE® BIO-A® Tissue Reinforcement

is a unique non-biologic scaffold that is gradually absorbed by the body. The open,

highly interconnected 3D pore structure facilitates cell infi ltration and growth.

Vascularization begins quickly within one to two weeks.

• 100% synthetic, bioabsorbable tissue scaffold

• Rapid cell population and vascularization

• Versatile for numerous applications

• Now available in large sizes up to 20 cm x 30 cm

With a three-year shelf life and no soaking, refrigeration or tracking required,

this versatile material is the easy-to-use, performance-proven alternative that

offers value for surgeons and hospitals alike.

Visit Gore at AHSBooth #117/216

of the propensity of this organism to cause endocarditis. Rosen et al determined that screening all patients who had a clinically uncomplicated CRBSI caused by S. aure-us with TEE was a cost-effective way to determine duration of therapy—as short as 2 weeks if the TEE result was negative.43

catheter Salvage StrategiesWhen the need to retain an exist-

ing long-term catheter in a patient with a CRBSI is significant, salvage can be attempted by using ALT as an adjunct to systemic therapy.12,19,44 Approxi-mately 2 mL of solution is infused into the lumen of the catheter and remains there for a certain amount of time per day during the course of treatment.12,44

Solutions consist of the appropriately selected antibiotic combined with hepa-rin (if compatible). In the lock, antibi-otic concentrations range from 100 to 1,000 times the usual systemic concen-trations. This increased concentration has a greater likelihood for killing organ-isms embedded in biofilm.44 Current guidelines recommend that antibiotic lock solution be used for 10 to 14 days in conjunction with SAT.19 Vancomycin, cefazolin, and ticarcillin-clavulanic acid (Timentin, GlaxoSmithKline)—all in combination with heparin—have excel-lent stability when used in ALTs, retain-ing 90% of their activity after 10 days of dwell time in the presence of susceptible organisms.45

CRBSIs caused by Candida species necessitate prompt removal of the cath-eter; however, this may not always be immediately possible. A solution of eth-ylenediamine tetraacetic acid (EDTA) with amphotericin B lipid complex showed promise during an in vitro model of a Candida biofilm formation, but more research is urgently needed.46 We do not recommend catheter salvage in the set-ting of S. aureus CRBSIs because of the high risk for metastatic infection and the slim likelihood of cure without removal of the catheter.

PreventionThe Healthcare Infection Control Prac-

tices Advisory Committee (HICPAC) of the CDC has published extensive guide-lines for the prevention of CRBSIs, with a recent update released in 2011.2,3 They emphasize the following: 1) educat-ing and training all health care person-nel who insert and maintain catheters; 2) using maximal sterile barrier precautions during CVC insertion; 3) using a greater than 0.5% chlorhexidine skin preparation with alcohol for antisepsis; 4) avoiding routine replacement of CVCs as a strate-gy to prevent infection; and 5) using anti-septic/antibiotic-impregnated short-term

CVCs and chlorhexidine-impregnated sponge dressings if the rate of infection is not decreasing despite adherence to prior strategies. The guidelines also emphasize performance improvements by imple-menting bundle strategies and document-ing and reporting the compliance rates for all components of the bundle as bench-marks for quality assurance and perfor-mance improvement.2 Novel strategies for the prevention of CRBSIs are sum-marized in Table 2.5,47,48,50-54,80,81,84,90

Highlighted below are important top-ics for the prevention of CRBSIs. The

recommendations are rated based on the strength of evidence supporting them as follows: IA, strongly recommended for implementation and strongly supported by well-designed experimental, clinical, or epidemiologic studies; IB, strongly rec-ommended for implementation and sup-ported by some experimental, clinical, or epidemiologic studies and a strong theo-retical rationale; IC, required by state or federal regulations, rules, or standards; and II, suggested for implementation and sup-ported by suggestive clinical, or epidemi-ologic studies or a theoretical rationale.3

cutaneous antisepsis

Historically, iodophors, such as 10% povidone-iodine, have been the most widely used skin antisepsis agents in the United States.5,55,56 However, recent studies demonstrate that a 2% chlorhex-idine preparation is the superior agent for preventing CRBSIs. A meta-analysisof 4,143 catheters found that chlorhex-idine preparations reduced the risk for CRBSIs by 49% (95% CI, 0.28-0.88) compared with povidone iodine.47 Also,

table 2. Novel strategies for the preveNtioN of Crbsis

Strategy Study Design Technology outcome

ant

imic

robi

al lo

ck s

olut

ion

Safdar et al, 200651

Meta-analysis Vancomycin-containing locks vs heparin 50% risk reduction (RR, 0.49;95% CI, 0.26-0.95)

Yahav et al, 200854

Systematic review and meta-analysis

Various antibioticsa

Antibiotic plus antisepticb

Antisepticc

Antibiotic solutions:RR, 0.44; 95% CI, 0.38-0.5Non-antibiotic antiseptic solutions + other prevention methodsd:RR, 0.25; 95% CI, 0.13-0.5Non-antibiotic antiseptic solutions alone:RR, 0.9; 95% CI, 0.48-1.69

Sanders et al, 200884

Double-blind randomized trial

Ethanol-containing locksvs heparin

OR, 0.18; 95% CI, 0.05-0.65

ant

imic

robi

al c

athe

ters

Veenstra et al, 199953

Meta-analysis Antiseptic-impregnated CVCse OR, 0.56; 95% CI, 0.37-0.84

Ramritu et al, 200850

Systematic review Antibiotic-impregnated CVCsf RR, 0.39; 95% CI, 0.17-0.92

Crnich et al, 20025

Meta-analysis Silver-impregnated CVCs RR, 0.40; 95% CI, 0.24-0.68

Ramritu et al, 200850

Systematic review Antibiotic vs first-generation antiseptic-impregnated CVCs

RR, 0.12; 95% CI, 0.02-0.67g

Hockenhull et al, 200981

Systematic review Anti-infective CVCs (all types) OR, 0.49; 95% CI, 0.37-0.64h

chlo

rhex

idin

e dr

essi

ngs

Ho et al, 200648 Meta-analysis Chlorhexidine-impregnated dressing vs placebo or povidone-iodine dressing

Catheter or exit-site colonization: 14.3% vs 27.2%; OR, 0.4; 95% CI, 0.26-0.61CRBSIs:2.2% vs 3.8%; OR, 0.58; 95% CI, 0.29-1.14; P=0.11

Timsit et al, 200980

Randomized controlled trial

Chlorhexidine-impregnated dressing vs standard dressing

0.4 vs 1.3 CRBSIs per 1,000catheter-days; HR, 0.024;95% CI, 0.09-0.65; P=0.005

cuta

neou

s an

tisep

sis Chaiyakunapruk

et al, 200247Meta-analysis Chlorhexidine vs povidone-iodine RR, 0.49; 95% CI, 0.28-0.88i

mup

iroci

n pr

ophy

laxi

s Tacconelli et al, 200352

Meta-analysis Mupirocin prophylaxis indialysis patientsj

Decrease in S. aureus bacteremiain hemodialysis patients by 78%;RR, 0.22; 95% CI, 0.11-0.42

chlo

rhex

idin

e ba

thin

g

Silva et al, 201090

Meta-analysis Daily chlorhexidine bathing (impregnat-ed cloths or solution) compared with soap and water baths

Decrease in risk for bloodstream infection (RR, 0.32; 95% CI, 0.22-0.46; P<0.0001, fixed-effects; I2=17%)

CI, confidence interval; CVC, central venous catheter; HR, hazard ratio; OR, odds ratio; RR, relative riska Gentamicin; gentamicin + citrate; gentamicin + vancomycin; gentamicin + cefazolin; cefotaxime. b Minocycline with ethylenediamine tetraacetic acid.c Citrate; citrate with taurolidine. d Nasal mupirocin and exit-site iodine dressing. e Chlorhexidine-silver sulfadiazine. f Minocycline and rifampin.g Reduced risk with antibiotic catheters. h Reduced risk with anti-infective catheters: all types combined, see text for subgroup analysis. i Reduced risk with chlorhexidine. j Six studies used intranasal mupirocin 2 to 3 times daily for 5 to 14 days with various maintenance schedules; 4 studies used mupirocin applied to catheter exit site.




Find out more about Atrium’s C-QUR CentriFX™ hernia repair solutions at the 2012 World Hernia Congress, New York, NY, Booth #215© Atrium Medical Corporation 2012. All rights reserved. Atrium and C-QUR CentriFX are trademarks of Atrium Medical Corporation, a MAQUET GETINGE GROUP company. www.atriummed.com

surgeon preferred anatomical coverage and conformance…

a new dimension in laparoscopic hernia repair.

www.atriummed.com/c-qur

MCGSN1127.indd 1 2/20/12 3:42 PM

12 General SurGery newS March 2012

according to Dr. Iannitti. “We had an opportunity to use it in some animal labs before it was released, and I was very impressed,” Dr. Iannitti said. In his first use of the instrument in an animal model, he successfully fired a vascular/medium (tan) load across a pig stomach. “It was ridiculous, in a good way,” he noted. Attempts to fire blue and green loads across the thick structure had not been very effective: “[The staple line] fell apart,” he added. “Then I used a [tan load] with the Tri-Staple™ technology and it [fired complete intact staple lines], no problem.”

In his typical procedures, Dr. Iannitti must transect a wide variety of tissue thicknesses. “In HPB surgery, a lot of what we do is vascular transection,” he explained. “I used every staple size and type. We used [tan loads]. For regular tissue we used blue loads and for thicker tissue, green loads,” he said. However, the variability of tissue can make the selection of the optimal cartridge a chal-lenging one. “Most tissues in the human body are not uni-form. The thickness of tissue in the liver and stomach can change dramatically in a short distance; that variability will require different staple heights. Every patient is dif-ferent and every part of the liver in an individual patient is different, so we always struggled with exactly what is the right load to use,” he added. “Even experienced surgeons in my field are challenged by that decision.”

Endo GIA™ Reloads with Tri-Staple™ technology have been designed to resolve some of that indeci-sion. For example, surgeons using the Endo GIA™ Reloads without Tri-Staple™ technology had to choose among 3 different reloads: white, blue, or green, the last of which requires a 15-mm port. With Tri-Staple™ reloads, cartridges are available in tan or purple, both of which can be used through a 12-mm port. Black reloads, for use across very thick tissue, can be used

through a 15-mm port (Figure 1). “With the Tri-Staple™ technology, there is pretty good overlap between the staple reloads,” Dr. Iannitti said. “There was not much overlap with blue and green reloads, but now we have more cushion to work with.”

The overlap between the currently available car-tridges may help reduce the learning curve for residents by easing the selection process. Also, fewer inappropri-ately selected cartridges may help reduce waste in the operating room. “Everyone tries to minimize waste and be thoughtful, but if you choose the wrong staple and realize it is not going to work, you ask for a different one,” Dr. Iannitti said.

Minimizing Adverse Events by Using Tri-Staple™ Technology

New surgical staplers have a stepped cartridge face with 3 rows of titanium staples at staggered heights, which are meant to facilitate better hemo-stasis and a cleaner staple line. “When you’re deal-ing with tissues of varying thickness that may be sensitive, if you clamp down with too small a load you may crush the tissue and it may bleed and leak,” Dr. Iannitti said.

Leaks are unwelcome during any surgery, particularly during HPB surgery. The Endo GIA™ Reloads with Tri- Staple™ technology appear to reduce this risk, according to Dr. Iannitti. “In my experience with progressive staple heights, we are finding this leads to more successful stapling, more formed staples, and fewer misfires, which is huge,” Dr. Iannitti said.

The latest model has better compression and tissue retention than previous models, according to Dr. Iannitti, who has found that the stapler does not shift during


IntroductionThe minimally invasive hepatic resection procedure has

become widely adopted by hepatobiliary (HPB) and liver transplant surgeons following its introduction by Gagner and colleagues in 1992.1 The availability and development of surgical stapling technology and endovascular energy devices to transect and adequately seal tissue may have fostered the adoption of this technique. “When we started using staplers and stapling technology on the liver and pancreas in the mid-1990s, that was a big jump forward in HPB surgery,” said David A. Iannitti, MD, chief of hepa-tobiliary surgery and program director of the Hepatobiliary Surgery Fellowship at the Carolinas Medical Center in Charlotte, NC.

“Before then, it was clamp and tie, clamp and tie, clamp and tie,” he said. “You could go through 100 ties on the liver,” which increased the time of surgical procedures and caused other effects on surgery and outcomes. “Are the staplers perfect? No. There are issues with them, but relative to non-stapling technology, they’re great in my opinion.”

Over time, research has shown that the use of staplers in HPB surgery is safe and effective, dramatically reducing operating time with complication rates comparable to the use of staplers in other approaches.2-4 Although limitations exist regarding stapler use, as Dr. Iannitti noted, the latest advancements in stapling technology may address these prior shortcomings when used in HPB procedures.

Endo GIA™ Reloads With Tri-Staple™ Technology

Endo GIA™ Reloads with Tri-Staple™ technology and the Endo GIA™ Ultra Universal stapler debuted in the surgical community in 2010 at the 27th Annual Meeting of the American Society for Metabolic and Bariatric Sur-gery. These devices were designed to be used across a broader range of tissue thicknesses than previous models could accommodate, and they possess many enhanced features.

Carolinas Medical Center is one of 11 accredited HPB surgery training programs in North America, and often tests new technology before it is widely available,

Figure 1. Endo GIATM reloads with stepped cartridge face and varied-height staples.

a Products depicted are not actual size.

Tan Reload for Vascular/Medium Tissue Reload a

Purple Reload for Medium/Thick Tissue Reload a

Black Reload for Extra-Thick Tissue Reload a

the Science Behind PoSitive Patient outcomeS

An Interview With:

David A. Iannitti, MDChief of Hepatobiliary Surgery Program Director of Hepatobiliary Surgery Fellowship Carolinas Medical Center Charlotte, North Carolina

12 General SurGery newS March 2012

according to Dr. Iannitti. “We had an opportunity to use it in some animal labs before it was released, and I was very impressed,” Dr. Iannitti said. In his first use of the instrument in an animal model, he successfully fired a vascular/medium (tan) load across a pig stomach. “It was ridiculous, in a good way,” he noted. Attempts to fire blue and green loads across the thick structure had not been very effective: “[The staple line] fell apart,” he added. “Then I used a [tan load] with the Tri-Staple™ technology and it [fired complete intact staple lines], no problem.”

In his typical procedures, Dr. Iannitti must transect a wide variety of tissue thicknesses. “In HPB surgery, a lot of what we do is vascular transection,” he explained. “I used every staple size and type. We used [tan loads]. For regular tissue we used blue loads and for thicker tissue, green loads,” he said. However, the variability of tissue can make the selection of the optimal cartridge a chal-lenging one. “Most tissues in the human body are not uni-form. The thickness of tissue in the liver and stomach can change dramatically in a short distance; that variability will require different staple heights. Every patient is dif-ferent and every part of the liver in an individual patient is different, so we always struggled with exactly what is the right load to use,” he added. “Even experienced surgeons in my field are challenged by that decision.”

Endo GIA™ Reloads with Tri-Staple™ technology have been designed to resolve some of that indeci-sion. For example, surgeons using the Endo GIA™ Reloads without Tri-Staple™ technology had to choose among 3 different reloads: white, blue, or green, the last of which requires a 15-mm port. With Tri-Staple™ reloads, cartridges are available in tan or purple, both of which can be used through a 12-mm port. Black reloads, for use across very thick tissue, can be used

through a 15-mm port (Figure 1). “With the Tri-Staple™ technology, there is pretty good overlap between the staple reloads,” Dr. Iannitti said. “There was not much overlap with blue and green reloads, but now we have more cushion to work with.”

The overlap between the currently available car-tridges may help reduce the learning curve for residents by easing the selection process. Also, fewer inappropri-ately selected cartridges may help reduce waste in the operating room. “Everyone tries to minimize waste and be thoughtful, but if you choose the wrong staple and realize it is not going to work, you ask for a different one,” Dr. Iannitti said.

Minimizing Adverse Events by Using Tri-Staple™ Technology

New surgical staplers have a stepped cartridge face with 3 rows of titanium staples at staggered heights, which are meant to facilitate better hemo-stasis and a cleaner staple line. “When you’re deal-ing with tissues of varying thickness that may be sensitive, if you clamp down with too small a load you may crush the tissue and it may bleed and leak,” Dr. Iannitti said.

Leaks are unwelcome during any surgery, particularly during HPB surgery. The Endo GIA™ Reloads with Tri- Staple™ technology appear to reduce this risk, according to Dr. Iannitti. “In my experience with progressive staple heights, we are finding this leads to more successful stapling, more formed staples, and fewer misfires, which is huge,” Dr. Iannitti said.

The latest model has better compression and tissue retention than previous models, according to Dr. Iannitti, who has found that the stapler does not shift during


IntroductionThe minimally invasive hepatic resection procedure has

become widely adopted by hepatobiliary (HPB) and liver transplant surgeons following its introduction by Gagner and colleagues in 1992.1 The availability and development of surgical stapling technology and endovascular energy devices to transect and adequately seal tissue may have fostered the adoption of this technique. “When we started using staplers and stapling technology on the liver and pancreas in the mid-1990s, that was a big jump forward in HPB surgery,” said David A. Iannitti, MD, chief of hepa-tobiliary surgery and program director of the Hepatobiliary Surgery Fellowship at the Carolinas Medical Center in Charlotte, NC.

“Before then, it was clamp and tie, clamp and tie, clamp and tie,” he said. “You could go through 100 ties on the liver,” which increased the time of surgical procedures and caused other effects on surgery and outcomes. “Are the staplers perfect? No. There are issues with them, but relative to non-stapling technology, they’re great in my opinion.”

Over time, research has shown that the use of staplers in HPB surgery is safe and effective, dramatically reducing operating time with complication rates comparable to the use of staplers in other approaches.2-4 Although limitations exist regarding stapler use, as Dr. Iannitti noted, the latest advancements in stapling technology may address these prior shortcomings when used in HPB procedures.

Endo GIA™ Reloads With Tri-Staple™ Technology

Endo GIA™ Reloads with Tri-Staple™ technology and the Endo GIA™ Ultra Universal stapler debuted in the surgical community in 2010 at the 27th Annual Meeting of the American Society for Metabolic and Bariatric Sur-gery. These devices were designed to be used across a broader range of tissue thicknesses than previous models could accommodate, and they possess many enhanced features.

Carolinas Medical Center is one of 11 accredited HPB surgery training programs in North America, and often tests new technology before it is widely available,

Figure 1. Endo GIATM reloads with stepped cartridge face and varied-height staples.

a Products depicted are not actual size.

Tan Reload for Vascular/Medium Tissue Reload a

Purple Reload for Medium/Thick Tissue Reload a

Black Reload for Extra-Thick Tissue Reload a

the Science Behind PoSitive Patient outcomeS

An Interview With:

David A. Iannitti, MDChief of Hepatobiliary Surgery Program Director of Hepatobiliary Surgery Fellowship Carolinas Medical Center Charlotte, North Carolina

General SurGery newS March 2012 13

Supported and approved by

transection, and the blade cuts evenly through tissues of all thicknesses. “You suffer when your stapler won’t lock down. That would lead you to use a larger staple height, which would lock down but then you’d potentially leak or bleed through it,” Dr. Iannitti said. “[The Endo GIA™ Reloads with Tri-Staple™ technology] give you graduated compression and a formed sta-ple line with a good seal.”

Device Design Leading to Improved Surgical Technique

With the introduction of this Tri-Staple™ technology, Dr. Iannitti believes there has been an improvement in the firing force over the previous generation of staplers, and how the jaws of the stapler close as the surgeon closes his or her hand. “We used to have this progressive locking, and for thick tissue the jaw might bend,” Dr. Iannitti said. “Now when you squeeze, the handle is locked down once you go to fire the blade. It’s nice and smooth.”

Dr. Iannitti also is pleased with the design of the anvil, which is slim and fixed. This facilitates maneuvering around target tissue. “In a laparoscopic procedure, you

don’t have a hand [to articulate] in there, so you are dependent on the stapler and angle to maneuver around a critical struc-ture like portal or hepatic veins. That rigidity helps tremendously.”

The Endo GIA™ Reloads with Tri- Staple™ technology and the Endo GIA™ Ultra Universal stapler incorporate a one-handed grasping mechanism, which makes it easier for surgeons to grasp and manipulate tissue. “In liver surgery, you may have bleeding and you have to move quickly,” Dr. Iannitti said. “The grasping mechanism allows you to grab the tis-sue with the same hand while using the other to hold something back, open the jaws, [and] quickly re-grab. It’s a huge advantage.”

Some Endo GIA™ Reloads with Tri-Staple™ technology are available with a curved tip option, which Dr. Iannitti finds valuable in certain procedures ( Figure 2). “The curved tip is an advantage in liver surgery,” he said. “When you are in a really tight space and need to get around something, it can be very difficult when your stapling device is straight. With the curved tip, you can hook it and slide forward.” In addition to being easier to

maneuver around critical structures, such as portal or hepatic veins, the curved tip makes the instrument easier to visual-ize (Figure 3). “You always want to see the back arm of your stapler,” Dr. Iannitti explained. “When you see the top of the curve, you know you are completely around what you need to divide.”

Tri-StapleTM Technology Ensures Graduated Compression During Pancreatic Surgery

Dr. Iannitti has found the Endo GIA™ Extra-Thick (black) Reload with Tri- Staple™ technology particularly well suited for pancreatic surgery. “You have to be careful not to crush the tis-sue when you put a stapler on it, which may put patients at risk for bleeding and pancreatic leaks.” The key to successful use of a stapler on a pancreas is grad-uated compression and a completely formed staple line. “You typically can’t drop a vascular load across the pan-creas. On the pancreas neck, you may be able to use a blue [cartridge], but more often you’d use a green [one],” Dr. Iannitti said.

Prior to the availability of the Endo GIA™ Extra-Thick (black) Reloads, Dr. Iannitti and his team used staple-line reinforcement and SEAMGUARD® Bio-absorbable Staple Line Reinforcement (W.L. Gore & Associates, Inc.) to oper-ate on the pancreas. “The black [reload] gives you a more gradual level of com-pression and the different staple heights give you a nicely formed staple line. For use across the thicker parts of the pan-creas, of all staples from any manufac-turer, the black one is my preference,” added Dr. Iannitti (Figure 4).

ConclusionAlthough perfection in a stapler may

not yet be attainable, Dr. Iannitti is quite pleased with his latest option. “It really is an advancement in stapling technol-ogy: The varying staple heights and the way the jaws close and compress make it better and easier for serious cases,” he said. “If you do a bowel resec-tion, that’s pretty straightforward. But in HPB [surgery], we are so dependent on those staples to form; it’s the differ-ence between massive blood loss and no blood loss with every fire, so it’s kind of a big deal.”

References1. Gagner M, rheault M, Dubuc J. laparoscopic

partial hepatectomy for liver tumor. Surg Endosc. 1992;6(2):99.

2. Kaneko h, Otsuka y, Takagi S, Tsuchiya M, Tamura a, Shiba T. hepatic resection using stapling devices. Am J Surg. 2004;187(2):280-284.

3. Schemmer P, Friess h, Dervenis c, et al. The use of endo-GIa vascular staplers in liver surgery and their potential benefit: a review. Dig Surg. 2007;24(4):300-305.

4. nanashima a, Sumida y, Oikawa M, et al. Vascular transection using endovascular stapling in hepatic resection. Hepatogastroenterology. 2009;56(90):498-500.

Figure 2. Curved tip reloads.

Some of the tan (vascular/medium tissue) and purple (medium/thick tissue) reloads come with an option of a gold-colored curved tip. The curved tip reload provides enhanced visualization and aids in tissue manipulation and blunt dissection.

