Evaluation of the Swedish adjustable gastric band VC (SAGB-VC) in an Australian population: early results.

BACKGROUND: The Swedish adjustable gastric band VC (SAGB-VC) has been in use in Australia since 2007. We evaluated its efficacy and safety. METHODS: We retrospectively analyzed the prospective clinical data of patients who received the implant between November 2007 and June 2009 at 3 Australian bariatric centres. RESULTS: In all, 1176 patients (mean age 45.9 [standard deviation (SD) 12.3] yr, mean body mass index 43.4 [SD 7.6]) received the SAGB-VC. At a mean follow-up of 11 (SD 3) months, weight reduced by a mean of 18.4 (SD 11.1) kg with an excess weight loss of 37.8% (SD 19.9%). Body mass index decreased (from mean 43.4 [SD 7.7] to mean 36.7 [SD 6.5], p < 0.001). Type 2 diabetes (T2DM) was reported in 167 patients and hypertension in 373. Improvement occurred in 73.5% of patients with T2DM and 31% with hypertension, with patient-reported reduction or cessation of medication. Metabolic syndrome indices improved during follow-up: high-density lipoprotein cholesterol (mean 1.3 [SD 0.3] v. mean 1.4 [SD 0.3] mmol/L, p < 0.001), triglycerides (mean 1.6 [SD 0.8] v. mean 1.3 [SD 0.7] mmol/L, p < 0.001), waist circumference (men 141 [SD 103] to 121 [SD 15] cm, women 117 [SD 14] to 105 [SD 14] cm, both p < 0.001), C-reactive protein (90.5 [SD 75.2] v. 53.3 [SD 61.9] nmol/L, p < 0.001). The complication rate was 4.2%. CONCLUSION: The SAGB-VC is safe and effective for treating obesity and its comorbidities. The results are reproducible in separate Australian centres and consistent with published literature.

International multicenter study of safety and effectiveness of Swedish Adjustable Gastric Band in 1-, 3-, and 5-year follow-up cohorts.

BACKGROUND: No long-term, international, multicenter studies of the effectiveness and safety of the SAGB in morbid obesity have been previously published. The objective of this study was to assess the effectiveness and safety of the Swedish Adjustable Gastric Band (SAGB) at 6 bariatric centers in Australia, Europe, and Brazil, with < or =5 years of follow-up; the effect on patient covariates; and changes in co-morbidity. METHODS: A 2-phase study design was used, involving both retrospective and prospective data. SAGB was implanted by way of the pars flaccida 1, 3, and 5 years previously. The retrospective phase entailed a review of the records. The prospective phase included a subset of eligible patients who agreed to undergo additional clinical assessments. The percentage of excess weight loss (%EWL), patient level predictors, change in co-morbidities, and complications were analyzed. RESULTS: A total of 481 patients in 3 mutually exclusive follow-up cohorts (1 yr, n = 200; 3 yr, n = 184; 5 yr, n = 97) participated in the present study. Of these 481 patients, 339 (1 yr, n = 139; 3 yr, n = 131; 5 yr, n = 69) underwent prospective evaluations. The mean %EWL was 43.5% + or - 21.8%, 57.7% + or - 25.9%, and 49.8% + or - 27.6% and the mean change in body mass index was -7.64, -10.75, and -9.52 in the 1-, 3-, and 5-year cohorts, respectively (P <.001). Gender and age did not predict the %EWL; however, a greater preoperative body mass index was inversely related to the %EWL. Longer postimplantation times were associated with greater improvement in co-morbidities and with greater frequencies of reoperation. Fewer than 15% of the patients in the 5-year cohort had undergone band removal and 10% required band revisions. No fatal or life-threatening complications occurred. CONCLUSION: SAGB is safe and effective in inducing weight loss and improvement of co-morbidities in morbidly obese patients at international bariatric centers at 1, 3, and 5 years postoperatively.