Interventional procedure consultation document - radiofrequency ablation of the soft palate for snoring

The National Institute for Clinical Excellence is examining radiofrequency ablation of the soft palate for snoring and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about radiofrequency ablation of the soft palate for snoring.

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 preliminary recommendation
• the identification of factual inaccuracies
• additional relevant evidence.

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

The process that the Institute 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• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 26 January 2005

Target date for publication of guidance: 27 April 2005

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence suggests that there are no major safety concerns associated with radiofrequency ablation (RFA) of the soft palate for snoring. However, evidence on the long-term efficacy does not appear adequate for this procedure to be used without special arrangements for audit, consent and research.

Clinicians wishing to undertake radiofrequency ablation of the soft palate for snoring should take the following action.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients understand the uncertainty about the procedure's efficacy and that they are fully informed about alternative treatment options, including lifestyle changes. Patients should also be provided with clear written information, and use of the Institute's Information for the Public is recommended.
• Audit and review clinical outcomes of all patients having radiofrequency ablation of the soft palate for snoring.
  

Publication of efficacy outcomes will be useful. The Institute may review the procedure upon publication of further evidence.

Snoring is a noisy inspiratory sound produced by vibrations and partial obstruction in the oropharynx. It is a form of sleep disordered breathing, and can lead to disrupted sleep and subsequent daytime tiredness and poor concentration. The condition is different from sleep apnoea.

Conservative treatments involve lifestyle changes, including weight loss, avoidance of alcohol and sedatives, smoking cessation, and sleep positioning training. Physical appliances have also been used to maintain normal airflow dynamics during sleep. Alternative interventions include procedures to address pharyngeal obstruction, including laser-assisted uvulopalatoplasty (LAUP) and uvulopalatopharyngoplasty (UPPP).

Radiofrequency ablation (RFA) of the soft palate aims to reduce the volume of the palatal tissue and to improve the texture of the remaining palate so that it becomes more dynamically stable.

A small controlled study compared people who had had RFA with those who had slept with an oral appliance in place. RFA improved snoring as assessed by patients' spouses on a 1 to 10 scale from 7.5 (± 2.5) at baseline to 2.8 (± 2.2) at 8 weeks (p < 0.001), but laboratory sleep assessment showed no significant difference between the two groups in the proportion of time spent snoring loudly. A randomised controlled study involving 17 patients found snoring loudness, as measured on a visual analogue scale, to be significantly improved following RFA, with scores falling from 7.5 (± 2.1) at baseline to 3.1 (± 2.6) at week 16. However, objective evaluation of snoring using digital audio monitoring found no significant improvement at the same time point and no intergroup comparisons were undertaken.

A case series of 60 patients undergoing RFA found that the mean snoring score was reduced from 9.0 at baseline to 3.5 at 12 months. In a small case series, symptoms were improved (as defined by a 3-point fall in snoring score) in 58% (11/19) of patients at 3 months and in 63% (12/19) at 9.5 months. A case series of 22 patients with a maximum follow-up of 12 weeks found a significant decrease in partner-assessed snoring disturbance from 8.3 (± 1.8) to 1.9 (± 1.2) and a decrease in daytime tiredness. For more details, refer to the sources of evidence.

The Specialist Advisors considered patient selection to be important. One Advisor also noted that RFA often requires repeated applications.

A comparative study of 41 patients comparing RFA, LAUP, and UPPP found the mean duration of pain to be significantly shorter following RFA (2.5 days compared with 14 days for the other procedures). Ten days after the RFA, pain assessment was rated 0 on a visual analogue scale. A small randomised controlled trial reported that pain persisted for an average of 7 days following RFA (n=10) compared with 15 days following LAUP (n=7).

In a case series of 60 patients undergoing RFA, adverse events included 'longer pain than expected' in 10% of patients (6/60), and bleeding requiring a visit to an accident and emergency department in 2% (1/60). A case series of 20 patients noted mucosal ulcers in 40% (8/20) of patients. Antibiotics were received by 20% (4/20) of patients. Following 117 treatments in the RFA arm of a comparative study, minor submucosal erosion was reported on 11 occasions (8%) - this resolved spontaneously within 7 to 21 days.

The Specialist Advisors had no major concerns about the safety of this procedure, but noted potential risks as haemorrhage, secondary infection and palatal ulceration.

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

Interventional procedure overview of radiofrequency ablation of the soft palate for snoring, September 2004

Available from: www.nice.org.uk/260overview