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 A non-systematic review article reported that 5 patients died because of major intrathoracic bleeding after endoscopic thoracic sympathectomy (ETS) but the total number of patients treated by the procedure was not documented: in 2 patients a trocar lacerated the subclavian artery; in 1 patient an intercostal vein was damaged; the causes in the other 2 patients were not described.

5.2 An additional 4 deaths after ETS were reported in the non-systematic review article: 3 were due to problems related to anaesthetic technique, and 1 patient had an unexplained cerebral event 'some hours' after ETS. The total number of patients treated by the procedure was not documented.

5.3 Compensatory hyperhidrosis occurring mainly at the axillae, trunk and groin (assessed using Hyperhidrosis Disease Severity Scale; scores range from 1 to 4, with higher score indicating intolerable sweating interfering with daily activities) was reported to be 'intolerable' in 4% (n=1) of patients, 'hardly tolerable' in 21% (n=5) of patients, and 'tolerable' in 54% (n=13) of patients with facial blushing in a case series of 73 patients (denominator unclear). Half of the patients had compensatory hyperhidrosis within 1 month of the procedure. Severe compensatory hyperhidrosis on the trunk and regret associated with having had the procedure was reported in 6% of patients in the case series of 831 patients at a mean follow-up of 29 months (absolute number not reported). Compensatory hyperhidrosis that was considered 'incapacitating' and regret associated with having had the procedure was reported in 11% (190/1700) of patients with facial blushing or hyperhidrosis at a mean follow-up of 15 years.

5.4 Horner's syndrome on one side of the face was reported in 10% (2/21) of patients with facial blushing in a case series of 202 patients (1 patient underwent blepharoplasty; no further details) and in 1 patient in the case series of 180 patients with isolated facial blushing: this resolved after 2 days.

5.5 Pneumothorax (needing a chest tube) was reported in 1 patient in the case series of 180 patients with isolated facial blushing. A chest drain was needed postoperatively (no further details provided) in 9% (5/59) of patients with facial blushing in the case series of 80 patients.

5.6 Worsening of symptoms was reported in 1 patient and worsening of quality of life was reported in 14% (8/59) of patients with isolated facial blushing or blushing with hyperhidrosis (n=59) in the case series of 80 patients.

5.7 In the case series of 1152 patients (244 patients with facial blushing), 13% of patients were 'dissatisfied to some extent' and 2% regretted the operation at a mean follow-up of 8 months (absolute numbers not reported). A randomised controlled trial (comparing sympathectomy of the second versus the second and third thoracic ganglia) of 100 patients with isolated facial blushing reported that overall 13% (12/93) of patients regretted the operation (reasons not reported) at a mean follow-up of 12 months; there was no significant difference between the groups treated by different extents of sympathectomy.

5.8 Additional safety events reported in a series of endoscopic thoracic sympathectomies done for a variety of indications were bleeding, haemothorax, chylothorax, pulmonary embolus and brachial plexus damage; it is unclear if these events were in patients with facial blushing.

5.9 The specialist advisers listed harlequin face, post-thoracoscopy chronic pain, and wound infection as adverse events reported in the literature. They listed anecdotal adverse events as air embolism and arm ischaemia. Theoretical adverse events were reported as death, dry hands and visceral injury.

  • National Institute for Health and Care Excellence (NICE)