risks and benefits of bariatric surgery: current evidence

CLEVELAND CL IN IC JOURNAL OF MEDICINE VOLUME 73 • NUMBER IN PRESS 2006 1

STACY A. BRETHAUER, MDSection of Advanced Laparoscopic andBariatric Surgery, Department of GeneralSurgery, Cleveland Clinic

BIPAN CHAND, MDDirector, Section of Surgical Endoscopy,Department of General Surgery, ClevelandClinic

Risks and benefits of bariatric surgery:Current evidence

REVIEW

! ABSTRACTObese patients lose more weight with bariatric surgerythan with medical weight-loss treatment. Thelaparoscopic Roux-en-Y gastric bypass procedure resultsin more short-term weight loss than laparoscopicadjustable gastric banding, but the latter has fewerpostoperative complications and a lower mortality rate;long-term comparative data are currently lacking. Thedecision regarding which procedure to perform should bebased on individual patient and surgeon factors.

! KEY POINTSPatients undergoing bariatric surgery must commit to aprogram of lifestyle changes, diet, vitaminsupplementation, and follow-up.

Early complications of gastric bypass surgery arebleeding, anastomotic leak, wound infection,thromboembolism, and anastomotic strictures. Longer-term complications can include marginal ulcers, bowelobstruction, gallstones, and nutritional deficiencies.

Complications of adjustable gastric banding includeprolapse and erosions.

Patients typically lose more than 50% of their excessweight after bariatric surgery. Obesity-related diseasesmarkedly improve after bariatric surgery, reducingcardiovascular risk and improving life expectancy.

*Dr. Brethauer has disclosed receiving research support from the Ethicon Endo-Surgery, BardDavol, and Tyco US Surgical corporations.

†Dr. Chand has disclosed serving as a consultant for the Ethicon Endo-Surgery, Sanofi-Aventis,and Gore corporations.

‡Dr. Schauer has disclosed receiving research support from, serving as a consultant for, orreceiving speaking honoraria from the Ethicon Endo-Surgery, Bard Davol, Gore, Baxter, Stryker,Invacare, Wyeth, and Dowden corporations.

UTCOMES OF BARIATRIC SURGERY are get-ting better all the time, as surgeons gain

experience in performing these technicallydemanding procedures laparoscopically. Therisks are not trivial, but they are acceptablylow. The benefits: not only do patients loseweight and keep it off, now there are convinc-ing data that many patients are cured of obe-sity-related diseases, notably type 2 diabetes.In fact, the procedure may pay for itself with-in a few years by reducing medical costs due toobesity-related illness. Best of all, the long-term mortality rate seems to be lower for mor-bidly obese patients who undergo this surgerythan for those who do not.

Managing obesity-related comorbid con-ditions is challenging, expensive, and oftenunsuccessful unless the patient can lose a sig-nificant amount of weight. Obesity is now epi-demic in the United States, affecting morethan 60 million people, and the problem willworsen in coming years as the incidence ofchildhood and adolescent obesity rises.1

This review examines the current evi-dence regarding the risks and benefits ofbariatric surgery. We will emphasize the twomost common procedures, laparoscopic Roux-en-Y gastric bypass and laparoscopicadjustable gastric banding, including the com-plications that internists caring for thesepatients should be aware of.

! WHO IS ELIGIBLEFOR BARIATRIC SURGERY?

Candidates for bariatric surgery must have abody mass index (BMI) greater than 40 kg/m2

or a BMI greater than 35 with significant obe-sity-related disease, according to the 1991

O

PHILIP R. SCHAUER, MDDirector, Bariatric and Metabolic Institute, ClevelandClinic; professor of surgery, Cleveland Clinic LernerCollege of Medicine of Case-Western ReserveUnivesity

2 CLEVELAND CL IN IC JOURNAL OF MEDICINE VOLUME 73 • NUMBER IN PRESS 2006

consensus guidelines from the NationalInstitutes of Health (TABLE 1).2 TABLE 2 lists someof the major obesity-related diseases.

Typical patients are between the ages of18 and 60. However, carefully selected olderpatients and adolescents can also benefit frombariatric surgery, and the current indicationswill likely broaden as long-term data on vari-ous subgroups of patients mature.

Other criteria for surgery: prior attemptsto lose weight by nonsurgical means musthave failed, and the patient must complete athorough, multidisciplinary preoperative eval-uation designed to identify comorbid condi-tions so that they can be optimally managedprior to surgery and to identify any contraindi-cations to surgery. Patients must be able tocomprehend the significant lifestyle changesrequired after surgery and comply with thepostoperative program of diet, vitamin supple-mentation, and follow-up.

Patients who cannot tolerate generalanesthesia because of cardiac, pulmonary, orhepatic insufficiency cannot undergo bariatricsurgery. Patients who have ongoing substanceabuse or unstable psychiatric illness are poorcandidates.

Most importantly, patients must under-stand that bariatric surgery is not a quick fix.Rather, it is a very powerful tool that, in con-junction with appropriate food choices andphysical activity, can produce significantweight loss, resolve comorbid conditions, andprolong life.3,4

! WHAT PROCEDURESARE BEING PERFORMED TODAY?

The weight-loss procedures in use today rangefrom placement of an intragastric balloon (theleast invasive option) to open biliopancreaticdiversion (the most invasive).