BB10

37

Figure 3. The tan curved tip enhances visibility and maneuverability. A) Tan curved tip dividing the extrahepatic right portal vein. B) Intrahepatic stapling of a portal pedicle using the tan curved tip.

Photos courtesy of David a. Iannitti, MD.

A B

Figure 4. Two Tri-StapleTM black loads across a thick pancreas in an open distal pancreatectomy operation.

Photos courtesy of David a. Iannitti, MD.

A

B

A) Stapler across the pancreas before firing.

B) Stapler after firing with visualization of the formed staple line.

Developed and authored by General Surgery News with the assistance of David A. Iannitti, MD, through funding from Covidien.

an economic decision analysis based on available evidence suggested that the use of chlorhexidine rather than povi-done iodine for CVCs would result in a 1.6% decrease in the incidence of CRB-SIs, a 0.23% decrease in the incidence of mortalities, and cost savings of $113 per catheter used.57 Currently, the CDC recommends a 2% chlorhexidine prepa-ration as the first choice agent for cuta-neous antisepsis (rating IA).2

Topical antimicrobialsThe HICPAC/CDC guidelines spe-

cifically recommend against the use of topical antibiotic ointments or creams at the catheter insertion site (except in the case of hemodialysis catheters) to avoid promotion of fungal infections and anti-microbial resistance (rating IA).2,3 The guidelines also discourage the admin-istration of intranasal antimicrobials before insertion or during the use of a catheter as a means to prevent coloniza-tion or CRBSIs (rating IA).3 A meta-analysis of mupirocin prophylaxis to prevent S. aureus infections in patients undergoing dialysis showed a 63% reduction (95% CI, 50%-73%) in the rate of overall S. aureus infections.52 The study population included both hemodi-alysis and peritoneal dialysis patients. Of the 10 studies, 6 used intranasal mupiro-cin 2 to 3 times per day for 5 to 14 days with various maintenance schedules, and 4 used mupirocin applied to the cathe-ter exit site. Among patients undergoing hemodialysis, S. aureus bacteremia was reduced by 78% (relative risk [RR], 0.22; 95% CI, 0.11-0.42). However, the dif-ferences in site, frequency, and duration of mupirocin treatment in these studies and the resulting clinical heterogeneity make it difficult to draw robust con-clusions. A randomized, double-blind, placebo-controlled trial evaluating

mupirocin prophylaxis for nosocomial S. aureus infections in nonsurgical patients found that routine cultures for S. aure-us nasal carriage at admission and sub-sequent intranasal mupirocin use did not prevent nosocomial S. aureus infec-tions.58 Additionally, reports of emerging mupirocin resistance are becoming com-monplace.59-64 Routine use of topical or intranasal mupirocin for prophylaxis against CRBSIs is not recommended.

The limitations of mupirocin suggest that other topical approaches for the pre-vention of CRBSIs should be studied. One such agent is honey. The antibacteri-al properties of some types of honey have made this a promising agent to study. The effect of 3-times-weekly Medi-honey (commercially available; pooled antibacterial honey including Leptosper-mum species honey; Medihoney Pty Ltd, Brisbane, Australia) on infection rates in 101 patients receiving hemodialysis via tunneled, cuffed CVCs was compared with topical mupirocin in a randomized controlled trial (RCT). The investigators found similar catheter-associated bacte-remia rates in the 2 arms (0.97 vs 0.85 episodes per 1,000 catheter-days, respec-tively; P>0.05).65 Although the prelimi-nary results are promising, a larger trial powered to show equivalence or superi-ority is needed to establish the utility of Medihoney for the prevention of CRB-SIs in patients receiving hemodialysis through tunneled, cuffed catheters.

maximal Barrier PrecautionsMaximal barrier precautions, includ-

ing cap, sterile gown, mask, large ster-ile drape, and sterile gloves, significantly reduce the rate of CRBSIs when used during catheter insertion.3,66 In a study comparing maximal barrier precau-tions with control precautions (eg, sterile gloves and small drape), the rate of CRB-SIs was 6.3 times higher in the control group (P=0.06).66 The HICPAC/CDC

guidelines recommend that maximal barrier precautions be used for all CVC insertions

(rating IB).2,3



The following advertorial is provided as a service to our valued advertisers. It is designed to support the advertisement presented to the right.

Introducing eXParel®: non-opioid Postsurgical Pain control For up to 72 HoursQ: what is eXParel (bupivacaine liposome injectable suspension)?a: EXPAREL is a local analgesic that uses bupi-vacaine and is indicated for administration into the surgical site to produce postsurgical anal-gesia. A single dose given at the close of sur-gery provides up to 72 hoursa of analgesia with reduced opioid requirementsb and without the need for catheters and pumps.

Q: what does eXParel do?a: In a pivotal soft-tissue trial compared with placebo, in which all patients with inadequate pain control received opioids for rescue pain relief, EXPAREL demonstrated a 30% reduction in cumulative pain scores and a 45% reduction in opioid consumptionb through 72 hours.c

Q: How does eXParel work?a: EXPAREL uses DepoFoam®, a multivesicular drug delivery technology, to release bupivacaine over time. Other formulations of bupivacaine should not be administered within 96 hours fol-lowing the administration of EXPAREL.

Q: How is eXParel administered?a: EXPAREL is infiltrated into the surgical site using the same technique surgeons already use to infiltrate local anesthetics for postsurgical analgesia, and can be administered using nee-dles as narrow as 25 gauge. The recommended dose is based on the surgical site and the vol-ume required to cover the area; the maximum dose should not exceed 266 mg (or one 20 mL vial).

Q: How is eXParel supplied?a: EXPAREL is available in 1.3%, 20 mL single-use vials. EXPAREL can be used as sup-plied or diluted with up to 280 mL of normal saline to accommodate administration into larger surgical sites.

Q: what important safety consider-ations should I know before using eXParel?a: EXPAREL is contraindicated in obstetrical paracervical block anesthesia and should not be used in patients under 18 years old.

As with other local anesthetic products, patients should be monitored for cardiovas-cular and neurological status, and vital signs should be performed during and after injection of EXPAREL. Because amide-type local anes-thetics such as bupivacaine are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inabil-ity to metabolize local anesthetics normally, are at a greater risk for developing toxic plasma concentrations.

The most common adverse reactions (inci-dence ≥10%) following administration of EXPAREL were nausea, constipation and vomiting.

Q: why is a new non-opioid option for postsurgical pain management valuable?a: More than 90 million surgical procedures are performed every year in the United States.d Surveys have indicated that postsurgical pain often is undertreated, with as many as 80% of patients reporting pain after surgery.e Cur-rent options to prolong postsurgical analge-sia rely heavily on medication delivery devices. Although effective, these devices can be prone to catheter-related issues and often deliver opi-oids, which are associated with a range of unwanted and potentially costly side effects.f As the only single-dose local analgesic capable of providing pain control for up to 72 hoursa with a reduced reliance on opioids,b EXPAREL has the potential to play an important role in the man-agement of postsurgical pain.

Please see brief summary of Prescribing Information on adjacent insert. For more information, visit www.EXPAREL.com or contact:

Pacira Pharmaceuticals, Inc.5 Sylvan WayParsippany, NJ 07054Phone: (855) RX-EXPAREL (855-793-9727)email: [email protected] Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy procedures; additional studies are under way to further demonstrate the safety and efficacy in other procedures.b The clinical benefit of the attendant decrease in opioid consumption was not demonstrated.c Gorfine SR, et al. Dis Colon Rectum. 2011;54:1552-1558.d Cullen KA, et al. Natl Health Stat Report. 2009(11):1-25.e Apfelbaum JL, et al. Anesth Analg. 2003;97:534-540.f Adamson RT, et al. Hosp Pharm. 2011;46(6 Suppl 1):1-8.

EXP-AP-0037-201201

Insertion SiteAccording to the HICPAC/CDC guidelines, the

preferred insertion site of nontunneled CVCs for adult patients is the subclavian vein (rating 1B).2,3 The femoral site is associated with higher rates of cathe-ter colonization as well as increased risk for deep vein thrombosis.3,67-70 In an RCT comparing the femoral and subclavian sites, use of the femoral site was asso-ciated with a higher overall rate of infectious compli-cations (19.8% vs 4.5%, respectively; P<0.001).70 The internal jugular site has been associat-ed with higher rates of CRBSIs than the femoral and subclavian sites in several studies.3,69,71 Howev-er, a recent RCT comparing the jugular and femoral sites found no difference in the rate of CRBSIs between the 2 sites (2.3 vs 1.5 per 1,000 catheter-days, respectively; P=0.42).72 A prospective, observational study comparing the subclavian, internal jugular, and femoral insertion sites found colonization lowest at the subcla-vian site but found no difference in rates of infection between sites.73

Using real-time ultrasound guidance for catheter insertion decreases associated mechanical complica-tions and infection.2,74 In a randomized study compar-ing real-time ultrasound guidance with the landmark technique for catheter placement in the internal jugu-lar vein, the latter resulted in significantly fewer com-plications, including fewer CRBSIs (P<0.001).74 A meta-analysis revealed that the use of ultrasound for insertion at the internal jugular and subclavian vein sites decreased failure (RR, 0.32; 95% CI, 0.18-0.55), complications during catheter placement (RR, 0.22; 95% CI, 0.10-0.45), and the need for multiple place-ment attempts (RR, 0.60; 95% CI, 0.45-0.79) in com-parison with the landmark technique.75

Although no RCT to date has compared the 3 inser-tion sites, based on available data, we recommend the subclavian site as the preferred site for CVC insertion along with the use of real-time ultrasound to minimize mechanical complications.

Simulation-based TrainingA recent observational study at an urban teaching

hospital evaluated the impact of a simulation-based educational intervention on the rates of CRBSIs in the medical ICU.76 Ninety-two second- and third-year internal medicine and emergency medicine residents completed the education program, which included a pretest, an instructional video on proper CVC inser-tion techniques, ultrasound training, hands-on practice with the simulator device, and a post-test with a mini-mum score requirement. There were 3.2 infections per 1,000 catheter-days in the 16 months prior to the inter-vention in the hospital’s medical ICU. There were 4.86 infections per 1,000 catheter-days in the hospital’s sur-gical ICU during this preintervention period. The rate of CRBSIs in the medical ICU during the 16-month intervention period, when all second- and third-year residents had completed the training, decreased to 0.5 per 1,000 catheter-days. The rate in the surgical ICU, where no rotating residents completed the simulation training, remained stable at 5.26 per 1,000 catheter-days during the same 16-month time period.76 The cost savings attributed to simulation training recently were evaluated using data from both the year before and the

year after training.77 The annual net savings from the simulation-based training, after accounting for the cost of the program, was more than $700,000 (2008 dollars), which translated into a 7 to 1 rate of return on invest-ment for the training program (based on the training cost of $112,000). The use of simulation-based train-ing exemplifies cutting-edge methods for the success-ful education of health care personnel regarding proper CVC insertion, which fulfills an important recom-mendation of the recently updated HICPAC/CDC

guidelines.2

chlorhexidine-Impregnated DressingsThe placement of a chlorhexidine-

impregnated sponge dressing (BioPatch, Ethicon, Inc.) over the CVC insertion site has been shown to decrease CRBSIsin several randomized trials.5,78-80 A

large, open RCT compared chlorhexidine dressings with standard sterile dressings in

601 chemotherapy patients (9,731 total cath-eter-days). The study found a significant reduction

in CRBSIs in the intervention group (6.35%; 19 of 300) compared with the control group (11.3%; 34 of 301; P=0.016; RR, 0.54; 95% CI, 0.31-0.94).79 Sim-ilarly, an RCT conducted in the ICU found that the use of chlorhexidine-impregnated dressings led to sig-nificantly fewer CRBSIs than the use of standard ster-ile dressings (hazard ratio, 0.024; 95% CI, 0.09-0.65; P=0.005).80

The recent HICPAC/CDC guidelines for the pre-vention of CRBSIs recommend the use of chlorhex-idine-impregnated sponge dressings with short-term CVCs in patients older than 2 months when insti-tutional rates of CRBSIs are higher than the institu-tional goal, despite the consistent use of now-standard prevention measures (using well-trained personnel, chlorhexidine skin antisepsis, and maximal barrier pre-cautions; rating 1B).2

antimicrobial-Impregnated cathetersThe HICPAC/CDC guidelines recommend the use

of antimicrobial-coated catheters if the device is expect-ed to remain in place longer than 5 days if, despite use of a comprehensive CRBSI reduction strategy, the rate of infections is not decreasing (rating IA).2,3 However, the majority of the studies have focused on the use of antimicrobial-coated CVCs used as short-term devic-es; few data are available on their use as long-term devices.18,50 Several types of antimicrobial-impregnated catheters are available: catheters coated either external-ly (first generation) or externally and internally (sec-ond generation) with chlorhexidine and sulfadiazine silver (CH-SS), catheters coated with minocycline or rifampin, and silver-impregnated catheters.12 Silver-coated catheters include silver-, platinum-, and carbon-coated catheters and silver ion/alloy catheters.5

A meta-analysis of externally CH-SS–coated cath-eters found that they decreased the incidence of both catheter colonization (OR, 0.44; 95% CI, 0.36-0.54) and CRBSIs (OR, 0.56; 95% CI, 0.37-0.84) com-pared with uncoated catheters.53 A recent meta-analysis found a reduced risk for CRBSIs when first-genera-tion CH-SS–coated catheters (RR, 0.66; 95% CI, 0.47-0.93) were compared with uncoated catheters, but no significant risk reduction among patients in the ICU (RR, 0.77; 95% CI, 0.53-1.13).50 The second-gener-ation CH-SS–coated catheters significantly reduced

CRBSIs in ICU patients (RR, 0.70; 95% CI, 0.30-1.62). Minocycline- and rifampicin-coated catheters were significantly more effective than chlorhexidine gluconate/silver sulfadiazine (CHG/SSD) catheters (RR, 0.12; 95% CI, 0.02-0.67).50

The most recent meta-analysis of 27 trials evaluating anti-infective catheters found a significant reduction in CRBSIs with their use when all types were analyzed (OR, 0.49; 95% CI, 0.37-0.64).81 Subgroup analysis based on catheter type revealed reductions in CRB-SIs for nearly all types compared with standard cathe-ters: CH-SS–impregnated (5 trials; OR, 0.51; 95% CI, 0.26-1.0), silver-impregnated (6 trials; OR, 0.55; 95% CI, 0.33-0.92), minocycline-rifampin (5 trials; OR, 0.26; 95% CI, 0.15-0.47), miconazole-rifampin (1 trial; OR, 0.12; 95% CI, 0-6.07), benzalkonium chloride–impregnated (1 trial; OR, 1; 95% CI, 0.06-16.45), and CH-SS–coated (9 trials; OR, 0.62; 95% CI, 0.4-0.98).81

The choice of which catheter to use is governed by many factors, including efficacy, cost, cost-effective-ness, and risk for promoting drug resistance. A 2008 analysis found an estimated cost savings of approxi-mately $227 for every anti-infective catheter inserted.82

Antibiotic resistance is a particular concern with anti-biotic-impregnated catheters, although trials assessing the efficacy of minocycline-rifampin–coated catheters found no evidence of the emergence of drug resistance.50

antibiotic lock SolutionsThe major mechanism for CRBSIs in patients with

long-term devices is intraluminal colonization. For this reason, antibiotic lock solutions have been considered as a logical step to prevent colonization of the intralu-minal surfaces of long-term devices and thereby reduce the rate of CRBSIs. A small amount of the antibiotic solution is instilled into the lumen of the catheter and allowed to remain for a specific amount of time, after which it is either flushed or removed. A meta-analy-sis of 7 randomized trials (primarily involving cancer patients) demonstrated a significantly reduced risk for CRBSIs (RR, 0.49; 95% CI, 0.26-0.95) when vanco-mycin-containing lock solutions were used.51

A recent systematic review and meta-analysis of patients undergoing hemodialysis included data on sev-eral lock solutions: various antibiotic combinations, minocycline with EDTA, and nonantibiotic antisep-tic solutions including citrate and citrate with tauro-lidine. All lock solutions included in this meta-analysis showed benefit for the prevention of CRBSIs.54 Etha-nol also has been shown to be safe and effective as an antibiotic lock solution.49,83,84

A recently published prospective, double-blind, randomized trial comparing ethanol with heparin-ized saline in immunosuppressed hematology patients showed a 4-fold decrease in the number of CRBSIs in the ethanol group compared with controls (OR, 0.18; 95% CI, 0.05-0.65).84 Although a number of new anti-biotics have shown promise as lock solutions during in vitro studies, more research on their efficacy is needed.85

In general, antiseptic lock solutions are preferred over antibiotic lock solutions because of their greater spec-trum of activity and smaller risk for promoting antibi-otic resistance.

The HICPAC/CDC guidelines include a recom-mendation for the use of antibiotic/antiseptic lock solu-tions in patients with long-term catheters who have had multiple CRBSIs despite good aseptic technique (rating II).2 The use of antibiotic lock solutions is also



recommended for the prevention of CRBSIs in long-term devices for patients with episodes of CRBSIs and a high risk for recurrence, such as those on hemodialysis.

Chlorhexidine bathing has been proposed and eval-uated as a strategy for reducing rates of CRBSIs.86-89

Bleasdale and colleagues compared daily chlorhexi-dine bathing (n=391; 2,210 patient-days) with soap and water bathing (n=445; 2,119 patient-days) among patients in 2 medical ICUs in a 2-arm crossover trial.86

There was a significant reduction in the risk for CRBSIs associated with the use of chlorhexidine bathing com-pared with the control group (4.1 vs 10.4 infections per 1,000 patient-days; incidence difference, 6.3; 95% CI, 1.2-11.0). A recent meta-analysis of RCTs and quasi-experimental studies evaluating chlorhexidine bathing versus a control bathing method (soap and water) dem-onstrated a significant reduction in the risk for CRBSIs with chlorhexidine bathing (pooled RR, 0.32; 95% CI, 0.22-0.46; P<0.0001, I2=17%).90 However, a separate retrospective analysis evaluating the effect of switch-ing from soap and water bathing to daily chlorhexidine cleansing in a surgical ICU found no difference in the rates of CRBSIs when the different periods were com-pared.91 The HICPAC/CDC guidelines recommend daily chlorhexidine bathing as a strategy for reducing the rates of CRBSIs (rating II); however, the conflict-ing results of recent studies warrant further research in this area.2

coated luer-activated DevicesIn addition to the previously described protection

measures, the role of needleless connectors warrants attention. Needleless connectors were developed in response to demands for the improved safety of health care workers (to prevent needlestick injuries) and are integral components of infusion systems across North America. Although needleless connectors, when prop-erly used, clearly reduce the risk for needlestick injuries during access of an IVD or injection port,92-95 reports published over the past decade have raised concerns about their potential to increase the risk for iatrogen-ic BSIs.96-101 Most of these studies have been retro-spective and uncontrolled; suboptimal manipulation of the device, rather than the device itself, may have been responsible for the increased incidence of CRBSIs in some settings. Typically, health care personnel disin-fect the connector with 70% (v/v) isopropyl alcohol before IV administration. Although needleless connec-tors appeared to reduce contamination compared with standard caps,102 a recent study by Menyhay et al found that conventional methods of disinfection may not pre-vent microbial entry if the luer-activated device (LAD) is heavily contaminated, which may account for the increased risk for CRBSIs observed in some reports.103

The HICPAC/CDC guidelines made no recom-mendation for or against LADs, given the lack of RCTs on this device. However, chlorhexidine may be the pre-ferred agent for cleaning the ports of needleless devic-es.2 A recent study evaluated the effect of switching to chlorhexidine for this purpose in a pre-post inter-vention design on a pediatric hemopoietic stem cell transplant ward.104 In this study, switching from 70% isopropyl alcohol alone to 2% chlorhexidine in 70% isopropyl alcohol for catheter connector antisepsis was associated with a reduction in the rates of CRBSIs from 12 to 3 per 1,000 catheter-days (P=0.004).

Novel technologies have been developed to address

the association of these devices with increased rates of CRBSIs. The V-Link with VitalShield (Baxter Health-care), which recently received FDA approval, is LAD protected, with an interior and exterior antimicrobial coating (silver). Recent in vitro studies compared the V-link with VitalShield with control devices. The stud-ies demonstrated that the antimicrobial coating is more than 99.99% effective in killing the most common organisms responsible for CRBSIs. It also prevented downstream spread and intra-device biofilm formation when Enterobacter cloacae was inoculated and allowed to dry on the septal membrane, followed by the infu-sion of Lactated Ringer’s running solution at 0.5 mL per minute for 72 hours through the connect-ed device.105

Another promising device, the Sara-lex-CL (Menyhay Healthcare Sys-tems), is an antimicrobial-barrier cap that threads onto the end of a needleless LAD system. A recent prospective, in vitro study com-pared standard disinfection tech-niques for common LADs using 70% isopropyl alcohol with the Saral-ex-CL.106 The Saralex-CL, which uses a solution of 0.25 mL of 2% chlorhex-idine gluconate in 70% isopropyl alcohol to bathe the connector septum, was effective in prevent-ing transmission of pathogens across the membranes of precontaminated LADs compared with standard tech-niques (positive control = 100% transmission, standard technique = 20 of 30; 67% transmission; Saralex-CL = 1 of 60; 1.6% transmission; P<0.001). Data on the clin-ical efficacy of antimicrobial-coated LADs and antimi-crobial-barrier caps are awaited.

catheter SecurementSutureless securement devices avoid disruption

around the catheter entry site and may decrease the degree of bacterial colonization.107 Catheter stabiliza-tion also helps decrease the risk for phlebitis and cath-eter migration/dislodgement while diminishing the risk for needlestick injury to the health care provider.2

Device securement options include sutures, tape, and catheter-specific devices such as the StatLock (Venetec International, Inc., a subsidiary of CR Bard). Sutures may be uncomfortable for the patient, pose a risk for needlestick injury to the provider, and foster inflam-mation at the catheter insertion site, increasing the risk for infection. StatLock, a sutureless catheter secure-ment device, reduces catheter-related complications, including CRBSIs.107-109 A randomized trial compar-ing sutures with StatLock for PICC securement found significantly fewer CRBSIs in the StatLock group than in the suture group (2 vs 10, respectively; P=0.032).107

The HICPAC/CDC guidelines recommend the use of a securement device for all intravascular catheters (rat-ing II).2

Intensive Insulin TherapyThe appropriate level of glycemic control for criti-

cally ill patients is controversial. A large RCT of 1,548 critically ill patients in a surgical ICU compared inten-sive insulin therapy (maintenance of blood glucose level between 80 and 110 mg/dL) with conventional insu-lin therapy (insulin given only for blood glucose lev-els >215 mg/dL and maintenance of levels between 180 and 200 mg/dL).110 The study found that intensive treatment reduced overall mortality rates (8% with con-ventional treatment vs 4.6% with intensive treatment;

P<0.04); the greatest mortality reduction was observed in patients with multi-organ failure caused by a septic focus. A similar study in medical ICU patients found no reduction in mortality or difference in rates of bac-teremia using intensive therapy.111

A meta-analysis that included 29 RCTs and 8,432 patients found no difference in hospital mortality rates with tight glucose control (21.6% vs 23.3%; RR, 0.93; 95% CI, 0.85-1.03), and the results did not change when patients were stratified by ICU type: surgical, medical, or medical-surgical. However, tight glucose control was associated with a reduced risk for septice-mia (10.9% vs 13.4%; RR, 0.76; 95% CI, 0.59-0.97).112

In the NICE-SUGAR (Normoglycaemia in Intensive Care Evaluation and Survival

Using Glucose Algorithm Regulation) study, a large RCT of 6,104 adult ICU patients, intensive glycemic con-trol (goal, 81-108 mg/dL) caused increased mortality compared with conventional control (goal, ≤180 mg/dL; OR, 1.14; 95% CI, 1.02-

1.28; P=0.02).113 The study popu-lation included more medical than surgical ICU patients (intensive group:

36.9% surgical, 63.1% medical; conven-tional group: 37.2% surgical, 62.8% medical).

