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Congress Report

Report from the 3rd noninva symposium

All the key presentations, data and findings from noninva

The 3rd International Symposium on Non Invasive Bariatric Techniques took place in Lyon France, in April 2013. Chairman of the meeting, Dr Jerome Dargent, reports on the key presentations and findings from the meeting.

Welcome address, April 26, 2013

Dear friends and colleagues,

It is with great pleasure that we welcome you in Lyon for our third "NON INVA" meeting, dedicated to new technologies in the highly evolving field of bariatric techniques. Like in 2011 and 2012, our guess is you are again going to witness both major and minor changes that eventually will matter, even if some of them are not likely to survive. Let me put it like this: some devices among those that are presented to you will fail, some will thrive.

But even those which have flaws are highly instrumental, because on many occasions, they will provide with clues and insights that will prove useful. For instance, endoscopic plication systems like the POSE from USGI, that we shall discuss, is more than likely to succeed; moreover, it is going to be a highly interesting benchmark to surgical plication, which we are going to debate in a few moments. This is also the reason why one of our focus this year will be the contradictions between ethics and economics: please feel free, members of the faculty as well as of the attendance, to express your concerns and how you feel we may reconcile these issues. Enjoy the meeting and please come back in 2014, because more surprises will be expected!

Laparoscopic gastric plication combined with gastric banding was presented by Chih-Kun HUANG (Taiwan). He has operated on 224 patients over three years, and compared the results with those of Laparoscopic Sleeve Gastrectomy. GE Reflux was a contra-indication to the technique. In terms of weight-loss, results were similar at two years in groups with plication, banding alone, and sleeve. The resolution of comorbidities was also similar in these groups. The surgical steps of the procedure have been standardized: a 36F bougie is used, the dissection starts 3cm away from the pylorus. Although controversial, this procedure seems interesting if it improves the results of gastric banding.

Laparoscopic gastric plication, an update: Salomon BENECHETRIT (France). Sixty two patients have been operated in 2011 and 2012 inLyon. Mean hospital stay has been 2,4 days. Four patients had nausea, there were two complications. EWL at one year has been 51%. This initial French experience seems satisfactory.

Laparoscopic gastric plication and Sleeve Gastrectomy with motorized stapling: Elie CHOUILLARD (France). Updated results of this surgeon’s experience were presented. The Endoflip System (presented during the 2011 meeting) makes it possible to adjust the calibre of the plication, with pressure measurement. Meanwhile, this surgeon has abandoned NOTES transvaginal sleeve gastrectomy.

 Routine sleeve gastrectomy through the SILS approach was presented by Philippe COSTIL (France). The cosmetic results are encouraging in women with relatively low BMI.

 Sleeve Gastrectomy with the SPIDER System; calibration with the MID-Sleeve: Michel GAGNER (Canada). The Single Port Instrument Delivery Extended Reach (SPIDER) is a flexible laparoroscopy system, with flexible instruments allowing a true intra-abdominal triangulation. A Nathanson retractor is also attached for liver retraction. It constitutes a stable platform with independence of instruments motion, up to 360°, and minimises torque on the abdominal wall. One additional trocar is used for placement of the stapler and the energy device. Michel Gagner described this technique as an “Enhanced cosmetic procedure”, that competes with the regular SILS approach, and with robotics as well.

Endoluminal approach of obese patients: Mostafa Ibrahim, ErasmeHospital, ULB , Brussels, Belgium: Obesity is a worldwide epidemic, complex metabolic disease associated with a variety of severe comorbidities. Bariatric surgery provides the patients with the benefits of sustained weight loss and improves obesity-related comorbidities, but can result in potentially life-threatening complications. Endoluminal approaches have recently been proposed as non invasive approaches to obesity.  

Most of the current endoluminal devices and techniques are comparable to restrictive surgery. A variety of medical devices and procedures have been evaluated in recent years; however, with the exception of the intragastric balloon, the numbers of patients treated limits the evaluation of these procedures. Endotherapy is likely best suited for non-morbid obese individuals with BMI 30 to 39 or as a bridge to bariatric surgery. This specific BMI range has been targeted by the National Institutes of Health for these emerging technologies. Pre-surgical weight loss to reduce surgical risk is another potential target group for such procedures.

On the other hand, there is a rising role for endoscopy in the diagnosis and management of complications after bariatric surgery as bleeding, ulcers, foreign bodies, stenosis, leaks, fistulas, bilio-pancreatic diseases, weight regain, and dilated outlets.

