Alejandro Nieponice, PhD1, Yves Borbely2, Leonardo Rodriguez3, Henning G Schulz4, Camilo Ortiz5, Michael Talbot6, David Martin7, Nicole Bouvy8. 1Fundacion Favaloro, 2Inselspital Bern University Hospital, 3Centro Clinico de Obesidad, Diabetes y Reflujo, 4Evangelisches Krankenhaus Castrop-Rauxel, 5Hospital El Tunal, 6St. George Hospital, 7Concord Hospital, 8Maastricht University Medical Center
LSG is the most commonly performed bariatric procedure in the US/Canada and the Asia-Pacific region. However, LSG can result in new GERD and may worsen preexisting GERD.i LSG patients with GERD not well controlled with PPI do not have good treatment options except for more invasive, anatomy-altering gastric bypass surgery. LES electrical stimulation therapy has shown to improve outcomes in GERD patients.ii-iii
Aim: To evaluate the safety and efficacy of LES stimulation in LSG patients with GERD not controlled with maximum dose PPI therapy.
Method: Patients with LSG associated GERD with bothersome symptoms on maximum PPI dose underwent LES stimulator implant procedure and were enrolled in an international patient registry prospectively tracking outcomes in GERD patients treated with LES electrical stimulation. Electrical stimulation was delivered at 5mA, 220uSec pulse in 12, 30 minute sessions daily. GERD outcomes pre and post-stimulation were evaluated.
Results: 12 patients, 66% (8/12) women at 8 centers have been treated. Median age was 46 (IQR 34-55) years. All (12/12) were on at least daily double-dose PPIs. At their last follow-up (median=12 months), 75% (6/8) were off-PPIs and one each was using PPIs on <50% of days and standard dose once a day. The latter was on daily PPI for GI prophylaxis for chronic steroid therapy for kidney transplants and not GERD symptoms. Median esophageal pH at baseline was 16.4% (IQR 8.5-22.4), which improved to 1.3% (IQR 0.4-2.2) % at last follow-up at least 6 month post-implant (n=6; p=0.01). All patients improved esophageal acid exposure, 83% (5/6) patients had normalized acid exposure and 1/6 patient had >40% improvement in distal esophageal acid exposure. Median GERD-HRQL scores at baseline was 25 (IQR 18-31) which improved to 4 (IQR 3-10) at last follow-up (n=6; p= 0.015). No SAEs related to the device or procedure were reported. No dysphagia or other GI side effects were reported.
Conclusion: Preliminary results on patients with LSG and GERD with bothersome symptoms despite maximal medical therapy, treated with LES electrical stimulation, revealed that LES stimulation is safe and results in a significant improvement in GERD symptoms and esophageal acid exposure. Most patients were off their PPI therapy with remaining taking PPI at a reduced dose. Data from a larger patient experience for this indication is being collected using the international registry trial.
iJAMA Surgery 2014; 149: 328-34.
iiSurg Endosc. 2013; 27(4):1083-1092.