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Meeting report

2nd International New Technologies and Expert Meeting (Part 3)

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.

Metabolic and hormonal effects of endoscopic bariatric procedures
Presented by Marek Buzga (Czech Republic)

Despite best efforts, conventional medical T2DM treatment is not always effective Based on CDC statistics: 43% of patients do not achieve HbA1c < 7.0%. Metabolic surgery is established as more effective and durable than medical management for treating T2DM in severe and non-severely obese patients,but surgery is selected by only 1%-2% of the eligible population.

Balloons: Ghrelin is produced in the gastric fundus and the intestine, it is an appetite stimulant and participates in the adaptive response to weight loss; it elevates in states of hunger, and rapidly declines post-prandially. Ghrelin secretion is suppressed by RYGB and LSG. There are various methods measuring ghrelin (ELISA, Multiplex). The peak of Ghrelin is 3 months after surgery, but not many studies measure the active Ghrelin. Six months after placement of the balloon, the rate of metabolic syndrome in the patients decreased from 42.9% to 15.1% (p < 0.005).  

DJBS treatment (Endobarrier): in patients with T2DM, the HbA1c level was decreased at 6 months compared to baseline (7.4% to 5.8%; p < 0.005).  There is evidence about effect on weight loss, changes in Ghrelin levels, glucose control, blood lipid levels, but the durability of these changes after balloon removal is questioned. Weight loss itself, rather than the DJBS, could be responsible for hormonal variation.  DJBS treatment compared with diet and/or lifestyle modifications alone resulted in a modest weight loss in obese subjects, insignificant reductions in HbA1c and FPG and no changes in antidiabetic medication among obese patients with T2D. It was associated with a high number of transient and mild AES and several SAE, causing early explantation in 19% of subjects. Yet the safety profile of DJBS treatment should be seen in the light of its minimally invasive and reversible nature. Long-term high-quality clinical trials, with long post-explantation follow-up periods, are needed to evaluate its applicability in clinical practice. RCTs comparing DJBS with RYGB or intensive pharmacological therapy would be of great clinical interest.

In conclusion, there is an endocrine effect in endoscopic procedures.  

FRACTYL (Duodenal Mucosal Rejuvenation) the new metabolic endoscopic technique
Presented by Giorgio G Gobbi (Director, Medical Affairs Europe Fractyl Laboratories)

If the mucosa in patients with type 2 diabetes has been transformed from prolonged exposure to high fat, high sugar nutrients, could we reverse that effect by remodeling the mucosa? In this experiment we took a diabetic rat model and tested the effect of denudation (abrasion) of the duodenal mucosa on glucose metabolism. Compared with sham (no abrasion), the plasma glucose response to an oral glucose tolerance test in the Goko-Kakizaki (GK) diabetic rat was significantly improved from baseline. Denudation of duodenal mucosa conducted through mechanical abrasion decreased 35% of hyperglycemia post oral glucose gavage. Glucose lowering was not observed in sham study or in non-diabetic Wistar rodents

Until now, there have been no pharmacological approaches for targeting this duodenal defect. Bariatric surgery is the only treatment that has provided evidence for duodenal exclusion to provide improved glucose metabolism, but it is a substantial intervention that has not garnered broad enough uptake to impact the worldwide epidemic of diabetes. Duodenal rejuvenation may offer a less invasive solution that works with the patients natural processes to improve glucose handling. Duodenal Mucosal Rejuvenation (DMR) procedure resurfaces the duodenal mucosa post-thermal ablation.

Designed to provide a metabolic reset to approximate the duodenal exclusion in bypass surgery, the procedure is conducted during an upper GI endoscopy: a single-use disposable catheter permits a resurfacing of +/-10 cm of post-papillary duodenum. Procedure: the duodenal mucosa is lifted by saline to create a thermal barrier protecting deeper tissues. Follow up endoscopies and duodenal biopsies at 1 and 3months document mucosal healing. 102 cases have been included. Minimal GI symptoms were observed. There were 3 duodenal stenosis in early experience, successfully treated with a single balloon dilation and no later sequelae; no further cases were seen in the 65 cases after implementation of the improved mucosal lift procedure One jejunal perforation was repaired laparoscopically with no further complications. There was no hypoglycemia, no malabsorption, and no late adverse events (50+ patients >12 months)

Revita-1 Multicenter Open label “Patient Selection” has demonstrated reproducibility of outcomes across EU centers. RCTs will introduce the next generation of catheter, the Revita-2.

