Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis (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 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The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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/ipprogrammemanual).

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: 30 January 2008
Target date for publication of guidance: April 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 safety and efficacy of balloon catheter dilation of paranasal sinus ostia for chronic sinusitis is inadequate in quantity. Therefore this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.
1.2	Clinicians wishing to undertake balloon catheter dilation of paranasal sinus ostia for chronic sinusitis should take the following actions. Inform the clinical governance leads in their Trusts. Ensure that patients understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. In addition, the use of the Institute's information for patients ('Understanding NICE guidance') is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). *[[details to be completed at publication]]* Audit and review clinical outcomes of all patients having balloon catheter dilation of paranasal sinus ostia for chronic sinusitis (see section 3.1).
1.3	This procedure should only be carried out by clinicians with experience in complex sinus surgery and specific training in the procedure.
1.4	Further publication of safety and efficacy outcomes will be useful. The Institute may review the procedure upon publication of further evidence.

The procedure

2.1

Indications and current treatments

2.1.1

Sinusitis is an infection of the small air-filled cavities (sinuses) located within the bony structures of the face. Sinuses communicate with the nasal space via small openings (ostia). Sinusitis most commonly affects the maxillary sinuses located behind the cheekbones. It is usually the result of infection, which causes the lining of the sinuses to become inflamed and swollen. Typical symptoms include fever, pain and tenderness over the infected area, and a blocked or runny nose. Contrary to acute sinusitis which usually develops quickly and resolves spontaneously with little or no treatment, chronic sinusitis is a less common condition in which symptoms persist for weeks or even months.

2.1.2

The symptoms of sinusitis are normally managed with decongestants, analgesics, antibiotics, topical steroids or nasal/sinus irrigation. Surgical procedures may be required to promote ventilation and enhance drainage of secretions from the sinuses when ostia remain occluded despite these interventions. The sinus may need to be cleared of obstruction (for example, polyps). Enlargement of sinus ostia can be achieved by removal of the mucosa and bone, usually using endoscopic techniques. In the longer term, formation of adhesions and scarring around the ostium may cause recurrent obstruction to drainage of secretions. This may limit the effectiveness of the surgical procedure but occurs in only a small proportion of patients. Bleeding and scarring occur less frequently if mucosa is preserved during sinus procedures.

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 lining of the sinus. The procedure is performed under general anaesthesia. A catheter and flexible guidewire are inserted through a nostril using endoscopic and fluoroscopic visualisation to locate the sinus orifice/s requiring intervention. A balloon catheter is advanced over the guidewire and positioned across the blocked ostium. Gentle inflation of the balloon catheter to a pressure of between 2 and 8 atmospheres aims to restructure and widen the walls of the ostium through microfracturing of the surrounding bone. If indicated, the inflamed sinus can 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 (see appendix).

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 (using repeat endoscopy) and in 81% (246/304) of sinuses at 24-week follow-up (not clear if additional endoscopic techniques were also used). Revision treatment was required in 3% (3/109) of patients (treatment not defined).

2.3.2

A second case series of 18 patients who were treated with balloon catheter dilation reported an operative success rate of 100% (18/18 sinuses). In this study, suitable sinuses were selected to be treated with balloon dilation rather than with other endoscopic methods.

2.3.3

In the first study (of 115 patients), sinus symptoms had improved significantly from a mean score of 2.14 at baseline to 1.27 after both 1- and 24-week follow-up (p < 0.0001) (measured by the Sino-Nasal Outcome Test (SNOT) 20 scale; 0 to 5 scale from less to more severe symptoms) when balloon catheter dilation was used without any adjunctive procedures. In the same study, patient satisfaction surveys reported that 80% (35/44) of patients experienced an improvement in sinusitis symptoms after 24-week follow-up.

2.3.4

The Specialist Advisers considered key efficacy outcomes to include demonstrable patency of sinus ostia, SNOT scores, standard sino-nasal symptom scores, and quality of life.

2.4

Safety

2.4.1

In the series of 115 patients, bacterial sinusitis occurred in 8% (9/109) of patients following the procedure, but resolved with appropriate antibiotic treatment. In this series, the balloon ruptured in seven sinuses, and a problem occurred with the catheter tip in four.

2.4.2

The mean fluoroscopy time per sinus was 0.81 minutes, with an average radiation dose of 730 millirem per patient in the series of 115 patients and 9.3 minutes per patient in the series of 18 patients.

2.4.3

One Specialist Adviser reported a case of balloon rupture resulting in an intra-orbital leak of X-ray contrast fluid, but with no adverse sequelae. The Advisers considered key safety outcomes to include intracranial injury, cerebrospinal fluid leak, scarring of the mucosa, orbital damage and bleeding. Additional theoretical adverse events considered were balloon misplacement and damage to the dura.

2.5	Other comments
2.5.1	The Committee noted that the procedure was frequently used in combination with other procedures and therefore interpretation of the evidence was difficult.
2.5.2	The Committee noted that both patient selection and the selection of specific sinus(es) for treatment can be difficult.

3	*Further information*
3.1	This guidance requires that clinicians undertaking the procedure make special arrangements for audit. The Institute has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
January 2008

Appendix:

Sources of evidence

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

'Interventional procedure overview of balloon catheter dilation of paranasal sinus ostia for chronic sinusitis', September 2007

Available from: http://www.nice.org.uk/guidance/index.jsp?action=download&o=38780.

This page was last updated: 30 January 2011