Bryan J Sandler, MD, Roberto Rumbaut, MD, C. Paul Swain, MD, Gustavo Torres, MD, Luis Morales, MD, Lizcelly Gonzales, MD, Sarah Schultz, MPH, Mark Talamini, MD, Santiago Horgan, MD. Division of Minimally Invasive Surgery, Department of Surgery, UC San Diego, San Diego, CA, USA; Hospital de Tec de Monterrey, Monterrey, Mexico; Imperial College of London, London, England
Introduction: 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 (ValenTx, Inc. Carpinteria, CA). In this report, we present the safety, feasibility of the device, weight loss, and changes in co-morbidities.
Methods and Procedures: A prospective, single-center, 12-month trial was designed. The patients are morbidly obese individuals who meet the NIH criteria for bariatric surgery. The gastro-duodeno-jejunal bypass sleeve (GJBS) is a 120cm 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 co-morbidities, specifically glucose control, use of anti-hyperglycemics, and changes in hemoglobin A1C levels.
Results: From July 2009 until August 2010, 13 patients were prospectively enrolled for the 1-year trial. The study included 5 men and 8 women with a mean pre-operative BMI of 42 kg/m2. 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 4 weeks, due to patient intolerance. Upon explant of the device, both patients’ symptoms improved. In the remaining 10 patients, the device was implanted, left in-situ for 12 months, and then retrieved endoscopically.
Safe delivery of the cuff at the esophago-gastric junction was seen in all 12 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 one-year mark. Of the 10, six had intact sleeves throughout the follow-up, without any evidence of cuff detachment during follow-up endoscopy. The mean percentage EWL, at one year, in this group was 54%. In the remaining four patients, partial cuff detachment was observed at follow-up endoscopy. As expected, the percentage excess weight loss was inferior in this group.
Co-morbidites measured included diabetes mellitus, hypertension, hyperlipidemia, and use of anti-hyperglycemics. Each of the measured co-morbidities showed improvement during the 12-month trial.
Conclusion: The endoluminal, gastro-duodeno-jejunal bypass sleeve can be safely placed. The mid-term data shows it is well tolerated with a good safety profile. It achieves excellent weight loss results with improvement of co-morbidities.
Program Number: S047