Andrew T Strong, MD1, Ivy N Haskins, MD1, Matthew Davis, MD1, Kevin El-Hayek, MD1, Michael S Cline, DO2, Matthew Kroh, MD1, John H Rodriguez, MD1. 1Section of Surgical Endoscopy, Dept of General Surgery, Cleveland Clinic, 2Department of Gastroenterology, Cleveland Clinic
Introduction: Gastric electric stimulation (GES) has been an option for patients with medically refractory gastroparesis for more than 15 years. Prior to implantation, patients are counseled that devices will need to be periodically exchanged for battery depletion and could be removed if infection or erosion of the device or leads develops. However, additional indications for re-intervention exist.
Methods: Demographic and operative information is prospectively collected at our institution for all patients undergoing GES therapy with Enterra® or Enterra2® (Medtronic, Dublin, Ireland) as a humanitarian use device. Patients who had undergone local revision, or had part or all of the GES system replaced since initial implantation from January 2002 to July 2016 were retrospectively identified. Patients were excluded if battery depletion was the only indication for reoperation. Operative and 30 day follow up information was collected.
Results: A total of 209 patients received GES therapy at our institution during the study period. There were 44 (21.1%) patients who had reoperations for GES revision or replacement; 8 of these patients had reoperation for battery depletion only and were thus excluded from our analysis. A total of 36 (17.2%) patients remained. This cohort had a median age of 53.9 years (IQR 31.2-48.3) and average BMI of 24.6 +/- 4.5 kg/m2 at the time of GES insertion. Eleven patients had diabetic gastroparesis and 25 patients had idiopathic gastroparesis. A total of 55 reoperations were performed in these 36 patients. The median time to first surgical intervention was 16.9 months. The median number of re-operations was 1 (range 1-4). There were 26 devices were replaced (47.2%), most commonly for unspecified device failure (n=9, 16.4%), followed by perceived shocking sensation (n=5, 9.1%) and lead failure/fracture (n=3, 5.4%).
Twenty-one generators (31.8%) were revised in place, most commonly for generator flipping or migration along the abdominal wall (n=14, 25.4%), followed by erosion or infection (n=3, 5.4%). In eight patients device explant was their final operation. There were no intraoperative complications. Complications after re-intervention included seroma formation in 6 patients (10.9%), gastrointestinal bleeding in 2 patients (3.6%), 1 superficial wound infection (1.8%) and 1 organ space infection (1.8%) requiring reoperation.
Conclusion: GES is shown to be effective for patients with both idiopathic and diabetic gastroparesis. GES device related complications needing re-intervention may occur more frequently than previously reported, and may represent a potentially significant burden for patients.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 80024
Program Number: P008
Presentation Session: Poster of Distinction (Non CME)
Presentation Type: PDIST