Electrical stimulation of the lower esophageal sphincter in patients with
gastroesophageal reflux disease is technically feasible and results in a decrease in
symptoms
Boudewijn F. Kessing1, Mark I. van Berge-Henegouwen2, Marlies P. Schijven2, André J.P.M.
Smout1 and Albert J. Bredenoord1
1Department
of Gastroenterology and Hepatology, Academic Medical Center Amsterdam, Amsterdam, Netherlands. 2Department of
Surgery, Academic Medical Center Amsterdam, Amsterdam, Netherlands.
Background: Patients with gastroesophageal reflux disease frequently exhibit excessive amounts of
gastroesophageal reflux episodes caused by LES dysfunction. Electrical stimulation of the LES could,
in theory, restore LES function in patients with LES dysfunction. Recently, a device was developed
which can provide electrical stimulation to the lower esophageal sphincter, the so called Endostim
device. In this pilot study, we aimed to determine whether implantation of the Endostim device is
technically feasible and safe. Furthermore, we aimed to determine whether electrical stimulation
of the LES will result in a decrease in symptoms of GERD.
Methods: We included 3 patients (median age: 51 (range: 45-54) years, 2 female) with typical
symptoms of GERD, a pathological esophageal acid exposure time (time pH<4 >6%) and a positive
correlation between symptoms and reflux episodes during ambulatory reflux monitoring
(SAP>95%). During a laparoscopic implantation, the device was connected to the endoscopically
identified LES with two electrical leads. Technical success of the procedure was evaluated by
measuring the electrical resistance in the two leads during the first electrical stimulation session.
Cardiac monitoring was performed during the first stimulation session after implantation to
evaluate cardiac safety. Symptoms of GERD were evaluated on PPI at baseline, off PPI at baseline
and 1 month after implant using the GERD-QOL questionnaire.
Results: Median (range) duration of the procedure was 2:51 (2:38-3:15) hours. No per-operative or
post-operative complications were observed. No cardiac rhythm abnormalities were observed
during electrical LES stimulation. All patients demonstrated resistance levels of the leads within the
normal range during first stimulation session, indicating correct placement. Median (range) postoperative GERD-QOL score (7 (4-13)) was significantly lower than the pre-operative GERD-QOL
score off PPI (38 (28-40), p<0.05) and on PPI (22 (17-22), p<0.05). All patients had ceased using
their PPIs at the 1 month follow-up visit. Furthermore, all patients were satisfied with their surgical
outcomes during the 1 month follow-up visit. Notably, all patients experienced mild epigastric pain
after the implantation which quickly resolved within 2-4 weeks in all patients.
Conclusions: Implantation of the Endostim device and stimulation of the lower esophageal
sphincter is a safe and feasible. Furthermore, stimulation of the lower esophageal sphincter results
in a decrease in symptoms of GERD, decrease in PPI usage and increased patient satisfaction.
However, further results have to be awaited to determine its potential use in clinical practice.