1. Maurizio De Luca MD Department of Surgery – Regional Hospital of Vicenza – Italy XXI Congresso Nazionale SICOB Cagliari, 25-27 Aprile 2013 La Gestione degli insuccessi del calo ponderale in Chirurgia Bariatrica Strategie di Trattamento dopo fallimento di Bendaggio Gastrico

2. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it 2 LAGB – first choice for obesity surgery

3. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Laparoscopic Adjustable Gastric Banding Development phase (pre-2000)Established phase (post-2000) Significant numbers received perigastric implants All pars-flaccida Laparoscopic surgery in its infancy – few surgeons with experience Advanced laparoscopic techniques well established and widely disseminated No specialist obesity surgery centresMany internationally recognised Centres of Excellence Early band technology – high failure rates due to leakage, erosions and tubing/access port probems. Improved band engineering and design, eliminating previous problems and offering innovations – eg development of rapid fixation technology for access port Little experience with band adjustment, erosion, pouch dilatation, prolapse etc Greater recognition of perils of over- adjustment and need for close follow-up and early intervention when problems arise. Two phases of LAGB development

4. Authors Size of cohort Duration of follow-up Implantation Operative mortality Port/tubing problems (e.g. leakage & infection) Slippage/pouch dilatation Erosion % Re-operation rate % EWL Pre-2000 Tolonen et al2807 yearsPF010.6%6.5%3.3%24.4%56% at 7 years Steffen et al8245 yearsPF06.8%2.7%1.6% Major 16.5% (minor 6.8%) 57% at 5 years Chevallier et al1,0007 years PG 37.8% PF 62.2% 05.7%10.4%0.3%11%Not reported Zehetner et al1906 yearsPF02.6% 2.1%8.5%50% after 2 ys Toouli et al1,0008 years PG 4.2% PF 95.8% 06.7%3.0%3.1%14.5%52% at 8 years Chevallier et al4002 years PG 94.5% PF 5.5% 07.5%8.5%0%8.8% 52.7% at 2 years Zinzindohoue et al [36] 5003 years PG 77.4% PF 22.6% 07.8%8.6%0%10.4% 54.8% at 3 years Ceelen et al6253 yearsPG02.9%5.6%0%7.8%47.4% Gastric Banding Studies before 2000

5. Authors Size of cohort Duration of follow-up Implantation Operative mortality Port/tubing problems (e.g. leakage & infection) Slippage/pouch dilatation Erosion % Re-operation rate % EWL Pre-2000 Favretti et al 1,79112 years PG 77.8% PF 21.5% 011.2%3.9%0.9%5.9%38.5% at 10 years Vertruyen et al5437 yearsPG02.9%4.6%0.9%6.8%52% at 7 years Michelleto et al6845 years PG 47% PF 53% 06.8%6.1%1%6.3%54% at 5 years Weiner R et al9848 years RG 58.7% Mixed 41.3% 02.5%4.5%0.3%3.9%59.3% after 8 years O’Brien et al7096 yearsPG03.6%12.5%2.8%18.9%57% at 6 years Belachew et al7634 yearsPF0.1%2.6%7.7%0.9%10.5%50-60% at 4years + Dargent et al1,1807 yearsPG/PF (not stated)0.16%N/S8.8%1.8%12.7%50% at 7 years Mittermair et al4543 yearsPF09.7%2.0%3.1%7.9%72% at 3 years Balsiger et al1967 yearsPF07.5%12%1%32%61% at 7 years Gastric Banding Studies before 2000

6. Authors Size of cohort Duration of follow-up Implantation Operative mortality Port/tubing problems (e.g. leakage & infection) Slippage/pouch dilatation Erosion % Re-operation rate % EWL Post-2000 Ponce et al 1,0144 years PG 4.3% PF 95.7% 01.2%2.3%0.2% 8 bands explanted 64.3% at 4 years Ren et al4451 yearPF0.2%2.2%3.1%0.2%7.2% 44.3% at 1 year Parikh et al 7493 yearsPF02.4%2.9%0.1%10.7%52% at 3 years Holloway et al [41]5003 yearsPF0.2%9.2%5.0%1.0%n/s65% at 3 years Sarker et al4093 yearsPF0.2%4.2%5.4%0.2%12.2%53.3% at 3 yrs Gastric Banding Studies after 2000

7. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Gastric Banding Studies Before vs After the year 2000 : difference? 50-60 %EWL before and after 2000 Steffen 57%EWL 824 pts 5 y Belachew 55%EWL 763 pts4y before 2000 Parikh 52%EWL 749 pts3y after 2000 Ponce 64%EWL 1014pts4y Efficacy – Weight Loss Steffen R, Biertho L, Ricklin T, et al (2003). Laparoscopic Swedish adjustable gastric banding: a five-year prospective study. Obes Surg 13:404-411 Belachew M, Belva PH, Desaive C (2002) Long-term results of laparoscopic adjustable gastric banding for the treatment of morbid obesity. Obes Surg 12:564-568 Parikh MS, Fielding G, Ren CJ (2005) US experience with 749 laparoscopic adjustable gastric bands: Intermediate outcomes. Surg Endosc 19:1631-1635 Ponce J, Paynter S, Fromm R Laparoscopic adjustable gastric banding: 1,014 consecutive cases. J Am Coll Surg 201:529-535 2005

8. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it 137 studies (33 SAGB and 104 LAGB) – 29980 Patients 3-Year mean weight loss was 53.3% Cunneen SA, Phillips E, Fielding G et al. Studies of Swedish adjustable gastric band and Lap-band: systematic review and meta-analysis. Surg Obes Relat Dis 2008; 4: 174-85 Efficacy – Weight Loss

9. LAGB vs RYGBP – long-term outcomes Systematic review of medium-term weight loss after bariatric operations Evaluation of 43 reports fulfilled the entry criteria (18 RYGBP; 18 LAGB; 7 BPD) %EWL Years of Follow Up O’Brien PE et al. Obes Surg 2006; 16:1032-1040

10. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Gastric Banding Studies Before vs After the year 2000 : difference? No significant difference in Operative Mortality Steffen 0% 824 pts 5 y Favretti 0.% 1791 pts 12 y Belachew 0.1% 763 pts4y before 2000 Parikh 0% 749 pts3y after 2000 Ren 0.2% 445 pts 1y Operative Mortality Steffen R, Biertho L, Ricklin T, et al (2003). Laparoscopic Swedish adjustable gastric banding: a five-year prospective study. Obes Surg 13:404-411 Favretti F, Segato G, Ashton D, et al (2007) Laparoscopic adjustable gastric banding in 1,791 consecutive obese patients: 12-year results. Obese Surg 17:168-175 Belachew M, Belva PH, Desaive C (2002) Long-term results of laparoscopic adjustable gastric banding for the treatment of morbid obesity. Obes Surg 12:564-568 Parikh MS, Fielding G, Ren CJ (2005) US experience with 749 laparoscopic adjustable gastric bands: Intermediate outcomes. Surg Endosc 19:1631-1635 Ren CJ, Weiner M, Allen RW (2004) Favourable early results of gastric banding for morbid obesity: The American experience. Surg Endosc 18:543-546

11. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it 137 studies (33 SAGB and 104 LAGB) – 29980 Patients early mortality ≤0.1% Cunneen SA, Phillips E, Fielding G et al. Studies of Swedish adjustable gastric band and Lap-band: systematic review and meta-analysis. Surg Obes Relat Dis 2008; 4: 174-85 Operative Mortality

12. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Gastric Banding Studies Before vs After the year 2000 : difference? Drammatically lower stomach slippage rate from Perigastric tecnique vs pars Flaccida tecnique Ponce 20.5% in PG vs 1.4% O’Brien four time higher in PG Stomach Slippage Ponce J, Paynter S, Fromm R Laparoscopic adjustable gastric banding: 1,014 consecutive cases. J Am Coll Surg 201:529-535 2005 O’Brien, PE, Dixon JB, Anderson M. A prospective randomized trial of placement of the laparoscopic adjustable gastric band: comparison of the perigastric and pars flaccida pathways. Obes Surg;15:820-6 2005

13. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Gastric Banding Studies Before vs After the year 2000 : difference? No significant difference in Gastric Erosion Rate Chevallier 0% 400 pts 2 y Favretti 0.9% 1791 pts 12 y Tolonen 3.3% 280 pts7 y before 2000 Watkins 0.1% 2411 pts 3y after 2000 Singhal0.09% 1140 pts 3y Gastric Erosion Chevallier JM, Zinzindohoue F, Douard R, et al (2004) Complications after laparoscopic adjustable gastric banding for morbid obesity: Experience with 1,000 patients over 7 years. Obes Surg 14:407-414 Favretti F, Segato G, Ashton D, et al (2007) Laparoscopic adjustable gastric banding in 1,791 consecutive obese patients: 12-year results. Obese Surg 17:168-175 Tolonen P, Victorzon M, Makela J (2008). 11-year experience with laparoscopic adjustable gastric banding - What happened to the first 123 patients? Obes Surg 18: 251-255 Watkins BM, Ahroni JH, Michaelson R, et al (2008) Laparoscopic adjustable gastric banding in an ambulatory surgery center. Surg Obes Rel Dis 4 (Suppl):S56-62 Singhal R, Kitchen M, Ndirika S, et al (2008) The “Birmingham” stitch” - Avoiding slippage in laparoscopic gastric banding. Obes Surg 18:359-363

14. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Gastric Banding Studies Before vs After the year 2000 : difference? Less common rate due to improved band design and surgical technique Mittermair 9.7% 454 pts 3 y Favretti 11% 1791 pts 12 y Tolonen 10.6% 280 pts7 y before 2000 Parikh 0%s 749pts 3y after 2000 Singhal 0.35% 1140 pts 3y Port Tubing leakage and infection Mittermair RP, Weiss H, Nehoda H, et al (2003) Laparoscopic Swedish adjustable gastric banding: 6-year follow-up and comparison to other laparoscopic bariatric procedures. Obes Surg 13:412-417 Favretti F, Segato G, Ashton D, et al (2007) Laparoscopic adjustable gastric banding in 1,791 consecutive obese patients: 12-year results. Obese Surg 17:168-175 Tolonen P, Victorzon M, Makela J (2008). 11-year experience with laparoscopic adjustable gastric banding - What happened to the first 123 patients? Obes Surg 18: 251-255 Watkins BM, Ahroni JH, Michaelson R, et al (2008) Laparoscopic adjustable gastric banding in an ambulatory surgery center. Surg Obes Rel Dis 4 (Suppl):S56-62 Singhal R, Kitchen M, Ndirika S, et al (2008) The “Birmingham” stitch” - Avoiding slippage in laparoscopic gastric banding. Obes Surg 18:359-363

15. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Gastric Banding Studies Before vs After the year 2000 : difference? Drammatically reduced due to improved band design and surgical technique Steffen major 16.5% - minor 6.8% 824 pts 5y Belachew 10.5% 763 pts 4 y Tolonen 24,4% 280 pts7 y before 2000 Sarker 2.6%s 7409 pts 3y after 2000 Singhal 2.1% 1140 pts 3y Reoperation Rate Steffen R, Biertho L, Ricklin T, et al (2003). Laparoscopic Swedish adjustable gastric banding: a five-year prospective study. Obes Surg 13:404-411 Belachew M, Belva PH, Desaive C (2002) Long-term results of laparoscopic adjustable gastric banding for the treatment of morbid obesity. Obes Surg 12:564-568 Tolonen P, Victorzon M, Makela J (2008). 11-year experience with laparoscopic adjustable gastric banding - What happened to the first 123 patients? Obes Surg 18: 251-255 Sarker S, Myers J, Serot J, et al (2006) Three-year follow-up weight loss results for patients undergoing laparoscopic adjustable gastric banding at a major university medical center: Does the weight loss persist? Am J Surg 191:372-376 Singhal R, Kitchen M, Ndirika S, et al (2008) The “Birmingham” stitch” - Avoiding slippage in laparoscopic gastric banding. Obes Surg 18:359-363

16. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Gastric Banding Studies Before vs After the year 2000 : difference? Reduced to the surgical skill Vertruyen M Micheletto G60-150 min Dargent J before 2000 Watkins40 min after 2000 Length of procedure Vertruyen M (2002) Experience with Lap-Band system up to 7 years. Obes Surg 12: 569-572 Micheletto G, Roviaro G, Lattuada E, et al (2006) Adjustable gastric banding for morbid obesity. Our experience. Ann Ital Chir 77:397-400 Dargent J (1999) Laparoscopic adjustable gastric banding: Lessons from the first 500 patients in a single institution. Obes Surg 9:446-452 Watkins BM, Ahroni JH, Michaelson R, et al (2008) Laparoscopic adjustable gastric banding in an ambulatory surgery center. Surg Obes Rel Dis 4 (Suppl):S56-62

17. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Gastric Banding Studies Before vs After the year 2000 : difference? Reduced up to ambulatory basis Vertruyen M Micheletto G3-4 days Dargent J before 2000 Watkinsambulatory after 2000 Coburn Hospital Stay Vertruyen M (2002) Experience with Lap-Band system up to 7 years. Obes Surg 12: 569-572 Micheletto G, Roviaro G, Lattuada E, et al (2006) Adjustable gastric banding for morbid obesity. Our experience. Ann Ital Chir 77:397-400 Dargent J (1999) Laparoscopic adjustable gastric banding: Lessons from the first 500 patients in a single institution. Obes Surg 9:446-452 Watkins BM, Ahroni JH, Michaelson R, et al (2008) Laparoscopic adjustable gastric banding in an ambulatory surgery center. Surg Obes Rel Dis 4 (Suppl):S56-62 Coburn C et al. Laparoscopic Gastric Banding is Safe in Outpatient Surgical Centres. Obes Surg 2010; Published Online, January.

18. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Gastric Banding Studies Before vs After the year 2000 : difference? Efficacy – Weight Loss in extreme cases Torchia F, Mancuso V et al (2008) LapBand system ® in super-superobese patients (>60 kg/m 2 ): 4-year results. Obes Surg [Epub ahead of print]. Fielding GA, Duncombe JE (2005) Laparoscopic adjustable gastric banding in severely obese adolescents. Surg Obes Relat Dis 1:399-405 52. Taylor CJ, Layani L (2006) Laparoscopic adjustable gastric banding in patients > or + 60 years old: Is it worthwhile? Obes Surg 16:1579-1583 Different Studies show that there are not differences in terms of safety and efficacy in Super-obese, Adolescents and Elderly Pts

19. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it LAGB– long-term outcomes  0 operative mortality  91% follow-up with 5.9% re-operation rate  Mean EWL% at 10 years was approximately 40% 9

20. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Kg 1307 976819 690 612523 381269197125 48 12 3 484 374 317274242 204 151 113 7041 15 3 Laparoscopic Gastric Banding for 1800 Patients: 12 Years Results Results in Super e Morbid Obese (BMI)

21. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Laparoscopic Gastric Banding for 1800 Patients: 12 Years Results Results in Super e Morbid Obese (% EWL) %EWL 1307 976819690 612 523 381 269197 125 48 12 3 484 374 317 274 242204151 113 70 4115 3

22. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Laparoscopic Gastric Banding for 1800 Patients: 12 Years Results Major Complications Requiring Reoperation (106/1791 pts.; Sept 1993-Dec 2005 ) ComplicationsNumberRate of Complications ReoperationNumberRate of Reoperation Stomach Slippage + Pouch Dilatation 703.9% Removal Repositioning 20 50 1.1% 2.8% Erosion160.9%Removal160.9% Psychological Intolerance 140.7%Removal140.7% Miscellaneous (HIV, Infections, Microperforation) 50.27%Removal50.27% Gastric Necrosis10.05%Gastrectomy10.05% Total1065.9%Total1065.9% Unsatisfactory Results (Lack of Compliance) 412.3% BPD Removal “ BandInaro ” 5 12 24 0.27% 0.7% 1.3%

23. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Lap-Band Patients: No Responders

24. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it … about “no responders”…. Strategie di trattamento dopo fallimento di Bendaggio Gastrico

25. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it No Responders Gastric Bypass and Functional Gastric Bypass Sleeve Gastrectomy Scopinaro or Duodenal Switch Mini Gastric Bypass

26. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Sleeve Gastrectomy Vicenza Series  14 Patients (December 2006 to January 2008)  F/M 9/5  14 cases of remedial surgery  5-6 green and blue staple cartridge after full devascularization and mobilization af the greater gastric curve  Running suture by 3-0 Prolene over-sewed the staple-line  Mean operative time was 95 min (70-135)  No peri-operative or post-operative complication  No mortality cccccccccccccccccccc

27. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Maurizio De Luca Gastric Bypass Small gastric pouch Roux –en-Y gastrointestinal anastomosis Food Intake reduction Early satiety Post-prandial discomfort Partial lipid malabsorption Functional Bypass

28. Maurizio De Luca Bilio Pancreatic Diversion BilioPancreatica Diversion (Scopinaro 1976)  distal gastrectomy  gastric reservoir 200-300 ml  common channel 50 cm  alimentary channel 200 cm