Severe hypoglycemia (≤40 mg/dL) was significantly more common in the intensive control group (6.8% vs 0.5%; P<0.001).113

A meta-analysis of 26 trials including 13,567 patients—with data from the NICE-SUGAR trial—found no reduction in mortality using intensive insu-lin therapy for critically ill patients (pooled RR of death with intensive vs conventional therapy, 0.93; 95% CI, 0.83-1.04).114 However, when analyzed separate-ly, surgical ICU patients did have a benefit, whereas patients in nonsurgical ICUs did not (RR, 0.63; 95% CI, 0.44-0.91).114

A recent meta-analysis of 20 RCTs evaluated the effect of intensive insulin therapy on the incidence of infections in medical and surgical ICU patients. The analysis revealed an overall reduction in the incidence of infections among all pooled studies (RR, 0.80; 95% CI, 0.71-0.90; P=0.0002; I2=53.5%).115 Subgroup analysis revealed significantly fewer infections in surgical ICU patients in the intensive insulin therapy group com-pared with standard therapy (11 studies; pooled RR, 0.66; 95% CI, 0.57-0.76; P<0.001). However, no dif-ference in infection rates among medical ICU patients was observed.

Pending the results of ongoing and future research, the use of intensive glycemic control for surgical ICU patients to reduce the risk for HAIs, particularly CRB-SIs, is recommended. However, avoiding severe hypo-glycemia is crucial, and a glycemic target that can be safely achieved should be used.

multifaceted approach using a checklistA multifaceted approach must be used to effec-

tively reduce the risk for CRBSIs. The Institute for Healthcare Improvement (IHI) developed the con-cept of “bundles” to aid risk reduction. According to the IHI, a bundle is a structured way of improving the processes of care and patient outcomes using a check-list of 3 to 5 practices that, when performed collectively and reliably, have led to improved patient outcomes.116

The IHI-recommended evidence-based bundle for CVC care includes the following: 1) hand hygiene; 2)




Your Grand Central Station for all the latest news, opinions and analysis in surgery.

Futura BT 66pt & Futura Extra Bold Condensed Oblique 66pt

Next stop: GeneralSurgeryNews.comGeneralSurgeryNews.comGeneralSurgeryNews.comGeneralSurgeryNews.comGeneralSurgeryNews.comGeneralSurgeryNews.comGeneralSurgeryNews.comGeneralSurgeryNews.comGeneralSurgeryNews.comGeneralSurgeryNews.comGeneralSurgeryNews.comGeneralSurgeryNews.com

®

GENERALSURGERYNEWS.COM

The Independent Monthly Newspaper for the General Surgeon

March 2012 • Volume 39 • Number 3

OpinionLarge Variation Found

In Payment for Nine Common

Surgical Procedures

Team Approach

Reduces Central-

Line Infections

By Kate O’ROuRKe

Houston—Can hospitals drive their

rates of central-line bloodstream infec-

tions to zero? Although it sounds like

a pipe dream, multidisciplinary team

approaches are making great strides

in dramatically reducing rates, new

research has found.

At the Universi-

ty of Massachusetts

Memorial Medical

Center in Worcester,

for example, a team

of clinicians dedicated

to preventing central-

line infections in eight

of the hospital’s inten-

sive care units (ICUs)

cut the rate by almost

90% over a seven-year

period. Similarly, a

team effort at the Ohio State University

Medical Center in Columbus, decreased

infection rates in a 25-bed ICU by

roughly 33% in one year. Researchers

presented details of the two approaches

at the 2012 annual meeting of the Soci-

ety of Critical Care Medicine (abstracts

Study of Accelerated Partial Breast

Irradiation Sparks Debate

By Kate O’ROuRKe

A new study has spurred some

doctors to urge caution in

selecting patients for accelerated par-

tial breast irradiation (APBI) and

angered others who say the study

is flawed and could derail a Phase

III clinical trial testing APBI. The

retrospective study, presented at the

recent San Antonio Breast Can-

cer Symposium (SABCS), conclud-

ed that APBI with brachytherapy is

associated with inferior effectiveness

and increased toxicity compared with

Spam in a Can II:

Another Perspective

By edwaRd M. COpeland III, Md

I always enjoy the opinion col-

umns written by David Coss-

man, MD. His opinions usually

reflect the constructive criticisms

that I would get from the pri-

vate sector as I traveled around

the country in my various capacities as

a representative of the leadership of the

American College of Surgeons (ACS).

Often these criticisms took the form of

“what have you done for me lately?” or

were made with minimal background

information. I have been gone from

a leadership role in the ACS now for

more than five years and cannot com-

ment on the views of the members of

the current Board of Regents.

What I can say is that I am a mem-

ber of the “then” generation and Tom

Russell, MD, became a member of the

“now” generation. These views put us

into conflict. From Dr. Russell’s posi-

tion as the executive director of the

ACS, he was able to see the “now”

generation of surgeons and health care



san Francisco—A new study reveals

vast discrepancies in surgeons’ hour-

ly payment for some common gener-

al surgery procedures—a finding that

demonstrates significant failings in the

current reimbursement formula.

Researchers compared the total

care time and payment per unit of

time for nine common inpatient and

outpatient procedures using Cur-

rent Procedural Terminology (CPT)

Procedure

Estimated payment

per hour

Lap gastric bypass

$707

Thyroidectomy

$693

Lap gallbladder with cholangiogram$541

Lap Nissen fundoplication$481

Partial mastectomy

$453

Lap appendectomy

$443

Inguinal hernia repair

$326

Umbilical hernia repair

$321


see Spam II page 39

see ReImbuRSement page 36

see paRtIal bReaSt IRRadIatIon page 50

see CentRal-lIne page 22

In the News

Statewide Data Initiative

Reveals Clues To

Improving Outcomes

............................

..............4

INSIDE Clinical Review

Catheter-related

Bloodstream

Infections

.......................7

Obesity Care

Study Shows Plateauing of

Obesity, Conflicting With

Earlier Studies ............ 26 CLINICAL

EXPERIENCE

Endo GIA™ Reloads With Tri-Staple™

Technology and Endo GIA™ Ultra Universal

Staplers in Minimally Invasive Liver and

Pancreatic Resections see page 12

SPECIAL

REPORT

ProGripTM Mesh: Self-Gripping Mesh for

Hernia Repair see InSeRt at page 6

NEW PRODUCT ANNOUNCEMENT

see page 38

SPECIAL

REPORT

Addressing Current Challenges in Managing

Postsurgical Pain With EXPAREL®, a New

DepoFoam® Formulation of Bupivacaine


maximal barrier precautions upon insertion; 3) chlorhex-idine skin antisepsis; 4) optimal catheter site selection, with the subclavian vein as the preferred site for nontun-neled catheters; and 5) daily review of line necessity with prompt removal of unnecessary lines.116 A large multi-center study by Pronovost et al that used evidence-based interventions nearly identical to the IHI CVC bundle for 18 months found a significant reduction in CRB-SIs from baseline. The incidence rate of CRBSIs at 0 to 3 months was 0.62 (95% CI, 0.47-0.81) and 0.34 at 16 to 18 months (95% CI, 0.23-0.5).117 These numbers represented up to a 66% reduction in the rates of CRB-SIs, a reduction that also was maintained 18 months after the intervention period. The intervention was incorpo-rated into standard practice at the individual centers, as described in a recent follow-up publication.118

Bhutta et al undertook a prospective quasi-exper-imental study in a children’s hospital, which included the stepwise introduction of interventions over a 5-year period.119 The interventions included maximal barrier precautions, transition to antibiotic-impregnated CVCs, annual hand-washing campaigns, and use of chlorhexi-dine in lieu of povidone-iodine. Significant reductions in CRBSI rates occurred over the intervention period, and were sustained over the 3-year follow-up. Annu-al rates decreased from 9.7 per 1,000 catheter-days in 1997 to 3 per 1,000 days in 2005 (RR reduction, 0.75; 95% CI, 0.35-1.26). The investigators agreed that mul-tifaceted interventions of this nature reduce the rates of CRBSIs but require a multidisciplinary team and insti-tutional support.

The recent implementation of a multifaceted approach in a pediatric cardiac ICU, which included CVC inser-tion and maintenance bundles, chlorhexidine-impreg-nated dressings, nurse and physician education, and the addition of a unit-based infection control nurse, result-ed in a reduction in the rates of CRBSIs from 7.8 to 2.3

infections per 1,000 catheter-days in less than 2 years.120

The HICPAC/CDC guidelines recommend that multifaceted per-formance improvement strategies be “bundled” to enhance compli-ance with evidence-based best prac-tices (rating IB).2

“Getting to Zero”: The crBSI mandateThe concept of “Getting to Zero” was first

applied by the IHI for ventilator-associated pneumonia. Since then, the concept has been used for other HAIs, including CRBSIs. In the effort to “get to zero,” the CMS recently partnered with the NHSN and listed CRBSIs as a “never event.” This partnership creates greater transpar-ency, builds accountability within the health care system, and promotes support for infection control programs and professionals.121 Certainly, by making CRBSI rates avail-able, the public has the opportunity to make informed decisions regarding health care. However, there are both concerns and controversy surrounding the concept of “getting to zero” and the CRBSI mandate.

Infection control experts have shared concerns that “getting to zero” is an oversimplification of the complex-ity of HAIs and does not convey the important mes-sage that although the majority of HAIs are preventable, some are not.122 A commentary by Victoria Fraser, MD, Washington University School of Medicine in St. Louis, MO, pointed out that this slogan is controversial because it seems scientifically unrealistic. Moreover, patients and the general public may misinterpret the message to mean that any HAI is the result of an error or a suboptimal process.123

The concern regarding the CRBSI mandate stems mainly from the CDC’s definition of a CRBSI itself. The definition is highly sensitive but poorly specific. The high sensitivity allows it to capture all cases of CRB-SIs, but the low specificity causes it to suffer from the inclusion of infections that may not be CRBSIs. In a

thoughtful commentary by Sexton et al,124

this limitation of the surveillance defini-tion is highlighted by specific examples where it seemed that the assignation of cases as CRBSIs was done by default (ie, simply because of the absence of proof

for a secondary source of infection). The low specificity also greatly undermines the

reliability of the publicly reported data on CRBSI rates. The authors then emphasize the

need to change and validate the existing definition. They propose the inclusion of an “indeterminate source” cat-egory for some CRBSIs, which is “more epidemiologi-cally and clinically useful than data derived from current definitions, which are inconsistent with common clini-cal practice.”124

Similarly, in a recent retrospective cohort study involv-ing 4 medical institutions, Lin et al125 assessed whether or not surveillance data are consistent across institutions, contending that public reporting and interhospital com-parisons of infection rates are only valid if the surveil-lance methods are uniform. The authors compared a computer algorithm reference standard for CRBSI rates with reported rates from the institution’s infection pre-ventionists. The expected rate varied significantly by medical center, suggesting that there is indeed local vari-ation among medical centers. This then raises doubt as to the validity of comparing published rates of CRBSIs among various institutions.125

The “getting to zero” initiative has many advantages. It has spurred dialogue about CRBSI prevention, pro-pelled institutions to devote more resources to CRBSI prevention, and increased awareness of these infections. However, the campaign to publicly report CRBSIs should incorporate a uniform application of standard-ized definitions in institutions and a greater emphasis on process measures known to reduce the overall incidence of CRBSI.

references1. Am J Infect Control. 2008;36(5):309-332.2. Am J Infect Control. 2011;39(4 suppl 1):S1-S34.3. Infect Control Hosp Epidemiol. 2002;23(12):759-769.4. Public Health Rep. 2007;122(2):160-166.5. Clin Infect Dis. 2002;34(9):1232-1242.6. Mayo Clin Proc. 2006;81(9):1159-1171.7. http://www.hhs.gov/ophs/initiatives/hai/draft-hai-

plan-01062009.pdf. Accessed February 24, 2012.8. Pear R. Medicare says it won’t cover hospital errors.

New York Times. August 18, 2007.9. Crit Care Med. 2009;37(7):2283-2289.10. JAMA. 1994;271(20):1598-1601.11. Am J Infect Control. 2008;36(10):S173.e1-S173.e3.12. Lancet Infect Dis. 2007;7(10):645-657.13. Crit Care Med. 2007;35(10):2424-2427.14. Clin Infect Dis. 2002;35(5):627-630.15. Clin Infect Dis. 2004;39(3):309-317.16. Intensive Care Med. 2004;30(1):62-67.17. J Clin Microbiol. 1985;21(3):357-360.18. Clin Infect Dis. 2002;34(10):1362-1368.19. Clin Infect Dis. 2009;49(1):1-45.20. Crit Care Med. 2002;30(12):2632-2635.21. Clin Infect Dis. 2010;50(12):1575-1579.22. Ann Intern Med. 2005;142(6):451-466.23. Lancet. 1999;354(9184):1071-1077.24. Pediatr Infect Dis J. 2008;27(8):681-685.25. J Clin Microbiol. 1998;36(1):105-109.26. JPEN J Parenter Enteral Nutr. 2003;27(2):146-150.27. Curr Infect Dis Rep. 2005;7(6):413-419.28. J Clin Pathol. 1997;50(4):278-282.29. Lancet. 1999;354(9189):1504-1507.30. JPEN J Parenter Enteral Nutr. 1996;20(3):215-218.31. Am J Med. 1991;90(1):128-130.32. Nephrol Dial Transplant. 1993;8(3):231-234.33. Clin Infect Dis. 1998;27(3):478-486.

34. Intern Med J. 2005;35(suppl 2):S45-S62.35. Cancer Invest. 2002;20(7-8):1105-1113.36. Infect Control Hosp Epidemiol. 2004;25(8):646-649.37. Pediatr Infect Dis J. 1994;13(10):930-931.38. Medicine (Baltimore). 2009;88(5):279-283.39. Arch Intern Med. 1995;155(22):2429-2435.40. Infect Control Hosp Epidemiol. 1998;19(11):846-850.41. Clin Infect Dis. 1999;29(1):102-105.42. Nephron. 1997;75(3):354-355.43. Ann Intern Med. 1999;130(10):810-820.44. Ann Pharmacother. 2005;39(2):311-318.45. Antimicrob Agents Chemother. 1999;43(8):2074-2076.46. Int J Antimicrob Agents. 2008;32(6):515-518.47. Ann Intern Med. 2002;136(11):792-801.48. J Antimicrob Chemother. 2006;58(2):281-287.49. JPEN J Parenter Enteral Nutr. 2007;31(4):302-305.50. Am J Infect Control. 2008;36(2):104-117.51. Clin Infect Dis. 2006;43(4):474-484.52. Clin Infect Dis. 2003;37(12):1629-1638.53. JAMA. 1999;281(3):261-267.54. Clin Infect Dis. 2008;47(1):83-93.55. Am J Infect Control. 1995;23(1):5-12.56. Lancet. 1991;338(8763):339-343.57. Clin Infect Dis. 2003;37(6):764-771.58. Ann Intern Med. 2004; 140(6):419-425.59. J Clin Microbiol. 2009;47(7):2279-2280.60. Ren Fail. 2008;30(4):417-422.61. Infect Control Hosp Epidemiol. 2008;29(3):284;

author reply 284-285.62. Jpn J Infect Dis. 2008;61(2):107-110.63. Mil Med. 2008; 173(6):604-608.64. Euro Surveill. 2008;13(14):pii=8084.65. J Am Soc Nephrol. 2005;16(5):1456-1462.66. Infect Control Hosp Epidemiol. 1994; 15

(4 pt 1):231-238.67. Infect Control Hosp Epidemiol. 1998;19(11):842-845.

68. Chest. 2000;117(1):178-183.69. Am J Med. 1991;91(3B):197S-205S.70. JAMA. 2001;286(6):700-707.71. J Clin Microbiol. 1990;28(11):2520-2525.72. JAMA. 2008;299(20):2413-2422.73. Intensive Care Med. 2008;34(6):1038-1045.74. Crit Care. 2006;10(6):R162.75. Crit Care Med. 1996;24(12):2053-2058.76. Arch Intern Med. 2009;169(15):1420-1423.77. Simul Healthc. 2010;5(2):98-102.78. Maki D, Mermel LA, Kluger DM. Presented at:

40th Interscience Conference on Antimicrobi-al Agents and Chemotherapy; September 17-20, 2000; Toronto, Ontario.

79. Ann Hematol. 2009;88(3):267-272.80. JAMA. 2009;301(12):1231-1241.81. Crit Care Med. 2009;37(2):702-712.82. Health Technol Assess. 2008;12(12):iii-iv, xi-xii,

1-154.83. Infect Control Hosp Epidemiol. 2005;26(8):708-714.84. J Antimicrob Chemother. 2008;62(4):809-815.85. Ann Pharmacother. 2009;43(2):210-219.86. Arch Intern Med. 2007;167(19):2073-2079.87. Crit Care Med. 2009;37(6):1858-186588. Infect Control Hosp Epidemiol. 2009;30(11):1031-1035.89. Infect Control Hosp Epidemiol. 2009;30(10):959-963.90. Silva GLM, Safdar N. Presented at: Fifth Decenni-

al International Conference on Healthcare-Associ-ated Infections; March 18-22, 2010; Atlanta, GA.

91. Intensive Care Med. 2010;36(5):854-858.92. J Healthc Mater Manage. 1993;11(8):44-46, 48-49.93. Infect Control Hosp Epidemiol. 1997;18(3):175-182.94. Infect Control Hosp Epidemiol. 1998;19(6):401-406.95. Am J Infect Control. 1993;21(1):39-41.96. Infect Control Hosp Epidemiol. 1998;19(1):23-27.97. J Infect Dis. 1999;179(2):442-448.98. J Pediatr. 1996;129(5):711-717.

99. Infect Control Hosp Epidemiol. 1998;19(10):772-777.100. Clin Infect Dis. 2007;44(11):1408-1414.101. Infect Control Hosp Epidemiol. 2007;28(6):684-688.102. J Hosp Infect. 2003;54(4):288-293.103. Infect Control Hosp Epidemiol. 2006;27(1):23-27.104. Am J Infect Control. 2009;37(8):626-630.105. Clin Infect Dis. 2010;50(12):1580-1587.106. Am J Infect Control. 2008; 36(10):S174.e1-S174.e5.107. J Vasc Interv Radiol. 2002;13(1):77-81.108. Infus Nurs. 2006; 29(1):34-38.109. J Infus Nurs. 2006;29(4):225-231.110. N Engl J Med. 2001;345(19): 1359-1367.111. N Engl J Med. 2006;354(5):449-461.112. JAMA. 2008;300(8):933-944.113. N Engl J Med. 2009; 360(13):1283-1297.114. CMAJ. 2009;180(8):821-827.115. Safdar N, Ziegler M, Abad C, Silva G. Present-

ed at: Fifth Decennial International Conference on Healthcare-Associated Infections; March 18-22, 2010; Atlanta, GA.

116. http://www.ihi.org/IHI/Topics/CriticalCare/Inten-siveCare/ImprovementStories/WhatIsaBundle.htm. Accessed February 24, 2012.

117. N Engl J Med. 2006;355(26):2725-2732.118. BMJ. 2010;340:c309.119. BMJ. 2007;334(7589):362-365.120. Pediatrics. 2008;121(5):915-923.121. http://www.infectioncontroltoday.com/articles/zero-

tolerance.html. Accessed February 24, 2012.122. Infect Control Hosp Epidemiol. 2009;30(1):71-73.123. Infect Control Hosp Epidemiol. 2009;30(1):67-70.124. Infect Control Hosp Epidemiol. 2010;31(12):1286-1289.125. JAMA. 2010;304(18):2035-2041.

Drs. Abad and Safdar reported no relevant conflicts of interest.



thoughtful commentary by Sexton et al,

For complete references, please visit www.generalsurgerynews.com.

®

Learn more. Visit www.cookbiodesign.com

MOVE BEYONDto a next generation biologic graft

© C

OO

K 2

011

SU

R-B

AD

V-M

BN

G-E

N-2

0110

9

MCGSN1075.indd 1 9/19/11 3:19 PM

MOVE BEYONDto continual improvementBiodesign® is the evolution of a technology that started the biologic graft soft tissue repair revolution.

2006

Processing improvementsIn response to surgeon feedback, substantial improvements in the process-ing are made, opening the structure to allow the body to more easily infiltrate and remodel the graft.

2008

Biodesign is releasedAdditional improvements are made to the base technology, speeding rehydration and mitigating perioperative issues. New generation of grafts are renamed Biodesign.

1989

Discovery of SISSmall intestinal submucosa (SIS) is used as an aortic replacement in a canine model. Remarkably, the SIS is fully remodeled into vascular tissue.

1999

Surgisis® is releasedAfter rigorous research and development, Cook receives FDA clearance for release of Surgisis, the first medical-grade hernia device made from SIS-based technology.

Learn more. Visit www.cookbiodesign.com

© C

OO

K 2

011

SU

R-B

AD

V-M

BC

I-EN

-201

109

®

MCGSN1076.indd 1 9/19/11 3:22 PM

New Technique Could Improve Pancreatic Cancer Staging, Treatmentlaparoscopy using Fluorescent Markers and

lED light


A new laparoscopic technique that uses fluores-cent antibody markers and an LED light source

has the potential to improve pancreatic staging and treatment, according to a report presented at the 2011 Clinical Congress of the American College of Surgeons.

Researchers took two antibodies commonly expressed by pancreatic cancer and tagged them with a fluorescent marker, making the cancer cells light up in bright green or red. The researchers then adminis-tered the fluorescent antibodies into mice and stud-ied the mice under LED light and during traditional laparoscopy.

Analysis showed that the LED light vividly iden-tified the primary and metastatic tumors, with a sensitivity rate of 96% compared with 40% for tradi-tional laparoscopy. Fluorescent laparoscopy rendered fewer false-positives than traditional laparoscopy and was sensitive enough to illuminate metastatic lesions

smaller than 1 mm, which are not visible with a stan-dard laparoscope.

The combination of fluorescent markers and LED light potentially could sharpen how surgeons detect and treat pancreatic cancer in human patients, said investigators Michael Bouvet, MD, and Robert M. Hoffman, PhD, both professors of surgery at the Uni-versity of California, San Diego (UCSD).

The LED light improves visualization of both the tumor and the surrounding anatomy in the abdom-inal cavity of the mice. “You can see both the nor-mal background of the anatomy plus the fluorescent tumor signal at the same time,” said Dr. Bouvet, in a press release.

The technology also could be used to target tumor cells for treatment with drugs, but the work is still in early stages. The surgeons plan to join forces with industry to secure FDA approval for clinical trials of the fluorescent antibodies in humans.

The research was funded by a five-year grant to UCSD and AntiCancer, Inc. from the National Can-cer Institute. The UCSD team worked with AntiCan-cer Inc. on the mouse model and with laparoscopic technicians at Stryker Corporation.

583 and 584).Involving caregivers at all levels and

providing frequent, regular feedback on infection rates to hospital staff are two key elements that have made these pro-grams a success, experts said.

Matthias Walz, MD, chief of vascu-lar anesthesiology at UMASS Medical Center, said the guidelines at his facility were developed by a small task force and then approved by the institution’s Crit-ical Care Operations Committee prior to implementation. “From the ICU phy-sicians to the ICU nurses, respiratory therapists, pharmacy team, occupational therapists ... everybody is at the table.” Because all disciplines were involved in creating the guidelines, all caregivers feel they have a stake in the process, he said.

