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Endostim safe, effective for certain patients with persistent GERD symptoms
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WASHINGTON — Electrical stimulation of the lower esophageal sphincter using the Endostim LES Stimulation System was safe and effective for treating carefully selected patients with persistent GERD symptoms despite proton pump inhibitor therapy, according to interim data from the LESS-GERD registry presented here.
“Electrical stimulation of the lower esophageal sphincter (LES) has been shown to be effective in animal and human studies,” Joachim Labenz, MD, of Diakonie Klinikum in Germany, said during his presentation. “It leads to a measurable normalization of acid reflux through improvement of LES function. It is effective in the long-term — 4-year studies have been published. It is safe in trials, with no dysphagia occurring after the implantation, and it is reversible. However, data from routine clinical practice is still missing.”
Therefore, Endostim launched the international, prospective, web-based LESS-GERD registry to evaluate patients undergoing LES electrical stimulation in routine practice for disruptive GERD symptoms despite daily PPI use through 5 years of follow-up. As of February 2018, 268 patients from 20 centers across seven countries in Europe and Latin America were enrolled.
Heartburn and regurgitation symptoms improved significantly at 1, 2 and 3 years (P <.001 at all time points vs. baseline).
Labenz noted that 53% of patients had moderate to severe regurgitation at baseline, which dropped to 23% at 3 months to 6 months and 20% at 12 months. Additionally, median 24-hour esophageal acid exposure improved in a small number of patients with esophageal pH testing data available. Notably, 60% to 70% of patients were able to completely stop PPI use, and sleep quality improved significantly through 24 months. The incidence of dysphagia was also reduced overall at each time point vs. baseline.
Seventeen serious adverse events related to the device occurred in 16 patients for a rate of 6%, five of which resulted in device explantation.
“Electrical stimulation of the lower esophageal sphincter is safe and effective in routine clinical practice,” Labenz concluded. “Results are similar to outcomes from clinical trials as reported so far. We saw improved quality of life, elimination or significant reduction in heartburn and regurgitation, improvement or normalization of esophageal acid exposure in a subset of patients, control of extraesophageal symptoms, and elimination or significant reduction of PPI medication use; two-thirds of the patients could stop PPI treatment. So electrical stimulation is a viable treatment option for well-selected GERD patients with bothersome symptoms on PPI.” – by Adam Leitenberger
Reference:
Labenz J, et al. Abstract 443. Presented at: Digestive Disease Week; June 2-5, 2018; Washington, D.C.
Disclosures: Labenz reports financial relationships with Endostim, AstraZeneca, Reckitt Benckiser, Pfizer and Torax. Please see the DDW faculty disclosure index for a list of all other authors’ relevant financial disclosures.
Perspective
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Kenneth DeVault, MD, FACG
Most patients with symptoms of GERD can have their symptoms and mucosal disease well controlled using medical therapy with PPIs, but a portion will suffer from ongoing symptoms despite that therapy, even when increased to twice daily. Appropriately evaluated patients with well-established pathologic reflux may respond to reflux surgery using either a fundoplication or, more recently with an implantable magnetic sphincter. The Endostim is a new technology that uses electrical stimulation of the lower esophageal sphincter to decrease GERD. This study reported an improvement in symptoms (particularly regurgitation) after Endostim that has persisted for up to 3 years with many patients stopping PPI.
One criticism of many endoscopic methods to treat reflux is the disconnect between symptom improvement and acid control as demonstrated by ambulatory pH testing. In this report, Endostim seems to also improve symptoms more than acid exposure. In a small subset of patients who had pH testing before and after implant, there was a significant decrease in acid exposure but the mean “after” exposure was 4.5%, which suggests that around half of the patients continued to have pathologic acid exposure. This is certainly an interesting technology that currently is only available in the U.S. as part of a clinical trial. I look forward to the continued report on the outcomes of these long-term patients as well as future studies that could lead toward approval in the U.S.
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