Balloon catheter dilation of paranasal sinus for chronic sinusitis (second interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis

Sinusitis occurs when the air-filled cavities of the face (the sinuses) become inflamed. Balloon catheter dilation aims to keep sinus passages open by gently inflating a small balloon, which is introduced through the nose via a flexible tube.

The National Institute for Health and Clinical Excellence is examining balloon catheter dilation of paranasal sinus ostia for chronic sinusitis and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. The Institute'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 balloon catheter dilation of paranasal sinus ostia for chronic sinusitis.

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The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

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

NICE is committed to promoting through its guidance race and disability equality and 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 guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and how it might be improved.

Closing date for comments: 25 June 2008
Target date for publication of guidance: September 2008

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

1	Provisional recommendations
1.1	Current evidence on the short-term efficacy of balloon catheter dilation of paranasal sinus ostia for chronic sinusitis is adequate and raises no major safety concerns. Therefore, this procedure can be used provided that normal arrangements are in place for clinical governance, consent, and audit.
1.2	This procedure should only be carried out by clinicians with experience of complex sinus surgery, and specific training in both the procedure and the use of fluoroscopy.
1.3	Publication of long-term outcomes will be helpful in guiding the future use of this technique. The Institute may review the procedure upon publication of further evidence.


2	The procedure
*2.1*	*Indications* *and current treatments*
2.1.1	The paranasal sinuses are small, air-filled cavities (sinuses) located within the bony structures of the face, which communicate with the nasal space via small openings (ostia). Sinusitis occurs as a result of inflammation of the mucosal lining of the paranasal sinuses: typical symptoms include fever, pain and tenderness over the infected area, together with a blocked or runny nose. Acute sinusitis frequently resolves spontaneously with little or no treatment. Chronic sinusitis is less common, and symptoms can persist for weeks or months.
2.1.2	The symptoms of chronic sinusitis are normally managed with decongestants, analgesics, antibiotics, topical steroids or nasal/sinus irrigation. If these interventions fail, surgical procedures to enhance drainage of secretions from the sinuses may be required. However, surgical procedures may be ineffective in the long term because of the development of adhesions and scarring around the ostium of the sinus. Scarring occurs less frequently if the mucosa is preserved.

*2.2*	*Outline of the procedure*
2.2.1	Balloon catheter dilation of paranasal sinus ostia aims to restore normal sinus drainage and function without damaging the mucosa of the sinus. Under general anaesthetic, a catheter and flexible guidewire are inserted through the patient's nostril using endoscopy and fluoroscopy to identify the target sinus. A balloon catheter is positioned across the blocked ostium. Inflation of the balloon catheter to a pressure of between 2 and 8 atmospheres aims to restructure and widen the the ostium by creating microfractures in the surrounding bone. The inflamed sinus may also be irrigated (sinus lavage). The catheter and guidewire are then removed.

Sections 2.3 and 2.4 describe efficacy and safety outcomes which were available in the published literature and which the Committee considered as part of the evidence about this procedure. For more details, refer to the Sources of evidence.
*2.3*	*Efficacy*
2.3.1	In a case series of 115 patients, balloon catheter dilation was attempted in 358 sinuses and cannulation of the sinus ostia was achieved in 97% (347/358). The ostium was patent in 68% (232/341) of sinuses at 1-week follow-up and in 81% (246/304) of sinuses at 24-week follow-up.
2.3.2	In a case series of 1036 patients (3276 sinuses) revision surgery for mucosal alteration or opacified sinuses was required in 2% (25/1036) of patients at a mean follow-up of 40 weeks. In another case series of 115 patients, revision surgery was required in 3% (3/109) at a mean follow-up of 24 weeks; in this series the indications for revision surgery are not described.
2.3.3	In the study of 1036 patients, 95% reported an improvement in sinus symptoms and 73% were completely free of symptoms at a mean follow-up of 40 weeks (absolute numbers not reported). In the study of 115 patients, sinus symptoms were measured by the Sino-Nasal Outcome Test [SNOT] 20, a scale on which symptoms are rated from 0 (less severe) to 5 (more severe). Symptoms lessened significantly from a mean SNOT 20 score of 2.14 at baseline to 1.27 at both 1-week and 24-week follow-up (p < 0.0001) in the subgroup of patients who had balloon catheter dilation with no adjunctive procedures. Patient satisfaction surveys in this subgroup showed that 80% (35/44) experienced an improvement in symptoms at 24-week follow-up. A non-randomised controlled trial of 70 patients showed significantly greater improvements in the 35 patients treated by balloon catheter dilation than in the 35 control patients treated by functional endoscopic sinus surgery (0.78 and 1.29 points, SNOT 20 scale).
2.3.4	The Specialist Advisers considered key efficacy outcomes to include demonstrable patency of sinus ostia, SNOT 20 scores, standard sino-nasal symptom scores and quality of life.

*2.4*	*Safety*
2.4.1	In the case series of 115 patients, bacterial sinusitis occurred in 8% (9/109) of patients following the procedure, but resolved with antibiotic treatment. In this series, the balloon ruptured in 2% (7/358) of sinuses, and a problem occurred with the catheter tip in 1% (4/358).
2.4.2	In the non-randomised controlled trial of 70 patients, 23% (8/35) of patients in the balloon catheter dilation group had turbinate lateralisation/scarring, compared with 9% of patients in the comparator group (not statistically significant).
2.4.3	In the case series of 18 patients, the mean fluoroscopy time per sinus was 0.81 minutes, with an average radiation dose of 730 millirem per patient. In the case series of 115 patients, the mean fluoroscopy time was 9.3 minutes per patient.
2.4.4	The Specialist Advisers considered key safety outcomes to include intracranial injury, cerebrospinal fluid leak, scarring of the mucosa, orbital damage and bleeding. Additional theoretical adverse events noted were balloon misplacement and damage to the dura.

*2.5*	*Other comments*
2.5.1	The Committee noted that the procedure is not used in ethmoid sinuses. Some of the evidence seen by the Committee was on hybrid procedures including concurrent conventional ethmoidectomy.
2.5.2	The Committee noted that both patient selection and the selection of specific sinus(es) for treatment can be difficult. The Committee also noted that the evidence presented relates to patients with chronic sinusitis who were refractory to medical treatment.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
May 2008

Appendix:	Sources of evidence

The evidence considered by the Interventional Procedures Advisory Committee is described in the overview, available at: www.nice.org.uk/ip670overview.

This page was last updated: 30 January 2011