Handgraaf H.J.M.,Atrium Medical |
Ashton D.,Healthier Weight Centres |
Favretti F.,San Bortolo Regional Hospital |
Segato G.,San Bortolo Regional Hospital |
And 3 more authors.
Background: Access port problems after laparoscopic adjustable gastric banding can be significant complications. The Easyband™ is an innovative type of gastric band, whose internal diameter can be adjusted by a telemetrically activated motor. The aim of this study was to evaluate safety, efficacy and performance of the Easyband™. Methods: A total of 110 morbidly obese patients were prospectively enrolled. The Easyband™ was implanted laparoscopically by experienced bariatric surgeons in six different hospital locations. Patient characteristics, surgery details, postoperative weight loss, and complications were recorded. Follow-up lasted 2 years. Results: Follow-up was completed by 78.2 % of the patients. Surgeons rated 71 % of each aspect of Easyband™ implantation as “easy” or “very easy”. Adjustments were successful in 91 % of the attempts. One or more adverse events occurred in 79.1 % of the patients. Thirty-six serious adverse events were reported, of which 50 % was device-related. One or more functional tests failed in 20.9 % of the devices, 8.2 % passed after a repeated test. A reintervention was necessary in 15.5 % of the patients. Mean weight loss after 2 years was 24.2 ± 14.0 kg, mean excess weight loss was 46.1 ± 24 %. Conclusion: Excess weight loss with the Easyband™ was comparable with other gastric banding devices. Adjustment of the device was simple, non-invasive and more acceptable to patients than with a standard access port. However, a high incidence of device-related problems requiring surgical explantation occurred. The Easyband™ represents a major advance in gastric band design, but significant technical problems need to be resolved before further implants can be recommended. © 2015, Springer Science+Business Media New York. Source