thor apr 2012 lores

B Y K E R R I WA C H T E R

Else vier Global Medical Ne ws

FT. LAUDERDALE, FLA. –

Cardiac procedures with trans-fusions were associated with asignificant risk of infection,such that “with every unit ofblood, you had a significant in-crease in the risk of infection forthe patient. It appears that theremight be some sort of thresh-old in the 2- to 4-unit range,whereafter the risk really seemsto increase. But statistically,

even that first drop of bloodcarried an additional infectiousrisk,” Dr. Keith A. Horvath saidat the annual meeting of the So-ciety of Thoracic Surgeons.

In a related study, pneumo-nia was the most common in-fection associated with cardiacsurgery. “Pneumonia, surpris-ingly, was the most commoninfection, at 2.4%. This wasmuch more common than oth-er infections that we certainlyworry about and get a fairamount of press and literature

on, specifically sternal woundinfections,” said Dr. GoravAilawadi of the University ofVirginia, Charlottesville.

Data for 5,184 adult cardiacpatients were used for bothstudies. The patients wereprospectively enrolled in a 10-center infection registry be-tween February and September,2010. Captured data includedinfection occurrence, type, andorganism. Adjudication was

VOL. 8 • NO. 4 • APRIL 2012

CABG Beat StentOutcomes in

High-Risk Patients

B Y K E R R I WA C H T E R



Coronary artery bypass graftsurgery shows a clear long-termsurvival advantage in certainhigh-risk groups over percuta-neous coronary intervention,based on results of the largeststudy of real-world data so far.

The survival advantage for acomposite high-risk group – in-cluding patients aged 75 yearsand older, patients with dia-betes, those with ejection frac-tions (EF) less than 50%, andthose with a glomerular filtra-tion rate (GFR) less than 60mL/min per 1.73 m2 – was28% at 4 years, Dr. Fred H. Ed-wards reported at the annualmeeting of the Society of Tho-racic Surgeons.

The findings come from theASCERT (The American Col-lege of Cardiology Foundation– The Society of Thoracic Sur-

geons Collaboration on theComparative Effectiveness ofRevascularization Strategies)study, in which researcherscompared catheter- andsurgery-based procedures us-ing the existing ACC and STSdatabases, as well as the Centersfor Medicare and Medicaid Ser-vices 100% denominator filedata. The study was designed toidentify specific patient charac-teristics that favor one mode oftreatment over the other.

The ACC and the STS bothhave large registries containingdetailed clinical informationon millions of procedures.However, the information inthese databases extends toonly 1 month after the proce-dure. The researchers linkedthis short-term clinical infor-mation with the administra-tive data registry from theCMS to provide long-term

Diagnostic Concerns inStaging With EBUS-FNA

B Y M A R K S. L E S N E Y



Appropriate staging ofnon–small cell lung cancer(NSCLC) is critical to patienttreatment and prognosis. Endo-bronchial ultrasound–guidedfine-needle aspiration (EBUS-FNA) has gradually gained ac-ceptance as a diagnostic tool topathologically stage the medi-astinum in patients withNSCLC, according to Dr. BryanA. Whitson at the annual meet-ing of the Society of ThoracicSurgeons.

Because EBUS-FNA is a test todetect cancer, it is critical that ithave few false-negative results,i.e., have a high negative predic-tive value (NPV). However, byvirtue of the size and volume ofmediastinal lymph node FNAsamples, nondiagnostic resultsoccur with some frequency.

Nondiagnostic samples de-crease a test’s diagnostic perfor-mance, since they cannot helpguide a clinical decision, and aportion of these samples may

actually be false negatives. The standard calculation of

NPV does not factor in nondi-agnostic samples. According toa study by the researchers inthe Division of Thoracic andForegut Surgery at the Univer-sity of Minnesota, which Dr.Whitson presented, one musttake nondiagnostic samples intoconsideration to determine thetrue diagnostic performance ofEBUS-FNA.

To conservatively calculateNPV, the researchers modifiedthe standard definition (truenegatives/[true negatives plusfalse negatives]), creating an al-ternative NPV definition (truenegatives/[true negatives plusfalse negatives plus nondiagnos-tic]). This definition takes intoaccount the possibility that thesenondiagnostic samples may befalse negatives, which assumesthe worst-case scenario.

The thoracic team at the Uni-versity of Minnesota then com-pared the results of these twodefinitions of NPV in a retro-

CO

UR

TE

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DR

. R

AF

AE

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Dr. Rafael Andrade (left) performing an EBUS-FNA (using real-time ultrasound and bronchoscopy correlated with the chest CTscan). The on-site cytopathologist is at the microscope.

Transfusions Linked to Infection Risk

See High-Risk • page 8

See EBUS-FNA • page 2

Long-term survival advantage seen.

Presorted StandardU.S. Postage

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See Transfusions • page 8

News

TAVR TalkMedical societies and the

manufacturer of the only U.S.

approved TAVR device address

the future of the procedure. • 4

Residents’ Corner

TSRA ForumThe Thoracic Surgery Residents

Association is seeking to address

some of the unmet needs of the

life partners of CT residents. • 6

News From AATS

President’sMessage

Dr. Craig R. Smith reveals

details of the new AATS

organizational structure that

will be unveiled at the annual

meeting in San Francisco. • 10

Devices, Drugs, & Trials

Of CABGs And Clots

The BRIDGE trial indicates

that using cangrelor gives

adequate platelet reactivity after

discontinuing thienopyridines

before CABG. • 15

I N S I D E

THORACIC

SURGERY

NEWS ONLINE!

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01_2_3_8_9TS12_4.qxp 3/28/2012 1:33 PM

2 NEWS A P R I L 2 0 1 2 • T H O R A C I C S U R G E R Y N E W S

THORACIC SURGERY NEWS

AMERICAN ASSOCIATION FOR THORACIC SURGERY

Editor Yolonda L. Colson, M.D., Ph.D.

Associate Editor, General Thoracic

Michael J. Liptay, M.D.

Associate Editor, Adult Cardiac John G. Byrne, M.D.

Associate Editor, Cardiopulmonary Transplant

Richard N. (Robin) Pierson III, M.D.

Resident Editors Robroy MacIver, M.D.; Bryan A. Whitson, M.D., Ph.D.

Associate Editor, Congenital Heart William G. Williams, M.D.

Executive Director Cindy VerColen

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THORACIC SURGERY NEWS is the official newspaper of the American

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timely and relevant news and commentary about clinical developments

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spective analysis of their prospective data-base of patients with NSCLC who hadEBUS-FNA between January 2007 andJuly 2011.

Dr. Bryan Whitson, who is a surgeonat the University of Minnesota, present-ed the team’s results.

A total of 120 patients with NSCLCwho underwent EBUS-FNA were in-cluded in the analsyis. EBUS-FNAswere assessed using rapid on-site cyto-logic evaluation (ROSE) and a false-negative definition consisting ofnegative FNAs coupled to NSCLC-pos-itive surgical biopsy of the same site.Diagnostic performance was evaluated

comparing results of the inclusion orexclusion of nondiagnostic samples inthe calculation of NPV.

Seven (5.8%) of the 120 patients hadnondiagnostic results. One patient had afalse negative. When the seven nondi-agnostic procedures were excluded, theNPV was 96.3%; when they were in-cluded, the NPV dropped to 76.5%.

Both sensitivity and accuracy alsodropped with the inclusion of the non-diagnostic procedures. Sensitivitydropped from 98.8% to 91% and overallaccuracy from 98.2% to 92.2% whennondiagnostic procedures were included.

“Our data indicate that a conservative cal-

culation of NPV that includes nondiag-nostic samples should be used to assess thereal diagnostic accuracy of EBUS-FNA inpatients with NSCLC. Otherwise, decisionsbased on these results could be flawed andpatients inappropri-ately staged. In ourexperience, and us-ing this assessment,EBUS-FNA shows atrue NPV that is lessthan most cliniciansassume,” Dr. Whit-son said.

Ultimately, thethoracic surgeonsat the University of Minnesota believethat “EBUS-FNA should be the primarymethod to stage the mediastinum in pa-tients with NSCLC, since it enables

pathologic staging without the need foran incision, with preservation of tissueplanes, and with minimal complications.”

However, in view of the limitationsof EBUS-FNA, “we perform an imme-

diate surgical biop-sy when in doubtof the reliability ofan EBUS-FNA re-sult. A thoracicsurgeon facile inEBUS can offermost patients min-imally invasivemediastinal stag-ing, with selective

surgical biopsy in the same anestheticsetting, which can ensure accuracy andstreamline patient care,” according toDr. Whitson and his colleagues. ■

Diagnostic StagingEBUS-FNA • from page 1

B Y N A S E E M S. M I L L E R


New federal regulations aim to accel-erate the use of electronic payments

to health care providers while reducingadministrative costs and saving re-sources.

The interim finalregulations – part ofa series of regula-tions coming fromthe Department ofHealth and HumanServices – standard-ize the format andcontent of thetransmissions thathealth plans send to banks when payingclaims via electronic funds transfer (EFT)and will require plans to use a trace num-ber to match the EFT with the remit-tance advice sent to providers. Currentlythe EFT and the remittance documents

are sent to providers separately, andmatching them is difficult.

The new standards took effect on Jan.1; full compliance will be required by Jan.1, 2014, according to the agency.

Under the new rules, “health care pro-fessionals will spend less time filling out

paperwork andmore time focusingon delivering thebest care for pa-tients,” HHS Secre-tary KathleenSebelius said in astatement.

Further, the ruleswill cost physicians,hospitals, and other

providers little or nothing, since“providers are the receivers of the stan-dardized transactions and not thesenders,” according to HHS.

The agency also estimated that wide-spread use of EFT should save physician

practices and hospitals between $3 billionand $4.5 billion over the next 10 years.The most common savings from imple-mentation of electronic fund transfersare in paper, printing, and postage, aswell as staff time for processing paperpayments and depositing checks.

The cost to implement the new stan-dards across all commercial health plansis estimated at between $18 million and$28 million. Implementation in Medic-aid, the Children’s Health InsurancePlan, and the Indian Health Service is es-timated at $400,000-$600,000. Mean-while, the savings for commercial healthplans could be as much as $40 millionover 10 years, and $31 million for Med-icaid, CHIP, and IHS, according to anHHS fact sheet.

Use of EFT, while widespread in manyindustries – has been slow in health care,partly due to lack of standardization oftransactions, HHS officials said.