Ethics versus economics: Pre-market application in the US requires more than 300 patients and costs US$30 million. As a consequence, most promising ideas won’t make it to the market. Any of the following event will kill a start-up:

  1. Ideas and prototypes: The market has not been clearly identified, or is too small; the device is too complex, or too expensive for its application.
  2. Development and regulatory process: Investors do not want to finance delays; regulatory bodies request additional trials; clinical results do not pass reimbursement thresholds; physicians do not want to change their habits, or patient access is barred.
  3. Marketing and sales: the adoption takes longer than anticipated; training for experienced physician is complicated; the start-up is bought by a major company in order to kill competition. 

Preliminary results of a study of a novel endoscopic bariatric device, the Aspire Assist (Henrik FORSSELL, Sweden): A new device for treating obesity has been evaluated, the AspireAssist Aspiration Therapy System, which consists of an endoscopically-placed gastrostomy tube (A-Tube) and siphon assembly. With the AspireAssist, patients aspirate gastric contents 20 minutes after meal consumption, removing about 30% of ingested calories. Twenty-five obese subjects (mean BMI of 39.9 kg/m2 [range 35.1-49.0], median age of 48 years [range 33-65]) were enrolled in a prospective (still ongoing) study, starting July 2012, at Blekinge County Hospital in Sweden. Six subjects had diabetes. The AspireAssist A-tube was placed during a gastroscopy performed under conscious sedation with midazolam and cetobemidone.

Approximately 14 days after A-tube placement, allowing the fistula to heal, a low-profile valve (the AspireAssist Skin-Port) was installed. Aspiration Therapy, along with a cognitive behavioral weight loss programme, was initiated at this time. Results: Weight reduction: 16 weeks after inclusion in the study mean weight reduction was 12.4 (range 3.8-21.9) kg, 32.2% (range 13.0%-58.7%) excess weight loss, and 11.4% (range 4.4%-18.1%) absolute weight loss. Procedure safety: Five subjects had adverse events. Two subjects were hospitalized (one subject due to stomy site leakage, treated conservatively; one subject due to pain, treated with analgesics). Two subjects had skin infections (ome treated with antibiotics). One subject had a skin damaged around the tube that healed completely in four weeks.

Changes in blood composition: at 16 weeks no reduction in potassium was noted median 4.3 (range 3.9-4.8) to 4.3 (range 3.1-5.0) mmol/L (p=0.194). HbA1c was reduced from 39 (range 35-68) to 38 (range 33-75) mmol/mol (p=0.002) and in the six subjects that had diabetes from 54.5 (range 43-68) to 44 (range 39-75) mmol/mol (p=0.206). The new AspireAssist method for weight reduction is a less invasive procedure and does not alter gastrointestinal tract anatomy, making it an attractive alternative for obese patients who are reluctant to have bariatric surgery. This study demonstrated that AspireAssist is a safe procedure and a potentially useful method for long-term weight loss.

Business models and financial pressure with current innovative bariatric devices. The French example has been detailed by Marc BOUILLET (France). Medical Devices: CE Marking is obtained through a notify conformity assessment Body (or by self certification, depending on the level of risk for the patient), which allows to sell the product within the European Union market. A device can be launched immediately with a CE Mark without reimbursement in France. In Europe, the medical device (MD) industry includes 22,500 companies and employs 500,000 people. More than 500,000 different products are marketed. 80% of MD companies have less than 250 employees. The R & D accounts for 8% of their budget. Sales of MDs represent 4.2% of the total health expenditure.

HAS (French Haute Autorité de Santé): All drugs have to be assessed by HAS to be reimbursed. Concerning medical devices, two options exist: generic list (without assessment by HAS), and brand name list with an HAS assessment. Following the HAS assessment, negotiation takes place with the Economic Committee (CEPS), with reviewing every five years. Transparency Committee (for drugs evaluation) and CNEDIMTS (Committee for MDs and procedure evaluation) have the same guide-lines. The evaluation is based on relevant clinical data, and the product should bring improvements towards existing therapies.

Price negotiation is based on: Additional medical benefit, European pricing, comparison to similar devices, target population and sales forecast. A Health Product’s reform has been initiated as a consequence of Mediator and PIP scandals: A new law has been published,  "Loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé". A complete independance of the experts is now required in health agencies. HAS performs the medico-economic studies that are deemed necessary for the purpose of Health Technology Assessment. The EU is suggesting update regulations on MDs (should be adopted in 2014).

