SURGICAL TREATMENT FOR OBESITY: WHAT S THE BEST OPTION? Natan Zundel, MD, FACS, FASMBS Professor of Surgery Vice-Chairman Department of Surgery Florida International University Herbert Wertheim College of Medicine Consultant MIS and Bariatric Surgery FSFB, Colombia Page 1 of 26
TWO QUESTIONS: 1. TO THE PATIENT 2. TO MYSELF TWO QUESTIONS: 1. TO THE PATIENT WHAT PROCEDURE DO YOU WANT AND WHY? Page 2 of 26
Recent Study of 468 patients demonstrated strong preference for LAGB vs. RYGB 2 RYGB LAGB 1.71M About 3 Million patients are likely to have surgery over the next 5 years. 1 (not reimbursed).75 M.88 M 1.36 Even though there are only half as many patients in the BMI 40 category (12 Million) as in the BMI 35-39 category (21 Million), more BMI 40 are expected to be treated. 0 0.50 0.70 0.24 0.18 0.35 Jul '05 Jul '05 Jul '05 BMI 30.0-34.9 BMI 35.0-39.9 BMI 40.0+ July 05 study of 468 patients interviewed who were in each of three BMI categories. Data were weighted to assure that the total is representative of the market with respect to BMI, age by sex, presence of significant co-morbidities, household income, race/ethnicity and health insurance. Patients were presented with comprehensive description of each procedure. * p < 0.05 Adjustable Gastric Banding Page 3 of 26
Procedure Mortality* Morbidity LAGB 0.05% 11.3% RYGB 0.50% 23.6% VBG 0.31% 25.7% LAGB Safety Chapman, et al. A systematic literature review. Surgery March 2004; 135:326-51 World literature review-comparison study 121 studies *LAGB 10 times safer than RYGB, and 6 times safer than VBG Mean EWL% 61.2% for all patients; 47.5% (40.7%-54.2%) LAGB; 61.6% (56.7%-66.5%), RYGB; 70.1% (66.3%-73.9%), BPD. Bariatric Surgery. A Systematic Review and Metaanalysis. Henry Buchwald, MD, PhD. Jama JAMA, October 13, 2004 Vol 292, No. 14 1737 Page 4 of 26
RESULTS Data Summary LAGB Type 3 year WL parameters Comorbidity Resolution Complication Rates* EWL BMI Δ DM HTN Early Late SAGB 56.4 % -12 61.5% 63.0% 0.3% 4.0% LB 50.2% -11.8 60.3% 46.3% 1.6% 4.7% * SAGB is marketed as Realize TM Adjustable Gastric Band in the USA. OUR OUTCOMES OR Early Female time Conversion N Complications Hosp. Reop Follow EWL Autor N (%) BMI (min) (%) (%) Stay (d) (%) Up (%) Zimmermann 894 85.2 42.0 35 1 (0.11) 3 (0.33) 3.0 2 1 y 40 Belachew * 550 73.0 43.0 62 5 (1.1) 2 (0.4) NI 56 5 y 50 Dargent 500 80.0 43.0 NI NI 4 (0.8) NI 3.6 28 mo 65 (2 y) Fielding 335 82.0 46.7 71 3 (0.9) 7 (2.1) 1.4 3.6 1.5 y 62 O'Brian 277 88.0 44.5 57 5 (1.8) 12 (4.3) 3.9 4 * 4 y 70 Favretti 260 72.0 45.5 90 10 (3.8) NI 2.0 4.2 NI NI Greenstein 250 NI 48.0 NI NI 14 (5.6) NI 5.2 * 5 y 42 Surgical Clinics of North America Volume 81 Number 5 October 2001 OR Early Female time Conversion N Complications Hosp. Reop Follow EWL Autor N (%) BMI (min) (%) (%) Stay (d) (%) Up (%) Zundel 3.348 65 44.7 50 First 100 (14%) 1 1.4 38 9y 42% Next (0.28%) Page 5 of 26
LAGB Complications Chapman, et al. A systematic literature review. Surgery March 2004; 135:326-51 Complication Band displacement Pouch dilatation LAGB (n=8,504) n % 138 1.62 338 3.97 Erosion 50 0.59 Port dislocation 74 0.87 Catheter rupture/ 68 0.80 disconnection/leak Infection band/port 31 0.36 BAND EROSION / MIGRATION / PENETRATION Page 6 of 26
How does it compare to other procedures? SLEEVE GASTECTOMY VS BAND Page 7 of 26
