Henricus J M Handgraaf1, David Ashton2, Franco Favretti3, Gianni Segato4, Bert van Ramshorst5, Berry Meesters6, Jan Willem M Greve7. 1. Department of Surgery, Atrium Medical Center Parkstad, Henri Dunantstraat 5, 6419 PC, Heerlen, The Netherlands. h.j.m.handgraaf@lumc.nl. 2. Healthier Weight Centres, 22 Upper Wimpole Street, London, W1G 6NB, UK. david.ashton@healthierweight.co.uk. 3. Department of Surgery, San Bortolo Regional Hospital, Viale Ferdinando Rodolfi, 37, Vicenza, 36100, Italy. ffavretti@gmail.com. 4. Department of Surgery, San Bortolo Regional Hospital, Viale Ferdinando Rodolfi, 37, Vicenza, 36100, Italy. gsegat@tin.it. 5. Department of Surgery, St. Antonius Hospital, P.O. Box 2500, Nieuwegein, 3430EM, The Netherlands. b.ramshorst@antoniusziekenhuis.nl. 6. Department of Surgery, Atrium Medical Center Parkstad, Henri Dunantstraat 5, 6419 PC, Heerlen, The Netherlands. b.meesters@atriummc.nl. 7. Department of Surgery, Atrium Medical Center Parkstad, Henri Dunantstraat 5, 6419 PC, Heerlen, The Netherlands. j.greve@ah.unimaas.nl.
Abstract
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.
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 obesepatients 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.
Authors: Rudolf A Weiner; Michael Korenkov; Esther Matzig; Sylvia Weiner; Woiteck K Karcz; Theodor Junginger Journal: Obes Surg Date: 2007-06 Impact factor: 4.129