Bariatric procedures are classified accord-ing to their mechanism of action: restrictive,malabsorptive, or a combination of restrictiveand malabsorptive (FIGURE 1).

Restrictive procedures are so calledbecause the surgeon creates a small gastricpouch with a narrow outlet that restricts theamount of food that the patient can eat at onetime. The two restrictive procedures mostoften performed are vertical banded gastro-plasty and laparoscopic adjustable gastricbanding.

Vertical banded gastroplasty was devel-oped in 1980 but only 5% of bariatric surgeonsstill perform it; many patients had long-termcomplications that necessitated another oper-ation, and long-term weight loss was small.5–9

Laparoscopic adjustable gastric bandinghas the advantage of using an adjustable innercollar that allows one to fine-tune the size ofthe outlet to minimize side effects and maxi-mize weight loss. It was approved for use in theUnited States in 2001 and now is the secondmost commonly performed bariatric proce-dure, after the Roux-en-Y gastric bypass (seebelow).

Malabsorptive procedures bypass a seg-ment of the small intestine so that less food isabsorbed.

Biliopancreatic diversion was developedin 1979 by Scopinaro et al,10 and is performedat specialized centers using the open andlaparoscopic techniques.

The duodenal switch, a modification ofthe biliopancreatic diversion, was developedto decrease the incidence of dumping symp-toms and anastomotic ulceration seen withbiliopancreatic diversion. It too can be per-formed laparoscopically.

These procedures are technically demand-ing to perform, and many patients developnutritional deficiencies afterward. Therefore,they account for only about 5% of bariatricprocedures performed in the United States.

Combination procedures, eg, the Roux-

Candidates forbariatricsurgery: BMI !40 or BMI > 35with significantobesity-relatedcomorbidities

BARIATRIC SURGERY BRETHAUER AND COLLEAGUES

Candidates for bariatric surgery

Body mass index (BMI) ! 40 kg/m2 or BMI ! 35 kg/m2

with significant obesity-related co-morbidities

Acceptable operative risk

Documented failure of nonsurgical weight-loss programs

Psychologically stable with realistic expectations

Well-informed and motivated patient

Supportive family/social environment

Absence of uncontrolled psychotic or depressive disorder

No active alcohol or substance abuse

T A B L E 1

en-Y gastric bypass, use both mechanisms toachieve weight loss. In this procedure, whichcan be performed either laparoscopically or asopen surgery, food intake is restricted by creat-ing a small (15–30 mL) gastric pouch, andabsorption is limited by bypassing the proxi-mal intestine with a Roux limb (FIGURE 1). Thestandard Roux limb is 75 to 150 cm long andbypasses the distal stomach, duodenum, and ashort segment of the jejunum. More than 95%of the small bowel is left intact, so malabsorp-tive side effects such as diarrhea and proteinmalabsorption are very uncommon. TheRoux-en-Y gastric bypass now accounts forapproximately 80% of all bariatric proceduresperformed in the United States.

At Cleveland Clinic, we currently per-form the Roux-en-Y gastric bypass in approxi-mately 75% of our bariatric patients, andlaparoscopic adjustable gastric banding in therest. The risks and benefits of each procedureare evaluated in the context of the patient’spreference, expectations, BMI, comorbidities,and ability to comply with the different fol-low-up requirements for each procedure.Surgeon experience and hospital volumedirectly affect outcomes in bariatric surgeryand should play an important role in deter-mining which procedure to perform.11,12

Overall, the benefits are greater than the risksfor most patients undergoing laparoscopicRoux-en-Y gastric bypass or laparoscopicadjustable gastric banding; thus, these havebecome our procedures of choice.

! RISKS OF BARIATRIC SURGERY

Open vs laparoscopic Roux-en-Y gastricbypassLaparoscopic bariatric surgery was introducedin 1994 when Wittgrove et al13 published theresults of their first five Roux-en-Y gastricbypass cases. Since then, several large series oflaparoscopic Roux-en-Y gastric bypasscases14–19 and three randomized controlled tri-als20–22 comparing laparoscopic and openRoux-en-Y gastric bypass have been published.

Each approach poses unique risks. Opensurgery results in more postoperative pain,slower return to normal activity, and higherrates of iatrogenic splenectomy and abdominalwall complications (up to 20% of patients

have incisional hernias). One review of morethan 3,000 gastric bypass cases showed thatthe laparoscopic approach results in less post-operative pain, better postoperative pul-


Patients mustunderstandthat bariatricsurgery is nota quick fix

Obesity-related diseases

CardiovascularCongestive heart failureCoronary artery diseaseHyperlipidemiaHypertensionLeft ventricular hypertrophyVenous stasis ulcers, thrombophlebitis

EndocrineInsulin resistancePolycystic ovary syndromeType 2 diabetes

Gastrointestinal and hepatobiliaryAbdominal herniaGallstonesGastroesophageal reflux diseaseNonalcoholic fatty liver disease

GenitourinaryStress urinary incontinenceUrinary tract infections

HematopoieticDeep venous thrombosisPulmonary embolism

MusculoskeletalCarpal tunnel syndromeDegenerative joint diseaseGoutPlantar fasciitis

Neurologic and psychiatricAnxietyDepressionPseudotumor cerebriStroke

Obstetric and gynecologicFetal abnormalities and infant mortalityGestational diabetesInfertilityMiscarriage

