Safety analysis of first 1000 patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease.

Antireflux surgery with a magnetic sphincter augmentation device (MSAD) restores the competency of the lower esophageal sphincter with a device rather than a tissue fundoplication. As a regulated device, safety information from the published clinical literature can be supplemented by tracking under the Safe Medical Devices Act. The aim of this study was to examine the safety profile of the MSAD in the first 1000 implanted patients. We compiled safety data from all available sources as of July 1, 2013. The analysis included intra/perioperative complications, hospital readmissions, procedure-related interventions, reoperations, and device malfunctions leading to injury or inability to complete the procedure. Over 1000 patients worldwide have been implanted with the MSAD at 82 institutions with median implant duration of 274 days. Event rates were 0.1% intra/perioperative complications, 1.3% hospital readmissions, 5.6% endoscopic dilations, and 3.4% reoperations. All reoperations were performed non-emergently for device removal, with no complications or conversion to laparotomy. The primary reason for device removal was dysphagia. No device migrations or malfunctions were reported. Erosion of the device occurred in one patient (0.1%). The safety analysis of the first 1000 patients treated with MSAD for gastroesophageal reflux disease confirms the safety of this device and the implantation technique. The overall event rates were low based on data from 82 institutions. The MSAD is a safe therapeutic option for patients with chronic, uncomplicated gastroesophageal reflux disease.

The future of gastroenterology in the era of managed care.

Specialty practice in general, and gastroenterology in particular, is undergoing significant transformation as we head into the new millennium. Gastroenterologists will need to adapt to the continued evolution and consolidation of managed care. Among other issues, gastroenterologists will need strategies for dealing with pricing pressures, changing technology, increased consumerism, a perceived specialist oversupply, and a rapidly aging population. These and other developments will drive a myriad of physician responses in an effort to confront changing practice realities.

Integrated delivery systems and the gastroenterologist.

This article describes the current managed care environment for gastroenterologists, and also explains the various merger and networking options that are currently available. The article contains a detailed discussion of regional versus national merger options. Specific integration models are outlined for forming a regional, single-specialty, gastroenterology network.