Although the landmark study by Peter Pronovost, MD, and colleagues is an example of a success story—a reduction in central-line infection rates of 66% in 18 months (N Engl J Med2006;355:2725-2732)—the UMASS project is unique for its long follow-up, Dr. Walz said.

Infection rates steadily declined throughout the study period, from 5.86 per 1,000 catheter-days in 2004 to 0.6 per 1,000 in 2011. Studies have shown that although programs can be success-ful in reducing the number of central-line infections, compliance can drop off over time (Arch Surg 2004;139:131-136).

The new study demonstrates a program with stamina.

In the UMASS program, ICUs receive data on their infection rates on a monthly basis, allowing for timely reac-tion. The program includes elements of the Pronovost study, such as the use of a dedicated catheter cart for supplies, checklists to ensure adherence to infec-tion-control procedures, empowering nurses to halt a procedure if checklist elements are not followed and removal of unnecessary catheters.

Clinicians also rely on a preproce-dural timeout, and they use chlorhexi-dine sponges and antibiotic-impregnated catheters. Re-education is key. “If you don’t continue to re-educate your staff and monitor progress, rates will creep back up again,” Dr. Walz said.

In both the UMASS and Ohio State approaches, researchers investigate any identified infections to determine if opportunities to prevent them were missed. At Ohio State, infection rates fell from 2.9 per 1,000 catheter-days in 2009 to 1.95 per 1,000 in 2010. The researchers noted that their data for 2011 were incomplete but appeared to indicate further reductions in infections.

The Ohio State approach includes weekly surveillance of infection rates from its clinical epidemiology unit.

“Previously, we would get quarterly data and you would hear that you had three central-line infections, but you wouldn’t hear who the patients were, and you were so far removed from the events that no one could remember what actual-ly happened,” said Mathew Exline, MD,

associate director of the ICU at the insti-tution. “Now, you can go to the nurse who drew the blood culture and you can go to the physician who put in the line and ask them questions about the event, because it is still fresh in everyone’s mind.”

Ohio State also incorporates com-ponents of the Pronovost study with an emphasis on re-education regarding line insertion and maintenance, the use of daily checklists to increase adherence to guidelines and identifying noncom-pliance with evidence-based guidelines. “Unless you really have someone who is a champion who says ‘this is really

important, we need to focus on it,’ there are so many things going on in the ICU, that it is easy for the checklist to fall by the wayside,” Dr. Exline said.

Trish Perl, MD, professor of medicine, pathology and epidemiology at Johns Hopkins University, in Baltimore, said the two studies add to the growing evi-dence that teamwork can reduce central line–related blood infections.

“I think the use of teams works so well because there is a lot of wisdom that you can get from individuals with different experiences. For example, my perspec-tive may be very different from some-body who is in the trenches,” Dr. Perl said. And she echoed the importance of having a champion.

“If you have a really good and engaged champion, it makes a lot of difference,” Dr. Perl said. “If people really believe low rates are achievable and it is an expec-tation and the institution and employ-ees have accountability and hence really facilitate the interventions, it makes a lot of difference.”


CeNtral-liNecontinued from page 1

‘I think the use of teams works so well because

there is a lot of wisdom that you can get from individuals with different experiences.’

—Trish Perl, MD

The leD light improves visualization of both the tumor and surrounding anatomy in the abdominal cavity.

Study Details Risks for Contralateral Cancer in BRCA1/2By Kate O’ROuRKe

A study has provided some hard statistics regarding the risk that women carrying BRCA1/2 mutations will develop a contralateral breast cancer (CBC) and how factors, such as age and a triple-negative diagnosis, affect that risk. The findings provide risk estimates that doctors can use to counsel patients when discussing

treatment options.“Medical decision making weighs

the risks and benefits of the situation at hand. For a woman with breast can-cer to make a decision on the manage-ment of the nonaffected breast, it is important to quantify the risk for devel-oping contralateral breast cancer,” said Catherine Van Poznak, MD, medical oncologist at the University of Michigan,

in Dearborn, who was not involved with the study. “The data generated in this study aids that risk assessment.”

Researchers have known for years that the risk that a woman will develop CBC is higher than an average woman’s risk for developing a first cancer; this risk is even greater if the woman carries the BRCA1/2mutation. But until this study, CBC risk estimates for a large unselected population

did not exist, said Alexandra van den Broek, doctoral candidate at the Nether-lands Cancer Institute who presented the work at the San Antonio Breast Cancer Symposium (abstract S4-2).

In the study, a consecutive series of patients with invasive breast cancer were tested for BRCA mutations. The study included women who were diagnosed before the age of 50 from 1970 to 2003 in 10 different hospitals throughout the Netherlands. Of the 5,061 women in the study, about 4% were BRCA carriers; 3.04% had BRCA1 mutations and 1.13% had BRCA2 mutations.

The cumulative 10-year CBC risk was 6% for noncarriers compared with 11.1% for BRCA2 carriers (P<0.05) and 20.3% for BRCA1 carriers (P<0.01). Age at diag-nosis was a significant predictor of cumu-lative 10-year risk for CBC in BRCAcarriers: 26% in women diagnosed young-er than age 41 and 11.6% in women diag-nosed between the ages of 41 and 50. The cumulative 10-year CBC risk was 18.9% in patients with triple-negative sta-tus compared with 11.2% in patients who were not triple-negative, but this was not statistically significant. “When looking only at the first five years, the effect is sig-nificant,” said Ms. van den Broek.

The analysis allowed the researchers to define subgroups of BRCA1/2 carriers with decreased and increased 10-year risk for CBC. “The low-risk subgroup [3.5%] were the patients with a non–triple-nega-tive first breast cancer diagnosed between the ages of 41 and 50, which had almost similar risk to the noncarriers,” said Ms. van den Broek. She defined two high-risk groups. The first group was women with triple-negative breast cancer who were first diagnosed between the ages of 41 and 50; they had a 15% risk. The second group was women with a first breast cancer diag-nosed before the age of 41; this group had a 26% risk.

This information should help doctors counsel patients, Ms. van den Broek said. “The analysis ... suggests that risks for contralateral breast cancer within 10 years may be estimated based on age and BRCA1/2 status,” she said. If the results are confirmed, age criteria and recep-tor status of the first breast cancers might be included in guidelines for prophylactic measures and screening in the follow-up of BRCA1/2 mutations carriers.

23GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012 In the news

‘when looking only at the first five years, the effect is

significant.’—Alexandra van den Broek

®

Now Available...

ChairStephen M. Cohen, MD, FACS, FASCRSAssociate Clinical Professor, Department of SurgeryEmory University School of MedicineVice Chairman, Department of Surgery Southern Regional Medical CenterAtlanta Colon and Rectal SurgeryAtlanta, Georgia

FacultyDaniel L. Miller, MDKanal A. Mansour Professor of Thoracic SurgeryEmory University School of MedicineChief, General Thoracic SurgerySurgical Director, Thoracic Oncology ProgramWinship Cancer InstituteAtlanta, Georgia

Samuel Szomstein, MD, FACSAssociate Director, The Bariatric and Metabolic Institute and Section of Minimally Invasive and Endoscopic SurgeryDirector, Bariatric EndoscopyCleveland Clinic FloridaWeston, FloridaAssociate Professor of SurgeryFlorida International UniversityMiami, FloridaClinical Assistant Professor of SurgeryNova Southeastern UniversityFort Lauderdale, Florida

Accreditation StatementThis activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of AKH Inc., Advancing Knowledge in Healthcare, and Applied Clinical Education. AKH Inc. is accredited by the ACCME to provide continuing medical education for physicians. AKH Inc. designates this enduring activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

GoalThe goal of this activity is to educate general and colorectal surgeons on strat-egies for optimizing outcomes in complex hernia repair and abdominal wall reconstruction through choice of biologic mesh and proper surgical technique.

Learning ObjectivesAt the completion of this activity, participants should be better prepared to:1 Classify the properties of biologic mesh available for addressing the chal-

lenges of complex hernia repair (eg, bovine pericardium, porcine intestine, porcine dermis, and human dermis) and their effects on tissue remodeling and revascularization.

2 Describe the importance of host response to the collagen scaffold and the balance between mesh degradation and new tissue infiltration with bovine pericardium-based mesh.

3 Identify appropriate surgical techniques to optimize the use of biologic mesh in abdominal wall reconstruction and complex hernia repair.

4 Review new treatment algorithms designed to provide best-practice measures and aid in handling surgical complications.

To participate in this FREE CME activity, log on to www.CMEZone.com and enter keyword “MN119”

Release Date: September 1, 2011 Expiration Date: August 31, 2013


Novel Applications for Biologic MeshInnovations in Complex Hernia Repair

Supported by an educational grant fromSponsored by Distributed via

MCGSN1086.indd 1 11/17/11 3:53 PM

Issues for the BarIatrIc & MetaBolIc ProfessIonal

Extended Quarterly Coverage

Endoscopic Bariatric Therapies Gain Traction With PaperBy ChRIstIna FRangOu

Endoscopic bariatric thera-pies may become an accept-

ed outpatient alternative to bariatric surgery, according to a new white paper supported by the American Society for Gastroin-testinal Endoscopy (ASGE) and the American Society for Metabol-ic and Bariatric Surgery (ASMBS). The two societies set up a joint task force to identify opportunities where endoscopic treatments could play a role in improving patient outcomes and reducing costs associated with obesity.

The task force, which included both gastroenterologists and surgeons, laid out the criteria for success as endo-scopic technologies and procedures are developed, addressing treatment classifi-cation, potential indications and efficacy, said Gregory G. Ginsberg, MD, presi-dent and chair of the ASGE/ASMBS task force on endoscopic bariatric thera-pies. To date, however, the technologies are still considered investigational; long-term studies involving significant num-bers of patients are still lacking.

The white paper is published in both Gastrointestinal Endoscopy (2011;74:943-953), the peer-reviewed scientific journal of the ASGE, and Surgery for Obesity and Related Diseas-es (2011;7:672-682), the peer-reviewed scientific journal of the ASMBS.

“This is an important paper. It does an excellent job of defining the issues and challenges of endoscopic bariatric therapies and provides a framework for the field to move forward,” said Stacy Brethauer, MD, staff surgeon at the Cleveland Clinic in Ohio, who was not involved in writing the paper.

The field of endoscopic bariatric therapy needs to advance because it fills a gap between medical therapy and sur-gery, he said. The white paper lays out a clear pathway to develop these thera-pies and establishes initial benchmarks for their development.

Moreover, the paper marks an impor-tant collaboration between gastroenter-ologists and bariatric surgeons.

“We need to work together on this issue and combine their technical and clinical expertise to provide bet-ter care for the obese patient,” said Dr. Brethauer.

The white paper describes several endoscopic bariatric therapies current-ly being developed, including gastric restriction or manipulation by endo-scopic placement of a space-occupying device, endoscopic stapling or sutur-ing, as well as malabsorptive tech-niques, such as endoscopic placement of a duodenal-jejunal barrier sleeve, or neurohormonal alterations. Although promising, these approaches are still in the very early stages of development.

Endoscopic techniques may be appli-cable to a wide range of obese patients, more than traditional primary bariatric surgery, provided that studies can val-idate the techniques, said the authors.

“Endoscopic therapy has the poten-tial to be applied across the continuum of obesity and metabolic disease,” said Bipan Chand, MD, chairman of the ASMBS Emerging Technology and Procedure Committee and co-chair of the ASGE/ASMBS task force.

Dr. Chand noted that endoscop-ic modalities must achieve weight loss superior to medical and intensive life-style interventions. A technique also will have to have a “favorable risk–ben-efit profile and scientific evidence to support its use,” he said.

As outlined in the white paper, endoscop-ic bariatric therapies can be used as a prima-ry weight loss procedure, or as a pre- or

postsurgical procedure. The procedures also could be used as an early inter-vention or preemptive obesity therapy for patients with less severe obesity or as a bridge therapy to ready very obese patients for follow-up interventions, such as bariatric or orthopedic surgery or organ transplants.

Endoscopic bariatric therapy also could be justified in patients with less severe obesity as a metabolic therapy, the task force found. Obese patients who lost 5% of their total body weight benefited from significant reductions in diabetes and cardiovascular risk factors. An endoscopic procedure that could produce a minimum 5% of total body weight loss could be used for this kind of therapy, the authors said.

Endoscopic modalities must meet standards for risk and efficacy, the report’s authors stressed. Higher-risk endoscopic modalities must yield more

substantial improvements in weight loss. The authors set out clear markers

for risk versus weight. For example, they found that an endoscopic treat-

ment designed for primary weight loss must have a Grade III weight

loss rating, which is equivalent to gas-tric banding, or achieve a minimum of 25% excess weight loss, have a moder-ate safety risk and have durable effects. In contrast, an acceptable bridge proce-dure would require total weight loss of about 5% or the same as medical thera-py, and a minimal safety risk, much like colonoscopy, or six-month duration.

As endoscopic techniques for bar-iatric patients are developed, programs will need to be modified to accom-modate patients who qualify for these treatments. Endoscopy suites will need updating to treat bariatric patients and their families. Nutritional support, experienced nursing care, behavior-al medicine specialists and physicians experienced in the management of obese patients will be essential to these programs, said the authors. Additional-ly, any practitioner who is interested in performing endoscopic bariatric tech-niques also should be educated in the clinical management of obese patients.

Currently, endoscopic therapies are only offered to patients in feasibili-ty trials. Patients are eager to try less-invasive procedures, and primary care physicians are excited about the possi-bility of referring patients for this less-invasive approach, said Dr. Brethauer.

“These therapies have great potential to get effective therapy to many more patients.” However, he added, “They will not replace surgery in the foresee-able future.”

Dr. Brethauer is a consultant for Apollo Endosurgery and BARD/Davol, and serves as a consultant and scientific advisory board member for Ethicon Endo-Surgery. The authors of the white paper reported the following disclosures: Dr. Chand serves in an advisory role for Apollo Surgery, BARD, Covidien and Hour-Glass, and has an advisory role and con-sultant position for Ethicon Endo-Surgery. Dr. Nguyen is a consultant to Covidien, Ethicon and Reshape Medical. Dr. Pryor has an ownership interest in BaroSense and TransEnterix, has received research support and honoraria from Covidien, and has received honoraria from Olympus. Dr. Thompson reported relationships with Apollo Endosurgery, BARD, BaroSense, Beacon Endoscopic, Boston Scientific, Co-vidien, Olympus, USGI Medical, ValenTx and Vysera. All other authors of the white paper disclosed no relevant financial relationships.

25GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012

as endoscopic techniques for bariatric patients are

developed, programs will need to be modified to

accommodate patients who qualify for these treatments. endoscopy suites will need updating to treat bariatric

patients and their families.

‘This is an important paper. It does an excellent job

of defining the issues and challenges of endoscopic

bariatric therapies and provides a framework for the field to move forward.’

—Stacy Brethauer, MD

substantial improvements in weight loss. The authors set out clear markers

loss must have a Grade III weight loss rating, which is equivalent to gastric banding, or achieve a minimum of 25% excess weight loss, have a moderate safety risk and have durable effects. In contrast, an acceptable bridge procedure would require total weight loss of about 5% or the same as medical therapy, and a minimal safety risk, much like colonoscopy, or six-month duration.

iatric patients are developed, programs will need to be modified to accommodate patients who qualify for these treatments. Endoscopy suites will need updating to treat bariatric patients and their families. Nutritional support, experienced nursing care, behavior

testinal Endoscopy (ASGE) and -

ic and Bariatric Surgery (ASMBS). The two societies set up a joint task force to identify opportunities where endoscopic treatments could play a role in improving patient outcomes and reducing costs associated with

The task force, which included both gastroenterologists and surgeons, laid out the criteria for success as endo-scopic technologies and procedures are developed, addressing treatment classifi-cation, potential indications and efficacy,

Study Shows Plateauing of Obesity, Conflicting With Earlier Studies

By geORge OChOa

Two new articles by researchers from the Centers for Disease Control

and Prevention (CDC) suggest that obe-sity has been plateauing in the United States in recent years, in contrast to the rising trend that has long characterized the problem. Although this news would appear to be promising, it conflicts with other studies that suggest obesity rates are not only rising but will continue to increase for years to come.

The new articles, which report that obesity trends are leveling off, are based on data from the National Health and Nutri-tion Examination Survey (NHANES). One trial found that from 2009 to 2010, obesity prevalence in adults aged 20 years or older was 35.5% among men and 35.8% among women, with no signifi-cant change compared with 2003 to 2008 (P=0.08 for men and P=0.24 for women; JAMA 2012;307:491-497). Over the 12-year period from 1999 to 2010, obe-sity did not increase significantly among women (annual change in odds ratio [AOR], 1.01; 95% confidence interval [CI], 1.00-1.03; P=0.07), but did slight-ly for men (AOR, 1.04; 95% CI, 1.02-1.06; P<0.001). Additionally, increases in obesity were statistically significant for non-Hispanic black and Mexican American women (P=0.04 and P=0.046, respectively).

“There’s been no [large or notable] change in recent years,” said Cynthia L. Ogden, PhD, MRP, epidemiologist and branch chief in the Division of Health and Nutrition Examination Surveys, National Center for Health Statistics, CDC, Hyattsville, Md., and lead author of the study.

The other study found no difference in obesity prevalence among men or women between 2007-2008 and 2009-2010 (P=0.62 and P=0.65, respectively). The obesity prevalence in children and adoles-cents between 2009 and 2010 was 16.9% (JAMA 2012;307:483-490). But the anal-ysis over a 12-year period indicated a sig-nificant increase in obesity prevalence from 1999-2000 to 2009-2010 in males aged 2 to 19 years (OR, 1.05; 95% CI, 1.01-1.10) but not in females (OR, 1.02; 95% CI, 0.98-1.07).

Overall, the plateau of obesity rates represents a marked change from the past, the study authors noted, reporting a substantial increase in population preva-lence of obesity of almost 8% from 1980 to 1994, and a similar increase from 1994 to 2000.

“Our data suggest [obesity among U.S. adults] is plateauing,” said Katherine M. Flegal, PhD, senior research scientist, National Center for Health Statistics, and investigator on both studies.

The results from several other recent studies, however, conflict with those from JAMA. A Lancet trial projected that there will be 65 million more obese adults in the United States by 2030 (2011;378:815-825). Additionally, a study presented at the 2011 American Heart Association Scien-tific Sessions by Mark Huffman, MD, MPH, used trends based on NHANES data from 1988 to 2008 to make forward linear projections to 2020. Applying these methods, the researchers estimated that 43% of men and 42% of women would be obese by 2020.

Dr. Huffman, assistant professor in the Departments of Preventive Medicine and Medicine-Cardiology, Northwestern University Feinberg School of Medicine, Chicago, said in an email that he stands

by his 2020 estimates “based on past pro-jections.” He observed that an increas-ing obesity trend among males aged 2 to 19 years between 1999 and 2010 “may increase the prevalence of obesity among adults 20 years and older, despite recent trends. Note that both the current preva-lence as well as our projections of obesi-ty prevalence are both unacceptably high and lead to substantial premature death and disability, necessitating population- and individual-level interventions.”

Michael Nusbaum, MD, chief of bar-iatric surgery, Morristown Medical Cen-ter, Morristown, N.J., and president, New

Jersey chapter of the American Society for Metabolic & Bariatric Surgery, said in an interview, “I would agree that the level of rise in obesity has decreased. The growth curve has started to flatten out, though not completely.”

However, Dr. Nusbaum added, “There’s such a push against obesity, we should be seeing a decrease and we aren’t.” An obesity prevalence rate of about 35% “is alarming and we shouldn’t downplay it.”

Asked about studies projecting a con-tinuing increase in obesity, Dr. Flegal said, “We don’t predict the future.” But lead author of the Lancet study, Y. Claire Wang, MD, ScD, assistant professor, Department of Health Policy & Man-agement, Columbia Mailman School of Public Health, New York City, asked in an email: “Can we really avoid making any projections? Or are we equally confi-dent that the trend will go flat from now on so we don’t need to anticipate or pre-pare for the increase in disease burdens?”

Drs. Flegal, Huffman, Nusbaum, Ogden and Wang reported no relevant financial disclosures.

Bariatric Surgery Associated With Reduced Risk for CV Events and Deaths

By geORge OChOa

Compared with usual care, bariatric surgery is asso-ciated with a reduced number of cardiovascu-

lar (CV) deaths and lower incidence of CV events in obese adults, according to the results of a Swedish study (JAMA 2012;307:56-65).

In the prospective, nonrandomized controlled trial, 2,010 obese patients underwent bariatric surgery (gas-tric bypass, banding or vertical banded gastroplasty) and 2,037 controls received usual care. Patients were recruited over a 13-year period and followed for a medi-an of 14.7 years. Body mass index (BMI) was at least 34 kg/m² in men and at least 38 kg/m² in women.

There were 28 CV deaths in the surgery group

versus 49 in the control group (P=0.002). The number of total first-time fatal or nonfatal CV events (myo-cardial infarction or stroke, whichever came first) was lower in the surgery group (199 events) than in the control group (234 events; P<0.001).

“The main finding, based on predefined aims, is that bariatric surgery is in fact reducing the incidence of CV events,” lead author Lars Sjöström, MD, PhD, professor, Institution of Internal Medicine, Universi-ty of Gothenburg and Sahlgrenska University Hospi-tal, Gothenburg, Sweden, wrote in an email. “This will further strengthen the position of bariatric surgery as an important obesity treatment.”

In post hoc analyses, a higher baseline insulin con-centration, but not preoperative BMI, was associated

with better outcome of bariatric surgery on CV events. Weight loss after surgery was not related to reduced incidence of CV events. Dr. Sjöström expressed hope that his study findings will “stimulate further research trying to identify mechanisms behind weight change–independent favorable effects of bariatric surgery.”

Dr. Sjöström reported the following financial disclosures: unrestricted Swedish Obese Subjects grants from Sanofi-aventis and Johnson & Johnson since 2007; lecture and consulting fees from AstraZeneca, Biovitrum, Bristol-Myers Squibb, GlaxoSmithKline, Hoffmann LaRoche, Johnson & Johnson, Lenimen, Merck, Novo Nordisk, Sanofi-aventis, and Servier; and holding stocks in Leni-men. He is also chairman of the board for Lenimen.

26 GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012

‘note that both the current prevalence as well as

our projections of obesity prevalence are both

unacceptably high and lead to substantial premature death and disability....’

—Mark Huffman, MD, MPH



Obesity and Chronic Pain Linked in Large-Scale Study

By geORge OChOa

Obese individuals are more prone to daily pain, new data show. In a study of more than 1 million

randomly selected individuals in the United States, a clear association between body mass index (BMI) and pain was seen, even after controlling for demographic variables (Obesity [Silver Spring]; 2012 Jan 19. [Epub ahead of print]).

Previous studies have suggested an association between obesity and pain, but “with data on over 1 million participants, this is likely the largest epidemi-ological examination of the pain–obesity relationship,” wrote Niloofar Afari, PhD, associate professor in the Department of Psychiatry, University of California, San Diego, in an email.

Dr. Afari, senior author of a previous study (Pain 2010;11:628-635) that analyzed twin data to deter-mine the relationship between chronic pain and over-weight and obesity, commented: “Like our own paper, this [new one] is a population-based study, meaning that the findings are likely not due to health care seek-ing.” However, Dr. Afari added, “Their finding of a modest relationship between pain and obesity, which is not accounted for by specific pain conditions, contrib-utes to the literature [on the topic].”

The new study analyzed telephone survey data on 1,062,271 adults collected from 2008 to 2010 by the Gallup Organization. Survey questions included height and weight, allowing researchers to calculate BMI, questions about pain conditions in the past year and a query about pain experience in the past day. The

participants were categorized by escalating BMI: low-normal group (BMI <25 kg/m2); overweight group (BMI 25-30); obese I group (BMI 30-35); obese II group (BMI 35-40); and obese III group (BMI >40).

