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 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. Intrathoracic venous bleeding of more than 300 ml was reported in 1 patient in a case series of 453 patients. Bleeding needing chest tube drainage was reported in 'about 0.1%' of patients in the case series of 9,988 patients.
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 was reported in 92% (416 out of 453), 86% (1,720 out of 2,000) and 74% (1,265 out of 1,700) of patients in 3 case series. In 2 of these studies, 33% (557 out of 1,700, and 150 out of 453) of patients reported compensatory hyperhidrosis that was either 'severe' or 'incapacitating'.
5.4
Studies reported a wide range in the proportion of patients reporting dissatisfaction with the procedure. The case series of 453 patients reported that 2% (7 out of 453) of patients were dissatisfied with the results at 5‑year follow-up. These patients had severe compensatory hyperhidrosis and said that they regretted having ETS. The case series of 406 patients reported that 7% (n=17) of patients treated by conventional ETS were dissatisfied and regretted the operation at a mean follow-up of 17 years. The case series of 1,700 patients with hyperhidrosis or facial blushing reported that 20% (absolute numbers not reported) of patients were dissatisfied or regretted having the procedure at a mean follow-up of 15 years.
5.5
Pneumothorax requiring drainage was reported in 0.5% (10 out of 2,000) of patients and 1% (8 out of 734) of procedures in the 2 case series of 2,000 and 406 patients respectively. Pneumothorax or haemothorax that needed to be drained was reported in 'about 0.3%' of patients in a case series of 9,988 patients. Chylothorax was reported in 3 patients included in the non-systematic review article, 2 of whom were described in more detail: 1 patient needed postoperative tube drainage and parenteral nutrition for 6 days and in 1 patient the leak was recognised at surgery and the thoracic duct clipped.
5.6
Intraoperative cardiac arrest was reported in 2 case reports. Both patients recovered after cardiopulmonary resuscitation.
5.7
Horner's syndrome was reported in less than 0.1%, 0.2% (1 out of 453) and 2% of patients in the 3 case series of 9,988, 453 and 406 patients respectively. No cases of Horner's syndrome were reported in the case series of 2,000 patients.
5.8
Other adverse events reported in case reports and in the non-systematic review included surgical emphysema, pleural effusion, bronchospasm, segmental collapse and atelectasis, wound infection, severe postoperative pain, brachial plexus injury, extensor pollicis longus paralysis, distal upper limb ischaemia, paraparesis, rhinitis, persistent bradycardia, heatstroke, and gustatory sweating.
5.9
In addition to the above, the specialist advisers described conversion to open surgery because of lung adhesions as an anecdotal adverse event. Additional reported adverse events were cerebral oedema, pulmonary oedema, and pulmonary embolus.