Long-term results of electrical stimulation of the lower esophageal sphincter for treatment of proximal GERD
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Electrical stimulation of the lower esophageal sphincter (LES) in gastroesophageal reflux disease (GERD) patients, using EndoStim® LES stimulation system (EndoStim BV, the Hague, Netherlands), enhances LES pressure, decrease distal esophageal acid exposure, improves symptoms, and eliminates the need in many patients for daily GERD medications.
To evaluate, in a post hoc analysis, the effect of LES stimulation on proximal esophageal acid exposure in a subgroup of patients with abnormal proximal esophageal acid exposure.
Nineteen patients (median age 54 years; IQR 47–64; men-10) with GERD partially responsive to proton pump inhibitors (PPI), hiatal hernia ≤3 cm, esophagitis ≤LA grade C underwent laparoscopic implantation of the LES stimulator. LES stimulation at 20 Hz, 215 μs, 5–8 m Amp sessions was delivered in 6–12, 30 min sessions each day. Esophageal pH at baseline and after 12-months of LES stimulation was measured 5 and 23 cm above the manometric upper border of LES.
Total, upright and supine values of median (IQR) proximal esophageal pH at baseline were 0.4 (0.1–1.4), 0.6 (0.2–2.3), and 0 (0.0–0.2) %, respectively, and at 12 months on LES-EST were 0 (0–0) % (p = 0.001 total and upright; p = 0.043 supine comparisons). 24-hour distal esophageal acid exposure improved from 10.2 (7.6–11.7) to 3.4 (1.6–7.0) % (p = 0.001). Seven (37 %) patients had abnormal (>1.1 %) 24-hour proximal acid exposure at baseline; all normalized at 12 months (p = 0.008). In these 7 patients, total, upright, and supine median proximal acid exposure values at baseline were 1.7 (1.3–4.1), 2.9 (1.9–3.7), and 0.3 (0–4.9) %, respectively, and after 12 months of LES-EST were 0 (0–0.0), 0 (0–0.1), and 0 (0–0) % (p = 0.018 total and upright; p = 0.043 supine comparisons). Distal esophageal pH for this group improved from 9.3 (7.8–17.2) at baseline to 3.2 (1.1–3.7) % at 12-months (p = 0.043). There were no GI side effects such as dysphagia, gas-bloat or diarrhea or device or procedure related serious adverse events with LES-EST. There was also a significant improvement in their GERD-HRQL scores.
LES-EST is associated with normalization of proximal esophageal pH in patients with GERD and may be useful in treating those with proximal GERD. The LES-EST is safe without typical side effects associated with traditional antireflux surgery.
KeywordsGERD Electrical stimulation Surgical treatment Proximal GERD
Study Sponsor—EndoStim BV, The Hague, Netherlands provided funding for the trial. Prof. Michael D Crowell and Blair Jobe are consultant for EndoStim Inc. Prof. Edy Soffer is a stock holder in EndoStim Inc. Remaining study authors or their immediate family has no financial relationship with the sponsor that would constitute a conflict of interest.
Supplementary material 1 (WMV 104242 kb)
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