Symptom responses, long-term outcomes and adverse events beyond 3 years of high-frequency gastric electrical stimulation for gastroparesis

Neurogastroenterol Motil. 2006 Jan;18(1):18-27. doi: 10.1111/j.1365-2982.2005.00732.x.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Body Weight
  • Diabetes Mellitus, Type 2 / epidemiology
  • Electric Stimulation Therapy* / adverse effects
  • Electrodes, Implanted
  • Female
  • Follow-Up Studies
  • Gastroparesis / physiopathology
  • Gastroparesis / therapy*
  • Glycated Hemoglobin / metabolism
  • Hospitalization
  • Humans
  • Male
  • Middle Aged
  • Nutritional Support
  • Treatment Outcome

Substances

  • Glycated Hemoglobin A