Welche Operation für welchen Patienten: Sleeve, Bypass oder?

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Shonda Alyson Cox
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Referenzzentrum Präsident der Swiss Society for

1 Welche Operation für welchen Patienten: Sleeve, Bypass oder?? Prof. Dr. med. Ralph Peterli Stv. Chefarzt Clarunis Leiter Forschungsplattform Viszeralchirurgie und bariatrisches Referenzzentrum Präsident der Swiss Society for the Study of Morbid Obesity and metabolic disorders (SMOB)

2 Disclosure consultant to Ethicon Endosurgery case mix disclosure 3% 19% 23% 55% LRYGB sleeve BPD revisions OAGB ( minibp ), SADI: 0%

3 BACKGROUND Factors influencing choice of operation health care system patient BMI, fat distribution age gender co-morbidity reimbursement of revisional surgery & outpatient visits adherence (size of country) institution's & surgeon s experience procedure effectivity T2DM GERD (hiatal hernia) early long-term ASA class previous surgery metabolic rate eating behaviour genetics IQ, compliance, adherence stool habits patient wish weight loss co-morbidities metabolic effect safety profile?

BACKGROUND ideal bariatric/metabolic operation simple, fast (easy to learn & teach) safe (early & late) good weight loss, durable strong metabolic effects high

4 BACKGROUND ideal bariatric/metabolic operation simple, fast (easy to learn & teach) safe (early & late) good weight loss, durable strong metabolic effects high rate of remission of co-morbidity (T2DM) known mechanism of action staged concept possible: salvage = standard procedure good quality of life reversible economic 4

5 BACKGROUND procedures worldwide/europe world: N= europe: N= % procedures Gastric Band Gastric Bypass Sleeve Gastrectomy BPD/DS OAGB Angrisani, Obes Surg

6 SM-BOSS & SLEEVEPASS RCT s 5 years FU? 6

Swiss Multicentre Bypass Or Sleeve Study SM-BOSS OBJECTIVE Is sleeve as effective and safe as bypass at 5 years METHOD: multicentre: endpoints: primary: weightloss (excessbmi loss) at 5 y secondary:

7 Swiss Multicentre Bypass Or Sleeve Study SM-BOSS OBJECTIVE Is sleeve as effective and safe as bypass at 5 years METHOD: multicentre: endpoints: primary: weightloss (excessbmi loss) at 5 y secondary: reductionof co-morbidity QoL safety metabolic effects (gut hormones, adipokines, bile acids, ) funding: (Peterli, Ann Surg 09, Obes Surg 12, Wölnerhanssen SOARD 11, Steiner Obesity 13) Swiss National Science Foundation Ethicon Endosurgery, USA 7

Patients SM-BOSS patients evaluated for surgery 1/2007 11/2011 N = 3971 randomized during outpatient visit N = 225 excluded: severe GERD, big hiatal hernia adhesions small bowel necessity to

8 Patients SM-BOSS patients evaluated for surgery 1/ /2011 N = 3971 randomized during outpatient visit N = 225 excluded: severe GERD, big hiatal hernia adhesions small bowel necessity to endoscopically examine duodenum Crohn s disease denied participation LSG LRYGB n = 112 n = 113 excluded: sleeve bypass crossover LRYGB LSG (n=1) operation > 1/2012 (n=7) n = 107 n = 110 dropouts (FU rate = 95%): sleeve n = 101 5y bypass n = 104 LRYGB ( =2, abroad 2, lost=1) LSG (abroad=3, lost=3)

9 Early / Mid-term Results SM-BOSS early (1 year): sleeve faster, (safer); equal weight loss 3 years: equal weight loss, complications, QoL, co-morbitiy except GERD, dyslipedemia: bypass better

10 5-year Results Weight loss SM-BOSS N = 217 (FU rate 95%) 70 mean Body Mass Index, kg/m kg kg Years Post-Surgery = 3.6 kg Peterli, JAMA 2018

11 5-year Results Excess BMI loss SM-BOSS Peterli, JAMA 2018

12 Weight loss Literature RCT Author Journal Year N FU years FU-rate % reported as Mean weight loss p sleeve bypass sleeve bypass Karamanakos Ann Surg % EWL Kehagias Obes Surg % EWL n.s. Schauer (Stampede) NEJM %WL NEJM % EBMIL Zang Obes Surg % EWL Ignat BJS % EWL Salminen (Sleevepass) Peterli (SM-BOSS) JAMA % EWL n.s. Ann Surg % EBMIL n.s. JAMA % EBMIL n.s.

13 Long-term Weight loss sleeve durable? N = 167 FU: min 5y (93%) -10 y (74%) Pat # Author Year N FU (years) FU (rate, %) % EWL Rawlins EBMIL (%) Pat # 1-86 Prager Himpens Gadiot (?) Kowalewski years after LSG Claraspital Kraljevic& Peterli, submitted 13

14 Long-term Weight loss bypass durable SOS trial Utah, USA: 12 y post bypass, 97% FU rate Sjöström, JAMA 2014 Adams, NEJM

15 Long-term Weight loss Literature Osland, Surg Laparosc Endosc Percutan Tech 2017; Buchwald, Am J Med 2009

16 5-year Results Diabetes SM-BOSS n=26 n=28 n.s. 0% 20% 40% 60% 80% 100% remission improved unchanged worsened 0% 20% 40% 60% 80% 100% remission improved unchanged worsened Gluc 6.4 ± ±0.31 (p=0.21) HbA1c 6.2 ± ±0.16 (p=0.09) Peterli, JAMA 2018