What will change? The scope for EU legislation on MDs will be extended to include, for example, aesthetic implants. There will be a stronger supervision of independent assessment bodies by national authorities, and of manufacturers; stricter requirements for clinical evidence of MDs; better traceability throughout the supply chain – enabling a swift and effective response to safety concerns (e.g. recalls).  A Unique Device Identification System will be introduced to enhance post-market safety and fight against counterfeiting; a better coordination between national surveillance authorities; an Extended Eudamed database on medical devices will provide comprehensive information on products available on the EU market. Non-confidential data will be publicly available; International guidelines are to be incorporated into EU law, to facilitate international trade. CE Mark will be more difficult to obtain and will require strong clinical evidence.

Is it possible to bypass the reimbursement process? Hospitals cannot charge non-reimbursed devices in addition to the cost of "groupe homogène de séjours". Private insurance is dedicated to co-payment in France. Experimentations to reimburse innovative health products are very rare. The requisite is to have an official positive clinical assessment for the product (in addition to CE mark) and to represent an attractive suggestion. A medico-economic study will be mandatory, starting October 2013, for every innovative product with a significant impact on the cost of NHI. The reimbursement process in France takes more or less one year.

Ethics and novel bariatric procedures, shall we reconcile this with economics? Karl MILLER. Karl Miller (Salzburg,   Austria), former president of the IFSO, analyzed the ethical challenges of the current trials involving new bariatric surgeries. To be recommended: Ethics committee, informed consent, mentioning that a device or procedure is investigational. Karl Miller cited other current discrepancies in the field of bariatric surgery: Hiatal Hernia + GERD and bariatric surgery; LGCP; Techniques of bypass: more than 50!

Hyaluronic Acid injection at the GE junction was presented by Jerome Dargent (Lyon, France). An update on the ongoing research with a sub-GE junction injection of hyaluronic acid (HA) for three years shows interesting results. The current stage of the trial (prospective, single blind, randomized and controlled study) has compared the effects of HA injection, balloon, and the combination of both in a sequential mode (98 patients included from 2010 to 2012). It has involved three groups of patients: group one (balloon alone), group two (balloon followed by injection at the time of removal, i.e. 6 months), group three (injection, and balloon placement at six months). Preliminary results are in favor of group three.

Results at 12 months

 

WL

%WL

BMI Loss

%BMI-Loss

%EWLoss

%EBMI-Loss

Group 1 (N=21)

5,8 (0-24)

6,3

 2,3

6,4

16,9

25,2

Group 2 (N=22)

7,9 (0-28)

9,5

3

9,1

27,9

36,6

Group 3 (N=22)

10,5 (0-36)

11,5

4,2

 12,1

31,4

45,4

Results at 18 months

 

WL

%WL

BMI Loss

%BMI-Loss

%EWLoss

%EBMI-Loss

Group 1 (N=10)

7,1 (0-27)

7,5

2,9

7,8

18,2

24,4

Group 2 (N=12)

7,3 (0-25)

11,8

3,2

9,3

25,5

35,3

Group 3 (N=12)

9,9 (0-18)

11,4

4,1

11,7

30,2

45,7

Gastric neuromodulation with the ABILITI system, an update: Günther MEYER (Germany). Alterations of eating behavior in obese subjects treated with the ABILITI System (IntraPace, Inc.) were assessed in an ongoing prospective clinical multicenter trial. More than 200 devices have been implanted. It is a closed loop gastric electrical stimulation device which features a transgastric sensor to detect food intake and an accelerometer to record physical activity. The stimulator delivers a tailored gastric stimulation in response to food consumption, inducing early satiety. EWL at 12 months is in line with the objectives. Weight-loss is achieved due to the assessed alteration of eating behavior in particular the reduction of loss of control and hunger.

Full-sense device, an update: Randal BAKER (USA). The Satiety Inducing-Full Sense Device for obesity was described as a “device inducing early satiety through pressure”, rather than a purely restrictive one. It has two parts that are connected: an oesophageal stent and a conic device secured by tethers and applied under the gastro-esophageal junction.  The placement is simple, under radioscopy guidance with a guide-wire.  The tolerance seems excellent and the results very satisfactory: studies have shown a continuous weight-loss as long as the device stayed in place, up to 75% of EWL. 

