One-year human experience with a novel endoluminal, endoscopic gastric bypass sleeve for morbid obesity.

Abstract

Here, we report the first series of patients with 1-year implantation of a novel, endoluminal, endoscopically delivered and retrieved gastro-duodeno-jejunal bypass sleeve (GJBS) (ValenTx, Inc. Carpinteria, CA, USA). In this report, we present the safety, feasibility of the device, weight loss, and changes in comorbidities. A prospective, single-center, 12-month trial was designed. The patients are morbidly obese individuals who meet the NIH criteria for bariatric surgery. The GJBS is a 120-cm sleeve secured at the esophago-gastric junction with endoscopic and laparoscopic techniques that is designed to create an endoluminal gastro-duodeno-jejunal bypass. The device was implanted and, at the completion of the trial, retrieved with an endoscopic technique. The primary endpoints were safety and incidence of adverse events. The secondary outcomes included the percentage of excess weight loss (EWL) and changes in comorbidities, specifically glucose control, use of antihyperglycemics, and changes in hemoglobin A1C levels. From July 2009 until October 2009, 13 patients were prospectively enrolled for the 1-year trial. The study included five men and eight women with a mean preoperative BMI of 42kg/m(2). One patient was excluded, at the time of endoscopic evaluation, due to inflammation at the GE junction. Two additional patients required early explantation of the device, within the first 4weeks, due to patient intolerance. Upon explant of the device, both patients' symptoms improved. In the remaining ten patients, the device was implanted, left in situ for 12months, and then retrieved endoscopically. Safe delivery of the cuff at the gastro-esophageal junction was seen in all ten patients whom had device implants, without complication. No esophageal leak was seen immediately post-procedure or during follow-up. The sleeve device was well tolerated within the bowel lumen during the 12-month study, specifically, no bowel erosions, ulceration, or pancreatitis was observed. All ten patients reached the 1-year mark. Of the ten, six had fully attached and functional devices throughout the follow-up, verified by endoscopy. The mean percentage EWL, at 1year, in this group was 54%. In the remaining four patients, partial cuff detachment was observed at follow-up endoscopy. The percentage EWL was lower in this group. Of the six patients that reached a year with a fully attached device, five were followed at an average of 14-months post-explant (26months from the time of device implant). These five maintained an average percentage EWL of 30% at the 14-month post-explant follow-up. Co-morbidites measured included diabetes mellitus, hypertension, hyperlipidemia, and use of antihyperglycemics. Each of the measured comorbidities showed improvement during the 12-month trial. The endoluminal, GJBS can be safely placed and retrieved. The short-term data show it is well tolerated with a good safety profile. It achieves excellent weight loss results with over 70% of all comorbidities resolved or significantly improved.