PulmonaryAsthmaObesity hypoventilation syndromeObstructive sleep apneaPulmonary hypertension

T A B L E 2


! Types of bariatric surgical procedures

FIGURE 1

CCF©2006Medical Illustrator: Joseph Pangrace

Restrictive procedures

Biliopancreatic diversion

Biliopancreatic diversionwith duodenal switch

Roux-en-Ydivided gastricbypass

Laparoscopicadjustable gastricbanding

Vertical bandedgastroplasty

Malabsorptive procedures

Combination procedures


monary function, and significantly fewerwound complications, but it has higher ratesof anastomotic stricture (4.7% vs 0.7%, P <.001), gastrointestinal bleeding (1.9% vs0.6%, P = .008), and late postoperative bowelobstruction (3.1% vs 2.1%, P = .02) thanopen surgery.23 The incidence of anastomoticleak was higher with laparoscopic surgery insome series, but not in the randomized trials orin a comprehensive review of the topic.23

Laparoscopic surgery takes time to learn,and complication rates with laparoscopicRoux-en-Y gastric bypass tend to decline assurgeons gain experience.24 With experience,operative time and rates of technical compli-cations such as gastrojejunal anastomotic leakdecline to those seen with the open approach.

! COMPLICATIONSOF LAPAROSCOPIC GASTRIC BYPASS

Conversion to open surgeryIn up to 8% of cases, surgery that is startedlaparoscopically must be completed as anopen procedure. However, in experiencedhands, this “conversion” rate is less than 5%.In a review of 3,464 laparoscopic gastricbypass procedures (10 series), Podnos et al23

found the conversion rate to be 2.2%. Themost common reasons for conversion to anopen procedure were hepatomegaly, equip-ment problems, inadequate instrumentlength, inadequate exposure, injury to thecolon or a major blood vessel, and bleeding.

BleedingBleeding complications occur in fewer than4% of patients. Postoperative bleeding can befrom mesenteric or omental vessels within theperitoneal cavity or from an anastomosis orstaple line. In the laparoscopic Roux-en-Ygastric bypass, the staple or suture lines of thegastrojejunostomy and the jejunojejunostomycan bleed. Postoperative bleeding from thegastrojejunostomy can be diagnosed and man-aged endoscopically. Bleeding from theexcluded gastric remnant can be more difficultto diagnose and treat, since there is no directendoscopic access to this lumen after gastricbypass. Techniques to decrease the incidenceof staple line bleeding include oversewing orbuttressing the staple lines.

Anastomotic leak:Tachycardia is a presenting signAnastomotic leak is a dreaded complicationof Roux-en-Y gastric bypass and carries a mor-tality rate of up to 30% when it occurs. Theincidence after laparoscopic Roux-en-Y gas-tric bypass ranges from 0% to 4.4%.

Leakage from the gastrojejunal anastomo-sis can be contained or can result in diffuseperitonitis. Technical failures of the anasto-mosis manifest in the early postoperative peri-od with rapid clinical deterioration, but mostleaks occur around 5 days after surgery andresult from perforation of an ischemic area atthe anastomosis.

Major complications often present withsubtle signs in these patients, and physicalfindings that confirm peritoneal irritation arethe exception rather than the rule when anabdominal catastrophe is developing. Often,tachycardia is the only presenting sign of ananastomotic leak. A heart rate greater than120 should prompt an investigation, even ifthe patient looks and feels well. Tachypnea ordecreasing oxygen saturation can also signalearly sepsis from a leak, and this presentationmay be clinically indistinguishable from a pul-monary embolism.

Surgeons or internists caring for bariatricpatients should aggressively evaluate any post-operative fever, tachycardia, or tachypnea, andthe patient should return to the operatingroom early if diagnostic tests are inconclusivebut clinical suspicion for a leak is high. If apatient is diagnosed with a contained leak oncomputed tomography or an upper gastroin-testinal study and is clinically stable, nonoper-ative management with adequate drainage,bowel rest, and antibiotics may be appropriate.

Wound infectionWound infection after laparoscopic Roux-en-Y gastric bypass occurred in fewer than 5% ofcases in most series. In a pooled analysis,Podnos et al23 found that wound infectionsoccurred in 97 (2.9%) of 3,258 laparoscopiccases, compared with 34 (6.6%) of 513 opencases (P < .001).

Laparoscopic port site infections are easyto manage with a short course of antibioticsand wound care and are less serious than openwound infections. The laparoscopic approach


We performlaparoscopicRoux-en-Ygastric bypassin about75% of ourbariatricsurgerypatients


eliminates the risk of wound dehiscence orevisceration.

ThromboembolismObesity is a risk factor for venous thromboem-bolism in general surgery patients.25 The high-er the BMI, the higher the risk of venousthromboembolism in patients undergoingabdominal operations, even with low-doseheparin prophylaxis,26 and obesity is an inde-pendent predictor of recurrent venous throm-boembolism.27 Morbid obesity is associatedwith elevated levels of fibrinogen, factor VII,factor VIII, von Willebrand factor, and plas-minogen activator inhibitor,28 and some evi-dence suggests a link between inflammatorymediators, central obesity, and a procoagulantstate.28

