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.


CONCLUSIONS
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.
Toouli
James
J
Department of Surgery, Flinders University of South Australia, Flinders Medical Centre, Bedford Park, South Australia 5042, Australia.
Kow
Lillian
L
Ramos
Almino C
AC
Aigner
Franz
F
Pattyn
Piet
P
Galvão-Neto
Manoel P
MP
Miller
Karl A
KA
Romano
Stefania
S
Gutierrez
Mario
M
Jokinen
Jeremy
J
D000328:Adult; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D015391:Gastroplasty / Q000295:instrumentation; D006801:Humans; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000150:complications / Q000601:surgery*; D016896:Treatment Outcome; D015431:Weight Loss; D055815:Young Adult