The new standards are required bythe Affordable Care Act, and fall underthe Health Insurance Portability andAccountability Act (HIPAA). They aresecond in a series of regulations that

aim to streamline health care adminis-trative transactions within the next 5years. Future efforts are slated to in-clude a standard unique identifier forhealth plans and standardized claim at-tachments. ■

Federal Rules Aim to Standardize Electronic Payments

‘SAVINGS FOR COMMERCIAL

HEALTH PLANS COULD BE AS

MUCH AS $40 MILLION OVER

10 YEARS, AND $31 MILLION

FOR MEDICAID, CHIP, AND IHS.’

A CONSERVATIVE NPV

CALCULATION ADDING NON-

DIAGNOSTIC SAMPLES SHOULD

BE USED TO ASSESS THE

ACCURACY OF EBUS-FNA.

THORACIC SURGERY NEWS

ONLINE!Visit our website for

archives and exclusive online content.

www.thoracicsurgerynews.com

The new standards took effect on Jan. 1; full

compliance is required by Jan. 1, 2014.

01_2_3_8_9TS12_4.qxp 3/30/2012 2:15 PM

A P R I L 2 0 1 2 • W W W. T H O R A C I C S U R G E R Y N E W S . C O M NEWS 3

B Y M A RY A N N M O O N


Surrogate decision makers for inca-pacitated, critically ill patients sys-

tematically interpreted prognosticinformation as being more optimisticthan it actually was, in a study publishedin the March 6 issue of the Annals of In-ternal Medicine.

These surrogate decision makers ac-curately interpreted prognostic infor-mation that was positive, but notprognostic information expressing a highrisk of death. Instead, they showed “asystematic bias,” consistently interpret-ing “grim” prognostic statements in anoverly optimistic way, said Dr. Lucas S.Zier of the University of California, SanFrancisco, and his associates.

“These findings challenge the prevail-ing assumption in the medical literaturethat discordance between physicians andsurrogates about prognosis is due large-ly to unclear disclosure by physicians orsimple misunderstandings by surro-gates,” the investigators noted.

The results also indicate that any ef-forts to improve this aspect of decisionmaking must address not just the clarityof prognostic statements but also the“emotional and psychological factorsthat affect how individuals process suchinformation,” they added.

Dr. Zier and his colleagues adminis-tered a questionnaire to 80 such surro-gates who were accompanying anincapacitated patient at medical-surgicalICUs in a Veterans Affairs hospital, a ter-tiary academic hospital, and a public

county hospital. The questionnaire presented 16 possi-

ble prognostic statements in the lan-guage used by physicians and made itclear that these represented hypotheticalclinical situations unrelated to their lovedone’s cases. Study subjects were askedwhat exactly each prognostic statementmeant to them, and used a numericalscale to demarcate the patient’s chanceof survival corresponding to each prog-nostic statement.

Examples of general and somewhatequivocal prognostic statements includ-ed “It is very likely that he will survive,”“It is very unlikely that he will die,” “I amconcerned that he will not survive,” “Itis possible he will not survive,” and “Heprobably will not survive.” Unequivocalprognostic statements were “He will def-initely survive” and “He will definitelynot survive.”

There also were three unequivocal nu-merical prognostic statements: “He hasa 90% chance of surviving,” “He has a50% chance of surviving,” and “He hasa 5% chance of surviving.”

Only twelve surrogate decision makers(15% of the entire group) interpreted thethree numerical prognostic statementsaccurately. Almost as many – 13% –in-terpreted all three numerical prognosticstatements more optimistically than theyactually were.

Most surrogates interpreted the state-ment of a low risk of death (“90%chance of surviving”) accurately, but se-verely misinterpreted the statements ofa median or high risk of death. Forty per-cent thought that “a 50% chance of sur-

viving” meant that the patient was like-ly to survive, and 65% thought that “a5% chance of surviving” meant that thepatient was likely to survive.

No surrogates interpreted any of thenumerical prognostic statements morepessimistically than they actually were.

Some experts have advocated usingstraightforward, numerical languagewhen communicating medical risk tosurrogate decision makers, but thesefindings clearly show that numbers arenot straightforward to everyone and arefrequently misinterpreted, Dr. Zier andhis associates said (Ann. Intern. Med.2012;156:360-6).

In the second phase of this study, 15subjects whose interpretations of prog-nostic statements had been particularlyoff-base were interviewed about whythere was such a discrepancy betweenwhat the physician said and what thesubject thought was meant.

Seven of the 15 said they were un-aware that almost all their interpretationswere overly optimistic. These subjectswere surprised when it was pointed outto them and couldn’t offer of an expla-nation. The other eight surrogate deci-sion makers gave four reasons for their“optimism bias.”

Some said they intentionally expressedoptimism as long as there was any hopewhatsoever. This may represent a copingstrategy to help surrogates deal with hav-ing a critically ill loved one. Or it may rep-resent “magical thinking” in whichpeople believe their positive thoughtsand expectations can actually improve thepatient’s outcome, the researchers said.

Other surrogate decision makers saidthey believed their loved one was excep-tional and wouldn’t die because of an un-usual will to live and ability to survive.This “may represent a cognitive biasknown as illusory superiority, unrealisticoptimism, or the ‘Lake Wobegon effect,’a cognitive bias that leads people to over-estimate, in relation to others, their like-lihood of experiencing positiveoutcomes and avoiding negative out-comes,” the investigators said.

Some study subjects said they inten-tionally ignored numerical probabilitiesand precise language, preferring to judge“the overall feeling that the doctor is con-veying.” And some said they didn’t be-lieve physicians could ever accuratelypredict survival. However, such skepti-cism about physicians’ accuracy wouldresult in a random distribution of inter-pretations rather than in the systematicoptimism observed here, Dr. Zier and hiscolleagues noted.

The findings of this study show that“clinicians who communicate with sur-rogate decision makers in the care of in-capacitated patients should be aware ofthe diverse causes for discordance aboutprognosis.” Unrealistic optimism maynot be benign; it can lead to treatmentdecisions that do not reflect the true val-ues of the patient but that instead servethe surrogate decision maker’s impulsetoward self-protection, they added.

This study was supported by the Na-tional Heart, Lung, and Blood Institute,the Greenwall Foundation, and the Uni-versities of California, Berkeley and SanFrancisco, Joint Medical Program. ■

Surrogate Decision Makers Show Systematic ‘Optimism Bias’

B Y J E N N I E S M I T H


Nearly half of U.S. surgeons who routinely per-form high-risk operations do not regularly ask pa-tients about their advance directives – also known

as living wills – before proceeding with a high-risk pro-cedure, results of a survey indicate. Perhaps more im-portantly, more than half of survey respondents saidthey would not operate if they were aware of a re-strictive directive.

The findings, published online and in Annals ofSurgery, were derived from a survey mailed to 2,100randomly selected vascular, neurological, and cardio-thoracic surgeons in 2010. Of these, 912 eligible re-sponses were entered into analysis, with the threetypes of surgeons responding at about the same rate:56% for vascular surgeons and neurosurgeons and 54%for cardiothoracic surgeons (Ann. Surg. 2012;255:418-23).

A majority of respondents (81%) however, reportedhaving conversations about patients’ preferences forlimiting the use of life-sustaining procedures postop-eratively. The surgeons said they tend to view factorssuch as a patient’s predicted postoperative quality oflife, age, comorbidities, and mental readiness as vastlymore important in determining whether to operatethan the existence of an advance directive, which 48%

said they do not routinely confirm, according to thestudy’s authors, led by Dr. Margaret L. Schwarze of theUniversity of Wisconsin, Madison.

Because most information about advance directivesand the surgical decision-making process thus far hasbeen anecdotal, she and her colleagues investigated howconversations about formal directives actually proceedin a surgical setting and their role in decision making.

A total of 54% of all surgeons who responded saidthat they would not operate if they knew a patient hadan advance directive that might limit the postoperativeoptions.

Among cardiothoracic surgeons, who routinely relyon ventilator support as part of postoperative care, 63%said they would not operate with prior knowledge ofa restrictive advance directive. Multivariate analysisshowed that cardiac surgeons were almost twice as like-ly to operate compared with their neurosurgeon coun-terparts (odds ratio, 1.96) and somewhat more likelythan were vascular surgeons (OR, 1.35).

Younger surgeons – those with 20 or less years of ex-perience – were less likely to discuss advance directivesregularly (44%) than were those with more than 20years of experience (69%).

Several of the survey results strongly suggest that sur-geons view advance directives as “an impediment to thegoals of surgical therapy” and that they interpret themas “a signal that patients with advance directives are nottruly committed to the operation and the invasivepostoperative therapy the operation necessarily en-tails,” wrote the investigators. Furthermore, surgeons“often find it difficult to shift goals when surgery does

not go as planned – the result of a surgical ethos whichdiscourages moving from a curative model to a pallia-tive mode of care.”

Dr. Schwarze and her colleagues noted that their find-ings raise the question of whether it is ethical for sur-geons to deny a patient a procedure because of arestrictive advance directive. While it may be reasonablefor surgeons to want every postoperative resourceavailable to them, they said, advance directives nonethe-less protect patient autonomy in the event of a devas-tating complication.

However, directives are not generally designed withhigh-risk surgical procedures in mind, they may bevague, and they potentially can create confusion in apostoperative context. Thus, the investigators con-cluded that communication prior to surgery is urgent-ly needed to “clarify patient preferences with respect tothe surgical endeavor and the patient’s advance direc-tive,” and that such communication should be docu-mented.

The investigators noted that, as with all surveys, thepotential for nonresponse bias was a limitation of theirstudy. More importantly, they stated that it was difficultto know whether the results were generalizable to oth-er surgical subspecialties that performed high-risksurgery.

Dr. Schwarze’s research was funded under a grantfrom the department of surgery at the University ofWisconsin. Mr. Andrew J. Redman was supported by agrant from the University of Wisconsin, and Dr. CalebG. Alexander received funding from the Agency forHealthcare Research and Quality. ■

Over half of CT surgeons would

not operate with a restrictive directive.

Survey: Many Surgeons Wary of Advance Directives

01_2_3_8_9TS12_4.qxp 3/30/2012 2:20 PM

4 NEWS A P R I L 2 0 1 2 • T H O R A C I C S U R G E R Y N E W S

The following articles are featured from the April2012 issue of the Journal of Thoracic and Cardio-

vascular Surgery.

2011 Scientific Achievement Award Recipient:Marc R. de Leval, MDThomas L. Spray

Cardiothoracic Surgical Education and TrainingDeveloping a curriculum for cardiothoracic sur-gical critical care: Impetus and goalsHisham M. F. Sherif

General Thoracic SurgeryFactors determining successful computed to-mography–guided localization of lung nodulesJung Min Seo, Ho Yun Lee, Hong Kwan Kim, et. al.Factors related to successful CT nodule localizationfor subsequent VATS lung nodule excision were an-alyzed in 174 patients. The results show that thedistance between the hook wire tip and pleural sur-face is the major significant factor. Thus, the local-ization of a hook wire adjacent to a target nodulewith sufficient depth from the pleural surface iscrucial to the success of the procedure.