The rate of deep vein thrombosis afterlaparoscopic Roux-en-Y gastric bypass withthromboprophylaxis ranges from 0% to 1.3%,and the rate of pulmonary embolism rangesfrom 0% to 1.1%. Pulmonary embolism andanastomotic leak are two major causes ofdeath after Roux-en-Y gastric bypass, andpulmonary embolism accounts for 50% ofpostoperative deaths. During laparoscopicsurgery the peritoneum is inflated, whichincreases the abdominal pressure andimpedes venous return, increasing the risk ofdeep vein thrombosis.29 On the other hand,laparoscopic surgical patients can get up andwalk sooner after surgery than patients whoundergo open surgery, which should decreasethe risk. In pooled data comparing 2,771open and 3,464 laparoscopic surgical cases,there were no differences in clinically signif-icant thromboembolic events (0.78% vs0.41%, P = .09).23

Currently, the American College of ChestPhysicians (ACCP) recommends routine peri-operative thromboprophylaxis for patients atincreased risk but provides no specific recom-mendations for bariatric surgery patients. Asurvey found that more than 95% of bariatricsurgeons used routine deep vein thrombosisprophylaxis and 38% used a combination oftwo or more methods of prophylaxis.30

These patients should be treated as high-risk general surgery patients, and shouldreceive thromboprophylaxis according to theACCP guidelines with low-dose unfractionat-

ed heparin 5,000 U twice a day or low-molec-ular-weight heparin up to 3,400 U once daily(grade 1A evidence) with the addition of legcompression devices if multiple risk factors arepresent (grade 1C evidence). Several studiesfound adjusted-dose unfractionated heparinand low-molecular-weight heparin effective inbariatric surgery patients.31,32 Dosing regimensfor low-molecular-weight heparin, however,were developed for normal-weight patientsundergoing general surgery procedures, andoptimal dosing in morbidly obese patients hasnot been determined.

In a retrospective, multicenter study eval-uating different enoxaparin dosing regimensin 668 bariatric surgery patients,33 pulmonaryembolism occurred in 0.9%, and there was onecase of deep vein thrombosis. These were clin-ically significant events and not detected by aspecific surveillance protocol. Depending onthe center, patients received enoxaparin 30mg preoperatively, 40 mg postoperativelyevery 12 or 24 hours, or 30 mg every 24 hoursfor 10 days upon discharge. Fewer eventsoccurred when prophylaxis was started in thehospital, and all events occurred after throm-boprophylaxis was stopped. This study empha-sizes the need to consider extended prophy-laxis in selected bariatric patients.

We give enoxaparin 40 mg subcutaneous-ly every 12 hours, starting the night of surgery.If the patient is at high risk (with a BMI > 55or multiple risk factors), we continue theenoxaparin after discharge, stopping it on acase-by-case basis depending on the patient’sactivity level and risk.

Preoperative placement of inferior venacava filters in high-risk bariatric patients iscontroversial, but it should be considered inpatients with known risk factors for fatal pul-monary embolism including venous stasis dis-ease, obesity hypoventilation syndrome, BMI60 or greater, prior thromboembolism, or aknown hypercoagulable state.34,35

Anastomotic stricturesAnastomotic strictures develop at the gastro-jejunostomy after laparoscopic Roux-en-Y gas-tric bypass in 2% to 16% of cases. The rate ofthis complication largely depends on the sur-geon’s experience and the technique used tocreate the anastomosis. The gastrojejunosto-

Tachycardiais oftenthe onlypresentingsign of ananastomoticleak


my can be hand-sewn (resulting in the loweststricture rate) or created with a linear stapleror a circular stapler (resulting in the higheststricture rate). Larger studies (with > 100patients) reported stricture rates of less than6%; these series included all three tech-niques.15–19,36,37

Strictures typically present within the first3 months after surgery with nausea and vom-iting. Most strictures result either fromischemia at the anastomosis due to tension onthe Roux limb or are associated with a mar-ginal ulcer.

About 85% of anastomotic strictures aremanaged with a single endoscopic dilation.36

Seventeen percent require a second dilation,and in a study by Nguyen et al,38 only 1 of 29patients with a stricture required a third endo-scopic dilation.

Marginal ulcersMarginal ulcers are postsurgical ulcers thatoccur at the gastrojejunal anastomosis, usuallyon the jejunal side. Marginal ulcers may berelated to tension or ischemia on the anasto-mosis and have also been associated with for-eign material (staples or nonabsorbablesutures), nonsteroidal anti-inflammatory drug(NSAID) use, excessive acid exposure in thegastric pouch due to gastrogastric fistula, andsmoking. Patients present with abdominalpain, vomiting, and bleeding or anemia. Theincidence of marginal ulcer after laparoscopicRoux-en-Y gastric bypass surgery ranges from0.7% to 5.1%.

This complication is treated with acid-suppression therapy and by stopping theoffending agent (NSAID, tobacco). Rarely,anastomotic revision is required for a refracto-ry ulcer.

Bowel obstructionBowel obstruction after Roux-en-Y gastricbypass can result from adhesions or internalhernias. Fewer intra-abdominal adhesionsform after laparoscopic surgery, presumablybecause there is less tissue trauma and bowelmanipulation; this may allow for more inter-nal hernias to develop in a laparoscopicapproach (due to fewer adhesions, more mor-bile loops of bowel that can herniate througha mesenteric defect or band) but may decrease

the incidence of adhesive obstructions com-pared with an open procedure.

In 10 large laparoscopic Roux-en-Y gas-tric bypass series,23 bowel obstructionoccurred in 3% of patients. To reduce theincidence of internal hernias, the mesentericdefects are carefully closed during the proce-dure.

