Clinical safety and effectiveness of a swallowable gas-filled intragastric balloon system for weight loss: consecutively treated patients in the initial year of U.S. commercialization.

BACKGROUND: Obesity is the most common chronic disease in the United States today. Additional therapies are needed to improve obesity treatment. OBJECTIVE: A swallowable, gas-filled intragastric balloon system was approved for the treatment of obesity by Food and Drug Administration in September 2016 and commercialization started January 2017. A registry was made available to physicians to capture evidence of safety and effectiveness with use. SETTING: United States private clinics, surgery centers, and hospitals. METHODS: This study is a retrospective analysis of a prospective registry of patients with body mass index (BMI) ≥25 kg/m2 that initiated therapy in the first year. Data on demographics, procedural timing, weight loss, adverse events, and device deficiencies were captured. RESULTS: The final analysis comprised 1343 patients across 108 treating physicians (mean age 45.7 ± 10.8 yr, 78.6% female, baseline BMI of 35.4 ± 5.4 kg/m2). Nonserious and serious adverse events were reported in 14.2% and .15% of patients, respectively. There were 7 balloon deflations, none caused obstruction. Weight loss in the indicated use (BMI 30-40 kg/m2) was 9.7 ± 6.1 kg and 10.0 ± 6.1% total body weight loss (TBWL). Weight loss in other BMI categories was 8.2 ± 5.6 kg or 10.3 ± 7.0% total body weight loss for BMI 25 to 29.9 kg/m2 and 11.6 ± 7.8 kg or percent total body weight loss 9.3 ± 6.0 for BMI >40 kg/m2. CONCLUSIONS: This swallowable gas-filled intragastric balloon system is safe and effective at inducing weight loss and offers physicians another tool for patients whose obesity has been resistant to noninvasive treatments.

Gastric pouch reduction using StomaphyX in post Roux-en-Y gastric bypass patients does not result in sustained weight loss: a retrospective analysis.

BACKGROUND: Gastric bypass is the "gold standard" procedure of bariatric surgery. However, 20.4-34.9% of these patients may fail to achieve or maintain the weight loss on long-term follow-up and may require additional procedures. StomaphyX has been promoted for weight reduction in such patients. OBJECTIVES: To study whether endoluminal reduction of gastric pouch and stoma using StomaphyX results in sustained weight loss in patients who regain weight after gastric bypass. METHODS: Retrospective chart review was performed on 59 postgastric bypass patients who underwent revision of gastric pouch using StomaphyX from 2007 to 2008. Postprocedure weight at 1 week, 1 month, and 6 months follow-up as well as weight at the time of the review was recorded for each patient. RESULTS: Average weight loss and excess body weight loss (EBWL) were 2.6 ± 2.3 kg and 7.3 ± 7.1% (n = 42) at 1 week, 3.7 ± 2.9 kg and 11.6 ± 12.1% (n = 31) at 1 month, and 3.8 ± 4.5 kg and 11.5 ± 17.9% (n = 10) at 6 months respectively. At the time of review, the average follow-up was 41 months, average weight loss was 1.7 ± 9.7 kg, and EBWL was 4.3 ± 29.8% (n = 53). Endoscopy in 12 patients at average 18 months follow-up showed no sustained reduction in pouch and stoma size. CONCLUSIONS: StomaphyX results in weight loss that is not sustained on long-term follow-up. Pouch and stoma tend to regain their preprocedure size on follow-up. StomaphyX cannot be recommended as a weight loss strategy in postgastric bypass patients who regain weight.

Endolumenal revision obesity surgery results in weight loss and closure of gastric-gastric fistula.

BACKGROUND: Approximately 20-50% of patients regain weight 3-5 years after Roux-en-Y gastric bypass (RYGB) surgery. Gastric-gastric fistulas and dilation of the gastrojejunostomy and gastric pouch have been reported in these patients. Traditional revision surgery after RYGB has greater morbidity and mortality compared with the index bariatric procedure. We studied our initial results with revision of obesity surgery using an endoscopic platform in a community hospital setting. METHODS: A retrospective review was performed of patients who had undergone this endoscopic revisional procedure secondary to significant weight regain with or without gastric-gastric fistula. All patients underwent revision of the gastrojejunostomy and/or closure of the gastric-gastric fistula using this minimally invasive approach. RESULTS: A total of 37 consecutive patients (36 women) with a mean age of 45 years and mean weight regain of 15.1 ± 10.0 kg were included in the present study. The mean interval between RYGB and revision was 5.2 years (range 1-11). The mean preoperative and postoperative stomal size was 21.5 and 10 mm, respectively. Anchors were successfully placed in all patients. The mean follow-up period was 4.69 months (range 2-10). The mean percentage of excess body weight loss was 23.5% ± 66.4%. No immediate complications developed. Two patients underwent endoscopic dilation of the stoma because of persistent meal intolerance. Three gastric-gastric fistulas were successfully closed. CONCLUSION: Revision of gastrojejunostomy after RYGB can be safely undertaken using this endoscopic platform. The short-term follow-up results showed clinically significant weight loss. Long-term follow-up is needed. Closure of gastric-gastric fistulas can also be achieved using this procedure.

Does transumbilical single incision laparoscopic adjustable gastric banding result in decreased pain medicine use? A case-matched study.

BACKGROUND: We report on our initial experience of laparoscopic adjustable gastric banding performed through a single transumbilical incision of approximately 2.5 cm. All single incision bands were placed using the Covidien SILS Port™ and the Allergan Lap-Band(®). The purpose of the present study was to report on the analgesic use after single-incision laparoscopic surgery (SILS) adjustable gastric banding versus that after conventional laparoscopic gastric banding at a community hospital. METHODS: A retrospective review of postoperative pain medication use and the time to return to work was conducted of 24 consecutive SILS adjustable gastric banding procedures compared with 24 traditional 5-incision laparoscopic adjustable gastric banding procedures. RESULTS: The patients in both groups were evenly matched for age, body mass index, and co-morbidities. All patients were discharged home on postoperative day 1. No complications developed. The mean patient-controlled analgesia morphine use during hospitalization for the SILS group was 33 ± 19.22 mg versus 49 ± 23.78 mg in the traditional group (P <.05). The mean period of postoperative pain medication use for the SILS group was 2 days versus 5 days for the traditional group (P <.05). However, the mean period to return to work was 9.5 days for the SILS group versus 11 days for the traditional group (P = NS). CONCLUSION: Transumbilical single-incision laparoscopic adjustable gastric banding with mechanical port fixation resulted in significantly decreased postoperative pain medication use compared with traditional laparoscopic gastric banding with suture fixation of the band port. Also, the patients tended to return to work earlier after SILS gastric banding.