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Meeting report

2nd International New Technologies and Expert Meeting (Part 1)

Summary of the Second International New Technologies and Expert Meeting

In 2015, the Non Inva Meeting has transformed itself into the 1st New Technologies and Expert International Meeting. We were happy to welcome again friends in Lyon and to continue to deliver state of the art expertise and a focus on innovative technologies in the bariatric field. The general theme of this 2017 meeting has dealt with weight-loss trajectories after bariatric interventions: Can they be improved? For a given intervention, is there a specific trajectory (or a set of trajectories) that can be well defined, i.e. a "signature".

By Jerome Dargent Co-Chairman, Non-Inva/New Technologies and Expert International Meeting

Organising such a meeting has become a challenge over the past few years. We are still convinced that while bigger meetings are important, more focus on key-issues and more discussion with a perspective are provided in smaller reunions. Times have changed, and there is nobody to blame for this. The industry has reduced is support, and new regulations have made it difficult for physicians to attend meetings abroad. We will continue to discuss the strategy with the companies designing new materials, while staying optimistic: innovative devices are implemented every year, and need a thorough evaluation, particularly in the endoscopic field.

General and follow-up

Surgical Outcomes of Current Bariatric Interventions, a Nationwide Study
Presented by Antoine Duclos (France)

Currently, the reoperation rates at 6 months after bariatric surgery (Chang et al, JAMA Surg 2014) are 7% (95% CI, 3%-12%) in RCT, and 6% (95% CI, 4%-8%) in observational studies. The risk seems more important with Gastric Banding than with Gastric Bypass and Sleeve Gastrectomy. Comprehensive data on a nationwide scale are important.

This study aimed at evaluating the real risk difference between bariatric procedures. This is a preliminary analysis in order to compare the reoperation risk among cases of sleeve gastrectomy, gastric bypass and gastric banding. 184 332 patients were operated on in 606 hospitals. The data came from the French nationwide hospitals database. Outcome: Reoperation within 6 months following bariatric procedure. Design: Exploratory descriptive analysis (2011-2014), retrospective cohorts of patients (2013-2015); matching inside hospital using propensity score (sex, age, comorbidities, BMI, median income, year of procedure); Cox proportional hazards models accounting for dependence of matched pairs and for competitive risk of death.

Reoperation risk increased over time and was lower for sleeve gastrectomy at 6 months compared to other procedures, final results are pending. This corroborates the previous literature based on a direct comparison of procedures at a nationwide level, with a longer follow-up. Questions remain: What is the validity of our findings according to the severity of reoperation? What are the underlying reasons of reoperation after an initial procedure? Are reoperation rates associated with patient-reported outcomes?

Immediate post-operative follow-up with IoT/ phone application
Presented by Vincent Frering and Marie-Cécile Blanchet (France)

The goal was to improve safety in bariatric patients, following a protocol of enhanced recovery after surgery (ERAS). Several means of tracking were used, while nurses stay on call 24h a day. 200 patients have been included from 08/2016 to 12/2016. There were two reoperations (1 bleeding, 1 occlusion), 47.4% of the patients have been contacted by smartphone, 35.7% by computer, 16% by tablet. There were 7 re-hospitalizations, and 15% unscheduled visits. In conclusion, a strict follow-up within weeks post-surgery benefits from tracking tools and increases safety.

Follow-up in bariatric techniques with telemedicine (MethodCo)
Presented by Vianna Costil (France)

Sustaining weight-loss after a bariatric surgical or endoscopic technique is a challenge that requires holistic solutions. A local system (Paris) has been initiated with 3 consultations a month by video-conference, including food-rebalancing, behaviour modifications, and physical activity advice. Connected tools are also available, for fitness tracking, personalized counselling, recipes, body-mass index scale.

Thirty patients with gastric balloon have been included, and 2 patients with Overstitch, and in parallel 30 after bariatric surgery. This initial experience is highly encouraging.