The researchers found that 19.2% of the participants were in the low-normal BMI range, 21.4% were classi-fied as overweight and the remaining 59.4% were in the three obese categories. Compared with the low-normal BMI group, the overweight group reported 20% more pain, and the obese I, II and III groups reported 68%, 136% and 254% more pain, respectively. The associa-tion held for both men and women and was stronger in older age groups. Women presented a steeper trend as BMI increased than the men.

The authors concluded that “BMI and daily pain are positively correlated in the United States,” adding that the association is “robust” and persists after controlling for several pain conditions and across gender and age.

Arthur A. Stone, PhD, distinguished professor and vice-chair, Department of Psychiatry and Behavioral Science, Stony Brook University, Stony Brook, N.Y., wrote that his article is an advance on the previous lit-erature in at least two ways. “First, prior studies dem-onstrating this association were limited by their small sample sizes and, often, by their restriction to certain geographic areas. This study is representative of the entire United States and has a very large sample size. … Second, pain was measured with a relatively new technique of asking respondents about their pain ‘yes-terday.’ This measurement technique avoids distortion in the results due to biases associated with imperfect recall.”

Much remains unclear about the relationship between obesity and pain, Dr. Afari noted. “There’s been some investigation of the link between obesity and pain, but there’s still lots to be known in terms of the mechanisms that underlie the relationship.”

Dr. Stone said, “[We] speculate that certain hor-mones associated with body fat could impact inflam-matory processes, which themselves are associated with increased pain. [F]uture research will have to confirm that speculation.”

Michael Nusbaum, MD, chief of bariatric surgery,

Morristown Medical Center, Morristown, N.J., and president of the New Jersey chapter of the Ameri-can Society for Metabolic & Bariatric Surgery, noted the role of musculoskeletal pain. “Morbidly obese patients carry much more weight, and are subject to joint pain and back pain,” Dr. Nusbaum said. “Morbid-ly obese people also suffer from a chronic inflammatory response as a result of being obese.”

Drs. Afari and Nusbaum reported no relevant financial disclosures. Dr. Stone reported the following relevant finan-cial disclosures: senior scientist with the Gallup Organiza-tion, senior consultant with PRO Consulting and member of the Scientific Advisory Board of Wellness & Prevention, Inc.

GERD on the Sharp Rise in Norway, with Obesity a Likely Culprit

By geORge OChOa

In Norway, the prevalence of gastroesophageal reflux disease (GERD) symptoms has risen almost 50%

in the past decade, and the main suspect is increased obesity, according to a population-based cohort study in Gut (published online Dec. 21; 10.1136/gutjnl-2011-300715).

Because GERD can lead to esophageal cancer, “in a public health view the increasing occurrence of GERD is alarming,” commented lead author Eivind Ness-Jensen, MD, PhD student, HUNT Research Centre, Department of Public Health and General Practice, Norwegian University of Science and Technology, and Department of Internal Medicine, Levanger Hospital, Nord-Trøndelag Hospital Trust, Levanger, Norway.

Conducted within the Nord-Trøndelag Health Study, a longitudinal series of population-based health surveys in a single county, the Gut study asked 59,000 participants from 1995 to 1997 and 45,000 from 2006 to 2009, “To what degree have you had heartburn or acid regurgitation during the previous 12 months?” and “If you have had heartburn or acid regurgitation during the previous 12 months, how often do you have complaints?”

During the intervening years, the prevalence of any, severe and at least weekly GERD symptoms increased, respectively, by 30%, 24% and 47%, according to the researchers. The average annual incidence of any and severe GERD symptoms in the study was, respective-ly, 3.07% and 0.23%. Age was an important risk fac-tor for incidence of GERD symptoms among women but not men. Average annual spontaneous loss of any

symptoms was 2.32%.Increased obesity is believed to be the main factor

contributing to the increase in GERD symptoms. Dr. Ness-Jensen noted in an email that this “is based on a strong and consistent association between GERD and obesity in other population-based studies, clinical studies and experimental studies. Other lifestyle fac-tors probably contribute as well, but to a lower degree.”

Asked whether weight loss in obese people would reduce the risk for GERD and esophageal cancer, Dr. Ness-Jensen replied, “We are doing a study on this now, and hope to publish our results during this spring.”

Dr. Ness-Jensen reported no financial disclosures relevant to this article.


‘There’s been some investigation of the link between obesity and pain, but there’s still lots to be known in terms of the mechanisms that underlie the

relationship.’—Niloofar Afari, PhD



Obese Children Require Less Propofol, Study SuggestsBy MIChael VlessIdes

cHicago—Contrary to what many anesthesiologists may think, the effective dose of propofol is significantly lower for obese children than their non-obese counterparts, a new study suggests. These findings become even more important, the researchers said, given that propo-fol decreases systemic vascular resistance, and unnecessarily large doses may result in moderate to severe hypotension.

“As we all know, there’s an increasing number of obese children presenting for surgery,” said study leader Olutoyin A. Olutoye, MD, staff anesthesiologist at Texas Children’s Hospital, in Houston. “As anesthesiologists, we’re faced with the challenge of how to exactly dose intravenous anesthetics in this subset of patients.”

As much as 75% of excess weight in obese children is fat, which alters the distribution of lipophilic drugs such as propofol.

For their study, Dr. Olutoye and her

colleagues enrolled 40 obese and 40 non-obese children (aged 3-17 years), all of whom were presenting for ambulatory surgical procedures. Obesity was defined as a body mass index above the 95th per-centile for age.

Each patient was assigned to receive a dose of propofol between 1 and 4.25 mg/kg, based on the previous patient’s response. “If a patient did not fall asleep with their assigned dose, the next patient received the next higher dose in the sequence,” Dr. Olutoye explained. “If a patient fell asleep, the next patient was randomized using a prestudy random-ization process with a 95% probability to receive the same dose or 5% proba-bility to receive the next lower dose. We didn’t really know what we would find when we designed the study, so we start-ed at the lowest dose of propofol where we did not expect a response,” said Dr. Olutoye, who presented her group’s find-ings at the 2011 annual meeting of the American Society of Anesthesiologists (abstract 048). “That way, we would be able to increase the dose until we got the

desired effect.”The effective dose for 95% of patients

(ED95) was significantly lower in obese patients (1.99 mg/kg; 95% confidence interval [CI], 1.745-2.183 mg/kg) than in non-obese patients (3.183 mg/kg; 95% CI, 2.681-3.225 mg/kg). “The con-fidence intervals of both groups did not show any overlap,” Dr. Olutoye said. “This suggests that there’s a statistically significant difference between the ED95 of both groups of patients.”

The researchers also measured blood pressure throughout the procedures, given propofol’s well-documented hemo-dynamic effects. Obese patients had a higher baseline blood pressure than non-obese patients. Moreover, both systolic and diastolic blood pressures were signif-icantly lower two minutes after propofol therapy in both groups of patients.

“We should bear this in mind, because propofol decreases blood pressure, and if these patients get an unnecessarily large dose to induce loss of consciousness—particularly in patients who have been fasting prior to surgery—they could have

an exaggerated decrease in blood pres-sure,” Dr. Olutoye said.

Cheryl K. Gooden, MD, associate professor of anesthesiology and pediat-rics at Mount Sinai School of Medicine, in New York City, said the results were impressive. “It is not part of my routine practice to administer less propofol to my obese pediatric patients on a milli-gram-per-kilogram basis as compared with non-obese patients,” Dr. Gooden told General Surgery News. “However, after reviewing the results of this study, I would definitely consider giving less pro-pofol on a milligram-per-kilogram basis to my obese patients.”

The results of this study are compel-ling for two reasons, Dr. Gooden contin-ued. “First, the ED95 of propofol in the obese patient group is significantly less. Next, with no overlap of the confidence intervals, this is indicative of results that are relevant,” she said. “However, we must keep in mind that this is one study and that more studies comparing these two patient populations are necessary.”

Low BMI Associated With Higher Postoperative 30-Day Mortality

By VICtORIa steRn

Patients with a lower than normal body mass index (BMI) appear

to have a higher 30-day mortali-ty risk following surgery than over-weight or heavy patients, according to a study published in Archives of Surgery (doi:10.1001/archsurg.2011.310).

According to the U.S. Centers for Disease Control and Prevention, a BMI below 18.5 kg/m2 is underweight, between 18.5 and 24.9 kg/m2 is nor-mal, 25 to 29.9 kg/m2 is overweight, and 30 kg/m2 and above is obese.

With a growing obese population in the United States, Florence Turrentine, PhD, RN, Department of Surgery at the University of Virginia, Charlottes-ville, and colleagues wanted to deter-mine the mortality risks associated with operating on overweight patients. The team of researchers retrospec-tively assessed the relationship between BMI and 30-day mor-tality risk among 189,533 cases of general and vascular surgi-cal procedures performed at 183 sites between 2005 and 2006. Patient infor-mation came from the participant use data file database of the American

College of Surgeons National Surgical Quality Improvement Program.

Using multivariate logistic regres-sion analysis, the team calculated the statistical significance of the rela-tionship between BMI and mortality, adjusting for differences in overall mor-tality risk and procedure type. Over-all, the researchers found that 3,245 patients (1.7%) died within 30 days of surgery; however, patients with a BMI less than 23.1 kg/m2 demonstrated a 40% greater risk for death postsurgery, a significant increase compared with heavier patients with a BMI range of 26.3 to 29.6 kg/m2.

Although the improved mortality risk in heavier patients was indepen-dent of type of surgery and a patient’s overall expected risk for death, the investigators did not know why being overweight appeared to be protective after surgery.

Peer Support Found To Spur Weight Loss

By VICtORIa steRn

Social pressures are known to affect how we dress or interact with others, but these peer influences also may help us lose weight.

According to a new study, team mem-bers who participated in a weight loss competition significantly influenced each other’s weight loss (Obesity 2012 Feb 7. [Epub ahead of print]). Investi-gators found that participants not only lost similar amounts of weight, but also reported that the support and encour-agement from their teammates helped motivate them to shed the pounds.

“This is the first study to show that in these team-based campaigns, who’s on your team really matters,” lead author Tricia Leahey, PhD, researcher with The Miriam Hospital’s Weight Control and Diabetes Research Center and assis-tant professor of psychiatry and human behavior at Alpert Medical School, both in Providence, R.I, said in a statement. “Being surrounded by others with sim-ilar health goals all working to achieve

the same thing may have real-ly helped people with their

weight loss efforts.”In recent years, online

team-based weight loss interventions have been

popping up with more frequency to help encourage weight loss in large groups of people. This study is the first to examine the effects of teammates on individual weight loss during one such competition.

The findings are based on the results of the Shape Up Rhode Island 2009 cam-paign, a 12-week online program open to adult residents of the state. Participants joined a team and competed with oth-ers in weight loss, physical activity and pedometer steps. The program includ-ed 3,330 individuals who were over-weight or obese. There were 987 teams; 76% of participants were women with an average body mass index of 31.2 kg/m2

(±5.3 kg/m2). The investigators found that over-

weight or obese individuals who com-pleted the competition reported losing 4.2% (±3.4%) of their initial body weight. Weight loss was similar among team-mates (P<0.001), and those who lost at least 5% of their body weight tended to be on the same team (P<0.001). Those who reported being more highly influ-enced by their peers had an increased likelihood of achieving a 5% weight loss (odds ratio, 1.20). Additionally, team captains also lost more weight than team members, possibly due to their increased motivation and engagement in the campaign.

28 GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012Issues for the BarIatrIc & MetaBolIc ProfessIonal


Featured Video of the Month


3 Vehicles

1. Video of the month

3. Video Arcade

2. Video E-newsletter

1 Video

INTRODUCING

Brought to you by GeneralSurgeryNews.com with its tra� c of more than 12,000 viewers per month

Manufacturer Halts Sales of Lap-Band to Certain Centers Decision Follows FDa Warning

about Misleading lap-Band ad Campaigns

By VICtORIa steRn

On Feb. 2, Allergan Inc., announced that it would no longer sell its Lap-

Band Adjustable Gastric Banding Sys-tem to surgical centers affiliated with the 1-800-GET-THIN marketing company.

The device maker will, however, contin-ue to sell the Lap-Band to other medical facilities and bariatric surgeons.

Less than one week after Allergan issued the statement, two Los Angeles–area ambulatory surgery centers—Val-ley Surgical Center in West Hills and New Life Surgery Center in Beverly Hills—said they were temporarily halt-ing all Lap-Band weight loss operations and thoroughly reviewing their surgical procedures.

“While we are disappointed by Aller-gan’s decision, we remain committed to the health and welfare of our patients interested in weight-loss solutions, of which a Lap-Band implant is one option,” said a statement from the surgery centers affiliated with the 1-800-GET-THIN marketing firm. “Our experienced sur-geons receive certification training from Allergan on proper Lap-Band proce-dures, and they have performed thousands of successful weight loss surgeries at the

centers and other outpatient facilities and hospitals since 2009.”

The surgery centers’ statement, provid-ed to General Surgery News by a lawyer representing the companies continued: “Pending the results of a full independent medical and operational review, we have voluntarily stopped scheduling new Lap-Band surgeries at two of our centers. We look forward to sharing the results of this review with Allergan and others to ensure complete confidence.”

General Surgery News contacted Aller-gan for a statem ent. Allergan declined to comment, stating that the company’s corporate policy does not allow it to dis-cuss its customer relationships with third parties.

This news comes on the heels of an FDA reprimand against eight California surgical centers and the marketing firm behind a surgical weight loss marketing campaign. As detailed in the February issue of General Surgery News warning let-ters from the FDA were sent to the com-panies in December for failing to inform consumers about the serious risks asso-ciated with the weight loss surgery (see “FDA Squeezes California Surgery Cen-ters, Marketing Firm for Improper Pro-motion of Gastric Banding,” by Victoria Stern. 2012;39:1).

Several of the companies are facing other accusations. Two former employ-ees and 11 patients of the surgical centers filed a lawsuit in January claiming that the centers performed Lap-Band and other medical procedures with unqualified staff, in unsanitary facilities and using unsafe equipment. Specifically, the lawsuit alleges that centers did not preserve equipment or own ventilators large enough for obese patients; had a high incidence of postoper-ative infections because of poor sanitation; employed nurses as surgeons and allowed unsupervised administration of anesthesia; carried out needless procedures; and one center—the Beverly Hills Surgery Cen-ter—is alleged to have covered up events leading up to the death of a patient.

30 GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012

‘while we are disappointed by allergan’s decision,

we remain committed to the health and welfare of our patients interested in weight-loss solutions.... implant is one option.’

—Statement from the surgery

centers



Your colleagues in beautiful San Diego for the 29th Annual Meeting of the ASMBS.

This year’s program will exceed all expectations. Anticipate more collaborative postgraduate courses designed for both the surgeon and the integrated health teams.

You’ll see more symposiums, debates and videos. Plan to participate in lively and interactive discussions in both the Integrated Health Main Session as well as the Plenary Session.

This year’s Mason Lecturer, Dr. John Birkmeyer, will speak on Composite Measure in Bariatric Surgery, and Basic Science invited lecturer, Dr. Robert O’Rourke, will speak

LODGINGN INFORRMATIONN Rising 30 stories above the edge of SanDiego Bay the Hilton San Diego Bayfronthotel is downtown San Diego’s newest waterfront hotel.

Hilton San Diego Bayfront Hotel1 Park BoulevardSan Diego, CaliforniaUSA 92101Tel: +1-619-564-3333Fax: +1-619-564-3344

Reserve your room now atwwwww.w.20202022 1212.a.asms bsbs.o.orgrg

YOU DON’T WANT TO MISS IT! SEE YOU IN SAN DIEGO!Visit www.2012.asmbs.org for more information

The American Society for Metabolic and Bariatric Surgery designates this educational activity for a maximum of 35.75 AMA PRA Category 1 Credit(s)™ . Physicians should only claim credit commensurate with the extent of their participation in the activity.

APA credits and NASW credits for the ASMBS Masters in Behavioral Health Course are pending approval by Amedco. This course will be co-provided by Amedco and American Society for Metabolic and Bariatric Surgery.

JOIN

Save the DateSave the Date

American Society for Metabolic & Bariatric Surgery100 SW 7th Street, Gainesville, Florida 32607Tel: 352.331.4900 | Fax: 352.331.4975 | www.asmbs.org

Bariatric Surgery Boosts Cognitive Function, New Study FindsBy lOuIse gagnOn

Montreal—Patients who underwent bariatric surgery showed a significant difference in memory function after one year compared with patients who did not have the surgery, according to a study presented at the 40th International Neuropsychological Society meeting.

“We know from our past work that people who are bariatric surgery candidates are at higher risk for problems with memory and other types of thinking,” said principal investigator John Gunstad, PhD, associate professor of psychology at Kent State University, in Kent, Ohio.

However, no study has examined the effects of bariatric surgery on cognitive function. Thus, Dr. Gunstad wanted to see whether bariatric surgery helped reverse these cognitive problems. “The question is that if excessive weight causes these problems, can losing the weight solve these problems,” said Dr. Gunstad.

In the new study, the investigators examined 137 patients, 95 of whom underwent bariatric surgery and 42 of whom served as obese controls. The mean age for the surgery group was 43 years and for the control group, 39.9 years. Bariatric surgery patients were part of the Longitudinal Assessment of Bariatric Surgery parent project. Both surgical patients and controls completed self-report measurements and a cognitive test battery prior to surgical intervention, and at the 12-week and 12-month marks after surgery. Investigators measured cognitive function over time and used statistical modeling to explore possible mechanisms of change in the surgical patients. The majority of patients underwent gastric bypass, while the rest underwent gastric banding, but the study’s sample size did not permit a comparison of the effects of the two procedures on cognition.

The investigators observed that surgical patients performed better on memory indices postsurgery than obese controls (P=0.02). The effect on memory was mainly attributable to the surgery itself and not changes in comorbid conditions like sleep apnea, diabetes and hypertension, Dr. Gunstad said. The authors plan to follow the patients for five years postsurgery to determine whether the effects are long-lasting.

“We wanted to know if there were continual gains [in cognition] after surgery, and there were,” said Dr. Gunstad, but the specific mechanisms of change remain unknown. “The results are encouraging and demonstrate that the negative impact that obesity can have on cognition may be reversed with weight loss.”

Robin Blackstone, MD, bariatric

surgeon, president of the American Society of Metabolic and Bariatric Surgery, medical director of Scottsdale Healthcare Bariatric Center, Arizona, said “There is a lot of interest in this [area]. We know the way in which [gastric bypass] works is primarily through changes in neural and hormonal signaling between the gut and the brain.”

Shedding excess weight may influence other variables that could improve

cognition such as reducing sleep apnea and hypertension and improving blood sugar control. Surgery also may affect hormone levels. It is important to separate the real, independent effect of the surgery itself from the positive effects of remission of diseases like sleep apnea, diabetes and hypertension, said Dr. Blackstone.

A future study should be designed to look at the effect of particular surgical interventions, whether gastric bypass,

gastric banding or sleeve gastrectomy, on cognition, said Matt B. Martin, MD, FACS, bariatric surgeon with Central Carolina Surgery in Greensboro, N.C. “It’s an intriguing study,” said Dr. Martin. “The limitation from a surgical standpoint is that they did not look at the impact [on cognition] of each surgical intervention. It would be important to know what kind of operation [patients] had and see if there’s any difference across groups.”

31GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012 Issues for the BarIatrIc & MetaBolIc ProfessIonal


Too Many Tacks Associated With Postoperative Hernia PainCaution advised against liberal use of Tacks, Regardless of Type


Fixing hernia meshes with more than 10 tacks, even if they are absorbable,

doubles the risk for early postoperative pain while having no benefit on reduc-ing rates of recurrence, suggests a review published in the Annals of Surgery.

Moreover, surgeons are more like-ly to use tacks liberally when using the absorbable variety, the study showed (2011;254:709-715).

“Absorbable tacks take months to degrade, and in the short-term, these tacks are just as liable to induce post-operative pain as their permanent coun-terparts,” wrote Igor Belyansky, MD, a fellow in laparoscopic surgery at Caro-linas Medical Center, Charlotte, N.C., and colleagues in their report.

Dr. Belyansky and colleagues used the International Hernia Mesh Regis-try (IHMR) to compare postoperative quality of life in patients undergo-ing laparoscopic totally extraperitone-al (TEP), transabdominal preperitoneal (TAPP) or modified Lichtenstein (ML) hernia repairs.

The IHMR is a prospectively col-lected, multicenter database with more than 30 participating sites in the Unit-ed States, Europe and Canada. “Patients

are allowed to enter their own quality-of-life data and this is the first study to directly compare quality-of-life out-comes of TEP, TAPP and open repair in such a manner,” said Dr. Belyansky.

Investigators studied almost 2,000 patients who underwent inguinal her-nia repairs completed between 2007 and 2010. The distribution of unilater-al procedures was TEP (n=217), TAPP (n=331) and open repair (n=953), with bilateral repairs in 413 patients.

Analysis showed that one month after surgery, patients in whom absorb-able tacks were used experienced high-er rates of postoperative pain than those in whom nonabsorbable tacks were used (25.7% vs. 11.5%; P=0.015).

However, further investigations found that absorbable tacks were, on average, applied in greater quantities than nonabsorbable tacks (P=0.001). When using absorbable tacks, surgeons placed more than 10 tacks in 33% of cases compared with 2.7% of cases with permanent tacks. When controlling for the number of tacks, no difference was observed in pain levels during early or long-term follow-up between absorb-able and permanent tacks. That sug-gests it is the number of tacks used, and not the materials used in the absorbable tacks, that account for the higher rates of postoperative pain.

There was no difference in recurrence rates when more tacks were used or with the application of absorbable or perma-nent tacks, the study showed.

Investigators encouraged surgeons to use the same degree of caution with absorbable tacks as they would with permanent ones.

Absorbable tacks do carry certain advantages, including the reduction of adhesion-related complications, but it’s their overuse that is problematic, said Todd Heniford, MD, principal investi-gator in the study and chief of gastroin-testinal and minimally invasive surgery at Carolinas Medical Center.

Some surgeons now use surgical glues alone for mesh fixation in order to reduce postoperative discomfort, said Dr. Heniford. This helps mitigate pain in the early postoperative phase, although their unpublished data now demonstrate that these patients com-plain of significantly more discomfort in prolonged follow-up than tack patients.

“With further investigation, we have found that with at least a year follow-up, nearly three times as many patients whose mesh was fixated with glue believe that their hernia has recurred because of increased symptoms and quality-of-life limitations,” said Dr. Heniford.

The finding needs to be validated

32 GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012Issues for the BarIatrIc & MetaBolIc ProfessIonal





®

GENERALSURGERYNEWS.COM

The Independent Monthly Newspaper for the General Surgeon

March 2012 • Volume 39 • Number 3

OpinionLarge Variation Found

In Payment for Nine Common

Surgical Procedures

Team Approach

Reduces Central-

Line Infections

BY KATE O’ROURKE

HOUSTON—Can hospitals drive their

rates of central-line bloodstream infec-

tions to zero? Although it sounds like

a pipe dream, multidisciplinary team

approaches are making great strides

in dramatically reducing rates, new

research has found.

