Safety and effectiveness of LAP-BAND AP System: results of Helping Evaluate Reduction in Obesity (HERO) prospective registry study at 1 year.

BACKGROUND: Laparoscopic adjustable gastric banding has several distinctive features, including band adjustability, easy reversibility, and lack of malabsorption, which contribute to its widespread use. The LAP-BAND AP System (LBAP; Allergan, Inc.), a redesigned and improved version of the original device, was approved by the US Food and Drug Administration in 2006. Because of limited information on LBAP, this study prospectively assesses the efficacy and safety of LBAP in real-world settings at clinical centers located in North America, Europe, and Australia. STUDY DESIGN: This interim report of the ongoing 5-year prospective, observational, international, multicenter registry, Helping Evaluate Reduction in Obesity (HERO) Study (NCT00953173), describes clinical efficacy and safety of LBAP in real-world settings at 1 year. RESULTS: One thousand one hundred and six patients were implanted with LBAP and 1-year data were available from 834 patients for efficacy analysis. At 1 year, the mean (SD) percentage of excess weight loss was 39.8% (22.3%), of weight loss was 16.9% (9.0%), and the mean (SD) body mass index decreased to 37.7 (7.0) kg/m(2) from 45.1 (6.9) kg/m(2) at baseline. Patients with type 2 diabetes mellitus or hypertension showed significant improvements at 1 year post LBAP (both p < 0.005). The most common device-related complications were port displacement (n = 20 [1.8%]), pouch dilation (n = 12 [1.1%]), band slippage (n = 7 [0.6%]), and band erosion (n = 5 [0.5%]). Eighteen (1.6%) patients had the device explanted. CONCLUSIONS: At 1 year post LBAP, progressive weight loss was associated with improvement and/or resolution of comorbid conditions and was safe and well tolerated. Patient follow-up continues.

Five-year weight loss experience of outpatients receiving laparoscopic adjustable gastric band surgery.

BACKGROUND: This study evaluated the efficacy and safety of laparoscopic adjustable gastric banding (LAGB) in a large cohort of morbidly obese patients followed for up to 5 years. METHODS: Morbidly obese patients, ≥ 16 years of age, who underwent LAGB surgery at the Surgical Weight Loss Clinic in Ontario, Canada, between May 2005 and January 2011 were eligible for this retrospective chart review. Electronic files were searched to identify all patients who met the inclusion/exclusion criteria. Demographics, weights at baseline and follow-up visits (up to 60 months following surgery), and post-operative complications were documented. As follow-up visits occurred at unevenly spaced intervals within and across patients, modeling methods were used to more accurately assess mean % weight loss (WL) and % excess weight loss (EWL) over time. RESULTS: This study included 2,815 patients (82 % female, mean age 43 years, mean baseline BMI 44.6 kg/m(2)) followed for a mean of 21.8 ± 15.4 months. Complications developed in 238 patients (8.5 %), the most frequent being prolapse/slippage (4.2 %), tubing/access port problems (1.2 %), and explantation (1.2 %). Mean %WL and %EWL progressed continuously over the first 2.5 years post-LAGB, plateauing at 20 and 49 %, respectively, for up to 5 years of follow up. Factors associated with increased weight loss were time since surgery, greater baseline weight (excess weight), older age at time of surgery, and male gender. CONCLUSIONS: Weight loss was maintained for up to 5 years in our population of patients who underwent LAGB for the treatment of morbid obesity.

Morbidity in patients with or at high risk for obstructive sleep apnea after ambulatory laparoscopic gastric banding.

Considerable controversy exists about the perioperative management of patients at high risk for obstructive sleep apnea (OSA) in free-standing clinics. Eighty-eight percent of an American Society of Anesthesiologists expert panel felt that upper abdominal laparoscopic surgery could not be performed safely on an outpatient basis. We sought to review the incidence of major adverse events after outpatient laparoscopic adjustable gastric banding (LAGB) in a high risk population for OSA at a free-standing facility. Research Ethics Board approval was obtained and charts were reviewed retrospectively for 2,370 LAGB performed at a free-standing clinic between 2005 and 2009. In this observational cohort study, patients were classified as high risk for OSA if they received continuous positive airway pressure (CPAP) treatment for OSA pre-operatively or had a history of at least three STOP-BANG criteria. Follow-up was verified and adverse events reviewed, including death, unanticipated transfer or admission to hospital within 30 days. A total of 746 of the 2,370 patients (31%) met criteria for or were at high risk for OSA (357 received CPAP for OSA and 389 by STOP-BANG criteria). The incidence of transient desaturation to less than 93% was 39.5%. There were no deaths and no cases of respiratory failure or re-intubation. The 30-day mortality was zero and the 30-day anesthesia related morbidity was less than 0.5%. For patients at high risk for OSA after LAGB, the significance of transient oxygen desaturation and the need to develop monitoring and admission standards remain to be determined.

Laparoscopic gastric banding is safe in outpatient surgical centers.

BACKGROUND: Due to constraints on resources and capacity, as well as advances in surgical technique and care, there has been progressive change toward converting surgical procedures to the outpatient setting when feasible. This study was designed to investigate the safety of laparoscopic adjustable gastric banding (LAGB) as an outpatient procedure for morbid obesity in Canada. METHODS: This retrospective analysis included consecutive patients who underwent outpatient LAGB at the Surgical Weight Loss Centre in Ontario, Canada, beginning with our initial experience in February 2005 and continuing to July 2009. Eligible patients were morbidly obese adults whose outpatient clinic surgery had been performed by one of two experienced surgeons. RESULTS: A total of 1,641 patients were included in this analysis. The average presurgical body mass index was 46.7 kg/m2 (range 35.0 to 79 kg/m2). Fifteen patients (0.91%) experienced minor complications during surgery or within 30 days of surgery (dysphagia, n=5; wound infection, n=3; port infection, n=2; all other complications occurred in one patient each). Four patients required transfer to hospital from the clinic on the day of surgery, and three were admitted. None of the complications were serious and all were resolved. The device was explanted in two patients. The average time from sedation to discharge was <4 hours (h). CONCLUSIONS: The ability to treat patients within 4 h and the extremely low complication rates reported here contribute to a growing literature supporting the safe performance of LAGB in an outpatient setting for the treatment of morbid obesity.