Bariatric surgery

Novel technologies in bariatric surgery: Are they properly evaluated?
Presented by Kamal Kumar Mahawar (United Kingdom)

There is none amongst the currently available bariatric and metabolic procedures that can permanently "cure" obesity or type 2diabetes mellitus without any complication or adverse consequences. There is a further need to lower the cost of our interventions and simplify them if possible. This has led to a rapid surge in the number of new bariatric and metabolic procedures in recent years. Some surgical procedures were adopted in routine practice too soon, only for the problems to become apparent later. It is hence incumbent upon us to ensure that any new procedure is thoroughly tested before rolling them out widely.

In a recent survey of 396 bariatric surgeons from around the world, we found that most surgeons would be happy with evaluation of a new procedure in at least 5 adequately supervised clinical studies (four of which must be randomized comparisons with one of the existing alternatives) reporting at least 5 years results on a minimum of 500 patients, before it is inducted into routine clinical practice. This was just an attempt to gauge community opinion prior to what we hope will lead to a serious discussion and attempts at consensus building.

The fact that we don't yet fully understand how our existing operations work makes the development of new ones difficult. In the past, we have rather simplistically used terms like "restriction" and "malabsorption" without defining what restriction means or understanding how much the success of a given bariatric procedure can be attributed to malabsorption. It is only recently emerging that profound and long-term suppression of appetite lies at the heart of how many of our procedures work.

There is no denying the fact that our processes of adoption of new procedures have in the past been somewhat arbitrary and dependent on "expert opinion" rather than a robust scientific process. Our recent survey will not answer all of a number of difficult questions that face us concerning the future innovations in our specialty. Nonetheless, it should help kick start a conversation. A little bit of time spent now will not only save us a lot more of it in the future but also potentially prevent embarrassment and ridicule from other groups of healthcare professionals.

Laparoscopic gastric banding: Game over?
Presented by Jerome Dargent (France)

The Laparoscopic Adjustable Gastric Banding (LAGB) procedure has been used in bariatric surgery for over 20 years. Having learned the technique of LAGB in 1995 from Mitiku Belachew (Belgium), a true pioneer in bariatric surgery, I remember the tremendous momentum owing to the surgical approach that was transformed. Gastric banding became the most commonly performed bariatric surgical procedure in Europe during the years 1995 to 2005. Then the formidable incentive represented by the feasibility of the laparoscopic approach has been progressively shared with all the other techniques. The rapid decline we have observed for a few years is not going away.

Reviewing current as well as historical results of laparoscopic gastric banding does not seem to help much against this trend. The spectacular and recent decision made by Johnson and Johnson, stopping the production of their gastric band, has come as a surprise, yet fully justified in this context. Whatever the endeavour and competence of any dedicated bariatric team, mediocre food compliance seems to be the main issue, and induces the patients to turn themselves to alternative procedures such as LSG.

It's not so easy to pronounce the demise of a surgical technique: one may be misled by temporary trends, success of alternative operations that will eventually fail, etc. The most important questions when deeming a surgical technique terminated result from definitions: Does this happen when nobody does it anymore? When it has no legacy? When nobody teaches it/learns it anymore? When no data are presented anymore and/or Evidence Based Medicine no longer supports its claims? Answering theses questions is often ambiguous in the case of LAGB, and perhaps makes the death certificate premature. Besides, technique may survive for a long time as a niche (vertical banded gastroplasty (VBG) is still an example of this), and we may also consider that a field of clinical research that has been opened cannot be entirely shut down.

Literature is difficult to analyze: the technique has evolved (ex pars flaccida approach in the years 2000), those still in favor of LAGB tend to minimize the necessity of switching to another operation even in the long term, and those against have most often abandoned it a while ago, therefore presenting a high rate of failures that led to revision.

In a personal series of 2200 cases for 22 years, our results show that complications continue to occur in the long term, but that the incidence of slippage and erosion has decreased over time. Esophageal dilation can be a serious problem, but this can be resolved by downward adjustment of the band. Most late removals of bands are indeed performed because of long-term lack of efficacy, and stand as a preliminary to conversion to a different procedure. The most commonly reported problems are related to long-term food intolerance or band adjustments difficulties, resulting in band removal and conversion to a different procedure when combined with weight regain. These problems lead to a high rate of band revision and/or removal, with great variations according to different reports, from 10% up to 60%. Repeated adjustments are initially useful, but the need for such adjustments is regarded as a disadvantage in the long term. Undeniable adverse effects explain why LAGB is no longer popular: short term inefficacy for a variable percentage of patients, difficulties with adjustments and follow-up, and food intolerance complaints, are the most cited.