At the Universi-

ty of Massachusetts

Memorial Medical

Center in Worcester,

for example, a team

of clinicians dedicated

to preventing central-

line infections in eight

of the hospital’s inten-

sive care units (ICUs)

cut the rate by almost

90% over a seven-year

period. Similarly, a

team effort at the Ohio State University

Medical Center in Columbus, decreased

infection rates in a 25-bed ICU by

roughly 33% in one year. Researchers

presented details of the two approaches

at the 2012 annual meeting of the Soci-

ety of Critical Care Medicine (abstracts

Study of Accelerated Partial Breast

Irradiation Sparks Debate

BY KATE O’ROURKE

A new study has spurred some

doctors to urge caution in

selecting patients for accelerated par-

tial breast irradiation (APBI) and

angered others who say the study

is fl awed and could derail a Phase

III clinical trial testing APBI. The

retrospective study, presented at the

recent San Antonio Breast Can-

cer Symposium (SABCS), conclud-

ed that APBI with brachytherapy is

associated with inferior effectiveness

and increased toxicity compared with

Spam in a Can II:

Another Perspective

BY EDWARD M. COPELAND III, MD

I always enjoy the opinion col-

umns written by David Coss-

man, MD. His opinions usually

refl ect the constructive criticisms

that I would get from the pri-

vate sector as I traveled around

the country in my various capacities as

a representative of the leadership of the

American College of Surgeons (ACS).

Often these criticisms took the form of

“what have you done for me lately?” or

were made with minimal background

information. I have been gone from

a leadership role in the ACS now for

more than fi ve years and cannot com-

ment on the views of the members of

the current Board of Regents.

What I can say is that I am a mem-

ber of the “then” generation and Tom

Russell, MD, became a member of the

“now” generation. These views put us

into confl ict. From Dr. Russell’s posi-

tion as the executive director of the

ACS, he was able to see the “now”

generation of surgeons and health care


BY CHRISTINA FRANGOU

SAN FRANCISCO—A new study reveals

vast discrepancies in surgeons’ hour-

ly payment for some common gener-

al surgery procedures—a fi nding that

demonstrates signifi cant failings in the

current reimbursement formula.

Researchers compared the total

care time and payment per unit of

time for nine common inpatient and

outpatient procedures using Cur-

rent Procedural Terminology (CPT)

Procedure

Estimated payment

per hour

Lap gastric bypass

$707

Thyroidectomy

$693

Lap gallbladder with cholangiogram$541

Lap Nissen fundoplication$481

Partial mastectomy

$453

Lap appendectomy

$443

Inguinal hernia repair

$326

Umbilical hernia repair

$321


see SPAM II page 39

see REIMBURSEMENT page 36

see PARTIAL BREAST IRRADIATION page 50

see CENTRAL-LINE page 22

In the News

Statewide Data Initiative

Reveals Clues To

Improving Outcomes

............................

..............4

INSIDE Clinical Review

Catheter-related

Bloodstream

Infections

.......................7

Obesity Care

Study Shows Plateauing of

Obesity, Confl icting With

Earlier Studies ............26

CLINICAL

EXPERIENCE

Endo GIA™ Reloads With Tri-Staple™

Technology and Endo GIA™ Ultra Universal

Staplers in Minimally Invasive Liver and

Pancreatic Resections see page 12

SPECIAL

REPORT

ProGripTM Mesh: Self-Gripping Mesh for

Hernia Repairsee page 6

NEW PRODUCT ANNOUNCEMENT

see page 38

SPECIAL

REPORT

Addressing Current Challenges in Managing

Postsurgical Pain With EXPAREL®, a New

DepoFoam® Formulation of Bupivacaine

see page 26

with randomized studies, said Robert J. Fitzgibbons, MD, the Harry E. Stuck-enhoff Professor of Surgery, Creighton University School of Medicine, Omaha, Neb.

“It’s interesting that surgeons use absorbable tacks more liberally and I’m sure I’m guilty of that myself,” he said.

However, the investigators used a database to which surgeons can volun-tarily submit data, which may skew the results.

“Before I really trust the conclu-sions or make any practice changes, I’d want to see a randomized trial,” said Dr. Fitzgibbons.

The investigators note that the study was carried out among regional and national hernia specialists. Of any group studies, patients undergoing TAPP repair had the highest frequency of symptoms after one month, as measured by the Carolinas Comfort Scale (CCS). More than 16% of first-time unilater-al TAPP repair patients and 40.7% of recurrent unilateral repair patients had CCS scores greater than 1.

Similar scores were reported by 8.9% of first-time and 21.4% of recurrent TEP repair patients and 16.5% and 20% of unilateral and current ML repair patients.

Subgroup analysis showed more tacks were used in patients who underwent TAPP repairs. In all, 18.2% of TAPP patients had more than 10 tacks com-pared with only 2.3% of TEP repairs. Tacks are not generally used for an ML repair: Only 0.2% of these patients received any tacks. When controlling for number of tacks, no difference in symptoms was observed between TEP and TAPP methods.

Some surgeons may choose to use tacks more often for TAPP repairs because of the need to close the perito-neum, said the authors.

“Excess tacks cause patients early postoperative discomfort and diminish some of the central benefits of the lap-aroscopic approach. We hope this body of work will encourage hernia surgeons to reassess their current practice of peri-toneal closure when performing a TAPP repair,” said Dr. Belyansky.

Alternative methods for mesh fixa-tion exist, including sutures, fibrin glue

and no fixation as mesh is placed in the preperitoneal space.

One surgeon expressed concern about the simplified pain score used in the analysis. “Your abstract suggests cau-sality with the use of tacks; you can-not, of course infer that from your data set,” said Dion Morton, MD, professor of surgery, University of Birmingham, United Kingdom.

Previous studies have shown that tacks in inappropriate locations or in excess can contribute to pain follow-ing laparoscopic hernia repair. Absorb-able tacks were developed in hopes

that the dissolution of the tack would reduce incidence of long-term pain and adhesions.

The study also showed that repair of recurrent hernia was a strong predic-tor of postoperative pain. “The differ-ence in quality-of-life outcomes may be secondary to extensive tissue trau-ma caused by dissection of reoperative, scarred area,” the authors concluded.

Bilateral inguinal hernia repairs also were associated with higher pain levels during the early postoperative period when compared with unilateral repairs. Here, too, use of more than 10 tacks

on each side was associated with high-er frequency of symptomatic patients in the first month.

There was little difference in recur-rence between the three operative meth-ods. Recurrence rates ranged from 0.5% to 1.4%.

The authors are currently investi-gating predictors of chronic pain after undergoing an inguinal hernia repair. After the key factors contributing to chronic pain are identified, they plan to develop an algorithmic model that can be used in the preoperative setting.


‘we hope this body of work will encourage hernia surgeons to reassess

their current practice of peritoneal closure when

performing a TaPP repair.‘—Igor Belyansky, MD

“we hope this body of work will encourage hernia

surgeons to reassess their current practice of peritoneal closure when

performing a TaPP repair.”—Igor Belyansky, MD



To learn more and request a demonstration of Tri-Staple™ technology, visit www.tristaple.com.

Stapling Made Smarter

In head-to-head comparisons, the Endo GIA™ Black reload with Tri-Staple™ technology outperforms the Echelon Flex™* Green in thick tissue.1

Get in the thick of it

1. When compared to Echelon Flex™ Green reloads in bench top testing using explanted porcine stomach. Always refer to Endo GIA™ IFU for complete indications, contraindications, warnings, precautions, and instructions for use. COVIDIEN, COVIDIEN with logo, and Covidien logo, are U.S. and/or internationally registered trademarks of Covidien AG. ™*Trademark of its respective owner. ©2012 Covidien

Surgery Society Updates Guidelines on Breast Cancer CareBy ChRIstIna FRangOu

A new study is already providing addi-tional evidence that axillary lymph

node dissection (ALND) does not add benefit to sentinel lymph node resection in clinically node-negative breast can-cer patients with minimal sentinel lymph node involvement, supporting one of the new consensus statements issued by the American Society of Breast Surgeons (ASBS) in August, examining controver-sial issues in breast cancer care.

The guidelines, available at www.breastsurgeons.org, address four key areas of debate: management of the axilla and of borderline or high-risk lesions seen on image-guided breast biopsy, acceler-ated partial breast irradiation and screen-ing mammography. The ASBS’s updated position on management of the axilla in patients with invasive breast cancer was based on recent data from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial. The Z0011 trial showed that ALND “may no longer be routinely required” for patients who meet all the following criteria: T1-2 tumors; one to two positive sentinel lymph nodes without extracapsular extension; comple-tion of whole breast radiation therapy; and completion of adjuvant therapy, including hormonal, cytotoxic or both. The results do not directly apply to patients who have T3 tumors, have more than two positive nodes, or are undergoing mastectomy or partial breast irradiation.

Now new results from an update of the Phase III International Breast Can-cer Study Group’s (IBCSG) trial 23-01, presented at the San Antonio Breast Can-cer Symposium (abstract S3-1), showed no difference between patients random-ized to receive ALND or no ALND in the primary end point of disease-free sur-vival and for the secondary end point of overall survival (see General Surgery News, February 2012, page 1). “Our findings are consistent with those of the ACOSOG Z0011 trial,” said Viviana Galimberti, MD, of the European Institute of Oncol-ogy, in Milan, Italy. Since then, surgeons gradually have been adopting the more conservative approach to surgery, and the two trials together should change clinical practice, Dr. Galimberti said.

“These consensus statements can be very helpful to providers of breast care; however, they are not published to estab-lish or change the standard of care in a legal sense but to provide guidelines for patient care,” said Victor Zannis, MD, medical director of the Breast Care Cen-ter of the Southwest, Phoenix, and past president of the ASBS. “Because medi-cal care can and should be influenced by

innumerable factors that make each clini-cal case unique, it is important for practi-tioners to also use their clinical acumen to make decisions and not use the guidelines in a vacuum,” he added.

Among the other highlights, the ASBS reiterated its support for annual screening mammography for women aged 40 years and older. That policy runs counter to the 2009 guidelines from the U.S. Preventive Services Task Force (USPSTF), which call for biennial screening mammography for women aged 50 to 74 years. The USP-STF recommendations, which exclude a small group of women with unusual risk factors for breast cancer, are aimed at reducing harm from overtreatment.

But the ASBS, like other oncologic societies, points to studies demonstrat-ing that screening mammography leads to improved survival due to earlier detec-tion of breast cancer, including in women between the ages of 40 and 49.

Deanna Attai, MD, a breast surgeon in private practice and ASBS board member, said the ASBS developed its statement as a response to the USPSTF recommenda-tions. “While we all realize that screening mammography has limitations, especially in younger women with dense breast tis-sue, it does remain the most cost-effec-tive and practical screening tool for the early detection of breast cancer,” said Dr. Attai. “Many women were confused and angered by the USPSTF recommenda-tions. We acknowledge the issues regard-ing dense breast tissue and young women; mammography is not a perfect tool, but it is the best screening test we have now.”

Controversy exists over the use of senti-nel lymph node biopsy after preoperative systemic therapy because selective steril-ization of lymph nodes may occur, possi-bly leading to reduced accuracy and high false-negative rates. The board found data that suggest a similar accuracy and false-negative rates for sentinel lymph node biopsy after neoadjuvant systemic therapy for clinically node-negative patients. But the data are less clear on the use of senti-nel lymph node biopsy after neoadjuvant systemic therapy in patients with clinical-ly positive nodes at presentation.

According to the guideline, patients who are node-negative based on clinical examination, radiologic examination and/or fine needle aspiration “may undergo sentinel lymph nodes biopsy” after preop-erative systemic therapy at the same time as their surgery for primary breast cancer.

It remains unclear whether patients with a positive clinical examination before preoperative systemic therapy are can-didates for sentinel lymph node biop-sy if they have axillary downstaging after therapy. But a multicenter, randomized controlled trial, currently under way in Europe, may alter future treatment rec-ommendations, according to the report.

The board also issued a guideline to help health care providers manage benign and borderline breast lesions diagnosed on needle biopsy of the breast. These lesions often cause difficulty for providers and patients when it comes to laying out a treatment plan. Sometimes the breast

core needle biopsy demonstrates a benign histology while the clinical or imaging findings point to a possible malignan-cy. Additionally, some core needle biop-sy findings are considered “borderline” because the biopsy indicates a nonmalig-nant diagnosis but cancer might be pres-ent at the biopsy site.

The ASBS recommends further evalu-ation in both of these instances. Discor-dant assessment should be followed by a repeat core needle biopsy, surgical exci-sional biopsy or clinical and imaging sur-veillance. Borderline lesions should be compared with imaging and clinical find-ings to determine concordance, followed by an action plan to either exclude malig-nancy or establish a plan of follow-up.

Multidisciplinary action is key for these patients, and should involve pathology, radiology and surgery to ensure adequate imaging and histologic tissue sampling of the targeted lesion, according to the guideline: “This approach optimizes the accuracy of diagnosis, prevents delays in cancer diagnosis and determines observa-tional and treatment planning.”

The authors also identified what kinds of benign and borderline lesions are at risk for upgrading to malignancy, such as

atypical ductal hyperplasia, lobular neo-plasia, columnar cell lesions, papillary lesions, radial scar, fibroepithelial lesions with cellular stroma, and spindle cell lesions. Management of all nonmalignant lesions should be individualized on a case-by-case basis, they said.

In a final statement, the ASBS outlined the patient criteria and appropriate tech-niques for accelerated partial breast irra-diation. “Maturing data is increasingly supportive of the use of partial breast irra-diation as an alternative to whole breast irradiation,” said Dr. Zannis.

The ASBS recommends that all patients who are treated with accelerated partial breast irradiation as a sole form of radiation therapy in lieu of whole breast irradiation be aged 45 years and older with invasive cancer or aged 50 years and older for ductal carcinoma in situ, have a total tumor size of less than or equal to 3 cm, have negative microscopic surgi-cal margins on excision and are sentinel lymph node-negative.

The ASBS board noted that sev-eral techniques can deliver this thera-py, including multiple catheters placed through the breast, a balloon catheter or multicatheter single-insertion device placed into the lumpectomy cavity, local-ized three-dimensional conformal exter-nal beam radiation, bead or seed implants and single-dose intraoperative treatment.

All patients should be monitored to identify adverse events and local recur-rences, according to the report, and con-tinuous long-term, outcomes-based monitoring is “desirable.”

Funda Meric-Bernstam, MD, wel-comed the guidelines, saying they come at a time when surgical management of breast cancer is undergoing major chang-es. “This is a very important initiative on the part of the ASBS. We are very lucky in that this is a very exciting time and a lot of clinical trials have come to fruition,” said Dr. Meric-Bernstam, professor of surgi-cal oncology and medical director of the Institute of Personalized Cancer Ther-apy, University of Texas MD Anderson Cancer Center, in Houston. “New tech-nologies have been introduced and this is definitely a time where breast surgeons have to incorporate a lot of new informa-tion rapidly to their practice to make sure they are delivering state-of-the-art care.”

The field’s understanding of lymph node status and management has evolved in recent years, and the guidelines will help surgeons make the necessary prac-tice changes, Dr. Meric-Bernstam said. They underscore the fact that many of the changes in practice are applicable only to specific patient populations. “That’s a critical element,” she added.


‘new technologies have been introduced, and this is definitely a time where breast surgeons have to really

incorporate a lot of new information rapidly to their practice to make sure they are delivering

state-of-the-art care.’ —Funda Meric-Bernstam, MD



3 Vehicles


3. Video Arcade

2. Video E-newsletter

1 Video

INTRODUCING


codes for the 2009 fiscal year. The analy-sis showed incongruities in payment for procedures, ranging from a low of $188 per hour for partial colectomy to a high of $700 per hour for laparoscopic gastric bypass. These figures do not include time spent in operative planning, administra-tive matters or overhead.

Still, “the discrepancy should be con-sidered a red flag,” said lead author Abhishek Chatterjee, MD, MBA, a senior resident in plastic surgery at

Dartmouth-Hitchcock Medical Center, in Lebanon, N.H., who presented the study at the 2011 Clinical Congress of the American College of Surgeons.

The wide range in hourly compensa-tion reflects major flaws in the formu-la used to set compensation rates, Dr. Chatterjee said. The formula is based on subjective assessments of physician work rather than hard data, he said. As a result, some procedures are reimbursed much better than others, regardless of case difficulty.

“I’m not saying the RVU [relative value unit] system should be thrown

out the door. It has its strengths, but the physician’s time element needs to be bet-ter objectively assessed.”

The relative value scale used for CPT reimbursement is based on a formu-la composed of 52.5% physician work, 43.6% practice expense and 3.9% pro-fessional liability. The physician work aspect covers mental effort, techni-cal skill, judgment and physician’s time. Physician’s time includes operating time, hospital days and follow-up clinic days in 15- or 30-minute segments.

The investigators reviewed physician payments for nine operations at a level

1 tertiary care academic health center. They analyzed five common outpatient procedures: laparoscopic gallbladder surgery with cholangiogram, inguinal hernia repair, umbilical hernia repair, thy-roidectomy and partial mastectomy with

36 In the News GeneralSurGerynewS.com / General SurGery newS / march 2012

The study ‘opens up a can of worms’ about inequities in payments to physicians.

Clearly, discrepancies exist in general surgery.

—Warren D. Widmann, MD

ReimbuRsementContinued from page 1




lymph node dissection, and four inpatient procedures: laparoscopic Nissen fundopli-cation, laparoscopic gastric bypass, partial colectomy with anastomosis and laparo-scopic appendectomy.

For each procedure, the investigators compared incision time, postoperative days per case, follow-up days, addition-al hours, total care hours and physician payment per case. The investigators then broke down the fee into payment per hour for each procedure.

Gastric laparoscopic bypass topped the reimbursement list at $707 per hour, followed by thyroidectomy at $693 and

laparoscopic gallbladder with cholangio-gram at $541. Laparoscopic Nissen fun-doplication, partial mastectomy with lymph node dissection and laparoscopic appendectomy were reimbursed at simi-lar rates of $481, $453 and $443 per hour, respectively. Near the bottom of the list were umbilical hernia repair at $321 and inguinal hernia repair at $326 per hour. Far below all other operations was par-tial colectomy with anastomosis at $188 per hour. Additionally, the study showed no noticeable differences in reimburse-ment between inpatient and outpatient procedures.

Dr. Chatterjee emphasized that the study was not designed to assess wheth-er surgeons make too much money or not enough for each procedure. In fact, the dollar value per hour for each pro-cedure does not accurately reflect what a surgeon earns each hour. It fails to take into account many things such as the time spent with patients doing informed con-sent or answering phone calls in the mid-dle of the night.

But what the study does clearly dem-onstrate is a lack of consistency in reim-bursements from one procedure to the next, Dr. Chatterjee said.

The study is “important and timely,” said Warren D. Widmann, MD, profes-sor of clinical surgery at the State Uni-versity of New York Downstate Medical Center, in New York City.

The finding comes as fee schedules are under reassessment and global fees for the care of patients are becoming more com-mon. The study should be a warning for policymakers that they need to set fee schedules “on the basis of solid data rath-er than historical use of subjective esti-mates,” said Dr. Widmann.

The study also “opens up a can of worms” about inequities in payments to physicians. Clearly, discrepancies exist in the field of general surgery, he said. But there are inequalities, too, among differ-ent specialists such as general surgeons, neurosurgeons, vascular surgeons and even internal medicine specialists and radiologists who perform invasive pro-cedures. That raises the issue of wheth-er physicians in all specialties should be compensated equally for their work.

“Currently, there is a trend for all spe-cialties to require five or six years of post-graduate training. Thus, it is reasonable to think about leveling the overall playing field for all proceduralists.”

Vascular surgeons conducted a simi-lar study in 2010, which compared reim-bursements for endovascular and open procedures (J Vasc Surg 2010;52:1094-1098). The study showed that the aver-age reimbursement was $316 per hour for open procedures and $556 per hour for endovascular. Procedures reimbursed at higher rates included visceral endovascu-lar procedures ($701 per hour) and caval filters ($751 per hour), which was reim-bursed at more than the rates for lower extremity bypass ($292 per hour), dialysis access ($268 per hour) and lower extrem-ity amputations ($223 per hour).

One of the most common practices used to measure time is historical surveys of surgeons, asking them how much time they take to do a procedure, said Dr. Chat-terjee. “With surveys, there’s an immense subjectivity, response bias, recall bias. You take what should be a very objective mea-sure and make it very subjective.”

Dr. Chatterjee suggested that policy-makers should use real data collected by national societies. The societies could set a figure for average total care times or best-practice total care time. The worth or value of the physician’s work aspect of an RVU then would be set based on national average total care time, thereby influenc-ing reimbursement rates.

Dr. Chatterjee also called on other specialties to do more studies looking at reimbursement across different proce-dures. “This clearly needs to be taken to another level looking at measures, nation-al measures that incorporate time and payment per unit time so that there’s a standard which you use,” he said.

37GeneralSurGerynewS.com / General SurGery newS / march 2012 In the News



Next stop:

®

Now Available...

ChairStephen M. Cohen, MD, FACS, FASCRSAssociate Clinical Professor, Department of SurgeryEmory University School of MedicineVice Chairman, Department of SurgerySouthern Regional Medical CenterAtlanta Colon and Rectal SurgeryAtlanta, Georgia



Accreditation Statement� is activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of AKH Inc., Advancing Knowledge in Healthcare, and Applied Clinical Education. AKH Inc. is accredited by the ACCME to provide continuing medical education for physicians. AKH Inc. designates this enduring activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Goal� e goal of this activity is to educate general and colorectal surgeons on strat-egies for optimizing outcomes in complex hernia repair and abdominal wall reconstruction through choice of biologic mesh and proper surgical technique.


lenges of complex hernia repair (eg, bovine pericardium, porcine intestine, porcine dermis, and human dermis) and their eff ects on tissue remodeling and revascularization.

2 Describe the importance of host response to the collagen scaff old and the balance between mesh degradation and new tissue infi ltration with bovine pericardium-based mesh.








FDA Warns of Risk for C. difficile–Associated Diarrhea With PPI UseExpert Offers Tips for using PPIs

In light of FDa Warning

By geORge OChOa

In a safety alert dated Feb. 8, the FDA warned that proton pump inhib-

itors (PPIs) may be associated with an increased risk for Clostridium dif-ficile–associated diarrhea (CDAD). The alert affects both prescription and

over-the-counter (OTC) PPI products. Evidence of a potential association

between PPI use and risk for CDAD has been accumulating for some time.

“The FDA reacted to a string of pub-lications showing that PPI therapy is associated with C. difficile and C. dif-ficile colitis,” commented Ronnie Fass, MD, professor of medicine, Universi-ty of Arizona College of Medicine, and director, GI Motility Laboratory, Univer-sity of Arizona Health Sciences Center,

both in Tucson. “It makes sense to me, and I think it is timely.”

Despite the warning, the FDA cau-tioned that patients should not stop taking prescription PPIs without first consulting their health care providers. Patients taking OTC PPIs should pay careful attention to the directions for use in the package inserts of those drugs, the FDA advised.

“Recommendations to avoid PPIs as a therapeutic class are unwarranted,” stated

Karen R. Mahoney, an FDA represen-tative, in an email to General Sur-gery News. “Since there are many causes of diarrhea, FDA is recommending that PPI users with diarrhea that does not improve should contact their health care professional to be evaluated for the pos-sibility that their symptoms could repre-sent CDAD.”

The FDA says it is working with manufacturers of PPIs to expand drug labels to include information about the increased risk for CDAD with PPI use. The FDA also is reviewing the risk for CDAD associated with the use of hista-mine H2 receptor blockers.

“PPIs are a therapeutic class of drugs which have known efficacy and safety profiles, having a therapeutic benefit for many patients with the labeled indica-tions,” Ms. Mahoney noted.

The FDA recommends that clini-cians consider a diagnosis of CDAD in patients taking PPIs who develop diar-rhea that does not improve. The agen-cy also advises that patients taking PPIs seek immediate medical care if they develop watery stool that does not resolve, abdominal pain and fever. PPI therapy should be limited to the lowest dose and the shortest duration appro-priate for the condition being treated, according to the FDA.

