NICE (UK) -- provisional guidance on ETS

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NICE (UK) -- provisional guidance on ETS

Postby admin » Fri Nov 22, 2013 2:20 pm

I saw this last week and forgot to post about it. Unfortunately, feedback opportunity ended yesterday, and findings will be released in February 2014. ... le&o=65566

In case they delete the link, below are the contents:

Endoscopic thoracic sympathectomy for primary hyperhidrosis of the upper limb: consultation document

Interventional procedure consultation document

Endoscopic thoracic sympathectomy for primary hyperhidrosis of the upper limb

Hyperhidrosis is excessive sweating, especially of the palms and armpits. 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 the affected sweat glands and so reduce sweating.
The National Institute for Health and Care Excellence (NICE) is examining endoscopic thoracic sympathectomy for primary hyperhidrosis of the upper limb 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 hyperhidrosis of the upper limb.
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The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 21st 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 hyperhidrosis of the upper limb 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 hyperhidrosis of the upper limb 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 elsewhere on the body is usual after the procedure, and that a minority of patients regret having had the procedure (especially because of subsequent hyperhidrosis elsewhere). Clinicians should also tell patients that the procedure sometimes does not reduce upper limb hyperhidrosis. 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 hyperhidrosis 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 hyperhidrosis of the upper limb 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 compensatory sweating.

2 Indications and current treatments
2.1 Primary hyperhidrosis of the upper limb is characterised by excessive sweating of the palms and/or axillae. It typically begins during childhood or adolescence, but can occur at any age and is usually life-long. In a few people, symptoms can spontaneously improve over time. Excessive sweating can have a profound effect on quality of life, interfering with daily activities and causing anxiety and embarrassment.
2.2 First-line management of primary hyperhidrosis includes lifestyle measures such as avoiding known triggers and tight clothing, and using antiperspirants (including aluminium chloride hexahydrate). Other treatments include iontophoresis, botulinum-toxin A injection and oral medications such as anticholinergics and antimuscarinics, beta-blockers, antihypertensives and anxiolytics. If these do not work, surgical options include local sweat-gland excision by subcutaneous curettage or tumescent liposuction, or sympathectomy. Sympathectomy can be done either by open or endoscopic approaches: endoscopic sympathectomy is now usually the preferred technique because it is associated with less pain, improved cosmesis and more rapid recovery than open sympathectomy.

3 The procedure
3.1 Thoracic sympathectomy aims to relieve hyperhidrosis from the palms and axillae permanently by dividing the sympathetic nerves that lie along the sympathetic chain beside the vertebral column.
3.2 Endoscopic thoracic sympathectomy 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 A non-randomised comparative study of 154 patients with palmar hyperhidrosis treated by endoscopic thoracic sympathectomy (ETS) or botulinum-toxin A injection reported statistically significant improvements in both groups at 6- and 12-month follow-up, assessed objectively using an iodine starch test and pad glove test (p<0.05). The improvement was significantly higher in the ETS group than the botulinum-toxin A injection group (94% and 30% change on the iodine starch test, respectively, p=0.01).
4.2 A case series of 1700 patients (1052 [62%] patients with hyperhidrosis, 536 [32%] patients with facial blushing and 112 [7%] patients with combinations of blushing and 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 406 patients with palmar and/or axillary hyperhidrosis reported that 91% (n=239) of patients treated by conventional ETS had dry limbs at a mean follow-up of 17 years.
4.3 The non-randomised comparative study of 154 patients reported a statistically significant higher mean satisfaction score for ETS compared with botulinum-toxin A injection at 12-month follow-up (4.52 and 3.12, respectively [score range 1 to 5 with 1 being very poor and 5 being excellent], p=0.001). The case series of 1700 patients reported satisfaction rates of 87% and 67% for palmar and axillary hyperhidrosis respectively (p<0.001). Overall, 75% of patients stated that the procedure had improved their quality of life (absolute numbers not reported).
4.4 A case series of 2000 patients reported recurrence rates of 0% and 4% for palmar and axillary hyperhidrosis respectively at 1-year follow-up and 1% and 17% respectively at 5-year follow-up. A case series of 9988 patients with palmar hyperhidrosis reported that ‘almost all’ patients obtained satisfactory relief immediately after ETS; recurrence rates were about 1% at 1-year follow-up and less than 3% at 3-year follow-up (absolute numbers not reported).
4.5 The case series of 453 patients with palmar, axillary or facial hyperhidrosis reported that 91% (412/453) had better quality of life 30 days after ETS and 90% (409/453) had better quality of life 5 years after ETS. All patients had poor or very poor quality of life before treatment.
4.6 The specialist advisers stated that key efficacy outcomes were reduction in hyperhidrosis and patient satisfaction.

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 9 patients died after endoscopic thoracic sympathectomy (ETS) but the denominator was not documented. Five of these deaths were due to major intrathoracic bleeding (described in 5.2), 3 were due to problems related to anaesthetic technique, and 1 patient had an unexplained cerebral event ‘some hours’ after ETS.
5.2 Intrathoracic bleeding that led to death was reported in 5 patients in the non-systematic review article described in 5.1: in 2 patients a trocar lacerated the subclavian artery; in 1 patient an intercostal vein was damaged; and the causes in the other 2 patients were not described. Intrathoracic venous bleeding of more than 300 ml was reported in 1 patient in the case series of 453 patients. Bleeding needing chest tube drainage was reported in ‘about 0.1%’ of patients in the case series of 9988 patients.
5.3 Compensatory hyperhidrosis was reported in 92% (416/453), 86% (1720/2000) and 74% (1265/1700) of patients in 3 case series. In 2 of these studies, 33% (557/1700 and 150/453) of patients reported compensatory hyperhidrosis that was either ‘severe’ or ‘incapacitating’.
5.4 The case series of 453 patients reported that 2% (7/453) 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.
5.5 Pneumothorax requiring drainage was reported in 0.5% (10/2000) of patients and 1% (8/734) of procedures in the 2 case series of 2000 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 9988 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% (1/453) and 2% of patients in the 3 case series of 9988, 453 and 406 patients respectively. No cases of Horner’s syndrome were reported in the case series of 2000 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.

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 the sympathectomy for primary hyperhidrosis of the upper limb. These variations may affect the efficacy and safety outcomes of this procedure.
6.2 The Committee noted that the primary indication for ETS is palmar hyperhidrosis. Axillary hyperhidrosis frequently coexists with this but it is seldom the primary indication for using the procedure because its benefit is somewhat less assured.

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.

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