Paradoxically, part of the literature is still in favor of LAGB, which could be compared to a patient dying in good health! Minor suggestions have been suggested, like banding a sleeve/a bypass as an adjunction or a failure treatment, using LAGB for adolescents, etc. This kind of strategy is unlikely to do more than buy some more years. More importantly, gastric banding is likely to remain useful in combination with future techniques, particularly endoscopic, and/or as a re-do procedure after these techniques have been implemented.

In general, we have to maintain a set of options for obese patients that includes simpler operations than GBP and even LSG; best candidates are endoscopic procedures such as gastric internal plication. In that sense, there is a strong legacy to the band, mostly playing the role of a "simple restrictive intervention" in comparison to more demanding procedures. When considering a larger spectrum of obesity treatments, for instance including class I obesity cases, there is a need for minimally aggressive techniques that would operate with a comparable status as LAGB.

LAGB has increased our understanding of the mechanisms underlying effective restriction of food intake. It has represented a major step in the field of obesity treatment, and using it for a long period has been valid and sound. But time passes rapidly in this field and this is for the best if new opportunities arise, which is the case now with novel and less invasive methods. There are no reasons to dwell on a technique that is not satisfactory in the eye of most patients and physicians anymore!

Omega bypass (One Anastomosis Gastric Bypass), biliary reflux, and denutrition: myths and reality
Presented by Jean-Marc Chevallier (France)

From October 2006 to December 2015, 1294  patients (721  women : 63,4 %) had an OAGB;  mean age was 41.12 ( 17.5-62.4 ), weight 131.9 (75-221 ), BMI = 47.03 (32.8-80.2 ). 228 patients had a previous restrictive operation (17.6 %): 156 gastric bandings (111 removed simultaneously), 13 VBG, 59 LSG.

There were 16 early complications: 6 leaks (3 at the gastro-jejunal anastomosis), 5 trocar’s incarcerations, 2 abscesses, 1 splenectomy, 1 endoscopic sclerosis, 1 dilatation. 22 late complications occurred: 3 perforated ulcers, 14 intractable biliary reflux, 5 obstructions. Failures, 6 cases: 4 weight regain, 2 malnutrition, no internal hernia and no hypoglycemia were reported.

There were 16 conversions to RYGB / 1294 = 1.2 %, 14 for intractable biliary reflux, 2 for marginal ulcer. At 3 years, 162 endoscopies were performed among 288 patients: normal in 75% (136), simple ulcer in 4, complicated ulcer in 7, foveolar hyperplasia in 15, dysplasia and metaplasia = 0. At 5 years, 74 patients, 55 endoscopies: normal in 68% (37) simple ulcer in 5, complicated ulcer in 1, foveolar hyperplasia in 12, dysplasia and metaplasia = 0. Questions asked: Does biliary reflux imply a risk of oesophageal adenocarcinoma? Does the presence of bile in the stomach involve a risk of stomach cancer in the long term? OAGB is wrongly compared to Billroth II, and the risk of cancer is not significantly increased after BII at 30 years, or slightly increased but if there is an ulcer. In retrospective studies, the role of Helicobacter Pylori is not taken into account, HP being a major risk factor of gastric cancer, as a type 1 carcinogenic agent (N Engl J Med 1996). Gastric cancer has environmental causes (smoking, HP, salted or smoked meat and too little fruit or vegetables). In the USA, mortality from gastric cancer has dropped from 28 to 5 per 100,000. The risk of gastric cancer is not increased after partial gastrectomy (J Gastroenterol Hepatol 2000). Cancers have already been reported after RYGB and OGB but in the excluded stomach mostly. The OAGB has nothing to do with the Mason initial OAGB procedure: it uses a long and narrow gastric tube, resembling the vertical part of a LSG.