Mark Reid, MD, a hospitalist at Den-ver Health Medical Center, and associ-ate professor of medicine, University of Colorado Health Sciences Center, both in Denver, observed that the FDA alert is “worded very gently.” He believes this is appropriate because at present only an association exists between PPI use and C. difficile; causation has not been proven.

“It’s a notification of a possibility of increased risk,” he said. “The wording fits the level of information we have.”

Dr. Reid added that “it’s reasonable to suspect, with the information we have now, that a patient on PPIs may be more likely to get C. difficile infection than a patient who is not on these medications. It’s a good time for clinicians to start looking at their own practice, to scruti-nize their use of these medicines.”

Dr. Fass speculated that the FDA alert was not more specific because more stud-ies need to be done. For example, age, high dosing and duration of PPI thera-py also are suspected risk factors, he said, but there is “no sufficient evidence to state that clearly.

“This warning will be the impetus for further research,” he predicted.

Drs. Fass and Reid reported no relevant financial disclosures.


Looking to lower your malpractice insurance premiums? Call 1-888-490-5185 or visit NovusMD.com/quick-quote for a quick quote.

The American Society for Metabolic and Bariatric Surgery (ASMBS) has endorsed Novus Insurance Program for its members.

“ ”A niche malpractice insurance program forbariatric and general surgeons

NovusMD.com

We understand your practice.We understand because the Novus program was created exclusively for surgeons by surgeons—

our owners are bariatric and general surgeons just like you. Novus is the medical malpractice

insurance solution for bariatric and general surgeons.

We work with you in creating systems of excellence to help reduce risk

Our goal is to provide stable premiums, long-term reliable coverage and enhanced benefits

Reinsured by NORCAL Mutual, A rated (A.M. Best) with $1.2 billion in assets

3 specialty classes: Bariatric/General Surgery, Gen. Surg., & Gen. Surg. w/gastric banding

Low $100 stock membership fee to join

Novus Insurance Program is underwritten by Healthcare Safety & Protection Risk Retention Group, Inc.

legislation coming at us “then” generation of surgeons like a freight train without brakes. He did an outstanding job of attempt-ing to integrate the “then” and “now” philosophies for the changing membership of the ACS. Possibly he did not project his leadership through this changing medical landscape as well as he potentially could have. This was the source of our conflict. I was in favor of fighting as good a battle as possible for the “then” generation, who made up the more “at-risk” members of the ACS, while working in the background to bring the ACS into the “now” generation, which was rapidly expanding. The former battle was doomed to failure from sources out-side the influence of the ACS. The better use of ACS resources was to position the membership into a position of influence within an evolving medical system that was going to be unpleasant for all of us.

As to this last point, anyone who read Dr. Cossman’s opinion piece should move their eyes to the immediate right to read the article entitled “ACOs: The Latest Experiment in Health Care Delivery.” Recorded here is the excellent job being done by your ACS representatives, espe-cially Andrew Warshaw, MD, and John Armstrong, MD, in this ever-changing landscape of health care delivery, which will not begin to be resolved until after November 2012.

A common misconception of members of the private sector throughout my career as an academic surgeon on the faculty of the University of Florida [Gainesville] was that my salary and support came from the state of Florida. In fact, my state sal-ary support was $8,000 (and yes, I made more than a total of $8,000). The sala-ries of the surgical faculty members along with medical malpractice premiums, trav-el funds, etc., came from the private prac-tice of surgery. The more competitive we were, the more we made. Any change in reimbursement was as detrimental to us as it was to you (the private sector). Our income supported the secretarial and clin-ic staff and the dean’s office. I would trade dean’s office support for office rent any-time. At least if the private sector paid for office space, the physicians usually had a say in what the space would look like! I record this information to substantiate my claim to be a part of the “then” generation.

In December 2008, I was fortunate to have an opinion column entitled “Health Care Delivery: Its Origin and Dilemma” published in General Surgery News. In it, I speculated as to what entity will con-trol health care delivery in the future. My conclusion was hospitals because the reimbursement system favored the

accumulation of medi-cal reimbursement dol-

lars on the hospital side of the business, which would soon force physicians into an employee role. This financial accu-mulation contin-

ues today and is abhorrent to the “then” generation for the reasons enumer-ated by Dr. Cossman and I added several more in my presidential address before the ACS in 2006. The dissolutions of conti-nuity of care and of pride of “ownership”

of the patient were the “biggies.”Dr. Cossman wonders why specialty

societies continue to remain members of the ACS. I will admit that a wonderful

opportunity to bring the societies togeth-er with the ACS was lost when the orga-nizational abilities of Gerald Healy, MD, a pediatric otolaryngologist, were not fully employed by the ACS when he was presi-dent in 2007. This fault lies with the ACS leadership, not with Dr. Healy.

Nevertheless, the ACS with all its bag-gage remains the best resource for all of surgery to influence current and future directions of medical services for all sur-geons. To remain fragmented accomplish-es nothing. Let me be quick to point out that no ACS officer receives any form of

39GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012 opinion

see Spam II page 40

spaM iicontinued from page 1

The better use of acS resources was to position

the membership into a position of influence

within an evolving medical system that was going to be

unpleasant for all of us.

IndicationOFIRMEV is indicated for the management of mild to moderate pain; the management of moderate to severe pain with adjunctive opioid analgesics; and the reduction of fever.

Important Safety InformationOFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation. Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment.

Do not exceed the maximum recommended daily dose of acetaminophen. Administration of acetaminophen by any route in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death.

OFIRMEV should be administered only as a 15-minute intravenous infusion.

Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy.

The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients.

OFIRMEV is approved for use in patients ≥2 years of age.

The antipyretic effects of OFIRMEV may mask fever in patients treated for postsurgical pain.

To report SUSPECTED ADVERSE REACTIONS, contact Cadence Pharmaceuticals, Inc. at 1-877-647-2239 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com.

Please see Brief Summary of Prescribing Information on adjacent page or full Prescribing Information at OFIRMEV.com.

* Randomized, double-blind, placebo-controlled, single- and repeated-dose24-h study (n=101). Patients received OFIRMEV 1 g + PCA morphine orplacebo + PCA morphine the morning following total hip or knee replacementsurgery. Primary endpoint: pain relief measured on a 5-point verbal scale over 6 h. Morphine rescue was administered as needed.

† SPID24=sum of pain intensity differences, based on VAS score, frombaseline, at 0 to 24 h.

References: 1. Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER,Groudine SB, Payen-Champenois C. Effi cacy and safety of singleand repeated administration of 1 gram intravenous acetaminopheninjection (paracetamol) for pain management after majororthopedic surgery. Anesthesiology. 2005;102:822-831.2. Data on fi le. Cadence Pharmaceuticals, Inc.

©2012 Cadence Pharmaceuticals, Inc. All rights reserved. OFIRMEV and the OFIRMEV dot design are trademarks of Cadence Pharmaceuticals, Inc. OFV11310112 OFIRMEV.com

Less pain. Less opioids.

OFIRMEV® provides signifi cant pain relief*1

• OFIRMEV 1 g (Q6h) + patient-controlled analgesia (PCA) morphine demonstrated signifi cant pain relief vs placebo + PCA morphine (P<0.05 over 6 h)1

• OFIRMEV 1 g (Q6h) + PCA morphine showed greater reduction in pain intensity over 24 h (SPID24)† compared to placebo + PCA morphine (P<0.001)2

OFIRMEV reduces opioid consumption*1

• OFIRMEV 1 g (Q6h) + PCA morphine signifi cantly reduced morphine consumption vs placebo + PCA morphine (–46% over 6 h, P<0.01; –33% over 24 h, P<0.01)1

• The clinical benefi t of reduced opioid consumption was not demonstrated

Schedule OFIRMEV Q6h for the fi rst 24 h• Continue OFIRMEV or transition to PO

analgesia based on patient assessment

personal reimbursements from the ACS and travel is tourist class. Those of us in academic surgery, at least at the Univer-sity of Florida, have had surgical partners who recognized the importance of having a national surgical leader in the depart-ment and were willing to subsidize my salary from their patient reimbursements. This subsidization has not always been the case in the private sector and too often excellent, qualified members of the private

sector have been precluded from involve-ment at the national level. Hats off to peo-ple in the private sector like Chuck Mabry, MD, Jim Elsey, MD, LaMar McGinnis,

MD (who, by the way, has been president of both the ACS and the American Cancer Society), Gary Timmerman, MD, Randy Bailey, MD, Dick Sabo, MD, and several others who have been able to be extreme-ly influential in national, medical politics while maintaining a private practice.

The apathy toward the ACS is expressed, as Dr. Cossman suggests, in the poor response to the ACS Political Action Committee (PAC) request for donations. A $250 donation from each member of the ACS would generate more money than is available from the lobbying efforts of the trial lawyers. Of course trial lawyers’

donations often come from the pooled resources of the firm and not directly from the pockets of the individuals, as has been the case until now for surgeons. Maybe one salutary effect of the “now” generation of surgeons is that they will convince their employer to donate money to the ACS PAC.

—Dr. Copeland is emeritus distinguished professor of surgery at the University of Flor-ida College of Medicine, Gainesville, and past president of the American College of Surgeons.

change or risk extinction

To the Editor:Natural selection applies not only to

the evolution of species, but also to the survival of professions. Over the centu-ries, innumerable industries have been rendered obsolete by their inflexibility (or unwillingness) to change. The field of surgery finds itself, in 2012, present-ed with the opportunity to change for the better, or to be relegated to relative extinction by continuing on a path lead-ing toward irrelevance. Capitol Hill has grown weary of an older generation of surgeons who speak wistfully of a past era that was not patient-centered. Indeed, it was the patients and society who felt as if they were the ones being treated like “spam in a can” back “then,” and who rebelled and are now forcing our profes-sion to change. As Dr. Cossman rightly asserts, the political process in Wash-ington D.C., has changed little over the decades, and physicians have had min-imal impact in health advocacy both “then” and “now.” I would encourage Dr. Cossman to venture to the front lines of Capitol Hill, where he would likely dis-cover that calling for a return to the past and criticizing his fellow surgical col-leagues are largely ineffective against the powerful forces aligned in opposition to the days of “that was then” in surgery.

—John Maa, MD, FACS, San Francisco, California

Member of General Surgery News editorial advisory board

Letters to the Editor

40 opinion GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012

spaM iicontinued from page 39

a $250 donation from each member of the acS would

generate more money than is available from the

lobbying efforts of the trial lawyers.

� +We would like your opinion.Please send letters to:

[email protected].

Comments on “Spam in a Can”To the Editor:[Re: Spam in a Can, January 2012,

page 1]The most recent Cossman editori-

al in General Surgery News is a sad and frankly embarrassing rant by an aging, cranky surgeon who pines for the “good old days” and who is clearly out of touch with modern medicine. Why you con-tinue to have him as a commentator is puzzling and diminishes the quality of your otherwise excellent product.

—James P. Morris, MDSan Francisco, Calif.

The following letters were posted at generalsurgerynews.com

[For more responses to this issue, visit www.generalsurgerynews.com and click on “Recent Comments” in the upper right-hand corner.]

Dr. Cossman, once again you have hit the nail on the head. As a young gener-al surgeon in solo practice, I see nearly all of my fellow young surgeons opting for employed positions. But this is not something that has happened overnight. The employment of physicians has been growing slowly for some time. I am not usually a conspiracy theorist, but I truly think that this is the way that the govern-ment has planned to control us. If they can get us to give up our independence and become part of the “labor” side, then it will be much easier for them to force changes in reimbursement, standards, etc. If we are in private practice, then the pro-cess is somewhat like herding cats. Once we all are in the employed side, then as a condition of employment, we will have to comply with all of the new standards, maintenance of certification, meaning-ful use, cookbook medicine etc. Just a thought, but one that unfortunately seems to be coming true.

—Posted Jan. 19, 2012

I wholeheartedly agree with you, Dr. Cossman. I’m a 41-year-old general and bariatric surgeon in private practice in southern New Jersey. More and more of

the newly graduated surgeons are becom-ing employed by the local hospitals, which puts tremendous financial pressure on us private guys. These systems can just keep hiring more and more competition for us, and because they are simultaneous-ly buying primary care practices as well, they can drive all the referrals to their own employed surgeons. The private prac-tice surgeon is becoming a dinosaur. I’m determined to fight until the end though!

—Posted Feb. 2, 2012

Dr. Cossman, you’re 100% correct but the problem is that you're talking to the few of us who want to be small business-men and run their own show. Hospitals have the gold and they make the rules, sorry to say. I, like you, are in the twi-light of my career and my only option after retiring from my own practice was to become an employee of a hos-pital, which is awful but allows me to stay active and not be hammered by all the worries of an office and malpractice.

The young have no clue, have large debts and want lifestyle over excellence. The fact that the hospital pays 10% of what my malpractice bill used to be while I’m doing the same operations is the government’s way of screwing the individual. Keep your chin up and your writing. Remember, the pen is mightier than the sword!

—Posted Jan. 20, 2012

41GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012 letters to the editor

carefusion.com/chloraprep | 800.523.0502

ChloraPrep® products have been shown to outperform iodine-based products.1,2

The evidence is in. When it comes to eliminating bacteria from the skin,

there is a difference. ChloraPrep® skin antiseptic is becoming a new standard

of care for preoperative skin antisepsis.

More effective than iodine-based products at eliminating skin microorganisms.

Period.

© 2012 CareFusion Corporation or one of its subsidiaries. All rights reserved. CHLORAPREP is a registered trademark of CareFusion Corporation or one of its subsidiaries. ADV-Period1211

“Chlorhexidine gluconate is superior to povidone-iodine for preoperative antisepsis for the patient and surgeon.” 3

References: 1. Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009;91(8):1949–1953. 2. Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005;87(5):980–985. 3. Fletcher N, Sofianos DM, Berkes MB, Obremskey WT. Prevention of perioperative infection. J Bone Joint Surg Am. 2007;89(7):1605–1618.

Dear readers,

Welcome to the March issue of The Surgeons’ Lounge. We welcome back our guest expert, Raul Rosenthal, MD, professor of surgery and chairman, Section of Minimally Invasive Surgery and The Bariatric and Metabolic Institute, as well as director of the General Surgery Residency Program and of fellowship in Minimally Invasive and Bariatric Surgery at Cleveland Clinic Florida,

Weston. Dr. Rosenthal is questioned regarding a patient with a bile leak following robotic laparoscopic cholecystectomy. Read on to see how this case is managed! The April issue will feature Jaime Garcia, MD, and Elias Chousleb, MD, both from Florida Interna-tional University Herbert Wertheim College of Medicine, in Miami. Take the Surgeon’s Challenge, and see what our experts say about laparoscopic cholecystectomy as an outpatient procedure in the Expert Express!

We look forward to your comments and questions.Sincerely,Samuel Szomstein, MD, FACSEditor, The Surgeons’ [email protected]

Surgeon’s challenge From the February 2012 issue

A 79-year-old male patient presents with abdominal pain and has a known umbilical her-nia. To date, the patient has been able to self-reduce the hernia. On presentation, there is a very hard, tender mass noted at the umbili-cal hernia site, which cannot be reduced in the emergency room. The patient is taken to the operating room where a small midline laparoto-my incision is placed about 5 cm above and 2 cm below the umbilicus. The hernia sac is opened and there is approximately 7 inches of incarcerated bowel with evidence of ischemia and suffering. However, there is no evidence of necrosis; there is good peristalsis along the incarcerated seg-ment of bowel; and after a brief observation peri-od, the ischemic segment looks well perfused. A partial omentectomy is performed and the bowel and the remaining omentum are reduced back into the abdominal cavity. The hernia sac is then excised. The defect is closed with 1 PDS [polydioxanone] interrupted sutures. On postop-erative day 2, the patient’s abdomen is markedly distended, and a nasogastric tube is placed. The output is approximately 2.5 L over 24 hours. The white blood cell count is 8 K/mcL with no shift, no fever and no abdominal pain. A com-puted tomography scan is ordered on postoperative day 3 and the impression is ileus versus partial bowel obstruction. The patient is comfortable, although the abdomen is still mark-edly distended and the nasogastric tube output is more than 1 L per shift. The patient’s vitals and labs are all normal. What would you do?

replyThe patient was observed for an additional 24 hours. He said he was relatively comfort-

able, although the abdomen was still distended; his labs were normal; and he was passing a small amount of gas. The nasogastric tube output continued to be more than 2 L every 24 hours. Consequently, the patient was taken to the operating room for re-exploration of a possible partial bowel obstruction. Access to the abdomen occurred through the previous laparotomy incision, and markedly distended bowel was evident with distal collapsed loops of bowel. On further exploration, a transition area of approximately 10 inches of adherent bowel loops in an “S” formation was noted (Figures 1 and 2). This segment was resected and a primary anastomosis was fashioned. The patient’s recovery was uneventful and he was discharged home after re-exploration and the initial laparotomy.

An 84-year-old patient arrived at the emergency room complaining of abdominal pain, which started one

week before and was localized to the right upper quadrant. The patient was seen six days previously by a health care provider and underwent robotic laparoscopic cholecystec-tomy. “My 78-year-old wife also had it last year, but with a single incision,” he added. He remained hospitalized for three days and was discharged home not feeling well, com-plaining of abdominal pain, nausea, anorexia and edema in the lower extremities. The abdominal pain continued for several days.

On arrival in the emergency room, the pain was described as diffuse and of moderate severity. The patient denied vomiting, fever or diarrhea. On physical examination, the patient was in no acute distress and on abdominal examina-tion, moderate diffuse tenderness was noted.

Laboratory tests showed significant results. White blood cell count was 17.80 K/mcL; hemoglobin was 12.9 g/dL; hematocrit was 39.7%; total bilirubin was 1.1 mg/dL (0.2-1.0); aspartate aminotransferase was 58 U/L; and amino-transferase was 72 U/L. Lipases and amylase were within normal ranges. Results of a computed tomography scan are shown in Figures 1 and 2. The patient was diagnosed with bile leak (probable common bile duct leak) and was managed with stent placement after endoscopic retrograde cholangiopancreatography.

Several questions were raised regarding this patient:• Should robotic surgery be used in acute settings? • Is age a contraindication for robotic surgery?• Do you feel there is any benefit in performing robot-

ic surgery on an 84-year-old man or a single incision laparoscopic surgery (SILS) procedure in a 76-year-old woman?

• What are the most appropriate indications for robot-ic surgery?

• Should the robotic technique be included in general surgery training programs?

From abraham Fridman, DO Lutheran Medical Center, New York City

Question for Dr. Rosenthal

42 Surgeons’ lounge GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012

ContInued on page 44

Dr. Szomstein is associate director, Bariatric Institute, Section of Minimally Invasive Surgery, Department of General and Vascular Surgery, Cleveland Clinic Florida, Weston.

Figure 1. adherent bowel in “S” formation.

Figure 2. excised bowel in “S” formation.

InnovatIng by being in Touch WiTh your needs

In hernia repair

At Covidien, hernia care innovation means something more: meeting the real needs of surgeons. Discover how our comprehensive product portfolio can help you enhance any procedure.

covidien.com/ahs2012Innovation that matters

COVIDIEN HERNIA CARE • MESH • FIXATION • PErMAcOl™ • dISSEcTION

COVIDIEN, COVIDIEN with logo, and Covidien logo, are U.S. and/or internationally registered trademarks of Covidien AG. ©2012 Covidien

VISIT US AT BOOTH 302/304

• Does robotic surgery need to be performed as part of a research protocol? What is the ethi-cal perspective?

• What is your opinion regarding the intro-duction of new techniques such as SILS or robotics?

I thank Dr. Szomstein for the opportunity to com-ment on this controversial case and answer sever-al very important questions related to robotic surgery and SILS. I would like to start by answering the last question posed.

what is your opinion regarding the introduction of new techniques such as SIlS or robotics?

In recent years, I have had, on many occasions, the opportunity to express my opinion regarding the introduction of SILS, robotic surgery and several other new surgical approaches that have been marketed by both industry and surgeons. One could imagine that my sometimes “rigid” position against these new sur-gical approaches is the result of many years of train-ing in Germany, where changes in standards are very difficult to introduce. However, I actively participate in numerous trials aimed to develop new approach-es and technologies in surgery. My caveat is that all trials are using an institutional review board (IRB)-approved protocol or are conducted as part of an FDA trial. Does the fact that these new approaches follow IRB protocol or are part of an FDA trial make them safer? Of course not, but it does let the patient know what the risks are when embracing research protocols and new technologies that are under investigation.

We teach our residents and fellows that, in surgery, the most difficult part is not the technical aspect of the operation, but rather the indication of when to and when not to operate. Furthermore, I teach my res-idents and fellows that a good surgeon not only knows

when (indication) and how (technique) to operate, but equally important, can recognize and manage the com-plications that might ensue after what is considered a sound and uneventful surgical procedure.

The case presented in this issue of The Surgeons’ Loungeobliges me to address another very important point when defining what is the most important quality of a “good surgeon”—honesty. Honesty in admitting gaps in knowl-edge for diagnosing and defining an indication for sur-gery is essential. In that case, why not ask your chairman, senior or mentor for advice if you don’t know? Honesty in admitting to not having the necessary skills to carry out a procedure in a safe and sound fashion is just as crit-ical. Why not request an expert’s assistance (your partner or a dear colleague) to help you in the operating room when tackling a difficult or unusual case?

As mentioned in one study, robotic surgery has been used by many, if not most, surgeons and hospitals as a way to attract business (J Healthc Qual 2011;33:48-52).

The literature showing the benefits of this robotic approach over conventional ones (laparoscopy) is scant. But I can hardly imagine that a surgeon or hospital requires a robot to lure a patient to the emergency room or a private practice when that patient has gallstones and is requesting a cholecystectomy.

A surgeon who performs a robotic cholecystectomy on an 84-year-old patient, who subsequently develops a bile leak, brings all the tenets of what a “good surgeon” is into question. One has to wonder what the symptoms were at presentation when a cholecystectomy was indicated for this patient. What went through this surgeon’s mind (or what was the surgical algorithm) when deciding to use a robot to remove a gallbladder? Would a robot make sur-gery faster? Safer? Result in less pain or a decreased hos-pital stay? How long did the operation take? What was the code used to bill the insurance? Why was an 84-year-old patient sent home with a symptomatic abdomen after undergoing a “non-standard” approach?

I also wonder if an intraoperative cholangiogram (IOC) was performed, and if not, was it because of the robot? The literature supports, loud and clear, that patients over 65 years of age have a higher incidence of biliary tract pathology and common bile duct stones than younger patients. Although IOC does not com-pletely remove the risk for a common bile duct injury, it does help identify abnormalities and decrease the injury level, resulting in less harm to the patient.

Finally, and to follow the four most important quali-ties of what I consider to be a good surgeon (indication, technical skills, recognition and management of compli-cations, and honesty), how was this patient educated for informed consent?

Should robotic surgery be used in acute settings?

I personally do not use robots in my practice because I do not see any benefit for my patients undergoing acute or elective foregut surgery. However, there is literature to support the benefits in trauma patients undergoing robotic-assisted procedures near the battlefield and away from major medical centers. In this scenario, the bene-fit is to allow the expert to be included in the treatment algorithm, despite being far away (and sometimes out of harm’s way) from the operating room.

Is age a contraindication for robotic surgery?I do not believe that in 2012, age per se should be

considered a contraindication to any surgical approach, provided there are sound benefits to its use. Neverthe-less, we should be conscious that as we get older, we get sicker, and the big question we cannot answer is how much gas do we have left in our tank to go the extra mile if there is a complication? A good aphorism I learned a while ago is “Elderly people tolerate surgery but not complications.” In summary, when operating on the elderly, one should be mindful not to innovate unless there is a good reason to do so.

