Faculty Bibliography

BACKGROUND:In 2008, the Realize Band (RB) adopted a precurved design (RB-C). We present 2-year outcomes data from the first multiinstitutional study of RB-C. The objective of this study was to analyze weight loss and safety data from bariatric practices in the United States, including academic, nonacademic, public, and private. METHODS:The study included adult RB-C patients with a preoperative body mass index (BMI)≥40 kg/m(2) or >35 kg/m(2) with co-morbidity. Exclusions included RB-C's label contraindications for use. Outcomes parameters were percent excess weight loss (%EWL), BMI change, number and volume of band adjustments, and adverse events. RESULTS:A total of 231 patients met inclusion/exclusion criteria. Of these, 161 had 24-month data available. Mean %EWL was 44.4%±26.9% (P<.0001). BMI decreased from 44.1±5.7 kg/m(2) to 35.3±6.9 kg/m(2) (P<.0001). Percent EWL varied by preoperative BMI (P = .0002), bariatric practice (P<.0001), aftercare frequency (P = .0004), and band fill frequency (P = .0271), but %EWL was not influenced by gender, race, or age (P>.20 each). Adverse events were dysphagia (21.2%), gastroesophageal reflux (21.6%), and vomiting (30.7%). Incidence of pouch dilation, esophageal dilation, and slippage was ≤1%. Revisions (2.2%) were for unbuckled band, tube kinking, slippage, and suspected band leak (1 each). No erosions, explants, or mortality were reported. CONCLUSION/CONCLUSIONS:RB-C appears to be as well tolerated and effective as the first generation RB for weight loss. The near 45% EWL at 2 years is consistent with other high-quality publications on the RB. Preoperative BMI and frequency of postoperative care, including frequency of band fills, influence %EWL. Significant weight loss is achievable with RB-C despite variable postoperative management practices. The low morbidity and the absence of mortality at 24 months reflect positively on the RB-C characteristics.

BACKGROUND:In 2008, the REALIZE Band (RB) adopted a precurved design (RB-C). The present study is the first multi-institutional report of RB-C outcomes. Our objective was to analyze the 1-year weight loss and safety data from adult RB-C patients treated at multiple U.S. centers (7 typical U.S. bariatric practices, including academic, nonacademic, public, and private practice). METHODS:Patients implanted with the RB-C (preoperative body mass index ≥ 40 kg/m(2) or >35 kg/m(2) with co-morbidity) were recruited. The exclusion criteria included the RB-C label contraindications for use. The outcomes parameters were the percentage of excess weight loss (%EWL), change in body mass index, number and volume of band adjustments, and incidence of complications. RESULTS:Of the 239 patients enrolled in the 2-year study, 158 had 1-year data available for analysis in November 2010. The mean %EWL was 39.2% ± 20.5% (range -7.7 to -116.8, P < .0001). The body mass index decreased from 44.4 ± 5.5 kg/m(2) to 36.4 ± 5.8 kg/m(2) (P < .0001). The variability in the %EWL was significant among the study centers (P < .0001). The average band fill volume at 1 year was 8.0 ± 2.0 mL (range .0-11.1). The total fill volume was >11 mL in 1 patient. No band erosions/migrations, explants, or deaths occurred. CONCLUSION/CONCLUSIONS:RB-C appears to be as safe and effective as the first-generation RB. The near 40% EWL at 1 year was consistent with other high-quality publications of the RB. Good weight loss results are achievable, despite the varying postoperative management practices. The low morbidity and the absence of mortality at 12 months reflect positively on the RB-C characteristics. Our findings suggest that the learning curve, related to the postoperative management of the RB-C, might vary by practice and that a greater frequency and smaller band fills might result in better weight loss at 12 months.