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Brücken bauen – von der Evidenz zum Patientenwohl: 19. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin e. V.

Deutsches Netzwerk Evidenzbasierte Medizin e. V.

08.03. - 10.03.2018, Graz

Electric stimulation therapy (EST) in patients with gastroesophageal reflux disease (GERD)

Meeting Abstract

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  • author presenting/speaker Michal Stanak - Ludwig Boltzmann Institute für HTA; Universität Wien
  • Katharina Hawlik - Ludwig Boltzmann Institut für Health Technology Assessment

Brücken bauen – von der Evidenz zum Patientenwohl. 19. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin. Graz, Österreich, 08.-10.03.2018. Düsseldorf: German Medical Science GMS Publishing House; 2018. Doc18ebmP7-11

doi: 10.3205/18ebm137, urn:nbn:de:0183-18ebm1379

Published: March 6, 2018

© 2018 Stanak et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at



Introduction: Electric stimulation therapy (EST) represents a novel method for the surgical treatment of Gastroesophageal reflux disease (GERD). The EST comprises of three components: a bipolar stimulation lead with two stitch electrodes, an implantable pulse generator, and an external programmer [1]. The EST implant procedure is performed using standard laparoscopic techniques where a pair of electrodes is placed in the anterior part of the lower esophagus and sutured in place [2]. The wires are then connected to a stimulator placed in the subcutaneous pocket in left upper quadrant of the abdominal wall [2]. The goal of the intervention is to reinforce the weak lower esophageal sphincter (LES) by delivering mild elec­trical signals to the LES throughout the day. The stimulation aims to restore normal function of the LES, preventing reflux from the stomach entering the esophagus.

Methods: The EUnetHTA Core Model for Rapid Relative Effectiveness was the main source for selecting relevant assessment elements. We conducted a systematic literature search (without restriction on publication date) in bibliographic databases (Medline via Ovid, Embase, the Cochrane Library, PubMed, database of the Centre for Reviews and Dissemination) to anwer the research questions in the domains effectiveness and safety. Two researcher selected the relevant documents (in English) independently. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used for qualitatively summarising the results for the domain: „Safety”. For analysing clinical effectiveness, prospective controlled studies were included. For analysing safety, prospective controlled and uncontrolled studies were in­cluded.

Results: A total of two single-arm prospective case series and one prospective registry were eligible for inclusion in the current report. Overall, safety was evaluated in the total of 70 patients. No study fulfilled the study inclusion criteria for assessing clinical effectiveness of the EST.

In the absence of data from controlled studies, no comparisons can made between the EST and the surgical alternative treatment, laparoscopic fundoplication (LF). Device and procedure related complications were reported in one study with 6 months follow-up [3]. Lead erosion through esophagus occurred in 2.4% out of 42 patients and was followed by the device explantation. One procedure related complication, trocar perforation of the small bowel during laparoscopy, occurred also in 2.4% out of 42 patients. No other device or procedure related complications were reported.

A number of short-term post-operative harms occurred. The following adverse events occurred in one study [3] (in% of patients): constipation 2.4%, epigastric pain 2.4%, hiccups 4.8%, inability to vomit 4.8%, and fever 2.4%. The following adverse events occurred in both case series [3], [4] (in% of patients): post-operative bloating/belching in 7.1% and 0%, post-operative dysphagia in 9.5% and 0%, nausea/vomiting in 7.1% and 12%, and pain/discomfort in 45.2% and 20%. No new adverse events occurred in the registry study.

Conclusion: The current evidence is not sufficient to prove that the EST is at least equally effective and as safe as the comparator LF. There are no available comparative data on the two procedures or placebo controlled data on the EST and hence, no conclusions are made about the device effectiveness. Concerning safety, only device related complications were reported based upon data from prospective case series. These suggest a relatively safe profile of the EST that, however, needs to be confirmed by a high quality RCT, which will potentially influence the effect estimate considerably.


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