ROUX-EN-Y GASTRIC BYPASS Laparoscopic adjustable gastric banding versus laparoscopic gastric bypass for morbid obesity: a single-institution comparison study of early results Jan J, Houng D, Periera N, Patterson E. J Gastrointest Surg. 2005 Jan;9(1):30-9 Oct 2000 - Nov 2003 LRYGB LAGB N 219 154 BMI 49.5 +/- 6.6 50.9 +/- 9.4 Age 42 +/- 9 47 +/- 11 Page 8 of 26
Sleeve Gastrectomy Procedure LSG Number of LSG Procedures are increasing all over the world Approved or soon-to-be approved by All Insurances Page 9 of 26
Sleeve Gastrectomy Mechanism of action Hormonal Action: Ghrelin Is predominantly produced by gastric fundus which is resected during SG resulting in less stimulation of hunger center Mechanical process Cummings DE et al. Physiol Behav 2006,89:71-84 Himnens J et al. Obes Surg 2006;16:1450-1456 Gastric Emptying SLEEVE GASTRECTOMY RESULTS Page 10 of 26
SLEEVE GASTRECTOMY RESULTS Jossart et al Page 11 of 26
Long Term Complications 1. GERD 2. Gastric atony 3. Weight loss failure 4. Vitamin Deficiency 5. Slippage of the reduced stomach 6. Sleeve dilation 7. Other Page 12 of 26
TWO QUESTIONS: 2. TO MYSELF: WHY I SHOULD NOT DO WHAT THE PATIENT WANTS? %EWL VG vs Banding Langer FB Obesity Surgery(2005) 15;1024-1029 Page 13 of 26
Sleeve vs Traditional Bariatric Procedures (* p vs GBP) VG n=68 Lap Band n=156 GBP n=245 DS n=66 Reoperations 1.5* 1.3 3.3 6.1 Major 0 2.6 6.4 16.6 complications Total complications 1.5* 2.6* 6.5 22.7 Readmissions 5.9 3.8 15.1 28.8 Lee C Presented at the 90 th Annual Clinical Congress LAGB / LSG NO INDICATIONS WHY IS IT SO IMPORTANT? Page 14 of 26
1. Diabetes??????? 2. Super Super Obese???? 3. Significant Hiatal Hernias??? 4. Sweet Eaters, Greasers?????? 5. GERD / BARRETT S ROUX-EN-Y GASTRIC BYPASS Page 15 of 26
ROUX-EN-Y GASTRIC BYPASS > Combination > Most frequently performed bariatric procedure in the U.S. > First done in 1967 > Laparoscopically since 1993 > 56 percent excess weight loss after four years 6 > Resolves type 2 diabetes in more than 83 percent of patients 8 LONG TERM PERSISTENT RESULTS 0 10 20 608 pts 93% follow-up %EWL 30 40 50 Poiries et al, Ann Surg 1995;222:339 0 2 4 6 8 10 12 14 83% DMT2 normal Glucose levels up to 14 years Page 16 of 26
Gastric bypass for DMT2 Author Procedure Pories et al 1995 Gastric Bypass 89% Torquati et al 2005 Gastric Bypass 74% Schauer et al 2003 Gastric Bypass 82% Sugerman et al 2003 Gastric Bypass 86% Cohen et al 2006 Gastric Bypass 100% LAGB NO INDICATIONS WHY IS IT SO IMPORTANT? BETTER PATIENT SELECTION LESS WEIGHT LOSS FAILURE LESS MORBIDITY BETTER RESULTS Page 17 of 26
LAGB Vs LSG Vs LRYGB in Special Situations Children and Adolescents Elderly (In the U.S. age greater than 65) As a primary bariatric for a second non-bariatric In low BMI s Transplant Candidates Cirrhotic Patients Extensive gastrointestinal surgery Inflammatory bowel disease Data suggest that the morbidity of bariatric operations performed in adolescents is significantly lower when compared to adults. However the Mortality is comparable. Varela JE et al, SOARD 2007 Page 18 of 26
Children and Adolescents More data is needed before any surgical procedures can be recommended as the standard of care for children or adolescents with morbid obesity. The need is there, however, because a fair amount of these adolescent patients with obesity, cannot and should not wait, until they are adults to get the treatment they need. Zundel et al. Bariatric Times Apr 2010 Elderly The clinical benefits of weight loss in elderly patients are often less dramatic than in younger patients AGB or LSG provides a safe alternative to surgical weight loss. LAGB combined with shorter operating times Absorption of vitamins, minerals and medications usually is not affected Page 19 of 26