Patients with intermittent, crampyabdominal pain that occurs months to yearsafter gastric bypass should be referred back totheir bariatric surgeons for evaluation. Wetypically perform exploratory laparoscopicsurgery in these patients to look for mesen-teric defects or internal hernias.

Cholelithiasis is commonWeight loss after gastric bypass surgery isaccompanied by a rise in incidence of gall-stones: 38% to 52% of patients develop stoneswithin 1 year of surgery.39,40 Between 15%and 28% of all patients, irrespective of gall-stone status at the time of gastric bypass,require urgent cholecystectomy within 3years.

Symptomatic cholelithiasis at the time oflaparoscopic Roux-en-Y gastric bypass is anindication for cholecystectomy during thebypass procedure. In patients with asympto-matic cholelithiasis or no gallstones, however,this practice remains controversial.41,42

Some surgeons advocate prophylacticcholecystectomy at the time of laparoscopicRoux-en-Y gastric bypass for all patients, dueto the high incidence of undiagnosed gall-bladder disease (sludge, cholesterolosis, unde-tected cholelithiasis) in this patient popula-tion.41 The disadvantages of this approachinclude the potential of performing an unnec-essary procedure and the risks (bleeding, bileduct injury, prolonged operative time) of per-forming a concomitant procedure in a mor-bidly obese patient.

Hamad et al43 confirmed the safety of per-forming combined laparoscopic cholecystec-tomy and gastric bypass in patients withasymptomatic cholelithiasis, but patientsundergoing the combined procedure had anoperative time that was 50 minutes longer anda hospital stay nearly twice as long comparedwith patients who underwent laparoscopicRoux-en-Y gastric bypass only.


Pulmonaryembolism andanastomoticleak are majorcauses of deathafter Roux-en-Ygastric bypass


We currently perform cholecystectomy atthe time of laparoscopic Roux-en-Y gastricbypass for patients with symptomaticcholelithiasis. Patients with asymptomaticstones are observed, and those withoutcholelithiasis are prescribed ursodiol 600 mgdaily by mouth for the first 6 months after theprocedure, which significantly reduces theincidence of gallstone formation (2% vs 32%with placebo, P < .01).39

Nutritional deficienciesBecause the stomach and duodenum arebypassed, iron, vitamin B12, and othermicronutrient deficiencies can occur afterstandard gastric bypass.44

Taking a single multivitamin tablet aloneis insufficient to prevent iron and vitamin B12deficiencies after laparoscopic Roux-en-Y gas-tric bypass. Iron deficiency occurs in 13% to52% of patients within 2 to 5 years aftersurgery, and supplementation with iron can

reduce iron deficiency significantly. Up to37% of patients who are prescribed a multivi-tamin after surgery still develop vitamin B12deficiency. Once a specific deficiency is iden-tified during follow-up, additional supplemen-tation is indicated.

Calcium absorption in the duodenum andjejunum and vitamin D absorption in thejejunum and ileum are impaired after Roux-en-Y gastric bypass as well. Calcium deficien-cies can occur in up to 10% of patients, andvitamin D deficiency in up to 51%, dependingon the length of the bypass.44 These deficien-cies can lead to secondary hyperparathy-roidism and can result in increased boneturnover and decreased bone mass as early as 3to 9 months after surgery.45

Series that reported nutritional deficien-cies after gastric bypass varied greatly in termsof vitamin supplementation regimens. In asurvey of 109 bariatric surgeons,46 96% saidthey prescribed multivitamins after Roux-en-

Esophagectomy

Gastrectomy

Pancreatectomy

AAA repairCABG

Carotidendarterectomy

Bariatric surgery

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Mortality rates after bariatric and other types of surgery

FIGURE 2. Unadjusted mortality rates for commonly performed cardiovascularprocedures, gastrointestinal procedures, and bariatric surgery in Medicare patientsover age 65.

MODIFIED FROM GOODNEY PP, SIEWERS AE, STUKEL TA, LUCAS FL, WENNBERG DE, BIRKMEYER JD. IS SURGERY GETTING SAFER?NATIONAL TRENDS IN OPERATIVE MORTALITY. J AM COLL SURG 2002; 195:219–227.

BARIATRIC SURGERY DATA FROM FLUM DR, SALEM L, ELROD JA, DELLINGER LP, CHEADLE A, CHAN L. EARLY MORTALITY AMONG MEDICAREBENEFICIARIES UNDERGOING BARIATRIC SURGICAL PROCEDURES. JAMA 2005; 294:1903–1908.


Up to half ofpatientsdevelopgallstones afterbariatricsurgery

Y gastric bypass, 63% prescribed iron, and49% prescribed vitamin B12. Surveillance fordeficiencies and patient compliance vary aswell, although most bariatric surgeons recom-mend annual blood testing.

We obtain a complete blood count andiron and B12 levels before surgery, 6 monthsand 1 year after surgery, and yearly thereafter.We recommend routine daily supplementa-tion with a multivitamin, iron, vitamin B12,and calcium.

