LAGB in low BMI patients Jaime Ponce MD FACS FASMBS Dalton GA MISS Salt Lake City UT February 24,...

LAGB in low BMI patients

Jaime Ponce MD FACS FASMBSDalton GA

MISS Salt Lake City UT February 24, 2012

Disclosures

• Allergan: speaker, proctor, consultant, research

• Ethicon: teaching• Vibrynt: consultant• ReShape: research, consultant• Cavu Medical: consultant

2

Obesity

• Incidence of obesity in the U.S. - National Health and Nutrition Examination Survey (NHANES):– BMI > 30: 34% population in the U.S.1

– BMI > 35: 14% population in the U.S.1

1 Flegal: JAMA 2010;303:235

Obesity Class I• Class I Obesity is a health problem:

– 30% greater mortality1 – 3 yrs decrease in lifespan1

1 Prospective Studies Collaboration. Body-mass index and cause-specific mortality in 900,000 adults: collaborative analyses of 57

prospective studies. Lancet 2009;373:1083-1096.

Obesity Class I• Disease Prevalence (NHANES):

– Type 2 DM increase 3-fold– HTN increase > 2-fold– Dyslipidemia > 2-fold

Medical Therapy

• Non-surgical therapy is not effective in the majority1

1 Svetkey LP, Stevens VJ, Brantley PJ, et al. Comparison of strategies for sustaining weight loss: the weight loss maintenance randomized controlled trial. JAMA 2008;299(10):1139-1148.

Literature: Low BMI LAGB data

• Angrisani, et al (2004)• Parikh, et al (2006)• O’Brien, et al (2006)• Dixon, et al (2008)• Sultan, et al (2009)• Choi, et al (2010)• BOLD data (2010)• Lap-Band® FDA study (2010)

Italian Group for Lap-Band System®: Results of Multicenter Study on Patients

with BMI < 35 kg/m2Angrisani, Favretti, et al (Italian Group for Lap-Band®)

Obesity Surgery, 14, 415-418 (2004)

• 27 centers• BMI < 35 pts: 210 (6.3%) out of 3,319 LAGB pts• Female N=176 (84%)• Mean age: 38+12 (17-66)• Mean BMI: 33.9+1.1 (25.1-35)

Italian Group for Lap-Band System®: Results of Multicenter Study on Patients with BMI < 35 kg/m2

Angrisani, Favretti, et al (Italian Group for Lap-Band®)Obesity Surgery, 14, 415-418 (2004)



FU(months)

%EWL

6 28.1±20.7

12 52.5±13.2

24 61.3±14.7

36 64.7±12.2

48 68.8±15.3

60 71.9±10.7

Laparoscopic adjustable gastric banding for patients with body mass

index of <35 kg/m2

Parikh, Duncombe and Fielding (NYU/Brisbane, Australia)Surgery for Obesity and Related Diseases 2 (2006) 518–522

• N=93 pts (1996-2004)• 2 centers• Age 44.6 (16-76)• BMI 32.7 (30-34)

LAGB patients with BMI < 35 kg/m2 Parikh, Duncombe and Fielding (NYU/Brisbane, Australia)

Surgery for Obesity and Related Diseases 2 (2006) 518–522

Early U.S. outcomes after laparoscopic adjustable gastric banding in patients with a body mass index

less than 35 kg/m2Sultan, Parikh, Youn, Kurian, Fielding and Ren (NYU)

Surg Endosc (2009) 23:1569–1573

• N=53 pts• 2002-2007• Age 46.9 (16-68)• BMI 33.1 (28.2-35)

Early U.S. outcomes after laparoscopic adjustable gastric banding in patients with a body mass index

less than 35 kg/m2Sultan, Parikh, Youn, Kurian, Fielding and Ren (NYU)

Surg Endosc (2009) 23:1569–1573

Outcomes of laparoscopic adjustable gastric banding in patients with

low body mass indexChoi, Digiorgi, Milone, Schrope, Olivera-Rivera, Daud, Davis and Bessler

Columbia University, New YorkSurgery for Obesity and Related Diseases 6 (2010) 367–372

• N=66 pts:– 22 pts (BMI 30-35 w/comorbidities)– 44 pts (BMI 35-40 w/o comorbidities)

• Control N=438 pts (NIH guidelines)• BMI 36.1+2.6 vs 46+7.3• Age 40.7 vs 43.7• Female (%): 89.4 vs 72.9

LAGB patients with low BMIChoi, Digiorgi, Milone, Schrope, Olivera-Rivera, Daud, Davis and Bessler

Columbia University, New YorkSurgery for Obesity and Related Diseases 6 (2010) 367–372

THE MANAGEMENT OF OBESITYTHE MANAGEMENT OF OBESITY

A PROSPECTIVE RANDOMISED CONTROLLED TRIAL OF A PROSPECTIVE RANDOMISED CONTROLLED TRIAL OF MEDICAL VERSUS SURGICAL THERAPYMEDICAL VERSUS SURGICAL THERAPY