Do you feel there is any benefit in performing robotic surgery in an 84-year-old man and a SIlS procedure in a 76-year-old woman?

I am unsure what the profession of the 76-year-old woman was at the time of surgery, using the SILS approach. Unless she was a bikini model and did not want to show a couple of 5 mm scars for a period of three months in her upper abdomen, I do not see any reason to choose this approach. Those who advocate SILS know full well that cosmetic results are tempo-rary (scars will heal) and, in the long term, the results are probably similar to those found with the conventional laparoscopic approach. Five-millimeter trocar site scars will heal and disappear over time. All that remains is an umbilical incision that is most likely larger in the SILS

44 Surgeons’ lounge GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012

I can hardly imagine that a surgeon or hospital requires a robot to lure a patient to the emergency room or a private practice when that patient has gallstones and is requesting a

cholecystectomy.

continued from page 42

Dr. Rosenthal’s

Reply

approach. Additionally, those perform-ing SILS in 2012 often violate the major tenets of what is good surgical technique: good visibility, traction and counter-trac-tion, and saving time under anesthesia.

what are the most appropriate indications for robotic surgery?

Reviewing the current literature, the most popular approach seems to be total prostatectomy. I have to emphasize, how-ever, that I have not seen a prospective randomized controlled trial compar-ing the outcomes of laparoscopic versus robotic prostatectomy.

Should the robotic technique be included in general surgery training programs?

Currently, 99.9% of surgical proce-dures are carried out via laparoscopy or open surgery. Why train a surgeon in an approach that he or she will not be able to use when going into practice? Our goal should be to deliver the safest and most efficient surgeons to our community. To date, robots have not proven to add safety in general surgery. So, the answer is prob-ably not yet.

Having said that, I am certain that in the near future robots in surgery may allow surgeons to improve their quality assessment pathways. With simulation and robots, we can better plan and pre-pare our residents and ourselves for per-forming surgery.

We also have to mention that the robots we currently have are very expen-sive remote-directed arms and not smart robots. If there is no surgeon behind the console, there is no surgery. I believe that robotic surgery will thrive and continue to improve, but it should be conducted under strict IRB-approved protocols or as part of FDA trials.

Does robotic surgery need to be performed as part of a research protocol? what is the ethical perspective?

I believe this question was partly answered above. According to Laurence B. McCullough, PhD, surgical innova-tion should undergo five stages before being introduced: innovation (the new idea), development, exploration, assess-ment and long-term implementation. The idea comes from thinking of a new procedure prompted by the need for a new solution to a clinical problem in a patient. The implementation of a new technique should indeed be done under an IRB-approved protocol, or under the guidance and oversight of what many believe should be newly developed “Inno-vation Committees” (J Am Coll Surg2002;194:792-802).

Let me conclude by adding a brief comment on the paradigm of the aviation industry and surgery. We surgeons strive to achieve the standards that the aviation industry has achieved. There are two sit-uations in life when we are not in control of our destiny: when undergoing general anesthesia (surgery) and when boarding a plane. You just have to trust that whoev-er takes over for you or your loved ones is not only good but honest as well.

Why do we never ask the airline we choose to fly with who the pilot is? Which planes are they flying? Why are they choosing one route over another?

The reason is a very simple one. The dif-ference between performing surgery and flying is that pilots are the first ones to arrive at the crash scene. They will not innovate unless they know it is safe and effective.

In surgery, however, we can operate and go home to spend time with our families and rest. I sometimes wonder how some of our colleagues, like the one depicted in this issue of The Surgeons’ Lounge, taking care of this patient, go home and sleep at night.

45GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012 Surgeons’ lounge

Those who advocate SIlS know full well that

cosmetic results are temporary (scars will heal)

and, in the long term, the results are probably similar

to those found with the conventional laparoscopic

approach.

YES

NO

Money for DrugsShould Physicians Be Paid for Pharmaceutical Development and Clinical Investigations?

[Editor’s Note: The following article was originally published in Missouri Medicine, September/October 2011;108:321. It has been edited slightly for in-house style.]

By ChaRles w. Van way III, Md, MsMa

Congratulations on well-reasoned commentaries from all of the

authors in this debate. Because I agree substantially with Ms. Powell (Febru-ary 2012, page 40), let me address the arguments of Drs. Bohigian (Decem-ber 2011) and Gale (February 2012, page 40).

Dr. Bohigian has focused largely on the support of physician speakers on behalf of pharmaceutical companies. I have little disagreement with him. This area has great potential for abuse. Indeed, I cited speakers’ bureaus as the “most troublesome facet of this issue.” It is in this particular area that we must be the most careful, both as speakers and as audiences. And Dr. Bohigian’s comments on the need for physi-cian-researchers to be independent of the company sponsoring a research

project are exactly correct. I have a bit more concern about Dr. Gale’s com-ments, which are unremittingly nega-tive. He cites extensively the books by Drs. Angell and Kassirer, but he fails to mention their substantial conflicts of interest. Both of these authors were editors of a highly respectable journal that derives a great deal of its income from pharmaceutical advertising. One is tempted to speculate that their books derive from a feeling of guilt, but per-haps that goes too far. The important point, as Dr. Gale notes, is that both of their books are directed to the pub-lic, not physicians. Simply repeating these well-known arguments adds lit-tle to this discussion. In short, his pas-sion for morality on this issue is clear. But while moral outrage may be admi-rable, it provides few guidelines for our conduct in the future.

Dr. Van Way III is a professor of surgery and the Sosland/ Missouri Endowed Chair of Trauma Services at the University of Mis-souri, Kansas City.

geORge BOhIgIan, Md, MsMa

Transparency and common sense are the keys to solving the dilem-

ma “that physicians must remain independent of the pharmaceutical industry.”

Furthermore, physicians should not profit from drug companies, medical device makers, lectures or CME [con-tinuing medical education] efforts. I do agree in part with my colleague, Dr. Charles Van Way (Dec. 2011), when he states, “We are having a national discussion over the propriety of the physician relationship with industry and that we need more transparency.”

Our trade journals are filled with biased articles written by physi-cians with pharmaceutical compa-nies. In contrast, well-recognized peer-reviewed journals are more sci-entifically based, but are supported by advertisements from drug companies. This conflict is apparent and transpar-ent to any journal reader.

Frequently, the response to new

public policy tends to allow the pen-dulum to swing too far to one side. Common sense is essential. One of the potential impending problems with the new pharmaceutical rules is the lack of samples for indigent patients, especially at university clinics. As stat-ed, all information should be trans-parent. Honesty and openness by the pharmaceutical industry and physi-cians are the keys.

The guiding principle should be that physicians always act as whatev-er is in the best interest of the patient. Ethical collaboration between physi-cians and the pharmaceutical indus-try is essential for the development of new treatments. Transparency is an integral component of ethical collabo-ration. Hopefully, common sense will prevail in the future evolution of new state and federal rules and regulations. However, as Mark Twain said, “Com-mon sense is not that common.”

Dr. Bohigian is a professor of clinical oph-thalmology in the Department of Ophthal-mology and Visual Sciences at Washington University in St. Louis.

Part 3 of a 3-Part Series

46 opinion GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012



3 Vehicles


3. Video Arcade

2. Video E-Alert

1 Video3INTRODUCING


Here are FREE educational activitiesavailable now on CMEZone.com

www.CMEZone.comYour premier source for practical, relevant and timely

continuing medical and pharmacy education

Novel Applications for Biologic Mesh: Innovations in Complex Hernia RepairExpires August 31, 2013

MN119

Brain Monitoring of Anesthetic Effect: An Evidence-Based Assessment of Clinical Impact and Safe UseExpires April 1, 2012

SR1058

47GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012 GSn Bulletin Board

GSN

-031

2-00

1

GSN

-031

2-00

5

GSN

-031

2-00

3

The Division of General Surgery at the University of Washington School of Medicine is seeking an applicant for a full-time faculty position in the Urgent Care Surgery section at the rank of Acting Instructor or Assistant Professor, depending on the applicant’s credentials. This position will be on a service with three other attending surgeons and will be based primarily at the University of Washington Medical Center. The main responsibilities are to develop a gen-eral surgery practice, with a focus on urgent surgical consults and referrals, and to participate in the teaching of surgical residents, medical students, and divi-sion fellows. They are expected to develop an area of scholarly expertise, as expected of every faculty member, in consultation with the Division and Sec-tion Chief. The University of Washington Medical Center is a nationally recog-nized academic medical center offering outstanding specialty and primary care. UW faculty engage in teaching, research, and service. The candidates must have an MD (or equivalent) and be board certified or board eligible (or equivalent) in surgery. Graduates of foreign medical schools must have completed the U.S. Medical Licensing Exam (USMLE), Step 3 or equivalent as determined by the Secretary of Health and Human Services.

The University of Washington is an affirmative action, equal opportunity employer. Applicants should submit their curriculum vitae, a cover letter, and references to:

Brant K. Oelschlager, MDByers Endowed Professor in Esophageal Research

Department of Surgery, General Surgery DivisionUniversity of Washington

1959 NE Pacific Street, Box 356410Seattle, Washington 98195-6410Email: [email protected]

Chief of Acute Care Surgery

Anne Arundel Medical Center, one of the fastest growing Health Systems in Maryland, is seeking an outstanding surgeon to lead our newly established Division of Acute Care Surgery.

Our successful candidate will be Board certified/Board eligible with a demon-strated interest, training and experience in Acute Care Surgery and Critical Care. The successful candidate should possess excellent clinical (surgical and critical care) skills, be a strong communicator — and bring demonstrated people, care coordination, and organizational management acumen to all facets of acute care surgical services. The professional we choose will take on both an operational and strategic role in a dynamic setting that does not, however, focus on trauma medi-cine. We seek a readiness to provide leadership, team building and inspiration in a culture of innovation, learning, and clinical excellence.

Previous experience in surgical division leadership is a plus, as is applicable Fellowship training.

Our location in Annapolis, MD, offers highly desirable living in a historic community on the Chesapeake Bay with close proximity to the cultural advan-tages of Washington D.C.

For details and personal consideration please direct your curriculum vitae to:[email protected]. EOE, M/F/D/V. Smoke-free campus. A subsidiary of

Anne Arundel Health System.www.aahs.org/careers

48 GSn Bulletin Board GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012

Surgery • Emergency Medicine • Anesthesiology • Radiology • Neonatology • Hospitalists

Opportunities Nationwide • Surgery 800.506.8482 • tivahealthcare.com

ONE POINT OF CONTACTmeans more opportunities that fit you.

When it comes to Locum Tenens & Permanent Placement,

FEATURED GENERAL SURGERY OPENINGS

Southern COLORADO Employed PositionBread & Butter Surgery1:2 Call Salary + Bonus Potential

Southern OHIOEstablished PracticeStrong Recruitment Package1:3 Call

Southern PENNSYLVANIAIncome Guarantee1:3 CallVasular Experience a Plus

GSN

-031

2-00

2

GSN-

0112

-002

• Full time or part time positions available• Add revenue to your current practice• Flexible schedule, complete autonomy• No call

SURGEONS NEEDED FOR EXPANDING NATIONWIDE WOUND CARE PRACTICE:

Please contact us for more information:Phone 1.877.878.3289Fax: 1.877.817.3227

Email: [email protected]

www.AdvantageWoundCare.org

Arizona • Phoenix • TucsonCalifornia • Bakersfield • Los Angeles • Orange County • San Francisco • San Diego • Sacramento • San Bernardino • Inland EmpireDelawareFlorida • Pensacola • Jacksonville • MiamiMaryland • Gaithersburg • Northern MD

Surgeons needed in:

* Competitive Pay

New HampshireNew Jersey • Northern • Central • SouthernNew OrleansNew YorkPennsylvania • GettysburgPhiladelphiaTexas • Austin • Dallas • Houston • San AntonioVirginiaWashington • Seattle

GSN-0112-004

Minimally Invasive FellowshipTulane University Department of Surgery, Section of General and

Minimally Invasive Surgery, is seeking a Minimally Invasive Surgery Fellow. The fellowship is a one-year commitment starting on July 1, 2012. The right individual should possess strong surgical and interpersonal skills. Responsibilities include patient care, resident education and research.

The Tulane’s Minimally Invasive Surgery program is focused on promoting the highest level of advanced, academic, surgical care to the Gulf South.

All interested applicants shoudl submit curriculum vitae to:

Charles Bellows, M.D.Chief, General Surgery and Minimally Invasive SurgeryTulane University School of Medicine1430 Tulane Avenue, Box SL-22New Orleans, LA 70112

Phone: (504) 988-2307Fax: (504) 988-3843Email: [email protected]

Tulane is an Equal Opportunity/Affirmative Action Employer

49GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012 GSn Bulletin Board

NW Vein Center for Sale

Well-established vein center with large patient and referral base. The center

has its own vascular lab and OR suite. Principles will help with transition and

stay until you are comfortable. The center is located in a university town with

excellent schools and quality of life. 541.484.6133

Inpatient Surgical Positions

Hospital-based Surgical positions with excellent earning potential

available in Northeast Ohio areas.

•Paidmalpractice

•Flexibleschedulingand

•NoOn-Call.

John S. Martin at Physician Staffing

30680 Bainbridge Rd,

Cleveland, OH 44139

Phone: 440-542-5000 Fax: 440-542-5005

E-mail: [email protected]

GSN

-110

8-00

1G

SN-0

312-

004

We’re in a

to fill your

contact Alina Dasgupta 212-957-5300 x338

[email protected]

For classified advertising:

position

position

GSn

-021

2-05

GENERAL SURGERY POSITIONS

ROCHESTER, NY AREA: Hospital employed-1-3 call-45 minutes to Rochester with modern hospital.

ST. LOUIS AREA PART TIME: Hospital employed part time-1-3 call-45 minutes to St. Louis suburbs.

Excellent salary, bonus and benefits.

SURGICAL SEARCH 800-831-5475 Fax: 314-984-8246 E/M: [email protected]

mammosite balloon inside tumor resection cavity.courtesy of Hologic, Inc.

whole breast irradiation (WBI) in older patients (abstract S2-1).

“From 2000 through 2007, older women in the United States treated with brachytherapy experienced higher risk for losing the breast, postoperative infec-tion, postoperative wound complications, breast pain and fat necrosis,” said Ben-jamin Smith, MD, assistant professor in the Department of Radiation Oncology at the University of Texas MD Ander-son Cancer Center in Houston, who pre-sented the study. He pointed out that the study results do not apply to APBI deliv-ered by external beam.

Press headlines following SABCS included “Quicker Radiation Therapy Doubles Mastectomy Risk” (Reuters) and “Mastectomy Risk High With Brachytherapy for Breast Cancer” (Medscape). These articles infuriat-ed some APBI investigators, including Robert Kuske, MD, radiation oncologist at Arizona Breast Cancer Specialists-Scottsdale, who says that the treatment’s effectiveness is measured by recurrence rates and survival after treatment, not future mastectomies.

“The consequences of this informa-tion out of the MD Anderson analysis are potentially damaging. If the ran-domized NSABP [National Surgical Adjuvant Breast and Bowel Project]-39 clinical trial fails to reach its goal of 4,300 patients because of this misinfor-mation, this would be a tragedy because real answers to all of our questions will come out of this scientifically pure study,” said Dr. Kuske, a principal investigator of this ongoing randomized Phase III trial, which is expected to provide a rigorous comparison of APBI and WBI.

In the SABCS study, researchers analyzed Medicare records of 130,535 women diagnosed with invasive breast cancer between 2000 and 2007 who were treated with lumpectomy followed by either WBI (n=123,244) or APBI with brachytherapy (n=7,291). To assess safe-ty and effectiveness, Dr. Smith and his colleagues compared overall survival, the risk for subsequent mastectomy, postop-erative complications and post-radiation toxicities.

The investigators did not identify any difference in survival, but brachythera-py was associated with an increased risk for mastectomy (4% vs. 2.2%; P<0.001). Patients undergoing brachytherapy had a higher rate of infectious postoperative complications (16% vs. 10%; P<0.001) and noninfectious postoperative com-plications (16% vs. 8%; P<0.001), such as a surgical wound breakdown, post-operative bleeding or seroma formation.

Complications occurring within five years after the start of radiation thera-py that also increased with brachyther-apy included breast pain (15% vs. 12%;P<0.001) and fat necrosis (9% vs. 4%; P<0.001).

“Fat necrosis may not have much clin-ical significance, but generally is con-sidered a marker of tissue injury from either surgery and/or radiation therapy,” said Dr. Smith. Radiation pneumonitis, however, was more common in patients receiving WBI (0.1% vs. 0.8%; P<0.001).

Study under a ScopeCritics say the study has many limita-

tions. First, it is a retrospective analysis examining Medicare patients who were treated at the discretion of thousands of physicians, said Dr. Kuske. As such, it could not take into account tumor char-acteristics, margin status or a patient’s general medical condition. “We do know that women received more chemothera-py in the whole-breast irradiation group of patients,” Dr. Kuske said. “This, by itself, could account for the small 1.8% difference in mastectomy rates between the two groups.”

He added that factors such as diabe-tes, obesity or smoking history were not taken into account and could have con-tributed to the higher complication rates. Potentially significant factors, he said, are controlled and recorded in greater detail in randomized trials such as the NSABP-39 trial. Dr. Kuske also pointed out that the rate of biopsy-proven breast cancer recurrence in the two groups was not stated, and there are many noncan-cer reasons for subsequent mastectomy, such as testing positive for the BRCA

gene or a false-positive magnetic reso-nance imaging scan.

Another limitation is that the SABCS trial analyzed procedures that used ear-ly-generation brachytherapy techniques and not the more advanced techniques used today.

In response to the study, the Amer-ican Society for Radiation Oncology (ASTRO) issued a statement saying it was concerned about the potential misin-terpretation of the data. “There are limi-tations to the interpretation of the data, given that it was drawn from records of patients [with] varying risk factors and stage treated between 2000 and 2007,” the statement reads. “Since that time, technology has dramatically improved, including the use of newer multichannel applicators with tighter dose constraints.” The statement also noted that although statistically significant, the rate of mas-tectomy is very low in either treatment group. Many patients, said Dr. Kuske, would accept a 1.8% difference in order to have a shorter treatment that exposes less normal tissue to ionizing radiation.

According to Peter Beitsch, MD, numerous retrospective studies and two prospective randomized studies have shown no difference in survival, locore-gional cancer recurrence rates and com-plications between APBI and WBI. Dr. Beitsch is co-principal investigator of the American Society of Breast Sur-geons (ASBS) MammoSite Registry, which includes information on 1,440 patients who were given APBI brachy-therapy with the MammoSite balloon

catheter device through 2004. Informa-tion gleaned from this registry shows a low rate of complications and a five-year local recurrence rate of less than 5%, which is comparable to that of WBI. Several single-institution randomized and nonrandomized studies using anoth-er APBI technique, multiple interstitial catheters, also report rates of local recur-rence comparable to WBI.

Dr. Beitsch also took issue with a study end point. “The study stated that sub-sequent mastectomy is a validated sur-rogate for local failure. However, I am unaware of any literature that states this,” he argued, adding that APBI often is used in older, sicker patients who may not be candidates for the six to seven weeks of WBI. This factor could introduce bias in the MD Anderson study results.

In response, Dr. Smith said the two-fold increased risk for subsequent mas-tectomy was found “even after adjusting for patient age, race, comorbidity, treat-ment with chemotherapy, surgical assess-ment of the axilla and axillary lymph node involvement.” Nevertheless, he added, “the absolute risk for subsequent mastec-tomy in patients treated with brachyther-apy was still quite small at only 4%, and was consistent with the risks for subse-quent mastectomy reported by the ASBS MammoSite Registry Study.”

According to Bruce Haffty, MD, pro-fessor and chairman of radiation oncol-ogy at the University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School in New Bruns-wick, the SABCS study should provide an additional incentive for physicians to adhere to ASTRO’s APBI consensus statement. This 2009 statement, which he and Dr. Smith helped author, outlines criteria for selecting patients to be treat-ed with APBI outside of a clinical trial.

While awaiting results from the NSABP-39 trial and six other ongoing randomized trials comparing APBI and WBI, oncologists may find themselves inundated by questions from patients who have heard about the retrospective study. They can point patients to the statements issued by ASTRO and ASBS. According to ASBS, “The evidence in the MD Anderson study should be con-sidered in presurgical counseling, but is not strong enough to preclude the use of WBI in properly selected patients.”

Dr. Beitsch has received lecture fees from companies making brachytherapy equip-ment. Dr. Kuske disclosed receiving teaching and lecture fees from companies making both external beam and brachytherapy equip-ment. Dr. Smith disclosed research funding from Varian Medical Systems, which makes a variety of radiation equipment, includ-ing WBI and APBI instruments. Dr. Haff-ty reported no relevant disclosures.


‘The study stated that subsequent mastectomy is a validated surrogate for

local failure. However, I am unaware of any literature

that states this.’—Peter Beitsch, MD

partial breast irradiatioNcontinued from page 1

‘The consequences of this information out of the mD

anderson analysis are potentially damaging.’

—Robert Kuske, MD

Health care workers may avoid entering a patient’s room because of the need to gown and glove and perhaps because of their own fear of picking up some ethe-real organism. We also must ensure that caregivers discuss fully with the patient the need to launch infection control guidelines. The sudden appearance of gowns and gloves hanging on the door and signs indicating isolation guide-lines might stress out even the most stal-

wart patient and his or her family. Many times these events occur without full dis-closure to the patient or without gain-ing additional information that might be helpful in avoiding an indiscriminate application.

My plea is that if infection control is being used, we need to have a solid rea-son for employing it. The global utiliza-tion and proliferation of gowns, gloves and masks may not accomplish our goal. Like universal precautions in the oper-ating room, we may get to the point where everyone has the obligate box of gloves and gowns and other parapher-nalia hanging on their door. I certain-ly hope this does not come to pass and would urge that good science and com-mon sense be employed in all of our infection control guidelines.

Take a look at your own hospital cor-ridors and your patients’ doors. Are you satisfied that there are good reasons for isolation and the donning of gowns and gloves? Perhaps all of us should be will-ing to ask the appropriate questions and to inquire as to why these measures have been instituted. Also, make sure that you are familiar with the actions that are need-ed (nasal swab, etc) at your institution to have a patient removed from question-able isolation. Good infectious disease practices are important, but they can be detrimental if used indiscriminately.

51General SurGery newS / march 2012

Gowns and GlovesContinued from page 3

My plea is that if infection control is being used,

we need to have a solid reason for employing it.

The global utilization and proliferation of gowns,

gloves and masks may not accomplish our goal.

� +we would like your opinion.Please send letters to:

[email protected].




®

Now Available...

ChairStephen M. Cohen, MD, FACS, FASCRSAssociate Clinical Professor, Department of SurgeryEmory University School of MedicineVice Chairman, Department of SurgerySouthern Regional Medical CenterAtlanta Colon and Rectal SurgeryAtlanta, Georgia



Accreditation Statement� is activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of AKH Inc., Advancing Knowledge in Healthcare, and Applied Clinical Education. AKH Inc. is accredited by the ACCME to provide continuing medical education for physicians. AKH Inc. designates this enduring activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Goal� e goal of this activity is to educate general and colorectal surgeons on strat-egies for optimizing outcomes in complex hernia repair and abdominal wall reconstruction through choice of biologic mesh and proper surgical technique.


lenges of complex hernia repair (eg, bovine pericardium, porcine intestine, porcine dermis, and human dermis) and their eff ects on tissue remodeling and revascularization.

2 Describe the importance of host response to the collagen scaff old and the balance between mesh degradation and new tissue infi ltration with bovine pericardium-based mesh.








the march2012 digital edition of general surgery news

Documents