Hormonal changes after gastric balloon: Elisabeth MATHUS-VLIEGEN (The Netherlands). Satiety is centrally and peripherally mediated by gastrointestinal peptides and the vagal nerve.  They investigated whether intragastric balloon treatment affects satiety through effects on fasting and meal-stimulated cholecystokinin (CCK) and pancreatic polypeptide (PP) secretion. They also hypothesised depressed fasting ghrelin concentrations and enhanced meal suppression of ghrelin secretion by the gastric fundus through balloon-contact and balloon-induced delayed gastric emptying. Methods: Patients referred for obesity treatment were randomised to 13 weeks of sham-treatment followed by 13 weeks of balloon-treatment (group one; sham/balloon) or to twice a 13-week period of balloon-treatment (group two; balloon/balloon). Blood samples were taken for fasting and meal-stimulated CCK, PP and ghrelin levels at the start (T0), after 13(T1) and 26(T2) weeks. Patients filled out visual analogue scales (VAS) to assess satiety and kept a diary the remainder of the day. 

Results: Forty-two patients (35 females, body weight 125.1 kg, BMI 43.3) participated. In group one, basal CCK levels decreased but meal-stimulated response remained unchanged after 13 weeks of sham-treatment. In group two, basal and meal-stimulated CCK levels decreased after 13 weeks of balloon-treatment. At the end of the second 13-week period, when group one had their first balloon-treatment, they duplicated the initial 13-week results of group two, whereas group two continued their balloon-treatment and reduced meal-stimulated CCK release. Both groups showed reduced meal-stimulated PP secretions at T1 and T2 compared to T0. Changes in diet composition and VAS scores were similar. Improvements in glucose homeostasis partly explained the PP results.

Forty obese patients (36 females; body weight 123.2 kg, BMI 43.1) participated in the ghrelin study. At the start, fasting ghrelin values were low with a blunted ghrelin response to a test meal. The presence of a balloon had no influence on fasting or meal-suppressed ghrelin concentrations. Despite a weight loss of 10% after 13 weeks and 15% after 26 weeks, fasting ghrelin concentrations did not change; neither did the ghrelin response to a meal. No relation was found between ghrelin and insulin, satiety, the number of meals or subsequent energy intake. Ghrelin concentrations were more suppressed with greater weight loss or with balloons located in the fundus.

Conclusion: The reduced CCK and PP secretion after balloon positioning was unexpected and may reflect delayed gastric emptying induced by the balloon. Improved glucose metabolism partly explained the reduced PP secretion. Satiety and weight loss were not adversely influenced by these hormonal changes. Ghrelin concentrations did not change by balloon treatment and, unexpectedly, did not rise despite substantial weight loss and negative energy balance. This suppression might be of benefit in the maintenance of weight loss but could not be ascribed to the balloon treatment.

Different types of balloons: Gontrand LOPEZ-NAVA (Spain). The following criteria may serve as guide-lines for the choice of a gastric balloon:

  • Long-term device > 1 year: EASY LIFE, DUO, SPATZ III
  • Bigger balloon: EASY LIFE, DUO
  • Smaller balloon: ENDOBALL, OBALON
  • Adjustabily: EASY LIFE, SPATZ III
  • Lighter balloon: ENDOBALL, OBALON
  • Filling with air and liquid: ENDOBALL, EASY LIFE
  • Antimigration system: DUO from RESHAPE
  • Swallowable balloon: OBALON, ALLURION
  • Easier and cheaper: MEDSIL

The SPATZ balloon was presented by his inventor, Jeffrey BROOKS (USA): 1-4% of the balloons are extracted within two weeks, and the current balloons have a duration of three to four months. The SPATZ balloon intends to avoid these downsides. weight loss at one year was24-25kg, 50% EWL. The SPATZ III has an external catheter that is soft and without chain, with a new valve. There is no case anymore of duodenal migration.

Long-Term, multiple intragastric balloon (BIB) treatment: a new strategy to treat morbid obese patients refusing surgery. Prospective study with five years of follow-up : Alfredo GENCO (Italy). A prospective study has been conducted in 100 patients, with diet or a second balloon after the first one had been removed, when and if the patient had achieved more than 50% EWL. 83% had a second balloon, and 22% a third, one patient had four. 22,2% requested surgery afterwards (between 12 and 72 months).

Relevance of the balloon as a strategy with regard to bariatric surgery: Robert BENAMOUZIG (France). Effects can persist over 24 months in 25% of the patients. The level of food intake usually drops from 2,700 Cal to 1900. The peptide response to meal has been analyzed (ghrelin, leptin, CCK, PP). What are supposed to be the endpoints: % EWL, morbidity, mortality? Large cohort studies have been published. The response has been demonstrated against sham and/or diet. Yet gastric balloon is still considered a second line therapy. Cultural changes are necessary: for instance the Cochrane review states that the balloon has no effect. Yet may studies have shown 50% EWL, 2.8 BMI Unit drop, 8.3% WL and 8kg WL. 