Perioperative mortalityBuchwald et al3 performed a meta-analysis of136 studies that included 22,094 patients whounderwent restrictive, malabsorptive, or gas-tric bypass procedures (open and laparoscop-ic). The 30-day mortality rate for gastricbypass was 0.5%. The three randomized trialscomparing open and laparoscopic Roux-en-Ygastric bypass showed no difference in mortal-ity rates. Podnos et al23 in their review founda lower mortality rate in laparoscopic patients.In laparoscopic Roux-en-Y gastric bypassseries with more than 100 patients, the mor-tality rate ranged from 0% to 0.9%.15,17–19,47

The risk of death after gastric bypasssurgery increases with age. Livingston et al48

found that patients older than 55 years had athreefold higher mortality rate compared withyounger patients, despite similar complicationrates.48 Sepsis was the leading cause of deathin the older patients.

In a review of 16,155 Medicare patientswho underwent bariatric surgery (81% Roux-en-Y gastric bypass), Flum et al49 found thatolder age, male sex, and lower surgeon volumewere associated with a higher risk of earlydeath. Overall, the 30-day all-cause mortalityrate was 2.0%, and the 90-day rate was 2.8%.For patients older than 65 years, these ratesincreased to 4.8% and 6.9%, respectively, andwere significantly higher than in youngerpatients (1.7% and 2.3%). This increase inrisk after age 65 is consistent with that afterother major gastrointestinal and cardiovascu-lar operations (FIGURE 2).50

A review of 60,077 Californians whounderwent Roux-en-Y gastric bypass between1995 and 2004 demonstrated mortality ratesmore consistent with published case series(0.33% at 30 days and 0.91% at 1 year).51

! COMPLICATIONS OF LAPAROSCOPICADJUSTABLE GASTRIC BANDING

The risk of death with laparoscopic adjustablegastric banding is the lowest for any bariatricsurgery performed today, making it an attrac-tive option for many surgeons and patients. Inthe meta-analysis of Buchwald et al,3 allrestrictive procedures had an operative mor-tality rate (" 30 days) of 0.1%. In a review ofthe international literature, Chapman et al52

compared the safety and efficacy of laparo-scopic adjustable gastric banding, verticalbanded gastroplasty, and Roux-en-Y gastricbypass. The operative mortality rate was0.05% for laparoscopic adjustable gastricbanding, compared with 0.5% for Roux-en-Ygastric bypass.

Early postoperative complications occurin 0.8% to 12% of patients.53–58 Bleeding afterlaparoscopic adjustable gastric banding is rare,occurring in only 0.1% of cases.53,54 Giventhat no anastomoses are formed during thisprocedure, no anastomotic leaks can form.Iatrogenic bowel perforation during the pro-cedure occurs in 0.5% of cases.53 Woundinfection rates are similar to those withlaparoscopic Roux-en-Y gastric bypass and,like other laparoscopic wound infections, areeasily managed with minimal morbidity. Therisks of deep vein thrombosis (0.01%–0.15%)or pulmonary embolism (0.1%) after laparo-scopic gastric banding are lower than for otherbariatric procedures.53,57 This may be relatedto patient selection or shorter operative times.

However, band-related complications canoccur in the early postoperative period oryears after the procedure. The placement of asilicone prosthesis in the abdomen carrieswith it a unique set of mechanical complica-tions not seen with other bariatric procedures.The range of complication rates reported inselected large case series of laparoscopicadjustable gastric banding is shown in TABLE

3.15,17–22,47,52–67

In a systematic review of the internation-al literature that included 64 studies and8,504 patients, Chapman et al52 reported tubeor port malfunction requiring reoperation in1.7% of cases, band erosion into the gastriclumen in 0.6%, and pouch dilation or bandslippage in 5.6%. Overall, complications


Onemultivitaminper day is notenough afterRoux-en-Ygastric bypass


requiring reoperation can occur in up to 18%of patients, but complications decrease asexperience with this procedure increases.

In a series of 1,120 patients, O’Brien andDixon reported a low incidence of early majorcomplications (1.5%) but higher rates of late

complications. Prolapse occurred in 25% anderosion occurred in 3% of their first 500patients. In their last 600 patients, prolapseoccurred in 4.7% of patients and there wereno erosions.56

TABLE 3 compares complication rates inlarge case series of laparoscopic Roux-en-Ygastric bypass and laparoscopic adjustable gas-tric banding.

! BENEFITS OF BARIATRIC SURGERY

Weight lossWeight loss after bariatric surgery is typicallyexpressed as the percentage of excess weightlost—excess weight defined as the number ofpounds above the patient’s ideal body weight.In the meta-analysis of Buchwald et al,3 excessweight loss for all bariatric procedures com-bined was 61%. Analyzed by procedure, excessweight loss was highest after biliopancreaticdiversion (70%), followed by gastroplasty(68%), gastric bypass (62%), and gastric band-ing (48%).3

Excess weight loss at 1 to 5 years afterlaparoscopic Roux-en-Y gastric bypass is similarto that with the open procedure and rangesfrom 68% to 80%.15,17–22,47,59 Durable weightloss after open Roux-en-Y gastric bypass hasbeen demonstrated up to 14 years.68 Superobesepatients (BMI > 50) have less excess weightloss than patients with lower BMIs after stan-dard Roux-en-Y gastric bypass. Excess weightloss after Roux-en-Y gastric bypass and laparo-scopic adjustable gastric banding is shown inTABLE 4.15,17–22,37,47,55–56,58,59,69–71

