SAN DIEGO — Endoscopic approaches to gastric remodeling are contributing to long-term weight loss and have a good safety profile, according to two studies presented here at Digestive Disease Week 2016.
Endoscopic procedures, which are unlikely to cause trauma to the abdominal wall and therefore reduce complications associated with standard abdominal surgery, have become an intensive area of research in bariatrics. They can be particularly appropriate for patients who are moderately rather than morbidly obese, speakers said.
"There are about 19 million morbidly obese Americans, and those are surgical candidates, but there are 88.6 million who are obese — with a body mass index [BMI] of 30 to 40 kg/m² — who have no viable options," said investigator Reem Sharaiha, MD, from the Weill Cornell Medical Center in New York City, who presented one of the studies.
"We know that diet and exercise are not effective in the long run, so we are left with a treatment gap. This is where endoscopic options come into play," Dr Sharaiha said.
"These patients are different from the bariatric surgery population," said Laurent Biertho, MD, from Laval University in Quebec City, Canada, who presented results from a study of a different procedure. "They have BMIs of 30 to 35 kg/m² or so, and need to lose 10 to 20 kg. They represent a very large group of people."
Endoscopic Sleeve Gastroplasty
Endoscopic sleeve gastroplasty is a technique that reduces gastric volume using full-thickness sutures. In a series of 242 patients followed for 18 months, the procedure safely and effectively induced weight loss in moderately obese patients, which was sustained 18 months after the intervention, Dr Sharaiha reported.
She and her colleagues evaluated weight outcomes, serious adverse events, and predictors of response in patients treated at three specialized centers: the Weill Cornell Medical Center; the Mayo Clinic in Rochester, New York; and Hospital Universitario Madrid. The mean age of the patients in the study cohort was 44 years, mean BMI was 37.8 kg/m², and 73% of the patients were women.
All procedures were performed using the OverStitch device (Apollo Endosurgery), which places full-thickness sutures to invaginate the greater curvature of the stomach. This creates a narrow luminal sleeve that can reduce gastric functional capacity by up to 80%.
At 18-month follow-up, 66.7% of patients had sustained weight loss of at least 15%, Dr Sharaiha reported.
Table. Total Weight Loss With Endoscopic Sleeve Gastroplasty
|Time from Baseline||Percentage of Body Weight Lost|
Sustained weight loss could be predicted by two factors: loss of at least 15% of total body weight at 6 months (likelihood ratio, 8.5; P = .0035); and continued weight loss from 6 to 12 months (likelihood ratio, 14.4; P = .001).
There were five (2%) serious adverse events in the study cohort: two perigastric inflammatory fluid collections (adjacent to the fundus), which resolved with percutaneous drainage and antibiotics; one self-limited hemorrhage from splenic laceration; one pulmonary embolism 72 hours after the procedure; and one pneumoperitoneum and pneumothorax requiring chest tube placement. All five patients recovered fully.
Ali Siddiqui, MD, from Thomas Jefferson University in Philadelphia, told Medscape Medical News that endoscopic sleeve gastroplasty is increasingly being performed at specialty centers, including his own.
The endoscopic procedure reduces the size of the stomach by pulling the walls together to create a tubular structure, reducing the capacity of the stomach. It also interferes with gastric motility. Both these factors allow the patient to feel full after eating a small amount of food.
"Gastric balloons act in a similar fashion — the fact that they lie in the stomach makes a person feel full — but the balloon has to be removed after 6 months. Endoscopic sleeve gastroplasty is a more permanent method," Dr Siddiqui explained.
Articulated Circular Endoscopic Stapler
Results from a 2-year multicenter safety and efficacy trial of a new endoscopic procedure for weight loss were presented by Dr Biertho.
The investigational articulated circular endoscopic stapler (Boston Scientific Corporation) reproduces the physiologic effects of sleeve gastrectomy using endoscopic techniques. The procedure creates 6 to 8 plications on the greater curvature, fundus, and body, and two plications on the proximal antrum.
