Totally endoscopic implant to effect a gastric bypass: 12-month safety and efficacy outcomes.

BACKGROUND: Only a small percentage of candidates for bariatric surgery ever undergo a procedure for weight loss. Devices duplicating key effects of bariatric surgeries with removable, fully trans-oral implants could extend their benefits to patients unwilling to undergo anatomy-altering abdominal surgeries. METHODS: Thirty-two obese subjects (mean BMI: 42.3) were enrolled in a prospective, multicenter, single-arm, feasibility trial of the first fully trans-oral endoscopic gastrointestinal bypass device. The device is a cuff attached to the distal esophagus by transmural anchors and connected to a 120-cm sleeve diverting undigested nutrients to the jejunum. Bodyweight, vital signs, adverse events, medications, HbA1c, fasting glucose, and lipids were collected at baseline and follow-up visits. Device status was endoscopically assessed every 6 months. RESULTS: The fully trans-oral procedure was successful in all subjects without intraoperative adverse events or postoperative infections. Twenty-eight of 32 subjects (88%) remained implanted with continuing follow-up beyond their 12-month visit. At 12 months, the 32 subjects had lost an average of 44.8% of excess body weight, 17.6% of total body weight, 20.8 kg, and 7.5 BMI points. Weight loss depended on capture of ingesta by the esophageal cuff, with 18 of 32 subjects without visible gaps around their cuffs at the 6 month endoscopy having significantly greater EWL (53.6 vs. 33.4% in the remaining subjects, p < 0.002). Mean HbA1c and fasting glucose declined by 1.1% points and 29 mg/dL in type 2 diabetic subjects, 80% of whom had remission of their diabetes at 12 months. CONCLUSION: This study demonstrates the feasibility, safety, and efficacy of a fully trans-oral gastrointestinal bypass implant. This purely endoscopic device may provide a valuable addition to the armamentarium of treatment available for the management of morbid obesity.

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

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 (GJBS) (ValenTx, Inc. Carpinteria, CA, USA). In this report, we present the safety, feasibility of the device, weight loss, and changes in comorbidities. 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 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. RESULTS: 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 42 kg/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 4 weeks, 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 12 months, 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 1 year, 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 (26 months 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. DISCUSSION: 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.

Human experience with an endoluminal, endoscopic, gastrojejunal bypass sleeve.

BACKGROUND: This report describes the authors' experience with a unique endoluminal, endoscopically delivered and retrieved gastroduodenojejunal bypass sleeve, including short-term weight loss and changes in comorbidities. METHODS: A prospective, single-center trial was designed. The patients were morbidly obese individuals who met the National Institutes of Health criteria for bariatric surgery. The device used was a unique gastroduodenojejunal bypass sleeve secured at the esophagogastric junction with endoscopic and laparoscopic techniques and designed to create an endoluminal gastroduodenojejunal bypass. At completion of the trial, the device was explanted with endoscopic retrieval. The primary end points were safety and incidence of adverse events. The secondary outcomes included the percentage of excess weight loss and changes in comorbidities, specifically glucose control, use of antihyperglycemic medications, and changes in hemoglobin A1c levels. RESULTS: From July 2008 to February 2010, 24 patients were enrolled in the trial. The gastroduodenojejunal bypass sleeve was implanted, left in situ, and then retrieved. The 7 men and 17 women in the study had a mean preoperative body mass index of 42 kg/m(2). The device was successfully delivered in 22 of the 24 patients (92%) and retrieved endoscopically from all 22 patients in whom it was implanted (100%). Two patients were excluded from the study preprocedurally. The one patient was excluded preoperatively due to noncompliance with the preoperative liquid diet. For the other excluded patient, the device was not attempted endoscopically due to significant inflammation at the gastroesophageal junction at the time of laparoscopic evaluation. Of the 22 patients who had the device implanted, 17 maintained it (77%) and completed the full 12-week trial. These patients had 39.7% excess weight loss at completion of the study. The primary reason for early explantation of the device was early postoperative dysphagia. The seven patients with preoperative diabetes mellitus all had normal blood glucose levels throughout the trial, and none required antihyperglycemic medications. All four patients with elevated hemoglobin A1c levels preoperatively showed improvement by the end of the trial. CONCLUSIONS: This trial demonstrated that the endoluminal gastroduodenojejunal sleeve can achieve excellent weight loss at 12 weeks. No patient safety issues were encountered. Adverse effects were minimal and resolved at endoscopic device removal. Effective glycemic control was demonstrated through use of the device during the trial. Long-term results are needed.

