Who Would Have Thought It? Banded Gastric Bypass Works! MAL Fobi MD FACS, FICS, FACN Medical Director Center for Surgical Treatment of Obesity Long Beach CA, USA

Banded Gastric Bypass Disclosures President of Bariatec Corporation. A device Compny I had a Banded Gastric Bypass

Why the Banded Gastric Bypass? Obesity, particularly Morbid Obesity, is a life long disease that is recalcitrant to any treatment, even surgical treatment.

Obesity: A World Epidemic

Obesity is a disease with a Genetic Predisposition PSYCHO- LOGICAL DIS. SOCIO-ECOMOMICS EATING DIS. HORMONAL IMBALANCE WILL POWER GENETIC The exact method of genetic translation is not known at this time. The Expression of obesity varies with social, cultural, environmental, economic and psychological influences.

Significant ramifications of obesity MEDICAL PSYCHOLOGICAL ECONOMIC SOCIAL

NIH Consensus Statements 1991 Prolonged and sustained weight loss has not bee proven with drug therapy. * Published studies of medical approaches to treatment of obesity include few reports or indications of efficacy in person with clinically severe obesity. Evidence of long-term efficacy of behavior modification in persons with clinically severe obesity is lacking. VLDC's used under close medical supervision generally have not been successful for achieving permanent weight loss.

Surgical Treatment and Management of Obesity Surgical Treatment is the only treatment that provides effective long-term control Gastric Bypass/Banded Gastric bypass Gastroplasty/Sleeve Gastrectomy Gastric Banding Bilio-pancreatic Diversion with or without a Switch Intestinal Bypass

INTESTINAL BYPASS

GASTRIC BYPASS

Mason Gastroplasty 1971 Simple operation??? As effective Less morbidity Less mortality

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Evolution of the Gastric Bypass Linner’s Banded Gastric Bypass 1984

Vertical Gastroplasty Distal RYGBP Evolution of the Gastric Bypass Salmon’s Banded Vertical Gastroplasty Distal RYGBP 1986

Evolution of the Gastric Bypass Banded Gastric Bypass Fobi Modification 1986

Banded Gastric Bypass

Howard, Obesity Surgery, 1995 VBG VS. GBP VS 3-4cm Howard, Obesity Surgery, 1995

Howard, Obesity Surgery, 1995 VBG VS. GBP Howard, Obesity Surgery, 1995

Average PEWL (All Pts.) Banded Gastric Bypass Fobi Obes. Surg. 2005

Why the Banded Gastric Bypass Historical and Experimental Data: There are eight series with long term (6-14years) follow-up documenting 70+ PEWL and weight loss maintenance in more patients, even the old and super obese Capella, USA, AJS; Fobi, USA, SOARD; White, New Zealand, Obes Surg; Salinas, Venuzuela SOARD; D.Margo, Obes Surg; Mali, Obes Surg; Cruz, Obes Surg; and Awad, Obesity Surgery 2012 There are only six long term series reported with the non-banded gastric bypass with an average of 55 PEWL, except Sutter with 70+ PEWL Pories, Sutter, Dinitz, Christou, Higa, and the Swedish study 22

% EWL Banded vs Non Banded Gastric Bypass Awad et al Obes. Surg. 2012 83,5(45-115) There is a significative difference in %EWL at 36-96 month. We followed the banded patients for 10 and 12 years and they maintaing the same %EWL. We do not know about the non banded because we started to do it latter. 61,5(27-109) There is a significative difference in %EWL at 36-96 month. We followed the banded patients for 10 and 12 years and they maintained the same %EWL. Presented at IFSO_LAC Congress Cartagenia, Columbia, March 2011

Banded Gastric Bypass vs. Non-Banded Gastric Bypass Dr. Lemmens IFSO Dehli 2012 Retrospective Review

BGBP vs. GBP Prospective comparative evaluation of the Laparoscopically banded gastric bypass vs. the Laparoscopically non-banded gastric bypass. Banded GBP Non-Banded GBP (n= 20) (n=20) BMI 58.7 51.18 Age (years) 46 47 6 months %EWL 43.1 38.6 12 months %EWL 64.0 57.800 36 months %EWL 67.6 55.7 Complications %(n) 20%(5) 35%.(7) % of patients achieving 50%EWL 85% 65% Fobi et al IFSO 2011 Hamburg Germany 25

Banded Gastric Bypass VS. Non Banded Gastric Bypass. Prospective comparative evaluation of the Laparoscopically banded gastric bypass vs. the Laparoscopically non-banded gastric bypass in the super obese. Banded GBP Non-Banded GBP (n=46) (n=44) BMI 59.4 59.7 Age (years) 40.6 42.6 6 months %EWL 43.1 24.7 12 months %EWL 64.0 57.8 24 months %EWL 64.2 57.1 38 months %EWL 73.4 57.7 Complications %(n) 23.9 (11) 29.5 (13) % of patients achieving 50%EWL 63% 45% His conclusion: It appears the banded gastric bypass produces more weight loss in more patients Marc Bressler, SOARD, July/August 2007 26