Experimentally, we have submitted 14 rats to a prolonged exposition to biliary reflux: 14 rats after OAGB + 4 Sham, operated when 20 weeks old (5 months rat’s life = 24 years human’s life), followed for16 weeks (16 years in man’s life), and sacrificed at 36 weeks (40 years in human). At16 weeks there was no dysplasia or metaplasia; there was hyperpapillomatosis in the lower esophagus in 50 % of OGB rats, 75 % in Sham. Foveolar hyperplasia was present at the level of the GJA, not above. RNA of specific genes for Barrett or EG carcinogenesis was not different in both groups.

Efficacy and safety of OAGB have been demonstrated in a randomized trial and confirmed in our preliminary results; the complication rate is low (5.3%) because there is only one anastomosis. Late reoperation rate was 3.6 %, marginal ulcers: 2 %, intractable bile reflux: 1%. Until now, no dysplasia nor metaplasia have been seen at 3 and 5 years. The main concern is the limb length: 1.5 m is enough when BMI < 50. Perspectives: we plan to collect 10 years-results after OAGB, with routine endoscopy and impedancemetry.

Sleeve Gastrectomy: is gastro-esophageal reflux a real killer?
Presented by Patrick Noel (Abu-Dhabi)

Patrick Noel presents the controversies related to GERD after sleeve gastrectomy, although being a very successful operation nowadays. In a consensus conference on LSG in 2016, 80% of  participants deemed Barret’s ulcer a contra-indication for LSG, 23.3% if there was a GERD, 11.7% in case of hiatal hernia, 5% if BMI>60.

Only 2 studies have reported the improvement of GERD >5 yrs after LSG, versus 8 the onset of new GERD symptoms (10-23%). Problems of definition: symptoms, questionnaires, endoscopy (high variability, low sensibility), 24h impedance monitoring, HRM, gastrografin swallow. GERD is also present in RYGB: 0.28% at 10 yrs. Comparisons of pre and postop GERD in RYGB, LAGB, LSG: 2.8 Vs 1.33/ 2.77 Vs 1.63/ 2.82 Vs 1.85 (change in GERD composite score). All exams: real de novo GERD occurs in 5.4% of LSG only. Hendricks (2015): 919 SG, 4% GERD (3% de novo, 1% pre-existing), 10.5% required conversion in RYGB. HH repair does not influence the evolution of GERD.

Yet the series of Prager, 2016, is more worrisome: 102 patients with minimum 10 years FU, 3 centers: 14% Barrett (5/36).  Radiofrequency ablation and RYGB represent current options. Esogastric cancer: scarce reports. SOARD 2017, Maret-Ouda, esophageal cancer after RYGB, LSG, LAGB: 34437 pts, 239775 person-years of FU (Sweden): 8 cases of cancer, the risk did not decrease owing to bariatric surgery.

Laparoscopic RYGB Vs Omega-loop bypass Vs LSG after gastric band failure: a multicentre comparative study (more than 1000 cases)
Presented by Juan Pujol Rafols (Spain)

A wide collection of data (still ongoing) of conversion from a gastric band to a gastric bypass or a sleeve gastrectomy has been reviewed in a retrospective way. So far, 1219 patients have been included (905 bypass, 314 sleeve). A BMI < 35 was obtained in almost all cases at 5 years. The success rate (EWL>50%) has been 76% (67% in sleeves, 85% in Omega bypass, 75% in RYGBP). The complication rate has been 11.5% (4.1% leak, 2.6% bleeding, 0.9% death).

Comparative study between Sleeve Gastrectomy and Gastric Bypass, 280 pts, 3 years FU
Presented by Jean-Marc Catheline (France)

This comparative study between LSG and RYGB included 277 patients, with 3 years of follow-up. The design is a multicenter, prospective study comparing complications, efficacy, and quality of life.

Two hypotheses have been tested: a difference in morbidity and mortality events; a non-inferiority in reduction of excess weight by more than 50% at 36 months. The percentage of patients with EWL > 50% at 36 months was not different. The study showed a better benefit /risk ratio in LSG patients compared to RYGB, while the two hypotheses were tested in parallel. However, this was not a fully randomized study.

