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


OBJECTIVE
To present broad health outcome data including weight change, patient reported outcomes, comorbidity change and complications during the 5-year study.


METHODS
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.
Clinical Obesity Research, Baker IDI Heart and Diabetes Institute, Melbourne, Victoria, Australia.
J B
JB
Dixon
UltaMed Corporation, Huntington Beach, CA, USA.
L L
LL
Eaton
Vernon Vincent Consulting, Santa Barbara, CA, USA.
V
V
Vincent
Northwest Surgical Weight Loss, Everett, WA, USA.
R
R
Michaelson
D000328:Adult; D001786:Blood Glucose; D001794:Blood Pressure; D015992:Body Mass Index; D050171:Dyslipidemias / Q000453:epidemiology / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D015391:Gastroplasty; D006801:Humans; D010535:Laparoscopy; D008137:Longitudinal Studies; D008297:Male; D009767:Obesity, Morbid / Q000453:epidemiology / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D015431:Weight Loss
D001786:Blood Glucose