1. 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

2. 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

3. 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

4. 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

6. 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/ /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

7. 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 no medication at follow-up, p<0.01

8. 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 (on follow-up 9 (off-PPI), p<0.01

9. 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 6.3 (p=0.003)

10. 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