Joachim Labenz1, Henning Schulz2, Andreas Leodolter3, Jan Pedersen4, Alejandro Nieponice5, Ralf Weise6, Nicole Bouvy7. 1Diakonie Klinikum, 2Evangelisches Krankenhaus Castrop-Rauxel, 3Evangelisches Krankenhaus Herne, 4Aarhus University Hospital, 5Fundacion Favaloro, 6St.-Marien-Hospital, 7Maastricht University Medical Center
Introduction: Safety and effectiveness of electrical stimulation (ES) of the lower esophageal sphincter using the EndoStim® LES Stimulation System has been demonstrated in clinical trials. Limited data is available on outcomes in clinical practice.
Aims and Methods: An ongoing, prospective international multicenter web-based registry is collecting data in patients with disruptive GERD symptoms treated with ES in clinical practice at baseline and at routine follow-ups for 5 years. Demographics, adverse events, GERD symptoms, GERD health related quality of life (GERD-HRQL), questionnaires for extraesophageal symptoms, use of proton pump inhibitors (PPIs) and physiological data (esophageal pH/manometry) are collected when available.
Results: To date, 125 patients from 11 sites are enrolled, 57% males and median(IQR) age is 50(41,60). Data was available in 72 patients with 6 months post-op follow-up (57% male) and 42 patients with 12 months follow up. Ninety% (56/62) patients showed an improvement in their GERD-HRQL score on ES at 6 months and 93% (31/33) showed an improvement at 12 months compared to baseline. The median(IQR) composite GERD-HRQL score improved from 22(17,27) preoperatively to 7.5(4.0,12.8) at 6 months (p<0.01) and from 21.0(17,24) to 5.0(2.0, 7.0) at 12 months (p=0.03).
At baseline, 50% of patients (51/102) complained of daily bothersome heartburn symptoms affecting sleep which decreased to 11% (8/70) at 6 months (p<0.01) and 2% (1/41) at 12 months (p<0.001). Regurgitation symptoms improved with 70% and 88% of patients who reported moderate/severe regurgitation at 6m and 12m improving to none/mild regurgitation (n=36 at 6m, n=17 at 12m).
All patients were prescribed PPI at baseline. Seventy-five% (55/73) at 6-months were completely off PPI. Data on 24h esophageal pH at 6m showed a nonstatistically significant improvement.
Safety data was adjudicated by an independent DSMB. Four serious adverse events in three patients were reported. One myocardial infarction related sudden death at 11 month post-op not related to device or procedure was reported. One event of lead erosion into the esophagus was detected during routine endoscopy. The device was removed during laparoscopic fundoplication procedure. Two events of gastroparesis, possibly related to the device requiring hospitalization were reported in one patient.
Conclusion: Electrical stimulation of the LES is safe and effective in clinical practice in treating GERD patients with disruptive GERD symptoms despite PPI. ES results in significant improvement in GERD outcomes and reduced healthcare resource utilization. ES should be considered a viable treatment option for treating GERD patients with disruptive GERD symptoms despite maximal medical management.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 80799
Program Number: S031
Presentation Session: Foregut 1
Presentation Type: Podium