Background:
Current safety data on the LAP-BAND® adjustable gastric banding system (LBS) is mixed, with early data and some current data indicating high rates of re-operations and explants. This study was designed in conjunction with the USFDA to evaluate the real-world safety and effectiveness of the LBS for 5 years following implantation.
Objective:
To explore whether the LBS explanation rate over the first 5 years was significantly lower than a historic rate criterion of 39.4%.
Methods:
This is a prospective, longitudinal, multicentre study conducted in U.S. and Canada on patients who decided to undergo implantation of LBS from 2009 to 2016. 652 patients with BMI > 40 kg/m2 or BMI >35 kg/m2 with one or more comorbid conditions were included. Duration of follow-up was 5 years. The primary outcome was percentage of subjects who had LBS explant over 5 years. Secondary outcomes include reoperation rate, clinical and biochemical measures and patient reported outcome measures over 5 years.
Results:
79.3% were female, with mean age of 44 years and mean BMI of 45.4 kg/m2. Primary endpoint was met with explant rate of 8.74% (95% CI: 6.6-10.9%) at 5 years. The rates for completer only analysis and imputed missing data analysis were 12.81% (95% CI: 9.7-15.9%) and 12.85% (95% CI: 10.2-15.5%) respectively. All were significantly lower than the historic rate of 39.4% (p<0.001). Sixty two reoperations or surgical revisions were performed in 50 subjects (7.7%). Mean weight loss of 18.7% was maximally achieved by 2 years, and weight loss was maintained through to 5 years. All patient-reported outcomes and quality of life measures showed improvement following LBS treatment, maintained through to 5 years.
Conclusion:
The HERO study validates the long-term safety and effectiveness of LBS for the treatment of patients with obesity and its related conditions.