Early results with a new telemetrically adjustable gastric banding.

BACKGROUND: It has already been demonstrated that laparoscopic adjustable gastric banding (LAGB) is a safe and effective alternative to other permanent bariatric surgery techniques. Although clinical complications have been managed through improvements in surgical techniques, port-related complications and adjustment process inefficiencies have persisted. To reduce and manage these issues, a new type of gastric band has been developed which uses telemetric technology to eliminate the use of hydraulic ports and simplify the overall gastric band adjustment procedure. METHODS: From June 2005 to October 2005, 37 patients were implanted in two German academic centers with the Easyband telemetrically adjustable gastric band (Endoart S.A., Lausanne, Switzerland), using standard gastric banding laparoscopic technique. Prospective data was collected and analyzed for a minimum of 6 months on all morbidly obese patients who underwent laparoscopic telemetrically adjustable gastric banding. RESULTS: Data on 37 patients was analyzed. The mean percent excess weight loss was 10.2% at 1 month, 21.6% at 3 months, and 29.4% at 6 months. In 12 hypertensive patients, the systolic blood pressure decreased from 143 +/- 24 mmHg at baseline to 131 +/- 10 mmHg after 6 months. Diastolic pressure did not change significantly. In all 5 patients with diagnosed type 2 diabetes, the fasting blood glucose normalized after 6 months (135 mg/dl at baseline, 81 mg/dl at month 6). CONCLUSION: These early results of the new telemetrically adjustable gastric banding device indicate clinical safety and efficacy comparable to that achieved by other commercially available gastric bands. Additional multi-center studies with long-term follow-up are recommended to confirm the benefits of telemetrically adjustable gastric banding.

Initial clinical experience with telemetrically adjustable gastric banding.

BACKGROUND: The feasibility and safety of laparoscopic adjustable gastric banding for treatment of morbid obesity has been demonstrated in a large number of studies. Access port-related complications constitute a significant part of all complications related to gastric banding. Further, adjustment of hydraulic gastric bands can be fairly lengthy, uncomfortable, and is not a precise procedure. A study was performed to assess the usefulness and efficacy of a new type of band adjusted telemetrically without the need for an access port. The initial worldwide results of the first telemetrically adjustable gastric band for morbid obesity (EASYBAND EndoArt Medical Technologies, Switzerland) in two German academic centers are described herein. METHODS: EASYBAND is a purely mechanical gastric band, in which adjustment is achieved by means of an embedded micromotor, controlled by an external control unit using telemetry. The exact band diameter is displayed continuously during adjustment on the external control unit screen. Thirty-seven patients, means 36 +/- 8 (range: 22-60) years, 7 (19%) men and 30 (81%) women, with a mean body mass index (BMI) of 44.1 +/- 4.5 (range: 35.6-59.6), were implanted using the standard laparoscopic technique during the period from June 2005 to October 2005. Prospective data were collected on all morbidly obese patients who underwent laparoscopic telemetrically adjustable gastric banding (LTAGB). RESULTS: No serious adverse events occurred during the operative period or immediately postoperatively in relation to the device. A mean of 3.0 +/- 0.6 adjustments per patients were performed during the follow-up schedule at one, three and six months. The band diameter was set to 29 mm (fully open) at implantation, 24.5 mm +/- 0.5 mm at one month, 23.3 mm +/- 0.7 mm at three months, and 23.0 mm +/- 1.0 mm at six months. The mean percent excess weight loss was 10.2% +/- 4.5% at one month, 23.8% +/- 8.8% at three months, and 30.2% +/- 10.5% at six months. CONCLUSION: This initial study shows that the new telemetrically adjustable gastric banding device is implanted and operated safely, allows for atruamatic band adjustments with superior patient comfort, and leads to early excess weight loss comparable to that achieved by other gastric bands. Longer-term follows and larger population studies are needed to establish the final safety and performance profile of the telemetric gastric band.