Swallowable balloon: Alfredo GENCO (Italy). This new device, made by the US commany OBALON, seems very promising since it is intended to avoid endoscopy and anaesthesia during its placement (not for removal). Early results are promising in terms of morbidity (mild) and weight-loss.

The safety and long-term efficacy of the transoral endoscopic restrictive implant system (TERIS) for the treatment of obesity was presented by EMH Mathus-Vliegen: Dietary and medical treatments of obesity often fail. Surgical treatment is successful but carries a considerable morbidity. Moreover, surgeons will have problems to handle large volume of patients. Endoscopic treatment could be an alternative with less morbidity. Several systems are available such as the TOGA (transoral gastroplasty), the TERIS (transoral endoscopic restrictive implant system) and the ACE (articulating circular endoscopic) stapler. Objective: To evaluate the long-term safety and efficacy of the TERIS device.

Methods: Patients 18-50 years of age with a BMI between 40 and 50 or between 35 and 40 with obesity-associated co-morbidity were eligible. The TERIS procedure included the placement of a 22mm endogastric tube, through which an endoscopic stapler alongside a 5mm endoscope was advanced. In the cardia, five plications were created with the stapler. Anchors were pulled through the plications and a silicone restrictive implant was attached. Upon removal the five anchors were transsected using a dedicated cutting device. The restrictor and the anchors were removed with an endoscopic grasper. Patients were followed for 6 months; thereafter the device was either removed or kept in place for another 6 months.

Results: Eighteen patients (BMI 42.1; three males) were included. Co-morbidities consisted of diabetes (n=4), hyperlipidemia (n=3) and hypertension (n=2). Three serious adverse events occurred: a gastric perforation and twice a pneumoperitoneum in the first seven patients. After technical adjustments no adverse reactions occurred in the next 11 patients. Adverse events were abdominal pain (n=14), gastric pain (n=13) and a sore throat (n=19). At six months the % excess weight loss in 15 subjects was 30.3% and the % excess BMI loss was 24.4%, after 12 months the figures were 36.8% and 29.9%, respectively. The maximum weight loss was achieved by the ninth month. The fouor patients with diabetes improved substantially: two did not need any insulin and two others could lower the oral medication. At the time of removal 15 of the 17 patients had detachment of anchors.

The TERIS device appeared to be safe after technical adjustments had been carried out. Short-time 6-month results as a bridge to surgery were good. However, due to the poor durability of the system no long-term efficacy could be demonstrated.     

Barosense endo-stapling: Simon BIRON (Canada). The ACE (for Articulated Circular Endoscopic Stapler) device has an articulated component; the mucosae is sucked in. The stapler fits into a 20mm tube. ten full-thickness plications are performed. The Canadian series has involved 21 patients in four sessions from April to July 2012, BMI 37 (30,7-44), 98 kg (71-153), duration 104min (71-153). Exclusion criteria: history of GI ulcer disease, poorly controlled diabetes or >10 years, significant WL in the last three months, diagnosis of eating disorder, esophageal disease. Hospital stay has been 24 hours, there were no complication. Evaluation of the efficacy in 21 patients: 10.8 kg, 10.6% WL, 33.6% EWL, 3.9 BMI U Loss, and 10.6% BMI-Loss.

Stem cells for fistula after sleeve gastrectomy : Matthieu POUSSIER (France). Five patients had a stem cell therapy treatment (CYTORI device, CELUTION) by the Montpellier team (David Nocca). There were two excellent results, and three failures depending of the fistulae duration (acute <3 months or chronic >3 months). The cells were obtained through liposuction. Among 13000 sleeve performed in France (2011), the rate of fistula has been 2%, so that this non invasive treatment could be instrumental.

The position of the anaesthesiologist has been presented by Jan Mulier (Belgium): Is opioid free anesthesia (OFA) something you should know when looking for ERAS and fast-track? What is Opioid Free Anesthesia (OFA)? Why is OFA useful for morbid obese patients? Why is OFA the way to apply ERAS, fast-track and should you as a surgeon known from this new method? But could OFA be less expensive in morbid obese patients? A few of the anesthesia drugs needed to give opioid free anesthesia are expensive when compared to those needed to give a traditional opioid anesthesia. However most drugs for opioid free anesthesia are dosed on IBW requiring not more drug in obese patients, while opioid consumption increases in obese patients. But the higher OFA price is small when compared with the surgical price for an extra laparoscopic tool. Moreover, Opioid free anesthesia improves enhanced recovery after surgery (ERAS) and reduces therefore postoperative nurse caring time and other drug consumption.