Acquired Cardiovascular DiseaseTranscatheter (TAVR) versus surgical (AVR) aor-

tic valve replacement: Occurrence, hazard, riskfactors, and consequences of neurologic eventsin the PARTNER trialD. Craig Miller, MD, Eugene H. Blackstone, MD,Michael J. Mack, et al. on behalf of The PARTNER Tri-al Investigators and Patients, The PARTNER StrokeSubstudy Writing Group and Executive Committee,Stanford and Irvine, Calif; Cleveland, Ohio; Dallas,Tex; New York, NY; and Vancouver, British Columbia,CanadaSix hundred fifty-seven high-risk patients with ASwere randomized to undergo AVR or TAVR. Neu-rologic events occurred significantly more fre-quently after TAVR during the early high hazardphase, but in the late constant hazard phase waslinked to patient-related factors in both treatmentarms.

Congenital Heart DiseaseQuality of life and perceived health status inadults with congenitally corrected transpositionof the great arteriesTimothy Cotts, Sanjana Malviya, and Caren GoldbergQuality of life and perceived health status of adultswith congenitally corrected transposition of thegreat arteries were reviewed. Some parameters ofperceived health status and quality of life werelower in adults with congenitally corrected trans-

position compared with controls.

Perioperative ManagementImplementation of a comprehensive blood con-servation program can reduce blood use in acommunity cardiac surgery programSteve Xydas, Christopher J. Magovern, James P. Slater,et. al.A comprehensive blood conservation program canbe rapidly introduced, leading to reductions in redcell and component transfusion with no detrimen-tal effect on early outcomes. Point-of-care testingcan direct transfusion in coagulopathic cases. Fur-ther research will determine the effects of reducedtransfusions on long-term outcomes.

Evolving Technology/Basic ScienceEffects of alcohol on pericardial adhesion for-mation in hypercholesterolemic swineAntonio D. Lassaletta, Louis M. Chu, and Frank W.SellkeReoperative cardiac surgery is complicated in partbecause of adhesions encountered during the sec-ond operation. We examined the anti-inflammato-ry effects of resveratrol with and without ethanol(red wine vs vodka) in a hypercholesterolemicswine model of chronic ischemia and found signifi-cantly fewer adhesions in pigs that received vodka.

Featured in the JTCVS



While commending theCenters for Medicareand Medicaid Ser-

vices on its proposed coverageof the transcatheter aorticvalve replacement procedure,makers of the SAPIEN artifi-cial valve asked for more flex-ibility in the clinical triallimitations set by the agency,in an official comment theyreleased on March 5.

Edwards Lifesciences, themanufacturer of the onlyvalve approved for the TAVRprocedure in the UnitedStates, posted its commentduring the 60-day period,which began after CMS re-leased its coverage proposalfor TAVR in February.

In its proposal, CMS re-stricts TAVR coverage to fivecriteria, including the use ofan approved valve, presence ofmultidisciplinary teams, andenrollment in a registry.

Edwards officials wrote theywere pleased that CMS hadproposed “clear and flexiblenational coverage for TAVR,”and added that “for appropri-ately selected Medicare bene-ficiaries, the evidence is morethan adequate for CMS to con-clude that TAVR improveshealth outcomes and should

be considered reasonable andnecessary under the Medicarestatute,” if provided under theCMS criteria.

The Edwards SAPIEN valveis currently approved for usein inoperable patients with se-vere aortic stenosis. Other useof the SAPIEN valve is limit-ed to clinical trials. In theircomments, Edwards officialsasked CMS for flexibility inthe trials they consider forcoverage determination.

“CMS’s proposed require-ment limiting coverage for un-labeled uses to ‘superioritytrials’ undermines theagency’s efforts to promotecontinued US-based clinical in-vestigations in Medicare ben-eficiaries aimed at betterunderstanding key determi-nants of health and quality oflife outcomes,” according tothe Edwards’ comments.

“Noninferiority and otherclinical trial designs play animportant role in the ad-vancement of medical tech-nology,” the company added,saying that if the proposedconditions aren’t revised, im-portant, yet relatively small,patient populations may notbe able to receive treatment.

Edwards, which said itstranscatheter aortic valveshave been implanted in morethan 25,000 patients around

the world, came in strong sup-port of multidisciplinary heartteams, one of the require-ments set by CMS for TAVRcoverage, and strongly en-couraged by leading cardio-vascular organizations.

“It is imperative that at leasttwo engaged cardiothoracicsurgeons and two interven-tional cardiologists at each sitecoordinate all clinicians toform a high-functioning multi-disciplinary heart team, a keyconcept integral to assuringTAVR success,” Edwards offi-cials wrote in their comment.

The company also addressedcredentialing, an issue whichfour leading cardiovascular or-ganizations also addressed in aconsensus document (see sto-ry at right).

“We support appropriate fa-cility and heart team criteria –rather than traditional indi-vidual physician-based cre-dentialing,” to achieve TAVRsuccess.

Following the CMS propos-al, the Society of ThoracicSurgeons and the AmericanCollege of Cardiology issueda statement, saying that theywere pleased with CMS’scomprehensive approach tothe coverage of TAVR.

CMS is expected to issue afinal decision on TAVR cover-age by May. ■

SAPIEN Valve Makers Comment

On Proposed TAVR Coverage

Societies Release TAVRCredentialing Suggestions



New credentialing recommen-dations for TAVR programs

released by four leading cardio-vascular organizations, serve as astarting point for programs andinstitutions that want to assesstheir potential for implementingor maintaining a TAVR program.

“As new technologies begin tobe incorporated into cardiovascu-lar practice, it is the responsibilityof the medical societies to worktogether to develop standards foroptimal patient care,” Dr. Carl L.Tommaso, chair of the writingcommittee, said in a statement.

The 48-page document, pre-pared jointly by the American Col-lege of Cardiology Foundation,the Society for Cardiovascular An-giography and Interventions, theAATS, and the Society of ThoracicSurgeons, defines operator and in-stitutional requirements for theprocedure, and emphasizes theuse of multidisciplinary teams,which go beyond the collabora-tion between interventional cardi-ologists and cardiac surgeons(www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

“A TAVR program that usesonly one specialty is fundamen-tally deficient, and valve therapyprograms should not be estab-lished without this multidiscipli-nary partnership,” they wrote.

The document also recom-

mends that irrespective of theirspecialty, physicians in TAVR pro-grams should all have extensiveknowledge of valvular heart dis-ease, and they should be able tointerpret images. Meanwhile, fa-cilities should contain a full rangeof diagnostic imaging, in addi-tion to an active valvular heartdisease surgical program and “atleast two institutionally basedcardiac surgeons experienced invalvular surgery.”

The role of an invested hospi-tal administration is also empha-sized. “There must be dedicationon the part of the hospital toprovide these services and sup-port, both financially and with notime constraints on the personnelinvolved,” the authors write.

While they lay out minimumcase number requirements for sur-geons and interventionalists, theauthors predict that simulators are“likely to play a significant role intechnical training and proficiencymaintenance for these evolving pro-cedures,” and the training strategywill evolve as the procedure be-comes mainstream. Therefore,there “is the need for this to be adynamic document that we willrevisit in the future as the tech-nology evolves, experience grows,and data accumulate,” Dr. R. Mor-ton Bolman, cochair of the docu-ment writing committee said in astatement.

Dr. Tommaso and Dr. Bolmanhad no relevant disclosures. ■

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A P R I L 2 0 1 2 • W W W. T H O R A C I C S U R G E R Y N E W S . C O M RESIDENTS’ CORNER 5

B Y S H E R RY B O S C H E R T


SAN FRANCISCO – The AmericanCollege of Surgeons could consider tak-ing over resident training from the Ac-creditation Council of Graduate MedicalEducation in order to avoid the council’slatest duty-hour restrictions, which wentinto effect last July.

In considering strategies to addressthe unwelcome restrictions, “we haven’ttaken anything off the table,” said Dr.L.D. Britt, immediate past president ofthe American College of Surgeons (ACS)and chair of the ACS Task Force on Res-ident Duty Hours. “We shouldn’t allowany entity to destroy our training pro-grams.”

At least one College official later saidthe College has no plans to take over ac-creditation of residency programs, butthe mere mention of this possibility as anoption drew cheers at an emotional,standing-room-only session on residentduty hours during the ACS annual clin-cial congress meeting. Dr. Britt and apanel of ACS leaders described their ef-forts thus far to modify the new duty-hour requirements before and after theywent into effect. The session was the firsttime surgeons had gathered in largenumbers since the new rules went intoeffect, and many of them took the op-portunity to vent their frustrations.

They objected most strongly to the 16-hours/day limit on first-year residents.“The 16-hour day is an enemy to educa-tion,” said Dr. Britt, Brickhouse Profes-sor of Surgery and Chairman at EasternVirginia Medical School, Norfolk.

Limitations on the work hours of sur-gical trainees in England, Switzerland,and other European countries have been“devastating” to the quality of educationthere, he said. “Why aren’t they lookingat the international experience?” Dr. Brittasked in a lengthy discussion session af-ter the formal presentations. He andothers emphasized that there are no datashowing that reduced hours lead to bet-ter outcomes for patients. On the con-trary, the limits could hurt patients byincreasing the risk for errors because thenew schedule leads to an increased num-ber of patient hand-offs and gives resi-dents less experience, they suggested.

Dr. Ajit K. Sachdeva, director of theACS Division of Education and moder-ator of the session, said in a phone in-terview afterward that there has been “alot of chatter” on ACS listservs about theduty-hour restrictions, but the ACS “hasno plans” to take over residency programacreditations.

“There’s a prevailing sense in the sur-gical community that the 16 hours a dayis not going to be good for surgical train-ing and actually will do harm, becauseyou will have less well-trained people inthe future,” said Dr. Sachdeva, adjunctprofessor of surgery at NorthwesternUniversity, Chicago. The ACS will con-tinue to try to get the AccreditationCouncil of Graduate Medical Education(ACGME) to expand the daily 16-hourlimit for first-year residents and to keep

Surgeons Decry Resident Hour Restrictions the 80-hour weekly limit from shrinking.

Under the 2011 regulations, residentsmust break the rules to get needed ex-perience in continuity of care, said Dr.Thomas V. Whalen, chief medical offi-cer, department of surgery, Lehigh Val-ley Health Network, Allentown, Pa.