Critical extreme anterior slippage (paragastric Richter's hernia) of the stomach after laparoscopic adjustable gastric banding: early recognition and prevention of gastric strangulation.

BACKGROUND: We report an unusual complication after Lap-Band placement characterized by herniation of the anterior stomach through the band. METHODS: Group 1 - 105 patients: Operated elsewhere (prior to US FDA approval) and followed by us; perigastric technique was used in 74 and pars flaccida in 31. Group 2 - 218 patients: Operated by us since August 2001 using the pars flaccida approach only. 4 patients with this unusual problem were identified. RESULTS: Patients were all female, with age 37.5 (3343) yr, weight 143.7 (123-167) kg, and BMI 54 (45-65). Onset occurred at 9 (5-16) months, with weight loss: 38.5 (27-53) kg and %EWL 47.3 (31-54)%. All had sudden nausea, vomiting and epigastric abdominal pain that persisted despite emptying the band. None of these symptoms were related to a recent band adjustment. CT scan showed a paragastric Richter's hernia of the stomach underneath the band. At exploration, the band was in the normal location. 3 patients from Group 2 had Richter's hernia of the anterior stomach through the band; reduction of the stomach with closure of the defect was performed. One patient from group 1 had gangrene of the entrapped stomach, resulting in band removal and gastrectomy. CONCLUSION: Lap-Band patients with sudden nausea, vomiting and abdominal pain, when not relieved by emptying the band, should undergo a CT scan. If a traditional slippage is not confirmed, paragastric Richter's hernia of the stomach through the band should be suspected. Immediate exploration with reduction of the stomach and closure of the defect can salvage the stomach and the band. Gastro-gastric sutures must completely close the space underneath the band to prevent this complication.

The Lap-Band system in a North American population.

BACKGROUND: European and Australian results with laparoscopic adjustable gastric banding (LAGB) using the Lap-Band (Inamed Health, Santa Barbara, CA) have been impressive, with over 100,000 procedures completed at this writing. However, prior to U.S. FDA approval in June 2001, U.S. patients had to travel out of the U.S. for this procedure. This study reports on a series of U.S. patients who requested off-shore referral for LAGB placement. METHODS: 105 U.S. patients were implanted with the Lap-Band System in Mexico by one surgeon in a private practice. 70% were implanted with the perigastric approach, while the final 30% were implanted using the pars flaccida approach. Routine postoperative visits, including band adjustments, were completed in a private U.S. clinic where medical staff performed frequent small adjustments as necessary to optimize results. Data were collected from concurrent and retrospective chart reviews and from telephone interviews. Summary statistics provided for baseline measures included mean +/- standard deviation. Postoperative measures of weight loss included mean +/- standard error. RESULTS: Weight loss results were comparable to international results: 61% EWL at 12 months (n=50), 75% EWL at 24 months (n=37), 72% EWL at 36 months (n=24), and 60% EWL at 48 months (n=7). There were few major complications. CONCLUSION: Attention to patient management is essential to success, and this study found that appropriately-managed U.S. LAGB patients can be as successful as their international counterparts. Frequent follow-up delivered by a bariatric team with easy access to band adjustments is essential.

Internal hernias in pregnant women with history of gastric bypass surgery: Case series and review of literature.

INTRODUCTION: Gastric bypass surgery is the most common obesity surgery procedure in women. Decreased weight loss favors fertility and leads to pregnancy sometimes just months after surgery, raising the risk of developing gastric bypass-related complications during pregnancy, including the formation of internal hernias. PRESENTATION OF CASE: The first patient presented at 37 weeks of gestation with abdominal pain, nausea and vomiting. X-ray revealed multiple air-fluid levels and absence of gas in colon. She underwent a cesarean section and exploratory laparotomy without complications. A Petersen's space internal hernia was found. The second patient presented at 25 weeks of gestation with abdominal pain and nausea. X-ray revealed multiple air-fluid levels and a "U-shaped" intestinal loop. She underwent exploratory laparotomy with reduction of an internal hernia also in Petersen's space. DISCUSSION: Pregnant patients with internal hernias after gastric bypass are usually of young age and with a several-day history of abdominal pain. Surgical exploration is safe and should not be delayed. The literature review showed that maternal death (9%) and fetal death (13.6%) rates are considerably high. CONCLUSION: The possibility of an internal hernia should always be considered in pregnant women with history of gastric bypass who present with abdominal pain, in order to prevent catastrophic outcomes such as maternal and/or fetal death.