This early mobilizsation, made possible with OFA, is also crucial to reduce postoperative complications in morbid obese patients. OFA is a new anesthesia approach that focuses on achieving hemodynamic stability intra operative by sympathetic block instead of opioid receptor stimulation. It improves wound healing, gives less immunosuppression, facilitates early mobilization as patients require less (or zero) postoperative opioids for pain management. This is very valuable for morbid obese patients having frequently OSAS and lung atelectasis. In conclusion OFA is less invasive with many advantages for morbid obese patients, and although some drugs are more expensive the total hospitalization cost for morbid obese patients is reduced.

The G-prox POSE procedure for obesity: the current experience: Roman TURRO ARAU (Spain). Results from the early commercial experience: there was more than 75% compliance at 6 months, and >50% EWL at six months, and 60% at 12 months. A satiety testing method has been used, which showed a reduced gastric capacity at 2-6 months, and earlier fullness (both in volume and time). A subset of 18 patients was analyzed in a “Motivate Study”: Mean BMI was 36, 14.3 anchors were placed, mean duration of 51min, no serious adverse effect. The results are compared to those obtained in the other experienced team (University Hospital in Madrid) in 147 patients.

The duodeno-jejunal bypass sleeve (Endobarrier) and type 2 diabetes, an update : Jan GREVE (The Netherlands). It replicates the gastro-jejunal bypass model: bilio-pancreatic secretions are excluded from the alimentary tract along the first 70cm of jejunum. The procedure has been upgraded (radio-guided). 800 patients have been treated so far. The average weight-loss at two years has been 24%. Complications occurred in the preliminary studies: bleeding (<1%), obstruction of the jejunal tube (3%), migration (two), esophageal perforation (two).

In a Dutch study, 22 patients have been thoroughly analyzed in terms of diabetic response. The level of HbA1c has dropped from 8.2 to 7.1. The following aspects have been improved: GLP-response, GIP-response, normalization of glucagon response pattern (Area Under the Curve response), effect on satiety and food intake, increase in post-prandial PYY, decrease in post-prandial CCK, increase of the orexigenic hormone ghrelin, decreased fasting leptin levels (positively correlating with BMI), improved plasma liver parameters (AST, ALT and gamma-GT drop), decreased L-FABP and CK-18 (liver fibrosis parameters). A recent study has addressed the possibility of reimplantation (8 patients, explants at 12 months, re-implant at 24 months).

  • Endobarrier, preliminary French experience : François PATTOU (France)
  • Endobarrier versus Loop duodenojejunal bypass with sleeve gastrectomy for low BMI type 2 diabetes : Chih-Kun HUANG (Taiwan)
  • Endoscopic band removal: Thierry MANOS (France), Vianna COSTIL (France). A simple and efficient technique has been presented, making it possible to retrieve a gastric band by purely endoscopic methods.

Endoscopic solutions for complicated sleeve gastrectomy: Marc BARTHET (France). The rate of post-sleeve fistula is 2.4% (in  series of 4888 patients). Three steps should be considered: 1. Infection management, 2. Clips, glue or suturing, 3. Stenting. The trends in our activity are: decreasing the delay between surgery and endoscopic rescue; Making use of OVESCO clips; Using less stenting; Using more internal drainage (transoral endoluminal approaches, combined with surgical-radiological drainage, e.g. pig-tail naso-catheter drains). Stent migration rate can be as high as 60% (our initial series), 43% in other series. Efficacy has been 41% in Marseille and 56% in Deviere (Bruxelles, Belgium).

Laparoscopic gastric plication; Sleeve Gastrectomy with motorized stapling: Patrick NOEL (France). The Powered Echelon from Ethicon offers compression, stability, ability for the surgeon to control the power, same range of cartridges.

Some of our next year topics: Fast track and ERAS in bariatric surgery ; Robotic bariatric surgery; Reshape duo-balloon: new results; Digestive artery embolization for obesity treatment; Transvaginal sleeve gastrectomy; Microchip vagal stimulation and other neuromodulation devices; Allurion technologies; Magnetic Internal video... and of course updates on what has been presented in 2013.

For more information please visit: www.noninva-obesity.com

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