5 Safety

5 Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

5.1 Death (within 30 days) was reported in 3% (2/72) of patients treated by gastroelectrical stimulation, due to small bowel infarction and heart failure, and 3% (1/31) of patients treated by gastrectomy, due to myocardial infarction, in a comparative case series of 103 patients.

5.2 Gastric perforation related to an episode of vomiting (2 months after the procedure) was reported in 1 patient in a case series of 17 patients. The device was removed and the perforation was repaired.

5.3 Device removal was reported in 11% (24/221) of patients in a case series of 221 patients (timing ranged from 1–43 months after the procedure). Reasons were infection at the pulse generator or electrode sites (13 patients), lack of symptom improvement (6 patients), lead dislodgements (2 patients), small bowel obstruction caused by wires (1 patient), penetration of electrode into the lumen of the stomach (1 patient) and 'associated with peptic ulcer disease' (1 patient). No further details were reported. Erosion through the skin (6 patients), device migration (1 patient) and pain at implantation site (4 patients) resulting in device removal or replacement (timing unclear) were reported in the systematic review of 364 patients.

5.4 Battery failure resulting in device replacement was reported in 2% (4/221) of patients in the case series of 221 patients (timing unclear).

5.5 Lead erosion (leading to a revision procedure) was reported in less than 1% (2/233) of patients in a case series of 266 patients.

5.6 Treatment failure was reported in 26% (19/72) of patients treated by gastroelectrical stimulation in a case series of 103 patients. Reasons included 'failure to respond' (14 patients), device malfunction (1 patient) and damage to the device (1 patient). The device was removed in 1 patient. Thirteen patients whose symptoms failed to respond were treated by gastrectomy.

5.7 The specialist advisers listed anecdotal events as pain at the site of insertion of the subcutaneous stimulation device, and 'pins and needles' sensation from the stimulation device.

  • National Institute for Health and Care Excellence (NICE)