Interventional procedure consultation document

Insertion of endobronchial valves for persistent air leaks

Treating persistent air leaks in the lungs by inserting valves into the airways

Persistent air leaks from the lungs can occur after chest surgery or injury, or because of underlying lung disease. Leakage of air into the area between the lung and rib cage can lead to collapse of the lung and difficulty breathing. To prevent this, a chest drain (a tube inserted through the skin and rib cage) may be temporarily used to remove the air. In some cases the air leak does not seal and alternative treatments are needed such as surgery or inserting a foam or gel to seal the leak.

Endobronchial valves are a possible treatment for patients with air leaks for whom the usual treatments have not worked or for those unable to have surgery.

The National Institute for Health and Clinical Excellence (NICE) is examining insertion of endobronchial valves for persistent air leaks 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 insertion of endobronchial valves for persistent air leaks.

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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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 (www.nice.org.uk/ipprogrammemanual).

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: 14 December 2012

Target date for publication of guidance: March 2013

1   Provisional recommendations

1.1   Current evidence on the efficacy and safety of insertion of endobronchial valves for persistent air leaks is limited in both quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2   Clinicians wishing to undertake insertion of endobronchial valves for persistent air leaks 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 NICE’s information for the public [[URL to be added at publication]] is recommended.
• Audit and review clinical outcomes of all patients having insertion of endobronchial valves for persistent air leaks (see section 3.1).

1.3    Selection of patients for insertion of endobronchial valves for persistent air leaks should be done by a multidisciplinary team including a chest physician and a thoracic surgeon.

1.4    NICE encourages further reporting about patient selection and outcomes (including long-term outcomes). NICE may review the procedure on publication of further evidence.

2   The procedure

2.1   Indications and current treatments

2.1.1   Leakage of air from the lungs into the pleural space can lead to collapse of the lung and difficulty in breathing. Persistent air leaks from the lungs can occur after thoracic operations or trauma, or because of underlying pulmonary disease.

2.1.2   Persistent air leaks may initially be treated with a temporary chest drain (inserted through the skin and rib cage) to remove the air from the pleural space. If air continues to leak from the lung, a surgical repair may be needed. In cases when surgical repair is not possible (for example in patients with poor cardiopulmonary reserve), pleurodesis may be an alternative option.

2.2   Outline of the procedure

2.2.1   Insertion of endobronchial valves for persistent air leaks aims to reduce or eliminate airflow through the leaks so that the rest of the lung can function normally. It may also allow the tissues around an air leak to heal so that the leak ceases.

2.2.2   The procedure is done using flexible bronchoscopy with the patient under deep sedation or general anaesthesia. The area of air leak is identified by occluding suspected segments with a saline-filled balloon and monitoring the air flow. A one-way valve mounted on a flexible catheter is passed through the bronchoscope and inserted into the target airway.

2.2.3   More than 1 valve may be inserted during a procedure. Valves may be removed when the defect on the lung surface has sealed.

2.2.4   Several different devices are available for this procedure.

Sections 2.3 and 2.4 describe efficacy and 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, available at www.nice.org.uk/guidance/IP/IP1025/overview

2.3   Efficacy

2.3.1   A case series of 40 patients treated by insertion of endobronchial valves reported a complete cessation of air leak in 48% (19/40) of patients, partial cessation in 45% (18/40), and no change in 5% (2/40) (range of follow-up 5–1109 days).

2.3.2   A case series of 7 patients (8 procedures) reported successful removal of chest drains in 5 patients at a median of 16 days after valve insertion.

2.3.3    A case report of 4 patients treated by insertion of endobronchial valves reported reduction in pneumothorax in 3 patients. Re-expansion of both lungs was reported in 1 patient within 2 days and at 6 months in another patient. Improvement of the pneumothorax in 1 lung was reported in a third patient (timing unclear).

2.3.4   In the case series of 7 patients, a ‘reduced’ air leak returned after valve removal in 1 patient (15 days after the procedure).

2.3.5   The Specialist Advisers listed efficacy outcomes as duration of air leak, reduction or resolution of air leak, recurrence of air leak or pneumothorax, reduction in hospital stay, reduction in intensive care or high-dependency unit stay, reduction in the use of non-invasive or intermittent positive pressure ventilation, and improvement in health-related quality of life.

2.4   Safety

2.4.1   Valve migration was reported in a case report (discovered on chest X-ray 2 months after the procedure). The valve was removed 5 months after the procedure.

2.4.2    Initial valve malpositioning (needing redeployment) was reported in the case series of 40 patients (numbers of patients not stated and timing of event not described).

2.4.3   Expectoration of a valve was reported in the case series of 40 patients (number of patients not stated and timing of event not described).

2.4.4   Recurrent chest infection was reported in a case report at 5 months after the initial procedure; the 2 valves were removed.

2.4.5   Partial atelectasis of the lower lobe was reported in a case report  (timing unclear; no further details).

2.4.6   The Specialist Advisers listed anecdotal adverse events as haemoptysis, respiratory failure, distal infection or pneumonia, and granulation tissue formation around valves. They listed death as a theoretical adverse event.

2.5   Other comments

2.5.1  The Committee noted that insertion of endobronchial valves for persistent air leaks is typically considered for patients when other treatment options have been exhausted.

3   Further information

3.1   This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE 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.

3.2   For related NICE guidance see www.nice.org.uk

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

November 2012