"The data suggest that the stapler procedure is safe and results in significant weight loss and improvement in quality of life at 12 and 24 months," Dr Biertho reported.
The prospective, nonrandomized, pilot study of 69 patients was conducted at six centers in four countries, and follow-up was 24 months. The mean age of the study cohort was 40 years, mean baseline weight was 102 kg, mean BMI was 38 kg/m², and 83% of the participants were women.
Mean operative time was 102.6 minutes, and an average of 9.2 gastric plications was placed in each patient. No intraprocedural adverse events occurred during the hospital stay, which averaged 1.1 days.
"In more than 600 firings, we had no stapler-related complications," Dr Biertho noted.
Two-year follow-up was available for 46 patients (67%). Mean excess weight loss was 35% at 1 year (P < .05) and 21% at 2 years (P < .05). At 2 years, mean total weight loss was 6.9 kg.
Weight loss was accompanied by the resolution of some comorbidities commonly associated with obesity. Type 2 diabetes resolved in 30% of the patients (with a nonsignificant drop in hemoglobin A1c) and hypertension resolved in 19%. The resolution of hyperlipidemia in 19% of the patients was significant (P = .03).
There was significant improvement in five of eight quality-of-life domains on the 36-item Short Form Health Survey at 12 months, and in three of eight domains at 24 months. And there was significant improvement in all three domains on the Three-Factor Eating Questionnaire-R18 at 12 months, and in two domains at 24 months (uncontrolled eating and emotional eating).
Almost all patients reported at least one adverse event, 58% of which were related to the device or procedure, but all were mild or moderate. The most frequent were abdominal pain (61%), oropharyngeal pain (38%), nausea (35%), and vomiting (29%). No serious adverse events were deemed to be related to the device or procedure.
Although the data are encouraging, they come from a phase 1 trial. "Controlled data will be required to better assess the long-term benefits of this procedure," Dr Biertho explained.
The main drawback to endoscopic approaches at this time is financial. "It's a cash-only procedure, not reimbursed by insurance, and it costs somewhere between $11,000 and $15,000," Dr Siddiqui pointed out.
For those willing or able to pay, however, endoscopic devices and approaches can jump-start one's dedication to more familiar, but perhaps more challenging, weight loss practices. "The reason these devices are good is that they are almost a conduit for behavior modification," Dr Siddiqui explained. "They are a starting point for moderately obese patients to be motivated to lose weight."
The major appeal of endoscopic approaches are that they are reversible, minimally invasive, and potentially less expensive than surgery, said session moderators Stuart Amateau, MD, PhD, from the University of Minnesota Medical Center in Minneapolis, and Faris Murad, MD, from the Northshore University Health System in Chicago.
The suturing device is "promising," said Dr Amateau, but "it's still unclear whether this will be different than suturing by devices that have failed in the past."
It is not clear why some devices have failed, but it is possible that the "hostile environment of the stomach" plays a role, added Dr Murad.
"The question is whether these newer procedures will be durable," said Dr Murad. "The stomach is a very vascular, muscular organ. It contracts and it breaks down food. Depending on how sutures or cinchers are placed, there's a potential for breakdown at a very early point."
In the case of the endoscopic sleeve gastroplasty suturing device, he said, there is a full-thickness "bite" aimed at creating fibrous bands that could be more long-lasting.
The pair agreed that, in general, the endoscopic approaches are desirable. "These approaches are reversible in case something goes wrong, and redoable if you have sutures or plications that fail," Dr Amateau explained.
Dr Sharaiha and Dr Ali report consulting for Apollo Endosurgery. Dr Biertho reports financial relationships with Boston Scientific, Johnson & Johnson, and ValentTx.
Digestive Disease Week (DDW) 2016: Abstract 101, presented May 21, 2016; abstract 396, presented May 22, 2016.
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Cite this: Endoscopic Approaches for Weight Loss Gaining Traction - Medscape - May 23, 2016.