As a primary bariatric for a second non-bariatric procedure Complex oncologic procedures (Szymanski et al. Obes Surg. 2010 Feb 24) Preoperatively in transplant patients (Koshy et al. Am J Kidney Dis. 2008 Oct;52(4):e15-7) But Postop Rejection after ( Unes K et al, J Cardivasc Med,Nov 2009) Transplantation Foreign Body vs Absorption vs Side effects of medications vs Anatomic changes Page 20 of 26
Transplant Candidates Severe obesity is associated with increased incidence of graft failure Transplant patient frequently require multiple medications, procedures that include malabsorption, interfere with the bioavailability of these drugs Obesity worsens after transplantation Campsen et al. Obes Surg. Dec 2008 Transplant Candidates Anatomy changes Transplant will be delayed until Weight Loss is achieved.. Contraindications from the companies for some medications Page 21 of 26
Extensive gastrointestinal surgery Inflammatory bowel disease In patients with previous extensive gastrointestinal surgery or multiple adhesions from prior abdominal surgery Adjustable gastric banding or LSG should be preferred over bypass/diverting procedures Patients with UC or Crohn s disease should not undergo malabsorptive operations that leave large segments of defunctionalized bowel. Foreign body and medications a concern for the band Extensive gastrointestinal surgery Talk with the patient and the insurance before the operation about the different options/ possible findings. Full abdominal laparoscopic evaluation of adhesions and anatomy, before you are committed Page 22 of 26
We really need studies. GERD Motility disorders are more common in Obese and Morbidly Obese population Patients with HX of GERD should be studied with EGD / GS / PH-Mann preop. If Positive What?? Page 23 of 26
LSG MASSIVE AND HIS.. VARIATIONS,INVENTIONS,MODIFICATIONS,ETC LRYGB STEADY, SOME DECREASE IS THE LSG THE NEXT BAND?? BETTER PATIENT SELECTION LESS WEIGHT LOSS FAILURE LESS MORBIDITY BETTER RESULTS Page 24 of 26
LAGB NO INDICATIONS. WHY IS IT SO IMPORTANT? THE BAND WAS NOT FOR EVERYBODY LIKE THE BYPASS, THE SLEEVE, ETC. ARE NOT FOR EVERYBODY Banding Sleeve Gastrectomy Gastric bypass Your Decision Invasiveness Least Middle Most Excess Weight Loss 40-60% 50-60% 50-70% Rate of Weight Loss Slower Faster Faster Risk of Death Lowest (1/1000) Middle (1/500) Highest (1/100) Complications Occur later Occur early Occur early or late Adjustable Yes No No Reversible Yes No Very difficult Implanted Device Yes No No Hospital Stay <1 day 1 day 2 days Time off work 1 week 1-2 weeks 2 weeks US track record Since 1991 Since ~2000 Since 1960 s Anti Inflammatory OK OK NOT OK Follow up Most frequent Less frequent Less frequent Page 25 of 26
Sleeve Gastrectomy Is considered more invasive than GB Does not have the possibility of restitutio ad integrum. But Cummings DE et al. Physiol Behav 2006;89:71-84 Himpens J et al. Obes Surg 2006;16:1450-1456 We really need options: 1. For Low BMI s 2. For the Obese population 3. For Revisions 4. More acceptable for patientes Page 26 of 26