BGBP vs. GBP Schauer and Associates at the Cleveland Clinic Presented Prospective Evaluation with two year follow-up at IFSO Congress in Hamburg (2011) Showed more weight loss and maintenance with the BGBP

Banded Gastric Bypass vs. Non-Banded Gastric Bypass Karcz et al. GaBP Ring European multicenter clinical trials. IFSO, Dehli 2012

BGBP vs. GBP Herrera, Mexico, SOARD 2009 Prospective Evaluation with two years follow-up Showed no difference

Banded Gastric Bypass Published reports of band placement in failed gastric bypass document increased weight loss and waight loss maintenance Bressler M. Obes Surg 2005;15:1443-48 Kyzer S. Obes Surg 2001;11:66-9 Gobble RM. Surg Edosc. 2008;22:1019-22 Heath D. Obes Surg 2009;19:1439-41 Himpens Obes Surg 2001, 11(4):528-31 Avinoah E. obes surg 2006; 6:213-15 30

Adjustable Band Placement for Revision of failed Gastric Bypass Bressler Obes. Surg. 2005

( E.Mason, Obesity Surgery 1994; 4:66-72) Banding the Pouch in GBP “Since Roux-en-Y Gastric Bypass is primarily a restriction operation, just as with VBG, it is important that the outlet of the pouch does not stretch.” ( E.Mason, Obesity Surgery 1994; 4:66-72)

MacLean, J Am Coll Surg 97; 185:1-7 Banded Gastric Bypass At this time, the most promising technique based on a large series is that described by Capella and Capella, the “Banded Gastric Bypass” MacLean, J Am Coll Surg 97; 185:1-7 33

Gastric Bypass Operation Why the Band in the Gastric Bypass Operation Fisher after an in depth review concluded that “Long-term results suggest that a silastic ring encircling the stomach pouch proximal to the gastroenterostomy may improve the outcome following gastric bypass surgery, resulting in more weight loss by a greater number of patients sustained for a longer time” - Fisher BL, Barber AE, Eur J Gatroenterol Hepatol 1999; 11:93-97

%EWL for standard RYGBP and its two hybrid forms of LL-RYGBP and Banded RYGBP [O’Brien P.E.:Systemic review of mdium term-weight loss after bariatric surgery.; Obesity Surgery:2006; 16; 1032-40]

Banded Gastric Bypass Why and how does banding the pouch make it more effective for weight loss and Weight loss maintenance? - Fobi, www.bariatec.com

Non-banded Roux-en-Y GBP Reservoir size change with time

Non-banded Roux-en-Y GBP

Non-banded Roux-en-Y GBP

Banded Roux-en-Y GBP Reservoir size change with time

Banded Gastric Bypass

Ring Banded Gastric Bypass Stubbs, Obes Surg; 2005

3-D Recon Image of Ring Banded Gastric Bypass French Catheter Size 1 Fr. = 1/3 mm diameter 34 Fr. = 1.13cm diameter 40 Fr. = 1.33cm diameter 60 Fr. = 2.0cm diameter Ring or band should be loose around the pouch at time of banding Optimal Ring Size 6.5 cm 2.07cm Diameter 1.47cm functional diameter. Mohit Bhandari Indore, India 2012

Banded Gastric Bypass Complications from Banding the Gastric Bypass Band erosion: - 0-7%. Incident directly related to type of the device used, the diameter and size of the device and the presence of contamination or infection. Ring sizes < 6.5cm cause more erosion and dysphagia without increase in effectiveness. Kinking or Slippage: - - 0-1%. Functional Obstruction Treated by endoscopic dilatation or laparoscopic re exploration Solid Food intolerance: - 5-7 %. Not disabling. Treated by dietary counseling. Occasional need for Ring removal

Surgeons have used various devices to band the pouch Surgeon fashioned devices Marlex Mesh Silastic Tubing Ethibond Suture Linea Alba Fascia Porchine Graft Bovine Graft Commercially prefabricated devices GaBP Ring. (Designed for use with the gastric bypass and sleeve gastrectomy) IOC Band AMI Band Minimizer Band Bioring