29. Maurizio De Luca Bilio Pancreatic Diversion BilioPancreatic Diversion Duodenal Switch (Hess 1988)  vertical gastrectomy  gastric reservoir 150-200 ml  duodenal switch  common channel 100cm  alimentary channel 150 cm

30. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Effects of BPD on comorbidities. Scopinaro N, Adami FA, Marinari GM et al. BilioPancreatic Diversion: Two Decades of Experience. Update: Surgery for the Morbidly Obese Patient. F-D Communication. Deitel M, Cowan G, 2000, Chap 23, 227-258

31. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Duodenal Switch Complication (Hess: 440 pts.) Medical perioperative complication Deep vein thrombofiblitis0.75% Non-fatal pulmonary embolism0.5% Pneumonia0.5% ARDS0.25% Surgical Complication Splenectomy (incidental)0.75% Duodenal Leak1.5% Distal Roux-en-Y Leak0.25% Post-op bleeding (requiring surgery)0.5% Abscess (not related to leaks)0.25% Late Surgical complication Duodenal stoma obstruction0.75% Small Bowel obstruction1.5% Hess DS. Biliopancreatic Diversion with Duodenal Switch. Obes Surg. 8, 267-282, 1998

32. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it Nutrients Most at Risk Iron Calcium Zinc VitaminD Vitamin A Vitamin K Protein Dolen K et al. A clinical and nutritional comparison of biliopancreatic diversion with and without duodenal switch. Ann Surg 2004; 240-51 Slater GH, Serum fat-soluble vitamin deficiency and abnormal calcium metabolism after malabsorptive bariatric surgery. J Gastrointestinal Surg 2004; 8: 48-65

33. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it BPD Standad and BPD DS prevalence side-effects Marceau P., Hould F, Lebel S et al. Malabsorbitive Obesity Surgery. The Surgical Clinics of North America. 2001, 81,5, 1113-1127. (p<0.0001 by Fisher t-test)

34. Maurizio De Luca Less surgery compared with GBP and BPD Low peri-operative comorbidities compared with GBP and BPD Long Term Weight Loss as BPD (75% EWL at 10 yrs) Resolution or improvement of Diabetes in 89% of Pts at 7 yrs Resolution of hyperlipidemia in 92% of Pts at 7 yrs Absence of BPD side effects (like diarrhea, hemorrhoids, proctitis etc.) Absence metabolic side effects of BPD (protein malnutrition) 20-30 ml Gastric pouch One gastro-jejunal anastomosis with a diameter of 1.5-2 cm L-L anastomosis and non T-L anastomosis Antireflux Stitches Omega Loop 200-220 cm (different mechanism of Billroth II) Antecolic anastomosis (avoiding holes in the mesocolon) Mini Gastric Bypas Omega Loop Long Limb Gastric Bypass Single Anastomosis One Anastomosis Gastric Bypass: a simple, safe and efficient surgical procedure for treating morbid obesity M Garcia Caballero and M Carbajo Nutricion Hospitalaria, XIX, (6) 372-375, 2004

35. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it BARIATRIC SURGERY Sequential Treatment LAP BANDTreated (72% of pts) Undertreated Malabsorption Treated (Comorbidities)

36. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it BARIATRIC SURGERY Sequential Treatment LAP BAND Treated (72% of pts) Undertreated Single Anastomosis Omega Loop Gastric Bypass Malapsorbitive procedure No compliant Patients

37. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it  The majority of Studies shows that LAGB is a safe and effective procedure  Operative mortality of 0-0.1%  Excess Weight Loss (%EWL) of 50-60%  Commensurate to this degree of weight loss, almost all studies show substantial improvements in obesity related comorbidities such as Hypertension, Type II Diabetes, and Dyslipidemia  LAGB has been shown to be both safe and effective in super-obese, adolescents, older patients Conclusion 1

38. Maurizio De Luca MD Executive Surgeon General Secretary of Italian Society of Bariatric Surgery Email: nnwdel@tin.it  The lessons from the development phase (before 2000) of LAGB taught, in the estabilished phase (after 2000), surgical techniques and band technologies  There is no agreement, to date, regarding: 1. LAGB indications 2.role of the multidisciplinary team 3.algorithm of band inflation  Redo Surgery in case of failure of LAGB is easy to be performed (sleeve gastrectomy, gastric bypass, mini gastric bypass, BPD) Conclusion 2 3 parameters of paramount importance for: further weight loss further reduction of reoperation rate