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ELECTRICAL STIMULATION OF THE LOWER ESOPHAGEAL SPINCTER (LES) IMPROVES GASTROESOPHAGEAL REFLUX DISEASE (GERD) IN PATIENTS WITH LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG)
Yves M. Borbély*1, Alejandro Nieponice2, Leonardo Antonio Rodriguez3, Henning G. Schulz4, Camila Ortiz2, Michael Talbot5, David Martin6, Nicole D. Bouvy7
1Clinic for Visceral Surgery and Medicine, University Hospital Inselspital Bern, Bern, Switzerland; 2Esophageal Surgery Program, University of Favaloro, Buones Aires , Argentina; 3Surgery, CCO Obesidad, Santiago, Chile; 4Evangelisches Krankenhaus , Castrop-Rauxel, Germany; 5St George Private Hospital, Kogarah, New South Wales, Australia; 6Strathfield Private Hospital, Strathfield, New South Wales, Australia; 7University of Maastricht, Maastricht, Netherlands
Background:
LSG is the most commonly performed bariatric procedure worldwide. However, it can result in de novo GERD and may worsen preexisting GERD. 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. The aim of this study is 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 and bothersome symptoms despite 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 16x20 minute sessions daily. GERD outcomes pre and post-stimulation were evaluated.
Results:
22 patients, 55% (12/22) women at 9 centers have been treated; 17 and 5 patients each had LES stimulator implanted at least 1 year post-LSG or peri/pre-LSG, respectively. Median age was 49.5 (IQR=39-56) years. All (22/22) were on at least daily PPIs.
At their last follow-up (median=12 months) in the post-LSG group the Body Mass Index (BMI) changed from 31.3kg/m2 to 29kg/m2 (p=0.08), GERD-HRQL scores had improved from 39.5 to 5 (p=0.0001), esophageal acid exposure had improved from 11.8% to 7.5% (p=0.04) and PPI use had significantly decreased (p=0.001).
At their last follow-up (median=6 months) in the peri/pre-LSG group, the BMI had improved from 40.7kg/m2 to 29.6kg/m2 (p=0.005), GERD-HRQL scores had improved from 30.5 to 7 (p=0.02), esophageal acid exposure had improved from 21% to 3.5% (p=0.02) and PPI use had significantly decreased (p=0.01). 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 in both pre/peri and post-LSG patients. 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.
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