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A New Biomechanical Device to Augment Lower Esophageal Sphincter (Les) Continence in Patients with Gastroesophageal Reflux Disease (Gerd). Initial Results of a Pilot Clinical Trial
Luigi Bonavina*1, Greta Saino1, Davide Bona1, Tom R. Demeester2, John C. Lipham2, Robert a. Ganz3, Daniel H. Dunn3
1Department of Surgery, University of Milano, IRCCS Policlinico San Donato, Milano, Italy; 2University of Southern California, Los Angeles, CA; 3Abbott Northwestern Hospital, Minneapolis, MN
Background: The high prevalence of GERD and the growing public awareness of the related malignant complications continue to generate new, minimally invasive treatments for this disease. Recently, a biomechanical device (Torax Medical, Inc. Minneapolis, MN) designed to augment LES strength has been developed and tested in animal models. The Magnetic Esophageal Sphincter (MES) deploys magnetic attraction forces, in a circular fashion, to precisely augment the LES. The forces can attenuate to accommodate swallow and belch functions. A multi-center pilot clinical study was designed to develop a minimal dissection technique for laparoscopic implantation of the device and to assess the clinical and functional outcome of the procedure.
Methods: The study was approved by the Ministry of Health and the local Ethical Committee. Patients with typical reflux symptoms responding to PPI, abnormal esophageal acid exposure, <3cm sliding hiatal hernia, and normal esophageal peristalsis were enrolled in the study. All patients had the MES device placed laparoscopically around the esophagus at the GE junction. A sizing tool was used to determine the outer circumference of the esophagus and the size of device to be used. The surgical approach involved partial dissection of the phreno-esophageal ligament and exclusion of the posterior vagus nerve. The fundus and short gastric arteries were left intact in all patients. After the procedure, position and function of the device were evaluated with barium esophagram. Upper endoscopy and 24-hour esophageal pH monitoring were planned at 3 months postoperatively.
Results: In our center, since March 13, 2007, 19 patients underwent laparoscopic MES device implantation. Operative time ranged from 24 to 84 minutes. No operative complications were recorded. A free diet was allowed after radiological assessment of esophageal transit on post-operative day 1, and patients were discharged within 48 hours. No migrations nor erosions of the device occurred. All patients stopped using proton pump inhibitors and other antireflux medications. 6/6 patients were found to have complete normalization of 24-hour pH at 3 months after operation.
Conclusions: Laparoscopic implantation of the MES is safe and requires a minimal surgical dissection compared to the conventional Nissen fundoplication. Control of reflux symptoms and complete normalization of pH occurred in all tested patients. Further follow-up of these patients is eagerly awaited.
