Interventional procedure consultation document

Endoscopic thoracic sympathectomy for primary facial blushing

Facial blushing is reddening of the face because of excessive blood flow to the skin. In endoscopic thoracic sympathectomy, keyhole surgery using an endoscope (a type of thin telescope) is done through a small incision in the armpit, to remove nerve tissue near the spine that controls small blood vessels supplying the skin of the face.

The National Institute for Health and Care Excellence (NICE) is examining endoscopic thoracic sympathectomy for primary facial blushing and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of specialist advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about endoscopic thoracic sympathectomy for primary facial blushing.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website.

Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 22 November 2013

Target date for publication of guidance: February 2014

 

 

 

1      Provisional recommendations

1.1   Current evidence on the efficacy and safety of endoscopic thoracic sympathectomy (ETS) for primary facial blushing is adequate to support the use of this procedure with normal arrangements for clinical governance, consent and audit.

1.2   Clinicians wishing to undertake ETS for primary facial blushing should ensure that patients understand the risks of the procedure. In particular they should explain that there is a risk of serious complications, that hyperhidrosis is usual after the procedure and that a minority of patients regret having had the procedure (especially because of subsequent hyperhidrosis). Clinicians should also tell patients that the procedure sometimes does not reduce facial blushing. They should provide patients considering the procedure with clear written information.

1.3   In view of the risk of side effects this procedure should only be considered in patients suffering from severe and debilitating blushing that has been refractory to other treatments.

1.4   This procedure should only be undertaken by clinicians trained and experienced in thoracic endoscopy.

1.5  Further research into ETS for primary facial blushing should include clear information on patient selection and should seek to identify which patient characteristics might predict severe side effects. All complications should be reported. Outcomes should include quality of life and social functioning, and in particular the frequency and severity of excessive sweating.

 

 

 

2    Indications and current treatments

2.1  Blushing or facial reddening is an involuntary reaction, usually as a result of a strong emotional response that stimulates the sympathetic nervous system to increase the flow of blood to the skin of the face. People with facial blushing may also have hyperhidrosis (excessive sweating).

2.2   Conservative treatment for facial blushing includes oral medications such as beta-blockers or anticholinergics. When anxiety is the cause of blushing, psychological treatments such as cognitive behavioural therapy may be used.

2.3   If blushing fails to respond to conservative medical treatment or behavioural therapy, then surgical sympathectomy is an option: this can be done either by open or endoscopic approaches. Endoscopic sympathectomy is now usually the preferred technique.

 

 

 

3     The procedure

3.1   The aim of endoscopic thoracic sympathectomy (ETS) for primary facial blushing is to reduce the frequency and duration of blushing by dividing the sympathetic nerves that lie along the sympathetic chain beside the vertebral column.

3.2  ETS is usually done with the patient under general anaesthesia. Small incisions are made in the axilla and an endoscope is inserted. The lung is partially collapsed; this is typically done by insufflating the chest cavity with CO₂. The sympathetic chain is visualised and the chosen part of the chain is divided by electrocautery or endoscopic scissors or surgical clips may be applied. The extent of division varies but usually involves the part of the sympathetic chain over the second or third ribs, or both. Gas is removed from the pleural space, allowing the lung to re-expand, and the wounds are closed. The procedure is then usually repeated on the other side.

 

 

 

4   Efficacy

This section describes efficacy 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 .

4.1 In a case series of 831 patients with facial blushing who had endoscopic thoracic sympathectomy (ETS), mean symptom improvement score (assessed on a visual analogue scale; scores from 0 to 10, with 10 indicating worst possible symptom) decreased from 9 before the procedure to 3 after the procedure in patients with facial blushing at a mean follow-up of 29 months; this difference was significant (p<0.0001).

4.2  A case series of 1700 patients with hyperhidrosis or facial blushing (648 patients with facial blushing or blushing with hyperhidrosis) reported that 85% of patients had a satisfactory and lasting effect from the procedure, at a mean follow-up of 15 years (absolute number not reported). A case series of 80 patients (12 patients with isolated facial blushing) reported complete resolution in 33% (4/12) of patients with isolated facial blushing at a mean follow-up of 20 months.

4.3  A case series of 180 patients with isolated facial blushing reported symptom recurrence (1 month to 1 year after the procedure) in 2% (4/173) of patients; all patients subsequently underwent reoperation with ‘good results’.

4.4  In the case series of 80 patients (59 patients with facial blushing, isolated or in association with hyperhidrosis) quality of life (assessed on a 5-point Likert scale) was reported to be ‘much better’ in 63% (37/59) of patients, and there was ‘some improvement’ in 15% (9/59) of patients and ‘no change’ in 8% (5/59) of patients.

4.5  The case series of 1700 patients (648 patients with blushing or blushing with hyperhidrosis) reported satisfaction rates of 74% in patients with facial blushing (n=536) at a mean follow-up of 15 years (absolute number not reported). In a case series of 1152 patients, 85% of the 244 patients with facial blushing reported being ‘totally satisfied’ at a mean follow-up of 8 months (absolute number not reported).

4.6  The specialist advisers stated that key efficacy outcomes were symptom improvement, absence of symptoms and patient’s perception of improvement of symptoms.

 

 

 

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  Compensatory sweating 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 sweating within 1 month of the procedure. Severe compensatory sweating 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 mean follow-up of 29 months (absolute number not reported). Compensatory sweating 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.

5.2  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.

5.3  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.

5.4  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.

5.5  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.

5.6  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.

5.7  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.

 

 

 

6    Committee comments

6.1  The Committee noted that techniques of endoscopic thoracic sympathectomy (ETS) vary in the way in which the sympathetic chain is dealt with and the precise extent of sympathectomy for primary facial blushing. These variations may affect the efficacy and safety outcomes of this procedure.

 

 

 

7     Further information

7.1   For related NICE guidance see the NICE website.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
October 2013

 

_{Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.}

_{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}