Dr. Whalen, who served on theACGME task force that reviewed and re-vised the 2003 regulations, said that pres-sure for tighter limits on resident dutyhours came largely from sleep scientists

such as Dr. Charles A. Czeisler, professorand director of the division of sleepmedicine, Harvard University, and chiefof the division of sleep medicine atBrigham and Women’s Hospital, Boston.

Dr. Czeisler said in an interview thathe is an advocate of patient safety and ev-idence-based medicine. “In fact, this yearis the 40th anniversary of the first studydemonstrating that extended-durationshifts double the rate of errors that in-terns make when detecting cardiac ar-

rhythmias,” he said. Since then, his re-search has shown that work shifts longerthan 24 hours lead to a 460% increase inserious diagnostic mistakes made by res-ident physicians caring for critically ill pa-tients in the ICU, a 73% increase in therisk of percutaneous injuries, and a 168%increase in the odds of a resident beingin a motor vehicle crash while drivinghome, among other adverse conse-quences.

Continued on following page

04_5_6_7TS12_4.qxp 3/28/2012 1:36 PM

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6 RESIDENTS’ CORNER A P R I L 2 0 1 2 • T H O R A C I C S U R G E R Y N E W S

An Institute of Medicine (IOM) con-sensus statement in December 2008 rec-ommended that 5 hours of sleep beallowed after any shift longer than 16hours, and that this sleep time be count-ed toward the 80-hour/week limit, av-eraged over 4 weeks. The ACS publisheda detailed response to the IOM report,arguing that the 16 hours/day limit “isentirely unworkable in the surgical en-vironment” (Surgery 2009;146:398-409).The ACGME rules don’t go as far as theIOM recommendations because theACGME only applied the 16 hours/daylimit to interns and not other residents.

Limiting duty shifts for surgical resi-dents will not necessarily hurt the quali-ty of education or increase the number ofyears of training needed, according to Dr.Czeisler. He pointed out that “surgeonsin New Zealand have been training witha 16-hour shift limit since 1985, withoutneeding a longer training program.”

Dr. Mark L. Friedell, president of theAssociation of Program Directors inSurgery, suggested that the fourth year ofmedical school be used to prepare stu-dents for surgical residency. Dr. Sachdevasaid that the ACS is working with otherorganizations to develop a surgery “bootcamp” for fourth-year medical students.

Another helpful alternative would beto develop a “milestone” for first-yearresidents that might make the ACGME

feel comfortable in letting them work 24consecutive hours, like other residents.

Reports from five residency programson their experience thus far with duty-hour restrictions suggest that surgery in-terns now are working 6 days/week, and“golden weekends” have disappeared, hesaid. Patient hand-offs have increased inmany programs. Faculty and senior resi-dents are under more stress as more ofthe workload shifts to them. Many pro-grams have hired additional nurse prac-titioners and physician assistants to helphandle the work residents no longer do.

First-year residents report that they donot feel blamed for the restrictions, butmany feel that they are being short-changed by not having the same dutyhours as other residents, Dr. Friedell said.

“Part of the reason we’re in the messwe’re in is because we didn’t pay enoughattention to what residents did in thepre–80-hour era,” said Dr. Joshua M. V.Mammen, past chair of the ACS Resi-dent and Associate Society (RAS). Heechoed a theme in the others’ presenta-tions suggesting that enhanced supervi-sion of residents – rather than limitingduty hours – is the key to safe practice.

In an ongoing survey of current RASmembers with 841 respondents so far,48% said that residents should work 60-80 hours/week, 47% believed 61-100hours/week was ideal, 2% favored few-er than 60 hours/week, and 3% wantedmore than 100 hours/week. ■

TSRA Plans Partners’ ForumFor AATS Annual Meeting

The Thoracic Surgery Residents As-sociation (TSRA) has a new initiative

to support the partners of thoracicsurgery residents. Too often partners oftrainees find they have no assistance inmoving, living, and looking for a newjob during the training process. Oncefinished, the trials, successes, and short-cuts they gained are lost as they move onto the next adventure. In addition, thetraining process can be a solitary one forthe partner as temporary movesthrough new towns can lead to isolation.

Surprisingly, no one has previouslystudied the demographics or concerns ofthe partners of surgical trainees. A sur-vey has recently been created and dis-tributed by Dr. Rishi Reddy at theUniversity of Michigan. The study in-vestigates partners of applicants to tra-ditional 2- or 3-year thoracic residencyspots and current thoracic residents.

One of the initial findings of thisstudy is that a void exists in supportingpartners who are coordinating finances,child care, and housing, often whilemaintaining their own professional ca-reer. Partners of thoracic trainees havealso voiced requests of “I just wouldlike to talk to someone going throughthe same thing as I am” to “talking to

someone is great, but I just need to getthe kids moved to Phillie and find anew job.” The results of this study arebeing submitted for publication.

The TSRA is creating two forums tosupport partners of trainees. The firstevent will be held on the Sunday eveningof the AATS meeting in San Franciscoto help bring partners together.

In addition, an online community isbeing created through the TSRA web-site to disseminate the vast informationand resources partners gain during thetraining process with the thoracic res-ident. With both a regional and na-tional presence the website willincorporate multiple social networkingsites to help connect those moving,working, and raising children in a newtown while their partner continuestraining in thoracic surgery.

Improvements in thoracic trainingdo not end when the resident walks outof the hospital.

If you would like to comment or addto the partner website for the TSRAplease write to [email protected] partners’ event for the AATS willbe at the Pied Piper Bar (inside thePalace Hotel) from 5 to 7pm on Sunday,April 29. ■

Continued from previous page

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A P R I L 2 0 1 2 • W W W. T H O R A C I C S U R G E R Y N E W S . C O M GENERAL THORACIC 7

B Y A L I C I A A U LT


HOT SPRINGS, VA. – Access to quali-ty-driven hospitals may help reduce dis-parities that exist for minorities who needcancer care, according to an analysis ofoutcomes at facilities participating in theAmerican College of Surgeons NationalSurgical Quality Improvement Project.

Minorities with cancer have dispro-portionately poorer outcomes, and theirtreatment tends to occur more fre-quently at low-volume or lower-qualityhealth systems, said Dr. Waddah B. Al-Refaie, associate professor of surgery atthe University of Minnesota, Min-neapolis, and the Minneapolis VeteransAffairs Medical Center. Dr. Al-Refaie and

his colleagues set out to determine ifthose who received care at higher-quali-ty hospitals had better outcomes.

They examined data from 2005 to 2008on 38,296 patients who had undergonethoracic, abdominal, or pelvic cancersurgery at National Surgical Quality Im-provement Project (NSQIP) facilities. Theresearchers then looked at 30-day mor-tality, major postoperative events, andlength of stay if it was beyond the 75thpercentile of the cohort’s length of stay.

Overall, 75% of the 38,296 patientswere white. In all, 9% were black, 4%Hispanic, 3% Asian/Pacific Islander,0.7% American Indian/Alaskan Native,and 8% other. Nonwhites tended to beyounger, with a third under age 55, com-pared with 23% of whites, Dr. Al-Refaiesaid at the annual meeting of the South-ern Surgical Association.

The minorities also were more likely tobe smokers – for instance, 38% of Amer-ican Indians were smokers, comparedwith 16% of whites – and to have morecomorbidities. A total of 66% of blackshad hypertension, compared with 53% ofwhites, 50% of American Indians, 49% ofHispanics, and 46% of Asians. Blacks andHispanics were more likely to have dia-betes – about 24% of each group, com-pared with 16% of whites.

Nonwhites were more likely to un-dergo emergent cancer surgery; 3%-4%of minorities had an emergent proce-dure, compared with 2% of whites. Mi-norities also were less likely to undergocomplex oncologic resection, that is, ofthe lung, pancreas, or esophagus.

Before adjustment, nonwhites, with theexception of Asians, had 30-day mortali-ty and major and minor complicationrates similar to those of whites. AmericanIndians, however, did have higher rates of30-day mortality (4%, compared with 2%for whites) and major complications(24%, compared with 19% for whites).

Minorities With Cancer Fared Better At NSQIP HospitalsBlacks and American Indians also hadprolonged lengths of stay compared withwhites. Sensitivity analyses showed nosignificant interactions between race,American Society of Anesthesiologistsclassification, functional capacity, orsmoking. The outcomes remained thesame after the data were stratified by on-cologic resection, said Dr. Al-Refaie.

The study did have some limitations,he said. There was no adjustment for so-cioeconomic or insurance status, both of

which are strong drivers to access. Sim-ilarly, there was no adjustment for hos-pital or surgeon volume. And there wasno information on cancer stage, which isan issue because nonwhites are morelikely to present with advanced disease,he said. However, the study shows thatexpanded access to higher-quality facili-ties can improve care and amelioratedisparities, he added.

“The authors have shown that quality-seeking organizations achieved equiva-

lent risk-adjusted postop complicationrates across populations,” said Dr. MaryT. Hawn, of the University of Alabama,Birmingham.

But the study also raises questions.Why can these facilities provide equiva-lent care while others cannot? Do thesehospitals have additional resources?

Dr. Al-Refaie said that the NSQIP hos-pitals most likely did have more resourcesand perhaps a better payer mix that al-lowed them to support better care. ■

NSQIP HOSPITALS MOST LIKELY

DID HAVE MORE RESOURCES

AND PERHAPS A BETTER PAYER

MIX THAT ALLOWED THEM TO

SUPPORT BETTER CARE.

04_5_6_7TS12_4.qxp 3/28/2012 1:36 PM

8 ADULT CARDIAC A P R I L 2 0 1 2 • T H O R A C I C S U R G E R Y N E W S

mortality, rehospitalization, and resourceutilization outcomes. The 3- to 5-yearoutcomes after coronary artery bypassgraft (CABG) surgery are being com-pared with those after percutaneouscoronary intervention (PCI) – primarilyusing drug-eluting coronary stents, fromthe STS and ACC databases, respective-ly. In addition to survival, researchers areassessing the need for additional proce-dures and hospitalizations, new cardiacdisease conditions, and the medicationsbeing taken at various points in time af-ter the coronary artery procedure.

Patients in this CMS population wereat least 65 years of age with two- tothree-vessel disease. Patients with eithersingle-vessel disease or left-main diseasewere excluded.

“[This study has] a population that is ac-tually 10 times greater than the sum totalof all patients ever having been enrolledin randomized [revascularization] trials,”said Dr. Edwards, who is medical directorof cardiothoracic surgery at the Universi-ty of Florida/Shands Jacksonville,andchairman of the STS National Database.

