1204 Could Pyloroplasty Combined With Gastric Electrical Neurostimulation Be the Optimal Treatment for Drug Refractory Gastroparesis Based on Pyloric Pathology, Clinical and Gastric Emptying Results?

Abstract

INTRODUCTION: Gastric electrical neuro-stimulation (GES) therapy for severe gastroparesis (GP) was approved under the Humanitarian Device Exemption (HDE) status in March of 2000. The lack of improvement in gastric emptying (GE) with GES generated our interest to supplement GES with a simultaneously performed pyloroplasty (PP). The aim of our investigation was to assess the long term effects of GES + PP on GE results and GP symptoms, while documenting the pathology of the pyloric smooth muscle. METHODS: Overall, 29 GP drug-refractory patients (19) diabetics (DM) with a mean 14.4 ± 7.3 years of DM, 8 idiopathic, and 2 post-vagotomy (PV) underwent surgical implantation of GES with the Heineke-Mikulicz PP. Biopsy of pyloric smooth muscle was obtained, and all samples were stained with C-Kit to identify the status of Interstitial Cells of Cajal (ICC) and trichrome for fibrosis. GP total symptoms score (TTS) of vomiting, nausea, early satiety, bloating, fullness and epigastric pain, were assessed with 5-point Liekert scale, and GE 4-hour scintigraphy test was performed before surgery and at the last follow-up visit. RESULTS: 29 patients, mean age 47 ± 14 years (range 21-78); 21 F; with mean 5.5 (1-20) years of GP symptoms were included in this observation. Overall, TSS improvement after a mean follow-up of 35 months (6-72) post-surgery was 58% (8-100) (Table 1), but 48% of GP patients improved their symptoms by >65% after GES + PP, and ED visits and days of hospitalizations were significantly reduced. GE tests showed 77% (range 53-100) retention at 2 hour and 48% (15-100) at 4 hour before the therapies, and these results improved to 40% (3-94) at 2 hour, and 14% (0-58) at 4 hour. Also, 83% patients normalized their GE at 2 hour, and 62% normalized at 4 hour (less than 10% retention) (Table 2). Interestingly, GE remained the most delayed (58%) at 4 hour in PV GP patients. Pyloric ICC depletion (≤10 ICC/HPF) was present in 75% of patients, with a mean 7 ICC/HPF, while 80% of them had minimal/moderate amount of collagen fibrosis between the muscle bundles. There were no unanticipated SAE's or technical problems reported during this study. CONCLUSION: GP drug-refractory patients, responded to combining GES and PP with a significant long-term symptom improvement (60%) and accelerated gastric emptying, which normalized in the majority of patients. The depleted ICC and fibrosis in the pyloric smooth muscle justifies the addition of PP to GES, and explains its success.