Patients typically lose less weight afterlaparoscopic adjustable gastric banding thanafter laparoscopic Roux-en-Y gastric bypassand lose it more gradually (the peak excessweight loss is at 2 to 3 years vs 12 to 18months with laparoscopic Roux-en-Y gastricbypass). However, Chapman et al52 reviewedthe international literature and found thatweight loss at 4 years was similar with bothprocedures. The success with laparoscopicadjustable gastric banding in Europe andAustralia was not reproduced in most early UStrials. Some recent US studies of laparoscopicadjustable gastric banding have approachedthe success rates seen in international studies,though, including a report of 1,014 laparo-

Risks of laparoscopic bariatric proce-dures

COMPLICATION LAPAROSCOPIC LAPAROSCOPIC GASTRIC ADJUSTABLEBYPASS* GASTRIC BANDING†

Conversion to open 0%–8% 0%–3%procedure

Bleeding 0.4%–4% 0.1%

Bowel leak 0%–4.4% 0.5%–0.8%

Wound infection 0%–8.7% 0.1%–8.8%

Deep vein thrombosis‡ 0%–1.3 % 0.01%–0.15%

Pulmonary embolism‡ 0%–1.1% 0.1%

Mortality 0%–2% 0%–0.7%

*References 15,17–22,47,54,59–62†References 53,54,56–58,63–67‡Diagnosis based on symptoms and standard clinical testing

T A B L E 3

Percent of excess weight lostafter bariatric surgery

LAPAROSCOPIC LAPAROSCOPICGASTRIC ADJUSTABLEBYPASS GASTRIC BANDING

All patients 68%–80%* 44%–68%†

Preoperative 51%–69%‡ 47%–49%§

body mass index> 50 kg/m2

Meta-analysisll 61% 48%

*At 12–60 months, references 15,17–22,47,59†At 12–72 months, references 52,56,57,69‡At 12–36 months, references 37,52,55,70§At 12–36 months, references 55,69,71llIncludes open gastric bypass and nonadjustable band series, reference 3

T A B L E 4



! Benefits of bariatric surgery

FIGURE 3. Resolution of obesity-related comorbidities after laparoscopic gastric bypass.4,15,18,19,77–81

CCF©2006Medical Illustrator: Joseph Pangrace

Depression55% resolved18

Obstructivesleep apnea74-98% resolved15,18

Asthma82% improvedor resolved18

Cardiovascular disease82% risk reduction4

Hypertension52-92% resolved15,18,19

GERD72-98% resolved15,18,19

Stress urinaryincontinence44-88% resolved15

Degenerativejoint disease41-76% resolved15,18

Migraines57% resolved18

Pseudotumorcerebri96% resolved79

Dyslipidemiahypercholesterolemia63% resolved18

Non-alcoholic fattyliver disease90% improved steatosis37% resolution ofinflammation20% resolution offibrosis77

Metabolicsyndrome80% resolved77

Type IIdiabetes mellitus83% resolved78

Polycysticovarian syndrome79% resolution of hirsuitism100% resolution of menstrual dysfunction81

Venous statis disease95% resolved80

Mortality89% reduction in5-year mortality4

Quality of lifeimproved in

95% of patients18


scopic adjustable gastric banding procedureswith 64% excess weight loss at 4 years.72

Morbidly obese patients lose less weightwith medical therapy than with bariatricsurgery. Medical weight-loss therapy consist-ing of diet modification, exercise, behavioraltherapy, and pharmacotherapy can be effec-tive in the short term, particularly when usedin combination, but recidivism ratesapproaching 100% are typical among morbid-ly obese patients. In a meta-analysis of the USliterature, low-calorie or very-low-calorie (<800 calories/day) diets resulted in the loss of2.1% and 6.6% of total body initial weight,respectively, after 5 years.73 At 1 to 2 years,behavioral therapy results in 8% to 10% totalbody weight loss, but patients return to theirbaseline weight without continued behavioralintervention.

Currently, two weight-loss agents areapproved for long-term use.

Sibutramine suppresses appetite byinhibiting reuptake of serotonin, norepineph-rine, and dopamine. At 1 year, average weightloss with sibutramine in combination with alow-fat, low-calorie diet is 5.5% of totalweight, and in a meta-analysis of randomizedcontrolled trials, patients receiving sibu-tramine had a 4.6% greater weight reductionthan those taking placebo.74

Orlistat acts by competitively inhibitingintestinal lipase and blocking the absorptionof approximately 30% of dietary fat. Averagetotal body weight loss at 1 year is 7.6%, and a4-year trial reported an average weight loss of5.2%.75 In a meta-analysis of 11 randomizedcontrolled trials, patients receiving orlistatlost 2.9% more weight than patients receivingplacebo. This drug typically provides an addi-tional 2-kg weight loss over behavioral thera-py alone.76

Resolution of comorbiditiesObesity-related diseases dramatically resolveor improve after bariatric surgery. No othermedical or surgical intervention simultaneous-ly treats as many disease processes as bariatricsurgery does.

Comorbidity resolution after laparoscopicRoux-en-Y gastric bypass has been studiedextensively (FIGURE 3).4,15,18,19,77–81 For dia-betes, resolution is defined as biochemical evi-

dence of resolution (normal fasting plasmaglucose or normal hemoglobin A1c) off med-ication. For other comorbid conditions, theclinical absence of the condition as deter-mined by history, physical examination, clini-cal testing, or normal values after stopping ofmedication determines resolution.