Data from both the STS and ACCdatabases were linked to data from theCMS. A propensity score – the probabil-ity of having CABG – was calculated foreach patient, and clinically importantsubgroups were identified before thefiles were linked. The propensity scoresand inverse weighting were used to cal-culate adjusted survival curves. “Thenwe compared the survival for coronarybypass and percutaneous intervention

for groups having very similar charac-teristics,” said Dr. Edwards.

High- and Low-Risk Groups IdentifiedThis analysis included a total of 189,793patients, of which 103,549 received PCI.Dr. Edwards presented the survival re-sults for high-risk subgroups; the overallresults will be presented at the ACC’s An-nual Scientific Session in March, he said.

High-risk subgroups include patientswho were aged 75 years and older, haddiabetes, had EFs less than 50%, and hada GFR less than 60 mL/min per 1.73 m2.

For those aged 75 years and older, themortality risk ratio at 4 years was 0.78 fa-voring surgery. Correspondingly, the sur-vival advantage in this group for surgerywas 22%. For patients with three-vesseldisease, the survival advantage at 4 yearswas 25%. Patients with insulin-depen-dent diabetes had a 28% survival advan-tage at 4 years with CABG, comparedwith PCI. For patients with EFs less than50%, the survival advantage with surgerywas 30% at 4 years.

However, there appears to be a survivaladvantage with PCI in these groups at upto 1 year of follow-up. “We should keepin mind that in many of these subgroups,the survival with percutaneous inter-vention is better than surgery in thatfirst 6-10 months after the procedure.The reason for that, of course, is the pro-cedural mortality,” Dr. Edwards said.

They also defined a low-risk popula-tion (about 20% of the total popula-tion). They looked at survival advantages

at years 1-4. “I think this is important be-cause it illustrates that surgery reallydoes start to declare its advantage inyear 1 to year 2. Then it looks like it be-gins to plateau off a little bit,” he said.“Still, at 4 years for both high-risk andlow-risk patients, you’ve got more thana 25% survival advantage for surgery.”

He noted that “this is a Medicare pop-ulation, so we would be on shakyground if we tried to extrapolate theseresults to a global population.”

He concluded by saying that “the re-sults should improve the quality of carefor patients with coronary disease, andit should clarify the indications for in-tervention in the subgroups that we’vepresented here.”

Prediction Models Gleaned From DataDuring the same presentation, Dr. DavidM. Shahian reported on long-term pre-diction models of death and nonfatalevents for both CABG and PCI. “Longerterm outcomes are clearly going to benecessary if we’re really going to deter-mine the true comparative effectivenessof these various strategies.” he said.

The researchers looked at all isolatedCABG patients at STS-participating hos-pitals who were discharged between thebeginning of 2002 and the end of 2007.STS procedural records were linked toCMS claims and denominator files.

The final cohort included 348,341CABG patients at 917 sites. Follow-upwas through 2008 (median follow-up, 4years). Long-term variables were basedon those from short-term CABG modelsand clinical experience. Separate hazardratios were estimated for each of thesevariables for four time intervals: 0-30

days, 31-80 days, 181-730 days, and morethan 2 years.

Kaplan-Meier estimated mortalityrates for CABG were 3% at 30 days, 6%at 180 days, 8% at 1 year, 11% at 2 years,and 23% at 3 years. Predicted mortalityrates were superimposable with ob-served mortality rates, said Dr. Shahian,who is a cardiothoracic surgeon at Har-vard Medical School in Boston. Dr.Shahian is also the chair of the STSAdult Cardiac Surgery Database and theSTS Quality Measurement Task Force.

“We did observe the obesity paradoxhere. It’s the frail, almost cachectic indi-viduals, who do the worst, while the moreobese individuals tend to do better overtime,” he said.

The impact of some predictorschanged over time. For example, pa-tients with an acute MI have an increasedinitial mortality risk, which becomesgenerally insignificant over 1-2 years. Inaddition, early reoperation, shock, andemergency status have high up-frontrisks that decrease over time. However,preoperative atrial fibrillation progres-sively increases risk over time, he said.

“Among hospital survivors, higherejection fraction and higher [body massindex] are protective at all time periods.A past history of stroke … [and] chron-ic lung-disease immunosuppression havea persistent and negative impact on sur-vival. Smoking, diabetes, dialysis-depen-dent renal failure – their negative impactincreases over time. … Some early im-portant risk factors, like shock, emer-gency status, and reoperation are notpredictors of late outcomes.”

Dr. Edwards and. Dr. Shahian report-ed no relevant financial relationships. ■

CABG OutcomesHigh-Risk • from page 1

performed by an independent panel of infectious dis-eases experts.

Major infections evaluated in the study includeddeep incisional surgical (chest), deep incisional surgi-cal (second incisions), empyema, endocarditis, medi-astinitis, myocarditis, pneumonia, bloodstreaminfections, Clostridium difficile colitis, and cardiac deviceinfections. Infections were defined by a combination ofclinical, laboratory, and/or radiologic evidence (ac-cording to Centers for Disease Control and Preventionsurveillance definitions) for a follow-up of 65 days.

The researchers included several types of surgical in-terventions: isolated coronary artery bypass graft(CABG), isolated valve surgery, CABG with valvesurgery, surgery for heart failure, thoracic aorticsurgery, and other procedures. The mean patient agewas 64 years, mean bypass time was 115 minutes, two-thirds (67%) were men, 71% had heart failure, a quar-ter (27%) had diabetes, 14% had chronic obstructivepulmonary disease (COPD), and 19% had prior cardiacsurgery. Mean hemoglobin was 13.2 mg/dL.

There was a significant dose-dependent associationbetween quantity of packed red blood cells (PRBCs) andrisk of infection, with the crude risk increasing by an av-erage of 29% with each PRBC unit. Several factors in-creased the risk of infection, including severe COPD(relative risk, 1.85), preoperative creatinine levels greaterthan 1.5 mg/dL (RR, 1.72), heart failure (RR, 1.49), mildto moderate COPD (RR, 1.36), PRBCs per unit (RR,1.24), and surgery time per 60 minutes (RR, 1.19).

Platelet transfusion occurred in 31% of patients, andplatelet use was associated with a decreased infection risk

(RR, 0.71). Cell Saver use was not related to infection.Creatinine levels greater than 1.5 mg/dL (RR, 2.40)

and PRBCs per unit (RR, 1.23) significantly increased therisk of death. Many factors significantly increased thelength of stay, including creatinine levels greater than 1.5mg/dL (RR, 1.26), severe COPD (RR, 1.41), mild to mod-erate COPD (RR, 1.14), heart failure (RR, 1.36), PRBCs(RR, 1.12), surgery time per 60 minutes (RR, 1.11), ageof 65-79 years (RR, 1.21), and age older than 80 years(RR, 1.44). The use of plateletswas associated with a decreasedlength of stay (RR, 0.71).

All risks of transfusion must beweighed against toleration ane-mia, which is also associated withadverse outcomes, added Dr.Horvath.

In the second study, the re-searchers used the same dataset.Captured data included infectionoccurrence, type, timing, and organisms. The risk ofpneumonia, mortality, and length of stay (time to dis-charge) were analyzed.

Major infections included bloodstream, pneumonia,C. difficile, deep sternal incisional, mediastinitis, deepgroin/leg incisional, endocarditis, and empyema.

Pneumonia was diagnosed using the 2010 surveillancecriteria from the CDC/National Healthcare Safety Net-work, including chest x-ray with new or progressive andpersistent infiltrate; fever greater than 38° C; leukope-nia (defined as fewer than 4,000 leukocytes per cc);leukocytosis (at least 12,000 leukocytes per cc); or al-tered mental status. At least two of the following musthave been present as well: purulent sputum or change;cough, dyspnea, or tachypnea; rales or bronchial breathsounds; or worsening gas exchange. Duration of follow-

up was 65 days. In all, 31% had isolated CABG, 30% hadisolated valve surgery, 11% had CABG and valve surgery,6% had thoracic aortic surgery, 2% had left ventricularassist device (LVAD) implantation/heart transplant,and 20% were categorized as other.

Overall, 2.4% of patients in the registry had pneu-monia, 1.1% had blood stream infection, 1% had C. dif-ficile colitis, and 0.5% had deep sternal infections.

The overall mean time to infection was 19 days and themedian was 14 days. The meantime to infection for pneumoniawas 15 days. A total of 68% and66% of pneumonias and bloodstream infections, respectively, oc-curred during hospitalization.

Increased risk of pneumoniawas associated with surgery time(RR, 1.42), a creatinine level of atleast 1.5 mg/dL (RR, 1.94), mildto moderate COPD (RR, 1.78),

severe COPD (RR, 4.12), and heart failure (RR, 1.76). Only nasal decontamination with mupirocin was as-

sociated with reduced risk of pneumonia (RR, 0.77).Nasal decontamination with other agents (RR, 1.44); an-tibiotics given within 24 hours after surgery (RR, 1.26)and within 48 hours postop (RR, 2.70); ventilator use of24-48 hours (RR, 2.31) and more than 48 hours (RR,4.58); nasogastric tube (RR, 2.07); and use of PRBCs (RR,1.10) were all associated with increased pneumonia risk.

Pneumonia was significantly associated with an in-creased risk of mortality (RR, 7.07), as were heart fail-ure (RR, 1.87), creatinine levels of at least 1.5 mg/dL(RR, 2.97), and surgery duration (1.27). However, blackrace appeared to be protective, with a significantly de-creased risk of pneumonia (RR, 0.43).

Dr. Horvath and Dr. Ailawadi had no disclosures. ■

Infection RiskTransfusions • from page 1

The crude risk [of surgicalinfections]increased by an average of29% with eachPRBC unit.

DR. HORVATH

01_2_3_8_9TS12_4.qxp 3/28/2012 1:34 PM

carefusion.com/chloraprep | 800.523.0502

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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.

A P R I L 2 0 1 2 • W W W. T H O R A C I C S U R G E R Y N E W S . C O M ADULT CARDIAC 9

B Y M I T C H E L L . Z O L E R


MIAMI BEACH – Researchers have de-veloped a way to quickly and objective-ly assess the risk for aortic valveregurgitation based on the measurementof aortic blood pressures immediately af-ter transcatheter valve replacement(TAVR). This new measure, the “aorticregurgitation index,” showed significantcorrelation with periprocedural aorticregurgitation as well as with patients’ 1-year survival following their procedure,Dr. Eberhard Grube said at the ISET2012 meeting.

