Top 10 Highlights From ACG 2013
Top 10 Highlights From ACG 2013
The next topic is a study that looked at the effect of an electric stimulation device made by EndoStim, a company from The Netherlands. Two presentations were given. A plenary session reported 3- and 6-month follow-up data from 25 patients with mild to moderate reflux disease. They excluded patients with very dysfunctional lower esophageal sphincters (end-expiratory pressures ≤ 5 mm Hg). Patients had positive pH tests, were at least partial responders to proton pump inhibitor therapy, and had only small hiatal hernias (< 3 cm) and erosive esophagitis. Of these 25 milder patients evaluated, 20 had completed 3 months of follow-up, and 17 had completed 6 months. In 88% of these patients, the pH normalized over that period of time. It was quite striking that more than 80% were off of proton pump inhibitors. Two serious adverse events occurred that were not device-related: a trocar perforation and an episode of atrial reentry tachycardia.
An open-label extension study with 2-year follow-up was reported in a poster session. This was the same population of patients. What caught my eye was the improvement in pH. The median 24-hour distal esophageal pH improved from 10.1% at baseline to 4.7% at 2 years; 71% reported normalization or better than 50% reduction in esophageal pH. I don't like that endpoint. Normalization is a well-defined endpoint, and that is what we saw in the 3- and 6-month data. The longer-term data suggest that there may be some waning of effect, so the durability of this needs to be described in subsequent follow-up of that multicenter international trial.
Electrical Stimulation Therapy for Reflux
The next topic is a study that looked at the effect of an electric stimulation device made by EndoStim, a company from The Netherlands. Two presentations were given. A plenary session reported 3- and 6-month follow-up data from 25 patients with mild to moderate reflux disease. They excluded patients with very dysfunctional lower esophageal sphincters (end-expiratory pressures ≤ 5 mm Hg). Patients had positive pH tests, were at least partial responders to proton pump inhibitor therapy, and had only small hiatal hernias (< 3 cm) and erosive esophagitis. Of these 25 milder patients evaluated, 20 had completed 3 months of follow-up, and 17 had completed 6 months. In 88% of these patients, the pH normalized over that period of time. It was quite striking that more than 80% were off of proton pump inhibitors. Two serious adverse events occurred that were not device-related: a trocar perforation and an episode of atrial reentry tachycardia.
An open-label extension study with 2-year follow-up was reported in a poster session. This was the same population of patients. What caught my eye was the improvement in pH. The median 24-hour distal esophageal pH improved from 10.1% at baseline to 4.7% at 2 years; 71% reported normalization or better than 50% reduction in esophageal pH. I don't like that endpoint. Normalization is a well-defined endpoint, and that is what we saw in the 3- and 6-month data. The longer-term data suggest that there may be some waning of effect, so the durability of this needs to be described in subsequent follow-up of that multicenter international trial.
