Clinical surgery–American
Emerging endoluminal therapies for gastroesophageal reflux disease: adverse events

Presented in part at the Southwestern Surgical Congress annual meeting, San Antonio, TX, April 10–12, 2005
https://doi.org/10.1016/j.amjsurg.2006.01.055Get rights and content

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.

Section snippets

Materials and Methods

The Manufacturer and User Facility Device Experience (MAUDE) Database from the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health Web site was used for this study [13]. This database consists of all user facility reports, voluntary reports, distributor reports, and manufacturer reports. The search was performed in April of 2005.

The MAUDE database was searched to examine all adverse events reported for the 4 specific emerging endoluminal therapies listed in

Results

There were a total of 50 adverse events reported for the 4 therapies. Half of the complications were found in the injection-based therapy. Table 2 lists the complications and classifies them as major or minor.

There were 8 deaths reported (3 in the radiofrequency ablation–based group and 5 in the injection-based group). Most (64%) of these adverse events resulted in hospitalizations and 10% of these patients required surgery. Postprocedure hemorrhage required 2 patients to receive a transfusion

Conclusions

These data show that adverse events do occur after endoluminal therapies for GERD; both major complications and death have occurred with these devices. Unfortunately, a true incidence of these complications is not calculated from these numbers. The denominator is difficult to obtain because even the manufacturers usually only keep sales data and not necessarily patient-use data. It has been estimated that approximately 3150 EndoCinch (C. R. Bard, Inc., Billerica, MA), 6000 Stretta, and 1700

References (22)

  • P.J. Kahrilas

    Surgical therapy for reflux disease

    JAMA

    (2001)
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