Until now, “there has been no way toquantify aortic regurgitation; it’s subjec-tive,” said Dr. Grube, professor and chiefof cardiology and angiology at the He-lios Heart Centre in Siegburg, Germany.The aortic regurgitation index (ARI) al-lows physicians “to quantify aortic re-

gurgitation periprocedurally byobjectively looking at the patient’s he-modynamics, regardless of the subjectiveevaluation of aortic insufficiency by an-giography or by echo,” he said. “We cansee the ARI and know what we need todo for postdeployment treatment.”

Dr. Grube and his associates set the ARIas equal to the patient’s diastolic aorticpressure minus the left ventricular end di-astolic pressure, all divided by the aorticsystolic pressure, and multiplied by 100.

For example, a patient with mildperiprocedural aortic regurgitation mighthave an aortic diastolic pressure of 60 mmHg, a left ventricular end diastolic pres-sure of 15 mm Hg, and an aortic systolicpressure of 150 mm Hg, which wouldproduce an ARI of 30, showing that thepatient had a low risk for dying during thesubsequent year. In contrast, a patientwith moderate or severe periproceduralaortic regurgitation could have an aorticdiastolic pressure of 40 mm Hg, a left ven-tricular end diastolic pressure of 20 mmHg, and an aortic systolic pressure of 120mm Hg, which would produce an ARI of16.7, flagging a higher mortality risk in thefollowing year.

His group assessed the prognostic abil-ity of the ARI in a series of 146 patientswho underwent TAVR. The group in-cluded 124 patients with no or mild aor-tic regurgitation following TAVR and 22who showed moderate or severe regur-gitation. During 1-year follow-up, the 96patients with a periprocedural ARI of 25or greater had an 83% survival rate; the50 patients with a periprocedural ARI ofless than 25 had a survival rate of 54%,a statistically significant difference. Theanalysis also showed a significant corre-lation between the ARI and the severity

Aortic Regurgitation After TAVR Poses Threatof aortic regurgitation. Among patientswith no discernible regurgitation, theaverage ARI was about 30, in those withmild regurgitation the average ARI wasabout 25, in patients with moderate re-gurgitation the average was about 18,and in patients with severe regurgitationthe ARI averaged about 10.

One recently identified key to limitingaortic regurgitation following TAVR isproper valve sizing relative to the pa-tient’s aortic annulus. “Appropriate valve

sizing is likely the most important factorthat will influence both the degree ofperivalvular regurgitation and pacemak-er need after TAVR,” said Dr. Jeffrey J.Popma in a separate talk at the meeting.

Until recently, many operators usedtransthoracic echocardiography for an-nulus sizing, but recently published evi-dence showed that imaging by CT or byMRI provides superior information, saidDr. Popma, director of interventionalcardiology at Beth Israel Deaconess Med-

ical Center in Boston. He cited a Britishreport published last November thatcompared transthoracic echo, CT, andMRI in 202 patients who underwentTAVR, which found both CT and MRIsuperior to echo for annulus measure-ment prior to TAVR ( J. Am. Coll. Car-diol. 2011;58:2165-73).

Dr. Grube and Dr. Popma disclosed fi-nancial relationships with several medicaldevice manufacturers including BostonScientific, Medtronic, and Cordis. ■

Proper valvesizing is likelythe mostimportant factoraffecting post-TAVR perivalvularregurgitation.

DR. POPMA

01_2_3_8_9TS12_4.qxp 3/28/2012 1:34 PM

20th European Conference on

General Thoracic Surgery

European Society of Thoracic Surgeons www.ests.org

Essen - Germany10 - 13 June 2012

www.estsmeetings.org/2012

SESSIONS AND TOPICS

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10 NEWS FROM THE AATS A P R I L 2 0 1 2 • T H O R A C I C S U R G E R Y N E W S

PRESIDENT’S MESSAGE

AATS Is the Antonym of ‘Retreat’

Dictionaries define “retreat” as ei-ther an act or process of with-drawing or a peaceful, quiet place

affording privacy or security.This past December, AATS conduct-

ed a “retreat” which resulted in a per-fect demonstration of the antonym of“retreat” which is to “advance.”

As promised in a prior message, theCouncil has moved quickly to imple-ment many of the recommendationsemanating from the four retreat work-ing groups by inviting the chairs to itsmeeting in late January in Ft. Laud-erdale, Florida.

I am pleased to report that at ourAnnual Meeting in San Francisco inlate April a new AATS organizationalstructure will be implemented whichwill address the recommendations ofthe working groups.

This reorganization will streamlinethe reporting processes for every aspectof the Association. It will provide anopportunity for significantly more in-volvement by individual members inthe organization’s activities enablingthe leadership to more fully utilize theextraordinary talents our membershiphas to offer.

Some of the recommendations will

be implemented in San Francisco withthe advent of PODs (presentation ondemand) in the exhibition area. Thesewill enable partici-pants to view videoand Powerpoint slidepresentations of origi-nal work selectedfrom abstracts submit-ted for considerationat this year’s AnnualMeeting for whichpodium space was notavailable.

An AATS WelcomeCenter in the registra-tion area will provideall participants with afocal point to whichthey might turn for in-formation on themeeting, the Associa-tion, and the City ofSan Francisco.

A number of significant changes areplanned for 2013 in Minneapolis to as-sure that attendees have an opportuni-ty to expand personal interactionthroughout the meeting.

Efforts are underway to enable thepublications of the Association

( JTCVS, OpTechs, Seminars, PediatricAnnual, and TSN) to be integrated onnew technology platforms which will

provide their variousaudiences with moreimmediate and inter-active access in thecoming years. Chargesare being developedfor each of the respon-sible editorial groupsthat will ensure themaintenance of theextraordinarily highcontent presentlyavailable.

The SAGR Commit-tee has been chargedwith working with theNIH to develop a mul-ti-centered TrainingGrant program. Addi-tionally the AATS

Leadership Academy has been askedto enhance the Developing the Acade-mic Surgeon program while the Edu-cation Committee identifiesopportunities to export the AATS sci-entific content internationally in con-junction with our sister internationalorganizations.

We intend to expand our collabora-tive efforts with STS and other relevantorganizations in the development ofclinical practice guidelines and creden-tialing initiatives.

During this past year alone we havecooperated in such activities with theAmerican College of Cardiology(ACC), the Society for CardiovascularAngiography (SCAI), and the Interna-tional Association for the Study ofLung Cancer (IASLC).

As I review the issues addressed dur-ing our Retreat this past year, I believethe AATS is well positioned to repre-sent our specialty during the comingyears. At the end of the Association’sExecutive Session on Tuesday, May 1st,Dr. Hartzell V. Schaff of the MayoClinic will assume the Presidency ofthe AATS.

It has been my pleasure to workwith Dr. Schaff and my colleagues onthe Council these past several yearsand I am certain that his efforts andthose of his successors will continue todemonstrate that AATS is the perfect“Antonym of Retreat!”

Craig R. Smith, MDAATS President

DR. CRAIG R. SMITH

10_15TS12_4.qxp 3/28/2012 1:38 PM

A P R I L 2 0 1 2 • W W W. T H O R A C I C S U R G E R Y N E W S . C O M NEWS FROM THE AATS 11

AATS 92nd Annual Meeting (Immediately following the Aortic

Symposium 2012 in New York, NY)April 28 – May 2, 2012

Moscone West Convention CenterSan Francisco, CA, USA

In addition to the outstanding educa-tion offered at the Saturday and Sun-day symposia, plenary and

simultaneous sessions and other cours-es, AATS Annual Meeting attendeesare encouraged to take advantage ofthe other offerings including:

SURGICAL ROBOTS/TECHNOLOGY BAZAAR *NEW!*Saturday April 28, 20121:00 p.m. – 4:45 p.m.

Chair: Dennis L. Fowler, MD, MPH,Columbia University

Current surgical robotics technologyhas changed little in the past decade,yet there is great need for more intelli-gent technology. Presentations in thissymposium will discuss current cardio-thoracic surgery results using surgicalrobots and the following potential en-hancements to surgical robots and oth-er surgical technology: P Enhanced robotic technology fo-cused on better access and automationof tasks.P Use of modern computation capa-bilities for patient care.P Enhanced non-robotic technology.Presenters will include visionaries, en-gineers, and surgeons engaged in de-veloping new technology for surgery.

BUILDING THE HYBRID OR OFTHE FUTURE©:A Practical Approach – How to Take YourIdeas and Concepts and Make Them a Re-ality

Monday, April 30, 20121:00 p.m. – 4:30 p.m.

The Hybrid OR of the Future© pro-gram will give attendees, who arethinking about building a hybrid OR intheir hospitals, real life examples ofwhat works and what doesn’t. The pro-gram will provide participants with abusiness approach to this type of pro-ject along with a real “nuts” and“bolts” discussion of what they need todo to get their projects off the groundand prepare the surgical community totake the lead in the design, selection,and implementation of the surgical en-vironment in their hospitals.

Target Audience:Hospital C-Suite Executives (CEO,CFO, COO, CMO); Thoracic SurgeonLeaders; Directors of Surgery, Operat-ing Room, Materials;Management/Purchasing, and Facili-ties; Nursing Leadership

Transcatheter Therapy and Collaboration: Defining Our Future *NEW!*

Wednesday, May 2, 201211:00 a.m. – 2:30 p.m.Chairs: A. Marc Gillinov, MD, Cleve-

land Clinic and Mathew R. Williams,MD, Columbia University

Don’t miss the newly added program“Transcatheter Therapy and Collabora-tion: Defining our Future.” The sessionwill provide valuable data and trainingon advancements in surgical tech-niques, such as lesser-invasive ap-

proaches, robotics, novel valves andrepair procedures, use of intraopera-tive imaging, novel devices, and opti-mal pharmacotherapy, in order toimprove outcomes for patients under-going cardiac surgery. With the expan-sion of hybrid surgical andinterventional revascularization forcoronary artery disease and the grow-ing use of endografts as primary thera-py for aortic aneurysms, thecontemporary surgeon has never hadmore options available for the treat-ment of patients with cardiovasculardisease. The session is an in-depthcourse focusing on novel and advancedsurgical techniques for surgeons inter-ested in the most contemporary surgi-cal techniques and catheter-basedapproaches.

Exhibit Hall Features:Open from Sunday, April 29th throughTuesday, May 1st

Presentations on Demand(POD) Digital Media *NEW!*Display Kiosks Access even more cutting-edge re-search via the POD digital media dis-play kiosks located on the Exhibit HallFloor. The kiosks feature more than 50electronic presentations and videos inthe areas of adult cardiac, congenitaland general thoracic.