GaBP RingTM Device GaBP Ring Autolock™ and Gastrostomy Site Marker Clinical Research Study Protocol IDE G050231 IPERSONNEL ---------------------------------------------------------------------------------------------------------2IISTUDY SYNOPSIS --------------------------------------------------------------------------------------------------3IIICLINICAL TRIAL --------------------------------------------------------------------------------------------------51.Introduction and Rationale -----------------------------------------------------------------------------------52.Study Objective ------------------------------------------------------------------------------------------------62.1Effectiveness Endpoints -----------------------------------------------------------------------------62.2Safety Endpoints --------------------------------------------------------------------------------------63.Study Design --------------------------------------------------------------------------------------------------74.Patient Population ---------------------------------------------------------------------------------------------84.1Exclusion Criteria -------------------------------------------------------------------------------------84.2Inclusion Criteria --------------------------------------------------------------------------------------95.Device Characterization -------------------------------------------------------------------------------------95.1Intended Use and Description ------------------------------------------------------------------------96.Study Methods -------------------------------------------------------------------------------------------------106.1Patient Entry and Pre-operative Evaluation -------------------------------------------------------106.2Device Installation and Intra-operative Evaluation -----------------------------------------------116.3Post-operative Care -----------------------------------------------------------------------------------116.4Post-operative Evaluation ----------------------------------------------------------------------------117.Study Procedures ----------------------------------------------------------------------------------------------138.Data Monitoring -----------------------------------------------------------------------------------------------138.1Data Reporting and Monitoring Procedures -------------------------------------------------------138.2Adverse Reaction and Adverse Event Reporting -------------------------------------------------159.Study Analysis -------------------------------------------------------------------------------------------------159.1Sample Sizes -------------------------------------------------------------------------------------------159.2Statistical Methods ------------------------------------------------------------------------------------1510.Bibliography --------------------------------------------------------------------------------------------------16IVAPPENDICES -------------------------------------------------------------------------------------------------------17Appendix 1:Consent to Act as a Human Research Subject -------------------------------------------------17Appendix 2:Device Design and Labeling --------------------------------------------------------------------27Appendix 3:Prior Clinical Investigations --------------------------------------------------------------------44Appendix 4:Surgical Procedure ------------------------------------------------------------------------------50Appendix 5:Device Removal Indications and Procedures --------------------------------------------------57Appendix 6:Examination Procedures, Study Equipment and Techniques -------------------------------58Appendix 7:Sponsor’s Commitments -------------------------------------------------------------------------60Appendix 8:Investigator’s Qualifications and Responsibilities -------------------------------------------61Appendix 9:Investigator’s Agreement ------------------------------------------------------------------------62Appendix 10:Investigator’s Financial Disclosure Declaration ---------------------------------------------65Appendix 11:Declaration of Helsinki/Protection of Human Subjects/Belmont Report/Institutional Review Board --------------------------------------------------------------------------------------66Appendix 12: Physician Information Letter --------------------------------------------------------------------96Appendix 13:Case Report Forms -------------------------------------------------------------------------------105

GaBP RingTM Device GaBP Ring™ is a prefabricated, sterilized ring designed to band the proximal pouch of the sleeve gastrectomy and gastric bypass operations.

Incidence of Band Erosion (May 1992 – May 2002) Banded Gastric Bypass 3,632 (100 %) Primary 3007 ( 82.79 %) Secondary 405 ( 11.15 %) Revision 220 ( 6.06 %) Band Erosion 57 ( 1.89 %) 24 ( 5.92 %) 10 ( 4.54%) Total Incidence of Band Erosion: 91/ 3,632 (2.5 %)

Banded Gastric Bypass vs. Non-Banded Gastric Bypass Dr. Lemmens IFSO Dehli 2012 Retrospective Review

Banded Gastric Bypass vs. Non-Banded Gastric Bypass Karcz et al. GaBP Ring European multicenter clinical trials. IFSO, Dehli 2012

Symptoms of Band Erosion 1. Outlet Stenosis/vomiting/dysphagia 2. Stomal Ulcer/ pain/bleeding/melana 3. Pain, epigastric and or left shoulder 4. UGI Bleeding 5. Acute weight loss followed by weight regain.

Treatment of Band Erosion 1 - Expectant treatment- spontaneous extrusion 2 - Endoscopic removal 3 - Surgical Removal with revision. Band replacement vs. addition of mal absorption component

Endoscopic Removal

Banded Gastric Bypass Outlet Stenosis Requiring Dilatation GBP 1-16% BGBP 1-3%

Reactive Hypoglycemia: Banded Gastric Bypass Reactive Hypoglycemia: -Observed in patients with Band removal or band erosion. Fobi et al. Presentation at OSSICON, 2004 -Treated with ring placement Kasper Z’Graggen. Obes Surg, 2008

Banded Gastric Bypass There is enough evidence that: CONCLUSION: There is enough evidence that: “The banding the Gastric Bypass to standardize the restrictive effect: results in more weight loss results in weight loss in more patients even the super obese and results in better weight loss maintenance” 57

Banded Gastric Bypass There is evidence that banding the CONCLUSION: There is evidence that banding the gastric bypass also results in less incidence of: outlet stenosis requiring dilatation, dumping syndrome reactive hypoglycemia 58

Banded Gastric Bypass BANDED GASTRIC BYPASS Is an operation with weight loss outcome similar if not better than the BPD and the Duodenal Switch operations without the associated metabolic consequences and complications? 1-7% Incidence of Band related complication is observed. (erosion, slippage, obstruction, infection, and device coming apart) Felipe De La Cruz, Handbook of Obesity Surgery, FD- Communications Inc 2010

Who would Have Thought It? Banded Gastric Bypass Works!

Center for Surgical Treatment of Obesity www.bariatec.com Thank You C.S.T.O. Merushi Dankeschön Grazie Obrigado Merci Gracias Center for Surgical Treatment of Obesity MAL Fobi MD FASMBS, FACS FICS, FACN. www.bariatec.com www.fobipouch.com

Banded Gastric Bypass Hand Sewn Gastro-jejunostomy distal to GaBP Ring

Ring placement forces use of a small tubular pouch with a standard stoma