In a study of 70 patients who underwentliver biopsy before and after surgery, there wassignificant improvement in liver steatosis,inflammation, and fibrosis. In these samepatients, 80% had resolution of the metabolicsyndrome based on the Adult TreatmentPanel III criteria (three or more risk factorsincluding abdominal obesity, elevated fastingglucose, hypertension, hypertriglyceridemia,and elevated high-density lipoprotein choles-terol).77 Proinflammatory and prothromboticstates are included in the definition of meta-bolic syndrome, but markers for these risk fac-tors are not routine diagnostic tests.

Comorbidities resolve significantly afterlaparoscopic adjustable gastric banding aswell. The resolution rates for hypercholes-terolemia (74%), gastroesophageal reflux dis-ease (76%–89%), and sleep apnea (94%) afterlaparoscopic adjustable gastric banding arecomparable to rates seen with laparoscopicRoux-en-Y gastric bypass. Diabetes resolves in54% to 64% of patients after laparoscopicadjustable gastric banding, and hypertensionresolves in 55% of patients.57,58

In an observational cohort study, Christouet al4 evaluated long-term morbidity and mor-tality rates in 1,035 morbidly obese patientswho underwent bariatric surgery (841 Roux-en-Y gastric bypass, 194 vertical banded gastroplas-ty) and 5,746 age- and gender-matched mor-bidly obese controls whose weight was managednonsurgically. The surgery group had a meanexcess weight loss of 67% at 5 years, more than60% excess weight loss at 16 years (72% follow-up), and significantly lower incidence rates ofcardiovascular disease (4.7% vs 26.7%, 82%relative risk reduction), cancer (2% vs 8.5%,76% relative risk reduction), infectious diseases(8.7% vs 37.3%, 77% risk reduction), andendocrinological (9.5% vs 27.3%, 65% riskreduction), musculoskeletal (4.8% vs 11.9%,59% risk reduction), and respiratory disorders(2.7% vs 11.4%, 76% risk reduction) comparedwith the nonsurgical cohort.


Life expectancyof a man in his20s is 13 yearsshorter if hisBMI is > 45

In their meta-analysis, Buchwald et al3calculated that diabetes improved or resolvedin 86% of patients, hyperlipidemia improvedin 70%, hypertension improved or resolved in78.5%, and obstructive sleep apnea improvedor resolved in 83.6%. Diabetic outcomes var-ied with operative procedure. Diabetesresolved completely in 99% of biliopancreaticdiversion/duodenal switch patients, 84% ofgastric bypass patients, 72% of gastroplastypatients, and 48% of gastric banding patients.Biliopancreatic diversion and gastric bypasspatients had the most improvements in hyper-lipidemia postoperatively (99% and 97% res-olution, respectively).

Life expectancyMorbid obesity is associated with decreasedlife span. The life expectancy of a man in his20s is 13 years shorter if his BMI is over 45.82

In their observational cohort study,Christou et al4 found that the 5-year mortalityrate in the bariatric surgical group was 0.68%compared with 16.2% in the medically man-aged patients— an 89% relative risk reduction.

Flum and Dellinger83 evaluated survivalafter gastric bypass in a retrospective cohortstudy and found a 27% lower 15-year mortali-ty rate in morbidly obese patients who under-went gastric bypass compared with those whodid not. After the surgical patients reachedthe first postoperative year, the long-term sur-vival advantage increased to 33%.

! IS BARIATRIC SURGERY COST-EFFECTIVE?

The direct and indirect costs of morbid obesi-ty are high. Most of the costs of obesity arerelated to the chronic comorbidities of dia-betes, hypertension, and cardiovascular dis-ease. In 2000, the Centers for Disease Controland Prevention estimated the total cost ofobesity at $117 billion per year.

Several studies evaluated the cost-effec-tiveness of bariatric surgery.

Sampalis et al84 compared long-termdirect health care costs in 1,035 patients whounderwent bariatric surgery and 5,746 age-matched and gender-matched obese controls.Open Roux-en-Y gastric bypass accounted for79% of procedures. The surgical group hadlost 67% of their excess body weight at 5years. At 3.5 years, the cost of surgery wascompensated for by a reduction in total costs.At 5 years, there was a 29% reduction in costsfor the surgical group.

Medication cost, specifically for antihy-pertensive and diabetic medications, arereduced by as much as 77% after bariatricsurgery.85

Snow et al86 found that after laparoscopicRoux-en-Y gastric bypass, the savings in drugcosts was equal to the cost of surgery at 32months.

The Swedish Obese Subjects trial com-pared drug use in 510 surgically treatedpatients, 455 medically treated patients, and958 normal-weight controls. At 6 years, surgi-cal patients had a significant reduction incosts for diabetic and cardiovascular medica-tion, but this was offset by increased use ofgastrointestinal medication and nutritionalsupplements.87

Assessments of quality-adjusted life-years have also been conducted and favorbariatric surgery over nonsurgical treatmentof obesity.85

! THE FUTURE

As new technologies emerge, bariatric surgerywill undoubtedly change. Endoluminalapproaches to bariatric surgery utilizing flexi-ble endoscopy are being investigated. Thesetechniques may further decrease the risk asso-ciated with bariatric surgery.


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ADDRESS: Philip R. Schauer, MD, Director, Bariatric and MetabolicInstitute, M61, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195;e-mail [email protected].

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