CT ICU of the Future©

The continuing evolution of ICU tech-nology and the increased complexity ofCVT Critical Care challenges CT sur-geons to keep current on new tech-nologies. AATS attendees will be ableto see firsthand what the future holdsfor cardiothoracic surgical critical careat the ICU of the Future display. TheCT ICU of the Future© will showcasethe newest equipment and the latesttechnological advances in imaging, ad-vanced information technology, andcritical care medicine used in cardio-thoracic surgical critical care. New for2012, the ICU of the Future displaywill feature two patient rooms high-lighting two different patient scenarios— one will be a high acuity room, theother a more “standard” ICU room.

Operating Rooms of the Future: Hybrid Technologies©

Stop by the display to learn what 21stcentury operating rooms offer to the

specialty of thoracic surgery.For the full program listing, please visitwww.aats.org/annualmeeting.

Mobile ApplicationAn interactive, electronic version ofthe program will be available fordownload via the AATS website as well

as on site at the Annual Meeting. It al-lows for searching of program topics,faculty, exhibitors, social functions, SanFrancisco information, and more. Themobile application will work on alliPhones, iPads, Androids, and Black-Berries. A mobile optimized websitewill be available for other platforms.

It’s not too late! Reserve your space atthe AATS Annual Meeting, register forthe Weekend symposia, and registerfor the Wednesday Transcatheter Therapy Session at www.aats.org/annualmeeting/Registration.html.

Target AudienceThe AATS Annual Meeting is designedto meet the educational needs of:P Cardiothoracic Surgeons. P Physicians in related specialties in-cluding Cardiology, CardiothoracicAnesthesia, Critical Care, Gastroenterol-ogy, Pulmonology, Radiology, ThoracicOncology, and Vascular Surgery. P Critical Care Teams including Anes-thesiologists, Critical Care Nurses,Hospitalists, and Interventionalists.

P Fellows and Residents in Cardiotho-racic and General Surgical training pro-grams. P Allied Health Professionals involvedin the care of cardiothoracic surgicalpatients including Nurses, Nurse Prac-titioners, Perfusionists, Physician Assis-tants, and Surgical Assistants.

P Medical students with an in-terest in cardiothoracic surgery.

Annual Meeting AccreditationThe American Association forThoracic Surgery is accreditedby the Accreditation Councilfor Continuing Medical Educa-

tion to provide continuing medical ed-ucation for physicians.

The American Association for ThoracicSurgery designates this live activity for amaximum of 37 AMA PRA Category 1Credits™. Physicians should claim onlythe credit commensurate with the ex-tent of their participation in the activity.

This program will be submitted to theAmerican Academy of Nurse Practi-tioners for continuing education credit.

Conference organizers plan to requestAAPA Category I CME credit from thePhysician Assistant Review Panel. Totalnumber of approved credits yet to bedetermined.

The American Board of CardiovascularPerfusion designates this educationalactivity for a maximum of 38.6 Catego-ry 1 CEUs.

For further information contact AATS:Telephone: +1 (978) 927-8330E-mail: [email protected] ■

Attend the AATS Annual Meeting

Featuring the ‘Battle of the Valleys’Wine Tasting Event

Tuesday, May 1, 20127:00 p.m. – 10:00 p.m.

Join us for the Battle of the Valleysat the California Academy of Sci-ences. While enjoying all that theAcademy has to offer, put yourpalette to the test while samplingthe finest wines from both Sonomaand Napa Valleys. Can you tellwhich wine is from Napa and whichis from Sonoma? Battle amongstyour peers as a winner will be an-

nounced at the end of the evening.Enjoy libations, passed hor d’oeu-vres, and live music from one of thetop swingin’ jazz bands in theworld. Don’t be afraid to tap yourfeet or even dance the night away.We encourage you to purchase tick-ets in advanced on our website.Tickets will be also be available forpurchase at Registration (MosconeWest Convention Center – Level 1). To register, please visit:http://www.aats.org/annualmeeting/Registration.html

AATS Special Reception at the California Academy of Sciences

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10_15TS12_4.qxp 3/29/2012 10:22 AM

12 NEWS FROM THE AATS A P R I L 2 0 1 2 • T H O R A C I C S U R G E R Y N E W S

AMERICAN ASSOCIATION

FOR THORACIC SURGERY

AATS Annual Meeting Accreditation

The American Association for Thoracic Surgery is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education

for physicians.

This live activity has been approved for AMA PRA Category 1 Credit(s)™.

This program will be submitted to the American Academy of Nurse Practitioners for continuing education credit.

Conference organizers plan to request AAPA Category I CME credit from the Physician Assistant Review Panel.Total number of approved credits yet to be

determined.

t� Cutting-edge Skills Courses

t� A Full-day Allied Health Personnel Symposium

t� AATS/STS Postgraduate Symposia with featured Luncheon Keynote Speaker: Scott A. Shappell, PhD

t� Building the Hybrid OR© Program / Displays and the CT ICU of the Future© Display

t� Presidential Address: Craig R. Smith, MD

t� Basic Science Lecture: John Bares, PhD

t� Honored Guest Lecture: Mehmet C. Oz, MD

t� AATS Special Reception at the California Academy of Sciences

FEATURING:

YMPOSIUMSORTIC

APRIL 26–27, 2012

Sheraton Hotel & Towers, New York City

Scan this code with

your mobile device

to access complete

meeting information

Cardio-Thoracic Surgery in Africa inthe 21st Century: Quo vadis? (Held during the 92nd Annual Meetingof the AATS) Saturday, April 28, 20127PM - 9PM in the Club Room of the San Francisco Marriott Marquis Hotel. (In walking distance from the San FranciscoConvention Center)

Course Director: Charles Yankah, MD,German Heart Institute BerlinProgram committee: Francis Fynn-Thompson, MD, Willie Koen, MD, Car-los Mestres, MD, Francis Smit, MD.

PROGRAMWelcome address: Charles Yankah, MD,Berlin, President, PASCaTS: Forgingahead capacity building programs: Trainingcourses and teleconferencing in Africa

Key-note speakers: Morton R. BolmanIII, MD, Brigham & Women’s Hospital,Boston: Outcomes of rheumatic valve repairversus replacement: Rwanda ExperienceFrancis Fynn-Thompson, MD, Children’sHospital, Boston: Concept and the chal-lenges of congenital heart surgery in sub-Sa-haran Africa: Ghana experienceModerators: Marko Turina, MD, Zurich,Charles Yankah, MD, BerlinPanelists: Morton Bolman III, MD,Boston, Francis Fynn-Thompson, MD,

Boston, Jose Pomar, MD, Barcelona, Her-mann Reichenspurner, MD, Hamburg.

Program Overview: It is a 2-hour inter-active discussion with a faculty whichconsists of leaders in cardio-thoracicsurgery practising in the developingworld. They will discuss indications andpatient selection for surgery, surgicalsafety and concepts to improve cardio-thoracic healthcare in Africa in collabo-ration with the internationalprofessional community through net-working and video teleconferencing.

Program format: The program consistsof experiences regarding decision mak-ing for palliative or corrective surgery,repair or replacement surgery (biologicalor mechanical) in many African patientswith advanced disease states. Dr. Mor-ton Bolmam III and Dr. Francis Fynn-Thompson will present challenges ofdynamic clinical practice and the charmof cardio-thoracic surgery in Ghana andRwanda which will create a memorableexperience for the attendees.

Send your registration for the RoundTable to: [email protected] Table is sponsored in part by aneducational grant from CryoLife USA,Sorin Group USA. ■

CT Surgery in Africa Session

2012 Heart Valve Summit: Med-ical, Surgical and InterventionalDecision-MakingOctober 11 - 13, 2012JW Marriott Chicago, Chicago, ILView program and REGISTER at:www.aats.org

Program Directors:David H. Adams, MD, FACCSteven F. Bolling, MD, FACCRobert O. Bonow, MD, MACC Howard C. Herrmann, MD, FACC

Nurse Planner:Michele Langenfeld, RN, MS

Course Overview: The AATS andthe American College of Cardiologyonce again are partnering to bringtogether CT surgeons and cardiolo-gists in a cooperative, case-basedcourse to address the rapid advancesin the treatment of valvular heartdisease. With the tradition of inter-activity and practical decision mak-ing, the unique Heart Valve Summitis designed to engage participants indiscussions, debates, and potentialcontroversies surrounding real-worldcases using renowned faculty on thecutting edge of the clinically rele-

vant data for valvular heart diseasemanagement. This inter-disciplinarycourse emphasizes clinical decisionmaking while combining the mostrelevant medical, surgical and inter-ventional options for patient care.Breakout sessions for cardiac sur-geons, cardiologists, nurses, andphysician assistants are designed toinvolve the specialists in managingtheir unique challenges from theteam perspective.

Target Audience: This course is in-tended for cardiothoracic surgeons,cardiologists, interventional cardiol-ogists, internists, nurses, physicianassistants, and all healthcare profes-sionals involved in the evaluation,diagnosis, and/or management ofpatients with valvular heart disease.

AccreditationPhysicians: This course has been ap-proved for AMA PRA Category 1Creditsª.Nurses: The American College ofCardiology Foundation is accreditedas a provider of continuing nursingeducation by the American NursesCredentialing Center’s Commissionon Accreditation. ■

Register for the 2012 Heart Valve Summit

10_15TS12_4.qxp 3/28/2012 1:38 PM

American Associationfor Toracic Surgery

2012Heart Valve SummitMedical, Surgical andInterventional Decision Making

October 11 – 13, 2012JW Marriott Chicago

Course Directors

David H. Adams, MD, FACC

Steven F. Bolling, MD, FACC

Robert O. Bonow, MD, MACC

Howard C. Herrmann, MD, FACC

Space is limited. Pre-register at

www.CardioSource.org/heartvalveP2

©2012 American College of Cardiology H193

A P R I L 2 0 1 2 • W W W. T H O R A C I C S U R G E R Y N E W S . C O M NEWS FROM THE AATS 13

21st Century Treatment of Heart Fail-ure: Synchronizing Surgical and Med-ical Therapies for Better OutcomesOctober 18-19, 2012Intercontinental Hotel & Bank of AmericaConference Center, Cleveland, OH(See agenda and registration informa-tion at www.ccfcme.org/heartfailure12)

Program DirectorsKatherine J. Hoercher, RNNader Moazami, MDSoon J. Park, MDNicholas G. Smedira, MDRandall C. Starling, MDJames B. Young, MD

2012 Kaufman Center Award Recipi-ent and Lecturer: O.H. Frazier, MD

Program Overview: The Kaufman Cen-ter for Heart Failure at Cleveland Clinicand the American Association for Tho-racic Surgery have partnered once againto present an educational event for allhealthcare providers who care for pa-tients with heart failure; 21st CenturyTreatment of Heart Failure: Synchroniz-ing Surgical and Medical Therapies forBetter Outcomes. Heart failure is notonly a growing and costly problem butone that is associated with significantmorbidity and mortality. The increasing

prevalence of heart failure is due to theaging population as well as the markedincrease in survival of patients who suf-fered from myocardial infarction andvalvular disease. The current state ofmanagement, however, is far from opti-mal. Moreover, the therapeutic arma-mentarium has remained stagnant sincethe introduction of resynchronizationdevices, with no new therapies in devel-opment. Given the undertreatment ofheart failure and the lack of new thera-pies, the focus of management has shift-ed to optimizing existing medical anddevice therapies, including long-termmechanical circulatory support. Now inits 15th year, this Summit will feature afaculty of world renowned cardiologistsand cardiovascular surgeons who will of-fer a clinically relevant review and dis-cussion of current and future therapiesfor managing heart failure.

