Safety and effectiveness of REALIZE adjustable gastric band: 5-year prospective study.

BACKGROUND: The long-term safety results of the REALIZE (Ethicon Endo-Surgery, Inc., Cincinnati, OH) adjustable gastric band collected in this prospective, multicenter study in patients with morbid obesity are presented. OBJECTIVES: To determine the reoperation rate, including band revisions, replacements, and explants, resulting from a serious adverse device-related event through years 4 and 5. Various efficacy measures were also assessed as secondary objectives. SETTING: Nine academic and/or private institutions. METHODS: The participating institutions enrolled 303 patients, who were then assessed on an annual basis, with 231 patients completing 5 years of follow-up. The study parameters included reoperation rates, changes in percentage of excess weight loss (%EWL), and changes in body mass index (BMI), as well as parameters of diabetes and dyslipidemia. Quality of life was assessed using the Short Form (SF)-36 and the Impact of Weight on Quality of Life-Lite questionnaires. RESULTS: The reoperation rate due to a serious adverse event in this population at 5 years after implantation with the REALIZE gastric band was 8.9%. The most common serious adverse event was band slippage, which affected 6.9% of the study population. The mean %EWL was 35.6% ± 26.84%, and the decrease in mean BMI was -7.01 ± 5.45 kg/m2 at 5 years. Patients experienced improvements in mean glycated hemoglobin and serum lipid levels, in addition to improvements in the quality of life measures. CONCLUSION: No new safety concerns were identified during the 5 years of follow-up. Although the results of this study did not meet the predefined safety criteria of 8% or less, the safety profile and long-term effectiveness observed in this study are consistent with those in the current literature.

Safety and effectiveness of Realize adjustable gastric band: 3-year prospective study in the United States.

BACKGROUND: The effectiveness and safety of bariatric surgery using laparoscopic adjustable gastric bands have been demonstrated in numerous published studies. We present the results of the first U.S. multicenter trial of the Realize adjustable gastric band, a laparoscopic adjustable gastric band previously available only outside the United States as the Swedish adjustable gastric band. METHODS: A total of 405 morbidly obese patients were screened at 12 different centers from May to November 2003 to participate in a prospective, single-arm study of the safety and effectiveness of the laparoscopically implanted Realize band. Changes in excess body weight, the parameters of diabetes and dyslipidemia, and the incidence of complications were assessed at 3 years of follow-up. RESULTS: Of the 405 patients, 276 (78.3% women and 61.2% white) qualified for the study. The average age was 38.6 + or - 9.4 years (range 18-61), and the preoperative body mass index was 44.5 + or - 4.7 kg/m(2). The mean hospital stay was 1.2 + or - 1.3 days. At 3 years, the average excess weight loss was 41.1% + or - 25.1% or a decrease in the body mass index of 8.2 kg/m(2) (18.6%) (P < .001). In diabetic patients with a baseline elevated hemoglobin A(1)c level, the level decreased by 1% (P < .001). The total cholesterol, low-density lipoprotein cholesterol, and triglycerides decreased by 9%, 16%, and 50%, respectively (P < .001), and the high-density lipoprotein cholesterol increased by 25% (P < .001) in patients with abnormal baseline values. One patient required conversion to an open surgical technique. No 30-day mortality occurred. The complication frequencies were generally low and included esophageal dysmotility in 0.4%, late balloon failure in 0.4%, band erosion in 0.4%, slippage in 3.3%, esophageal dilation in 3.3%, pouch dilation in 3.6%, catheter kinking in 1.1%, port displacement in 2.5%, and port disconnection in 4.3%. Reoperations were required in 15.2% of the patients and involved 2 band replacements, 9 band revisions, 5 port replacements, 22 port revisions, and 4 explants. CONCLUSION: The results of our study have shown that the Realize adjustable gastric band is safe and effective in a diverse U.S. population of morbidly obese patients. Significant weight loss was achieved throughout the 3 years of follow-up, with corresponding improvements in the indicators of diabetes and dyslipidemia.

Ethnic differences in obesity and surgical weight loss between African-American and Caucasian females.

BACKGROUND: In the general population, African-American females are more obese and resistant to weight loss than Caucasian women. In the present study, we examined the severity of obesity among morbidly obese African-American and Caucasian females, studied the effectiveness of Roux-en-Y gastric bypass (RYGBP), and sought to identify factors contributing to obesity and weight loss. METHODS: The study population included 153 morbidly obese females randomly selected from our general bariatric patient population. Anthropometric measurements consisted of body weight, body mass index (BMI), excess weight, and waist, hip, thigh, and neck circumferences. Factors that may contribute to obesity included age, age of obesity onset, number of childbirths, calorie intake, diet composition, and degree of psychological distress. The effects of RYBGP were studied in weight-matched groups of African-American and Caucasian females (n=37 per group) at weight loss nadir, i.e. 12 to 18 months after surgery. RESULTS: We found that morbid obesity is more severe among African-American than Caucasian females. The greater degree of obesity of African-American, as compared to Caucasian, females is not due to ethnic differences in calorie intake, diet composition, age or age of obesity onset, number of childbirths, and psychological distress. RYGBP is less effective in reducing body fat and, consequently, excess body weight of the African-American than the Caucasian females, suggesting possible ethnic differences in fat metabolism. CONCLUSION: African-American females with morbid obesity have greater adiposity than do Caucasian women and lose significantly less body fat after RYGBP.