Atul K Madan1, Craig A Ternovits, David S Tichansky. 1. Department of Surgery, University of Tennessee Health Science Center, 956 Court Ave., Room G210, Memphis, TN 38163, USA. amadan@utmem.edu
Abstract
BACKGROUND: Endoluminal therapies are emerging as a new therapeutic option for the treatment of gastroesophageal reflux disease (GERD). Many of these endoluminal therapies are touted as short outpatient procedures with minimal complications. It is thought that these complications are uncommon and minor. This investigation sought to summarize the adverse events of these endoluminal therapies for the treatment of GERD. METHODS: The Manufacturer and User Facility Device Experience Database for the U.S. Food and Drug Administration's Center for Devices and Radiological Health Web site was searched to examine all voluntary adverse events reported on emerging endoluminal therapies. The adverse events can be divided into 3 categories: (1) radiofrequency ablation based, (2) injection based, and (3) suture based. RESULTS: There were a total of 50 adverse events reported on 4 specific therapies. Half of the complications were found to result from injection-based therapy and 44% of the complications were found to result from radiofrequency ablation-based therapy. There were 8 deaths reported (5 in the injection-based group and 3 in the radiofrequency ablation-based group). Sixty-four percent of the adverse events resulted in hospitalizations and 10% of these patients required surgery. CONCLUSIONS: Physicians must be aware that no endoluminal therapy is truly noninvasive. Complications and even deaths are associated with these treatments for GERD. Patients must be informed of all the potential risks and complications of these new technologies.
BACKGROUND: Endoluminal therapies are emerging as a new therapeutic option for the treatment of gastroesophageal reflux disease (GERD). Many of these endoluminal therapies are touted as short outpatient procedures with minimal complications. It is thought that these complications are uncommon and minor. This investigation sought to summarize the adverse events of these endoluminal therapies for the treatment of GERD. METHODS: The Manufacturer and User Facility Device Experience Database for the U.S. Food and Drug Administration's Center for Devices and Radiological Health Web site was searched to examine all voluntary adverse events reported on emerging endoluminal therapies. The adverse events can be divided into 3 categories: (1) radiofrequency ablation based, (2) injection based, and (3) suture based. RESULTS: There were a total of 50 adverse events reported on 4 specific therapies. Half of the complications were found to result from injection-based therapy and 44% of the complications were found to result from radiofrequency ablation-based therapy. There were 8 deaths reported (5 in the injection-based group and 3 in the radiofrequency ablation-based group). Sixty-four percent of the adverse events resulted in hospitalizations and 10% of these patients required surgery. CONCLUSIONS: Physicians must be aware that no endoluminal therapy is truly noninvasive. Complications and even deaths are associated with these treatments for GERD. Patients must be informed of all the potential risks and complications of these new technologies.