Target Audience: This program is in-tended for cardiologists, cardiovascularsurgeons, internists, nurses, physicianassistants, perfusionists, and researchersinvolved in the management of patientswith heart failure.

Accreditation: The Cleveland ClinicFoundation Center for Continuing Edu-cation is accredited by the Accreditation

Council for Continuing Medical Educa-tion to provide continuing medical edu-cation for physicians. The ClevelandClinic Foundation Center for Continu-ing Education designates this live activi-ty for a maximum of 14 AMA PRACategory 1 CreditsTM. Physicians shouldclaim only the credit commensuratewith the extent of their participation inthe activity. Participants claiming CMEcredit from this activity may submit thecredit hours to the American Osteo-pathic Association for Category 2 credit.

Nurses: For the purposes of recertifica-tion and relicensure, The AmericanNurses Credentialing Center acceptsAMA PRA Category 1 Credit issued byorganizations accredited by the ACCME.

Abstract Submission: The Heart-FailureSummit invites you to submit abstracts oforiginal investigation for consideration inthe Poster Session on Thursday evening,October 18 from 6:00 pm to 7:30 pm. Ab-stracts previously presented at national orinternational meetings will be accepted.Accepted abstracts will be printed in thesyllabus. Submission deadline is Septem-ber 21, 2012. There is no limit to thenumber of abstracts a presenter can sub-mit. Abstracts must be submitted by e-mail to [email protected]. ■

Attend 2012 Heart Failure Conference

The National Heart, Lung, andBlood Institute (NHLBI) and

the National Institutes of Health(NIH) have posted their FY 2012Funding and Operating Guide-lines. The NHLBI will continueto apply NIH cost managementguidelines when making fiscalyear 2012 grant awards. Fundswill be restored as appropriatefor FY 2012 awards previouslymade at the 90% provisionalamount. Although funding deci-sions are usually made in priorityscore or percentile order, finalfunding decisions are based onconsiderations of program rele-vance, overlap with existing pro-grams, availability of funds, andNHLBI Advisory Council recom-mendations. More information,including payline informationand future year commitments onFY 2012 new and competing re-newal awards can be found on-line at http://www.nhlbi.nih.gov/funding/policies/operguid.htm. ■

NIH/NHLBI FY2012 FundingAnd Operating

Guidelines

10_15TS12_4.qxp 3/28/2012 1:38 PM

14 A P R I L 2 0 1 2 • T H O R A C I C S U R G E R Y N E W S

C L A S S I F I E D SA l s o a v a i l a b l e a t w w w. i m n g m e d j o b s . c o m

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CARDIOTHORACIC SURGERY FELLOWSHIPS

WITH A NATIONAL LEADER

UPMC IN PARTNERSHIP WITH THE UNIVERSITY OF PITTSBURGH IS WELCOMING CANDIDATES

FOR THE FOLLOWING FELLOWSHIPS:

• Advanced General Thoracic Surgery: Program Director: James D. Luketich, MD; Chair, Dept. of Cardiothoracic Surgery; Chief, Division of Thoracic and Foregut Surgery

Designed to offer experience in advanced general thoracic and minimally invasive surgical techniques of the lung, esophagus and mediastinum. Gain significant expertise in minimally

invasive esophagectomy, laparoscopic anti-reflux surgery, thoracoscopic lobectomy, CT-guided chest interventions, endoscopic therapy and many other advanced minimally

invasive procedures of the chest and foregut. Send applications to www.fellowshipcouncil.org.

• *Adult Advanced Cardiac Surgery: Program Director: Victor Morell, MD; Vice-Chair, Dept. of Cardiothoracic Surgery

Designed to provide advanced, concentrated training in adult cardiac surgery to refine and advance the fellows’ surgical skills required to treat adult and acquired cardiac disease.

Completion of a two-year cardiothoracic surgery residency accredited by the ACGME or comparable training and experience in a non-accredited program are required.

• *Cardiopulmonary Transplantation and Cardiac Assist Device: Program Director: Christian Bermudez, MD; Interim Director, Cardiopulmonary Transplantation

Provides extensive exposure in the disciplines of heart transplantation, lung transplantation, mechanical cardiac assistance and other aspects of surgical therapy for end-stage

heart failure. It is anticipated that fellows will meet UNOS requirements for heart and lung transplantation during the fellowship.

• *Pediatric Cardiac Surgery: Program Director: Victor O. Morell, MD, Chief, Pediatric Cardiac Surgery

Offers an investigational year in ventricular mechanical support and a clinical year that will provide extensive exposure in the management of simple and complex congenital heart

lesions, including cardiopulmonary transplantation and assist devices.

Each fellowship offers a position at the instructor level, with a competitive salary, and is designed for board certified or board eligible cardiothoracic surgeons or those with

comparable training or experience. Fellows are encouraged to participate in clinical research efforts and present at national and international meetings.

*Applicants should submit letter of fellowship preference/interest, current curriculum vitae, 3 reference letters, USMLE & ECFMG status, and current Visa status (if applicable) to:

Christine Regan Carey, Fellowship Coordinator

UPMC Presbyterian, Suite C-800

200 Lothrop Street

Pittsburgh, PA 15213

412-648-6359 or [email protected]

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• & much more!Learn more at my.americanheart.org/cvsacouncil

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10_15TS12_4.qxp 3/28/2012 1:38 PM

Visit our web site designed for cardio-thoracic surgeons.

w w w . t h o r a c i c s u r g e r y n e w s . c o m

T H E O F F I C I A L N E W S P A P E R O F T H E A M E R I C A N A S S O C I A T I O N F O R T H O R A C I C S U R G E R Y

·Specialty news and events in real time

·Galleries of clinical images, videos, and podcasts

·Commentaries and residents’ news

·Topic-specific newsletters

·And much more

A P R I L 2 0 1 2 • W W W. T H O R A C I C S U R G E R Y N E W S . C O M DEVICES, DRUGS & TRIALS 15

B Y M A RY A N N M O O N


Intravenous cangrelor may prove to bea useful “bridge” in patients awaitingnonemergency CABG who must first

discontinue their regular antiplatelettherapy, according to the results of theMaintenance of Platelet Inhibition WithCangrelor (BRIDGE) trial.

The practice of discontinuation of an-tiplatelet therapy is associated with sig-nificant morbidity and mortality; inpatients who have coronary stents, itraises the risk of stent thrombosis that of-ten leads to myocardial infarction anddeath. “Cessation of thienopyridinetreatment for nearly a week beforesurgery, with patients not hospitalized ormonitored but carrying an excess risk ofmajor ischemic events, has been a trou-bling and not infrequent problem forclinicians, because it is estimated that ap-proximately 5% of patients will requiresome type of surgery within the first 12months after stent implant or [acutecoronary syndrome] diagnosis,” said Dr.Dominick J. Angiolillo of the depart-ment of cardiology, University of Flori-da, Jacksonville, and his associates.

In this multicenter clinical trial spon-sored by the drug’s maker, cangrelor“achieved and maintained target levels ofplatelet inhibition known to be associat-ed with a low risk of thrombotic eventscompared with placebo, without a sig-nificant excess in bleeding complica-tions,” the investigators noted.

Cangrelor is an investigational non-thienopyridine adenosine triphosphateanalogue that acts as an antagonist of theP2Y12 receptor. It is characterized by“rapid, potent, predictable, and reversibleplatelet inhibition,” and its extremelyshort half-life (3-6 minutes) allows “rapidoffset of effect.”

The investigators hypothesized thatcangrelor would allow patients whomust discontinue antiplatelet therapyprior to cardiac surgery, especially ifthey’re taking a P2Y12 inhibitor such asticlopidine, clopidogrel, or prasugrel, togo off their usual drug without raisingtheir risk for thrombotic events. Theytested this hypothesis in a two-part trial.

The first part was an open-label dose-finding study involving 11 adults andconcluded that the optimal intravenousdose needed to maintain antiplatelet ac-tivity without raising bleeding risks was0.75 mcg/kg per minute. In the secondpart of the trial, 210 patients awaitingCABG at 34 medical centers around theworld were randomly assigned to re-ceive either cangrelor (106 subjects) orplacebo (104 subjects) after thienopy-ridines were discontinued and through-out the preoperative period – that is,until 1-6 hours before surgical incision.

The mean interval between discontin-uation of thienopyridines and infusion ofthe study drug was 29 hours, and themean duration of the infusion was ap-proximately 3 days. The primary endpoint was the percentage of patients whoshowed platelet reactivity of less than 240P2Y12 Reaction Units (PRUs) throughout

Antiplatelet Bridges Between Thienopyridine and CABGthe infusion of the study drug.

“This level approximated the levels ofplatelet reactivity expected to be main-tained if a thienopyridine had not beendiscontinued,” the investigators ex-plained.

This end point was met by 99% of thecangrelor group but only 19% of theplacebo group ( JAMA 2012;307:265-74).

Moreover, cangrelor did not raise therate of excessive bleeding related toCABG surgery. This safety end point oc-

curred in 22 patients: 11.8% of the can-grelor group and 10.4% of the placebogroup, a nonsignificant difference.

The number of minor bleeding eventswas numerically higher with cangrelorbut did not reach statistical significance.This favorable safety profile, even withprolonged infusion of up to 7 days, was“reassuring,” the researchers noted.

Ischemic end points prior to surgerywere low, occurring in 2.8% (3 of 106)and 4.0% (4 of 101) of patients in the can-

grelor and placebo groups.“These observations support the hy-

pothesis that intravenous cangrelor is afeasible management strategy, provid-ing prolonged platelet P2Y12 inhibitionin patients who must wait for cardiacsurgery after thienopyridine discontinu-ation,” they said.

The study was sponsored by the Med-icines Company. Dr. Angiolillo reportedties to various pharmaceutical compa-nies. ■

10_15TS12_4.qxp 3/28/2012 1:39 PM

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