Other devices

VERJU, an innovative and convenient laser for post-operative aesthetic cares in bariatrics
Presented by Simon Ramshaw (United Kingdom)

A randomized pilot study has been recently conducted at the Mayo Clinic (USA), combining low-level laser therapy (LLLT- Erchonia Zeron 2.0). LLT is a non-invasive body-contouring technique that aims at local excess-fat, mostly sub-cutaneous, and does not emit heat, sound or vibration. It allows extravasation of intra-cellular lipids from adipocyte cell membranes. Six independent diodes laser heads emit 532 nm (= green) laser light, generating a 17 milliwatt output. Lasers are focused around the stomach and abdomen for 30 minutes, and then aimed at the back for another 30 minutes.

Lorcaserin is an FDA approved drug, acting as a serotonin 2C receptor agonist while stimulating pro-opiomelanocortin secretion from the hypothalamus, leading to weight loss through satiety.  44 patients (84%) with BMI 27-40 were enrolled in this open-label clinical trial and randomized in three groups: 1) Lorcaserin 10mg twice a day for 12 weeks, 2) LLLT for one hour once a week for 12 weeks, 3) Combination of both for 123 weeks.

Results: Significant reductions in waist circumference were obtained for each group at the end of treatment (-2.3 +/-4.1 cm, -6 +/-7.3 cm, and -4.0 +/-5.5 cm respectively), but the reduction in body weight was only significant in those receiving lorcaserin and combination treatment (-1.3kg). At 6 months, weight-loss was respectively1.4 kg, 2.4kg and 2.0 kg. A significant decrease in triglycerides was observed in the lorcaserin monotherapy group. Non side effects were observed with the LLLT.

RefluxStop trial for GERD, commonly linked to obesity
Presented by Peter Forsell (Sweden) and Milos Bjelovic (Serbia)

Dealing with GERD, there are problems associated with drug therapy, increased risks of esophageal cancer, renal deficiency, osteoporosis, and dementia. The Nissen laparoscopic fundoplication procedure may lead to dysphagia (43% at 4-6 weeks, 19% at 1 year, 18% at 10-14 years); regurgitation in 10%, 2%, 18%; hearburn/epigastric pain in 39%, 17%, 30%. A new mechanical device (RefluxStop) has been developed, that is inserted laparoscopically around the GEJ. With Refluxstop, 92% of the patients had reduced total GERD-HQRL score of more than 50%. One SAE occurred in 22 implanted, an intra-abdominal bleeding (reoperation), there were no device-related AE.

Non invasive neuromodulation as an obesity treatment
Presented by Radwan Kassir (France)

Comorbidities associated with obesity are related to the autonomous nervous system, e.g. elevated blood pressure or depression. Vagal neurostimulation may act upon these diseases, while when being performed in cases of depression and epilepsy it had also a weight-loss action. The study compared in a double-blind randomized prospective way, the effect of transcutaneous vagal neurostimulation on weight-loss in morbid obese patients (BMI > 40), who were candidates for a bariatric surgery. Vagal branches permeate in the subcutaneous external part of the ear (concha): an electrode was placed in the external left ear and activated by the patient himself 4 to 5 hours a day with intervals of 1 hour at least, with no feeling of electricity intensity (1.0mA, frequency 25 Hz). In the control group, the stimulator was not activated. The secondary objectives was the follow-up of related comorbidities and bio-markers (such as digestive hormones), and the assessment of autonomous nervous system according to the weight-loss. 

There was 1 case of local irritation, 2 nausea, 1 increased migraine. We introduced modifications with the earpiece cable length and battery autonomy, and downsized the device. There were 53% premature discontinuation because of lack of compliance. In 17 patients, there was an average 33% EWL. 40% of patient the patients were less anxious, with a good feedback about satiety sensation and reduction of snacking. In order to complete our study, it has been important to unblind the randomisation. We wish to recruit more patients to prove the effectiveness of the device.

Please click here to read Part 1 of the Non-Inva Report or here to read Part 2

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