title: Symptom responses, long-term outcomes and adverse events beyond 3 years of high-frequency gastric electrical stimulation for gastroparesis.
abstract: The aims were to determine symptom responses and long-term outcomes in gastroparetic patients receiving gastric electrical stimulation (GES) therapy beyond 3 years by presenting per protocol analysis and intention-to-treat (ITT) analysis. Data collected at baseline, 1 year and beyond 3 years in 55 patients included total symptom scores (TSS), nutritional status, weight, hospitalizations, the use of prokinetic and/or antiemetic medications, HbA1c in diabetics and adverse events. Of the 55 patients, 10 died of non-pacemaker-related complications, six had the devices removed and two could not be reached. The remaining 37 patients had the device activated for a mean of 45 months. Both per protocol and ITT analysis demonstrated that TSS, hospitalization days and the use of medications were all significantly reduced at 1 year and were sustained beyond 3 years. Average TSS decreased by 62.5% for the 37 patients completing 3 years of GES. At implantation, 15/37 patients required nutritional support and only five continued beyond 3 years. Mean HbA1c level in diabetics was significantly reduced from 9.5 to 7.9% at 3 years. We conclude that a significant improvement in symptoms and all measures of clinical outcome can be maintained for greater than 3 years with GES in patients with refractory gastroparesis.
authors.affiliation: Department of Medicine, University of Kansas Medical Center, Kansas City, 66160, USA.
authors.forename: Z
authors.initials: Z
authors.lastname: Lin
authors.forename: I
authors.initials: I
authors.lastname: Sarosiek
authors.forename: J
authors.initials: J
authors.lastname: Forster
authors.forename: R W
authors.initials: RW
authors.lastname: McCallum
mesh_terms: D000328:Adult; D000368:Aged; D001835:Body Weight; D003924:Diabetes Mellitus, Type 2 / Q000453:epidemiology; D004599:Electric Stimulation Therapy / Q000009:adverse effects; D004567:Electrodes, Implanted; D005260:Female; D005500:Follow-Up Studies; D018589:Gastroparesis / Q000503:physiopathology / Q000628:therapy*; D006442:Glycated Hemoglobin / Q000378:metabolism; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D018529:Nutritional Support; D016896:Treatment Outcome
chemical_list: D006442:Glycated Hemoglobin