Paul O’BrienPaul O’Brien, , John Dixon, Cheryl Laurie, Stewart Skinner, Joe Proietto, John McNeil, Boyd Strauss, Sharon Marks, Linda

Schachter, Leon Chapman and Margaret Anderson.. Centre for Obesity Research and Education Centre for Obesity Research and Education

Monash University, Melbourne, AustraliaMonash University, Melbourne, Australia

Annals of Internal Medicine, May, 2006Annals of Internal Medicine, May, 2006

RCT of Medical vs Surgical Therapy for Obesity % of Excess Weight Lost

8787%

21%21%

RCT of Medical vs Surgical Therapy for ObesityEffect on Metabolic SyndromeEffect on Metabolic Syndrome

N.S.

P < 0.001P < 0.001

%%

38%

24%

38%

3%

Surgical Change vs Medical Change P < 0.006O’Brien et al, Ann Int Med. 2006O’Brien et al, Ann Int Med. 2006

The Management of Type-2 DiabetesThe Management of Type-2 Diabetes

A Randomized Controlled Trial of A Randomized Controlled Trial of Surgical and Non-surgical TherapySurgical and Non-surgical Therapy

John B. Dixon, Paul E. O'Brien, Julie Playfair, Stewart Skinner, John B. Dixon, Paul E. O'Brien, Julie Playfair, Stewart Skinner, Joseph Proietto, Linda M Schachter, Leon Chapman, Margaret Joseph Proietto, Linda M Schachter, Leon Chapman, Margaret

AndersonAnderson

Centre for Obesity Research and EducationCentre for Obesity Research and Education

Monash University, MelbourneMonash University, Melbourne

JAMAJAMA, Feb, 2008, Feb, 2008

Type-2 Diabetes – A Randomised TrialType-2 Diabetes – A Randomised TrialWeight Loss - % of excess weight lostWeight Loss - % of excess weight lost

6565%

6%6%

Type 2 Diabetes – A Randomised TrialType 2 Diabetes – A Randomised Trial

Weight Loss – Change in BMIWeight Loss – Change in BMI

36.336.3

28.428.4

37.137.1

Type 2 Diabetes – A Randomised TrialType 2 Diabetes – A Randomised TrialRemission of Diabetes - ITTRemission of Diabetes - ITT

73%73%

13%13%

Type-2 Diabetes – A Randomised TrialType-2 Diabetes – A Randomised Trial Effect on Metabolic Syndrome (ATP III criteria)Effect on Metabolic Syndrome (ATP III criteria)

(N.S.)

P < 0.001P < 0.001%%

97%

88%

97%

28%

Non-surgical vs Surgical Change P < 0.001

Methods

• 66,264 research-consented BOLD patients• 794 (1.2%)had BMI 30-34.9 kg/m2

• 235 (29%) diabetes requiring any medication– LAGB 109– RNY 109– SG 7– BPD 1

Baseline Characteristics of the Population

N % P

Gender Female Male

18055

76.623.4

0.3476

Race White African-American Other

1892026

80.48.5

11.1

0.5695

Complications

Band data

• N=109• Preop BMI 33.9 (+1.1) kg/m2

• %EBW 57.9 (+7.8) lbs• Total # T2DM meds: 1.3 (+1.1)• 38.5% off meds in 3-6 months• BMI change: 33.9 to 29.9

FDA Clinical Study of LAP-BAND®

in BMI ≥ 30 and < 40 kg/m2

FDA panelDec 3, 2010

Change in Hypertension Status from Screening to Month 12

FDA Panel

• Voted 8-2 in favor:– Safe– Effective– Benefits outweight risks

LAGB Low BMI Data SummaryStudy Type of Study BMI

BaselineBMI Final

%EWL Duration N

Angrisani et al Retrospective, Multicenter

33.9 28.2 71.9% 5 yrs 210

Choi et al Prospective Case Control

36.1 N/A 42.2% 1.5 yrs 66

Dixon et al Randomized Controlled Trial

36.9 29.5 62.5% 2 yrs 30

O’Brien et al Randomized Controlled Trial

33.7 26.4 87.2% 2 yrs 40

Parikh et al Prospective, Single Center

32.7 27.6 53.8% 3 yrs 93

Sultan et al Prospective, Single Center

33.1 25.8 69.7% 2 yrs 53

FDA Study Prospective, Multicenter

35.4 28.8 64.5% 1 yrs 143

Conclusions

• LAGB in Low BMI patients:– Safe– Effective– Improves comorbidities/QOL

• LAGB benefits outweight risk in low BMI patients

LAGB in low BMI patients Jaime Ponce MD FACS FASMBS Dalton GA MISS Salt Lake City UT February 24,...

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