Electrical Stimulation of the Lower Esophageal Sphincter improves Gastroesophageal Reflux Disease in Patients after Laparoscopic Sleeve Gastrectomy Borbély, Yves M.1; Nieponice, Alejandro2; Rodriguez, Leonardo Antonio3; Schulz, Henning G.✝4; Ortiz, Camila2; Talbot, Michael5; Martin, David6; Bouvy, Nicole D.7 Clinic for Visceral Surgery and Medicine, University Hospital Inselspital Bern, Switzerland Esophageal Surgery Program, University of Favaloro, Buones Aires , Argentina Surgery, CCO Obesidad, Santiago, Chile Evangelisches Krankenhaus , Castrop-Rauxel, Germany St George Private Hospital, Kogarah, NSW, Australia Strathfield Private Hospital, Strathfield, NSW, Australia University of Maastricht, Maastricht, Netherlands

Background Laparoscopic Sleeve Gastrectomy (LSG): most commonly performed bariatric procedure worldwide technical simplicity low morbidity access to biliary tree, stomach, duodenum comparable results to RYGB can result in de novo GERD and may worsen preexisting GERD

Background LSG patients with GERD not well controlled with PPI: standard treatment option is switch to more invasive, anatomy-altering Roux-Y Gastric Bypass Lower Esophageal Sphincter (LES) electrical stimulation therapy has shown to improve outcomes in GERD patients Aim of this study: to evaluate safety and efficacy of LES stimulation in LSG patients with GERD not controlled with maximum dose PPI therapy

Methods international patient registry prospectively tracking outcomes in GERD patients treated with LES electrical stimulation Patients with LSG-associated GERD with bothersome symptoms on maximum PPI dose underwent LES stimulator implant procedure and were enrolled in the registry Electrical stimulation was delivered at 5mA, 220uSec pulse in 12, 30 minute sessions daily GERD outcomes pre and post-stimulation were evaluated GERD-HRQL Esophageal Acid Exposure (after 6-12 months) PPI medication Use Adverse events – Serious and Non-Serious

Results: demographic data, safety 22 patients (13 female, 59%) median age 47.5y (min 25 – max 76) median BMI 31.7kg/m2 (22.5 – 57.6) during follow-up 30.3kg/m2 treated at 9 centers, 05/14 - 10/16 median follow-up 15.5 months (6 – 36) no serious adverse event related to device or procedure no dysphagia or other GI side effects

Results: PPI use (cumulative dose per day) dosage equivalents to 40mg Pantoprazol note: 2 patients with chronic steroid use, 1 patient post-renal transplantation median 2x40mg/d @baseline, no medication at follow-up, p<0.01

Results: follow-up of typical GERD-symptoms heartburn/regurgitation overall heartburn/reg when lying down heartburn/reg when standing up heartburn/reg after meals affecting meals? affecting sleep? difficulty swallowing pain assoc with swallowing bloating/gassy feeling medication affects daily life? 0: no symptoms << 5: incapacitating max 50 points Velanovic V, J Gastrointest Surg 1998; 2:141 median 32 @baseline (on PPI), @last follow-up 9 (off-PPI), p<0.01

Results: esophageal acid exposure 24h-off PPI- pH-metry median follow-up 9 months solid line represents median dotted line at 4% normalization (esophageal pH<4 <4%) in 10 patients (45%) median %time pH <4 @baseline 12.7, @follow-up 6.3 (p=0.003)

Conclusion Electrical stimulation of LES (preliminary data): is safe has no GI side-effects results in significant improvement of GERD symptoms and esophageal acid exposure in post-LSG patients most patients are off PPI therapy with remaining taking PPI at reduced dose expands bariatric armentarium and offers solution for patients with post-LSG GERD impossible to undergo RYGB