Pouch and sleeve reduction for weight-loss, with or without banding, long-term results
Presented by Sébastien Murcia (France)

Reducing the gastric pouch or the sleeve in case of weight regain is a strategy that makes sense in selected cases, possibly in combination with the placement of a non-adjustable band around the pouch/sleeve. 41 patients have been included from 2009 to 2017, 23 after RYGB, 16 after LSG, mean BMI 46 at the time of primary surgery. Mean interval between procedures was 5.4 years. Resection of the primary staple line was always performed.  There were two cases of late staple line dehiscence (D 30 and 90), and 2 bandings had to be removed. Median EWL was 49%, mean FU was 4.9 years.

Single Port revival! Standardized approach for RYGBP with SILS (initial 100 patients)
Presented by Elie Chouillard (France)

Single Incision Trocar has still supporters, who use it on a routine basis. In this series, 104 patients, 88F, 16M, age 33, BMI 42.2 (35-53) were operated on. 14 patients had a conversion to a multiple port procedure. Early morbidity was 3.8%. Mean operative time was 136 min (75-265). SILS-RYGBP is feasible, reproducible but with a learning curve. We need more evidence based data.

Likewise, Guillaume Pourcher (France) has presented his series of SILS-LSG, with overall good results.

SADI procedure after sleeve gastrectomy failure (20 pts)
Presented by Elie Chouillard (France)

What to do when LSG fails? Re-SG is an option that has limitations. We used SADI in 24 patients, 18F, age 39, with an early morbidity of 4.2%, and 0 mortality. FU was 19 months (6-28). EWL at 12 months was 57% (31-99). FU is organized like in BPD-DS. SADIs is safe as an alternative to DS after LSG failure, but the question is asked: should it be a primary or  a second step procedure? It also fits to current trends: less invasiveness, less anastomosis, more preservation of the anatomy, less malabsorption and less exclusion, and a multi-stage approach.

Pre or post-pyloric one anastomosis bypass, evidence based discussion
Presented by Karl Miller (Austria)

Addressing the issue or choosing between pre and post-pyloric one anastomosis bypass.  The total length of the small bowel ranging from 2.75 to 10.49 m, a common channel below 2 m carries a risk of short bowel syndrome. Risk of dumping: 17% after GBP, 1.5% after LSG. Pre-pyloric one anastomosis bypass entails 2% bile reflux.

In summary, one can argue that pre-pyloric anastomosis is technically easier, safe and effective, tension-free anastomosis, less internal hernia, anatomical obstacles, but more dumping? Bile exposure? Easier revision?

New approaches to Laparoscopic Greater Curve Plication, hopes and expectations
Presented by Martin Fried and Karin Dolezavola (Czech Republic)

In our experience, 212 patients had more than 5 years FU, 79.2% achieved >50% EWL, 20.8% <40% EWL, maximum EWL regain was 9.2%. Mean operative time 69 +/- 11 min, hospitalization 38 h, 1.6% urgent reoperation rate and 3.27% elective reoperation rate. There was an improvement in insulin sensitivity and increased beta-cell glucose sensitivity. 49 of 52 pre-op diabetic patients had improvement or remission of T2DM: 94.2% at one year, 89.7% at 2 years, 65.5% at 5 years.

Since 2009, more than 3000 operations have been performed. Predictors of success: BMI 35-40, F age 50, EWL 45 kg, waist-height ratio<0.7. Stapled plication seems to increase the durability of the plication, its reproducibility, its standardization (with a more symetrical pattern). Suturing skills can be improved, with adequate spacing of the stitches, and carefully considering the anatomy (avoiding a twist around the incisura angularis).

Patient selection: no Evidence Based medical approach, individual clinical profile, perioperative risk, team and institutional experience. Quality of life remains as long as WL is maintained above 10%, a realistic goal being a 5-10% WL. This method should be positioned between LAGB and LSG.

Please click here to read Part 2 and the Non-Inva Report or here to read Part 3

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