17 Diabetes Literature Schauer, NEJM 2017 & Diabetes care 2016; Müller, Ann Surg 2015, Buchwald, Am J Med

18 5-year Results Dyslipidemia SM-BOSS n=68 n=53 p=0.09* 0% 20% 40% 60% 80% 100% remission improved unchanged worsened 0% 20% 40% 60% 80% 100% remission improved unchanged worsened LDL 3.0 ± ±0.08 (p=0.008) Chol/HDL q 3.3 ± ±0.09 (p=0.02) * after adjustment for multiple comparisons Peterli, JAMA 2018

20% 40% 60% 80% 100% remission improved unchanged worsened new onset

19 5-year Results GERD SM-BOSS n=44 n=48 p=0.002/0.006* 0% 20% 40% 60% 80% 100% remission improved unchanged worsened 0% 20% 40% 60% 80% 100% remission improved unchanged worsened new onset GERD: 31.6% vs 10.7% (p=0.01) * after adjustment for multiple comparisons Peterli, JAMA 2018

20 Complications early / mid-term SM-BOSS = Peterli, Ann Surg 2017

21 Complications 5 years SM-BOSS Complication necessitating reoperation/endoscopic intervention sleeve n = 101 bypass n = 104 GERD 9 LRYGB p insufficient weight loss 3 lap. BPD-DS 2 LRYGB 1 banded bypass 1 pouch resizing 0.12 small bowel obstruction internal hernia severe dumping 0 1 banded bypass 1 Apollo 1 reversion 0.25 incisional hernia laparoscopy for gastroscopy NA 1 total >30d all reoperations/interventions (early* & late) * Peterli, Ann Surg 2013 Peterli, JAMA 2018

Surgery for GERD & Stenosis & hiatal hernie sleeve Author Year N FU years reop% type % t postop m Prager 16 53 10 11 Himpens 16 110 12 4 bypass 95 BPD-DS 5 bypass 50 hiatoplasty 50 Gadiot 16 276 5-8

22 Surgery for GERD & Stenosis & hiatal hernie sleeve Author Year N FU years reop% type % t postop m Prager Himpens bypass 95 BPD-DS 5 bypass 50 hiatoplasty 50 Gadiot (15) bypass Claraspital Barrett s oesophagus 17% in asymptomatic pts >4y postop * 12% 5 y postop # bypass 82 hiatoplasty * Genco, SOARD 2017; # Felsenreich & Prager, Obes Surg

23 Surgery for internal hernia bypass Aghajani & Gislason, Surg Endosc 2017 Stenberg, BJS

24 SM-BOSS in brief sleeve vs bypass at 5 years (95% of 217 pts): weight loss not sign. different* co-morbidities: T2DM: remission: 62 vs 68% (underpowered) dyslipidaemia: bypass ±better(p=0.09*) GERD: bypass better(remission25 vs 60.4%; de novo: 31.6 vs 10.7%) QoL improved markedly with bothprocedures numberof complicationsnecessitatingreoperation/intervention: 15.8 vs 22.1% *after adjustment for multiple comparisons Peterli, JAMA 2018

25 Other procedures bilio-pancreatic diversion effective %EWL 75-80% 95% T2DM remission known mechanism of action safety: diarrhea, odorous stool deficiencies (macro- & micronutrients) liver, kidney Scopinaro Marceau, Hess indication: salvage (2 nd stage) 25

26 Other procedures one anastomosis gastric bypass effective %EWL superior to bypass? T2DM remission known mechanism of action? bile diversion safety: bile reflux indication: in Switzerland: only allowed in trials 26

27 Other procedures one anastomosis gastric bypass effective %EWL superior to bypass? T2DM remission known mechanism of action? bile diversion safety: bile reflux indication: in Switzerland: only allowed in trials 27

28 Endoscopic procedures Endoscopic sleeve gastroplasty highly experimental Humanforschungsgesetz in der Schweiz* (effective since 1/2014): experiments onlyin trials with ethical approval and informedconsent at reference centers * 28

29 Endoscopic procedures Endoscopic sleeve gastroplasty highly experimental Humanforschungsgesetz in der Schweiz* (effective since 1/2014): experiments onlyin trials with ethical approval and informedconsent at reference centers * 29

30 SUMMARY ideal bariatric procedure sleeve bypass OAGB SADI simple (to learn & teach) +++ +(+) ++ + fast to be performed (+) ++ + safe (early & late) ++(+) ++ +? + good weight loss, durable strong metabolic effects (+) +++ high rate of T2DM remission known mechanism of action ? +++ staged concept possible salvage = standard procedure good quality of life ? ++(-) reversible (+) economic ? ++? BPD 30

31 CONCLUSION 1 not one operation type = ideal for all patients every institution should know their own results (high FU rate) no unnecessary human experiments with new methods each patient needs: interdisciplinary evaluation choice of operation according to patient factors and risk/benefit profile of procedure optimal information 31

32 CONCLUSION 2 in 2019 a good candidate for: bypass: GERD, large hiatal hernia esophageal motility disorder T2DM, dyslipidemia sleeve: very high BMI necessity of endoscopic access extensive previous surgery (expected adhesions) Crohn s disease professional driver (fear of dumping) elderly patient BPD: second stage OGBP/SADI? 32

Disclosure. consultant to Ethicon Endosurgery. case mix disclosure. LRYGB sleeve BPD revisions OAGB ( minibp ), SADI: 0% 19% 55% 23%

Disclosure. consultant to Ethicon Endosurgery. case mix disclosure. LRYGB sleeve BPD revisions OAGB ( minibp ), SADI: 0% 19% 55% 23% Disclosure consultant to Ethicon Endosurgery case mix disclosure 3% 19% 23% 55% LRYGB sleeve BPD revisions OAGB ( minibp ), SADI: 0% Disclosure consultant to Ethicon Endosurgery case mix disclosure 3%