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Enterra II Gastric Neurostimulation for Refractory Gastroparesis: Outcomes at a Single Center Rahul Parupalli*1, Mohammed Saadi1, William Hughes2, Michael A. Edwards1, Ron Schey1, Henry P. Parkman1 1Temple University School of Medicine, Philadelphia, PA; 2Temple University Hospital, Philadelphia, PA
Gastric electric stimulation (GES) is used in patients with medically refractory gastroparesis (GP). Enterra GES uses high frequency neurostimulation. Recently, the Enterra II GES (EII GES), with improved user features, has been released. There have been no reports with this device since it has been approved. Aims: 1) Report outcomes of patients undergoing EII GES placement in our center; 2) Assess effects of EII GES in diabetic (DG) vs idiopathic gastroparesis (IG); 3) Compare outcomes of laparoscopy vs laparotomy placement of EII GES. Methods: From 12/2014 through 11/2015, patients with refractory GP underwent EII GES placement at our center. Patients filled out Patient Assessment of Upper GI Symptoms (PAGI-SYM) which includes Gastroparesis Cardinal Symptom Index (GCSI) prior to and at follow up visits (2 weeks, 3 months and 6 months) and Clinical Patient Grading Assessment Scale (CPGAS, +7=completely better; 0=no change). Results expressed as mean±SEM. Results: 34 patients (mean age=38 years, 28 f, 15 DG, 18 IG, 1 Parkinson’s disease) underwent GES placement: 16 laparoscopy (10 IG, 5 DG, 1 Parkinson’s), 18 laparotomy (10 DG, 8 IG - 1 lost to follow up) with mean follow up of 129 days. 11 of 16 laparoscopic placements underwent additional procedures during surgery, including pyloroplasty (n=6), feeding jejunostomy tube (n=3), or both (n=2). 22 of 33 (67%) patients reported improved symptoms (CPGAS>0) on follow-up. Nausea, abdominal pain and GCSI significantly decreased with treatment (4.0±0.2 vs 3.3±0.2; p=0.01), (3.1±0.3 vs 2.2±0.3; p=0.04), and (3.1±0.2 vs 2.3±0.2; p<0.01) respectively. Significant reductions were also seen in symptoms of stomach fullness, loss of appetite, upper abdominal discomfort, bloating, early satiety and post prandial fullness. 11 out of 17 (65%) patients that underwent a laparotomy GES (mean follow up 143 days) and 11 out of 16 (68%) who underwent laparoscopy (mean follow up 113 days) reported improved symptoms. Significant reduction in GCSI was also seen for both laparotomy and laparoscopy. 12 of 15 (80%) DG compared to 10 of 17 (58%) IG patients reported symptom improvement. GCSI scores significantly decreased with treatment for both DG (3.0±0.3 vs 2.0±0.3; p=0.02) and IG (3.2±0.2 vs 2.5±0.2; p=0.03), however, only patients with DG had a significant reduction in nausea (3.9±0.3 vs 2.8±0.3; p=0.02). Conclusions: Approximately two-thirds of patients that underwent Enterra II GES placement, by either laparoscopy or laparotomy, reported symptom improvement. GCSI, nausea, vomiting, abdominal pain, stomach fullness, loss of appetite, upper abdominal discomfort, bloating, early satiety, and post-prandial fullness were significantly lower on follow-up compared to prior to insertion. DG patients had a significant reduction in nausea. These results from clinical practice support Enterra II therapy in refractory GP patients. Back to 2016 Annual Meeting |
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