Interventional procedures consultation document - radiofrequency volumetric tissue reduction for turbinate hypertrophy

The National Institute for Clinical Excellence is examining radiofrequency volumetric tissue reduction for turbinate hypertrophy and will publish guidance on its safety and efficacy to the NHS in England and Wales. 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 volumetric tissue reduction for turbinate hypertrophy.

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

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 the Final Interventional Procedures Document (FIPD) and submit it to the Institute.
• The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

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

Please note that NICE is extending the consultation period for this interventional procedure by a further two weeks. Consultation will now close on the 7 October 2003.

Target date for publication of guidance: November 2003

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

Current evidence on the safety and efficacy of radiofrequency volumetric tissue reduction for turbinate hypertrophy does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research. Clinicians wishing to undertake radiofrequency volumetric tissue reduction for turbinate hypertrophy should inform the clinical governance leads in their trusts. They should ensure that patients offered it understand the uncertainty about the procedure's safety and efficacy and should provide them with clear written information. Use of the Institute's Information for the Public is recommended. Clinicians should ensure that appropriate arrangements are in place for audit or research. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. NICE is not undertaking further investigation at present.

Turbinate hypertrophy refers to the persistent enlargement of the inferior turbinates, part of the nasal air passages.

Symptoms of turbinate hypertrophy range from total nasal obstruction to mild congestion and/or excessive mucous secretion from the nose (rhinorrhoea). People with turbinate dysfunction experience sleep apnoea, nasal congestion, postnasal drainage and, occasionally, mid-facial headaches or facial pain and discomfort.

Conservative medical treatment of turbinate hypertrophy includes steroid injections, nasal sprays and decongestants. Surgical treatment is reserved for symptomatic individuals who have a persistent enlargement of the turbinates, who are not responding to medical management or in whom medical management is contraindicated. Other surgical treatments include laser reduction, electrocautery and partial turbinate resection

Radiofrequency volumetric tissue reduction for turbinate hypertrophy is an outpatient procedure in which a submucosal scar is created by the use of a needle electrode inserted into soft tissue. Under local anaesthetic, a needle electrode is placed into the anterior inferior turbinate and radiofrequency energy is delivered by a power generator. There is variation in the energy levels and temperatures used.

In all studies considered, patients reported an improvement in nasal obstruction. In a controlled trial of 24 patients, the severity and frequency of nasal obstruction improved in 81% and 94% of patients, respectively, at 8 weeks. However, there was a large placebo response in this study. Other problems with interpretation were the use of subjective outcomes measures and the application of different amounts of energy.

Two of the Specialist Advisors expressed uncertainty regarding the efficacy of the procedure, based on the lack of evidence. One Advisor commented that, while the literature appeared to suggest that the procedure is as effective as laser reduction, it was based on small patient numbers with only a short-term follow-up.

The most common complications reported in the studies were bleeding, swelling, crusting and formation of adhesions. Some patients reported experiencing pain during the procedure (19-40%). It is unclear, however, what impact the delivery of different energy levels has on the incidence of complications.

The Specialist Advisors listed potential adverse events as bleeding, infection, and more extensive necrosis than was intended. One Advisor commented that there are no more safety concerns than for any other electrical procedure but noted the importance of using correctly regulated equipment.

The Advisory Committee noted that there was insufficient evidence to assess efficacy, given that patient numbers were so small in the studies reviewed.

The Committee questioned whether efficacy should be measured in terms of clearing nasal obstruction or the elimination of other symptoms such as obstructive sleep apnoea.

The evidence considered by the Interventional Procedures Advisory Committee is described in the following document.

• Interventional Procedure Overview of Radiofrequency Volumetric Tissue Reduction for Turbinate Hypertrophy, April 2003