LAP-BAND for BMI 30-40: 5-year health outcomes from the multicenter pivotal study

JB Dixon, LL Eaton, V Vincent, R Michaelson

Research output: Contribution to journalArticleResearchpeer-review

13 Citations (Scopus)

Abstract

We performed a 5-year multicenter study to evaluate the safety and effectiveness of the LAP-BAND System surgery (LBS) in patients with obesity with a body mass index (BMI) of 30-39.9 kg m-2. This pivotal study was designed to support LBS application to the US Food and Drug Administration for broadening the indications for surgery and the lower BMI indication was approved with 1-year data in 2011, with the intention to complete the 5-year evaluation.Objectives:To present broad health outcome data including weight change, patient reported outcomes, comorbidity change and complications during the 5-year study.Setting:The study was conducted at seven US private practice clinical trial sites.Methods:We enrolled 149 BMI 30-39.9 subjects into a 5-year, multicenter, longitudinal, prospective post-approval study. Data for those completing each time point are presented.Results:The predefined target of at least 30% excess weight loss was achieved by more than 76% of subjects by 1-year and at every year thereafter during the 5-year study. Mean percentage weight loss at 5 years was 15.9±12.4%. Sustained weight loss was accompanied by sustained improvement in generic and weight-specific quality of life, symptoms of depression and the prevalence of binge-eating disorder. The number of subjects with normal fasting triglyceride, high-density lipoprotein cholesterol, plasma glucose and HbA1c increased significantly between baseline and 5 years. Fifty-four months after LBS implantation, the rate of device explants without replacement was 5.4%; however, the rate of explants increased to 12.1% by month 60 owing to no cost-elective band removals offered to subjects at study exit. No deaths or unanticipated adverse device effects were reported.Conclusions:The LBS is safe and effective for people with BMI 30-39.9 with demonstrated improvements in weight loss, comorbidities and quality of life, and with a low explant rate through 5 years following treatment.

Original languageEnglish
Pages (from-to)291-298
Number of pages8
JournalInternational Journal of Obesity
Volume40
Issue number2
DOIs
Publication statusPublished - Feb 2016
Externally publishedYes

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