Bronchoscopic lung volume reduction with an airway valve for advanced emphysema (interventional procedures consultation)
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional procedure consultation document
Bronchoscopic lung volume reduction with airway valves for advanced emphysema
Emphysema is a chronic lung disease in which the walls of the smaller airways inside the lungs disintegrate, creating abnormally large spaces. These air-filled spaces compress the healthy parts of the lungs, blocking airflow in normal breathing.
The aim of lung volume reduction surgery is to help shrink the diseased parts of the lung so that as much air as possible can enter into the healthy parts. The procedure is carried out using a small flexible camera which is inserted down the wind pipe. A thin, hollow tube, called a catheter, is used to place small, one-way valves into the airways. Usually, 3 or 4 valves are inserted.
The National Institute for Health and Clinical Excellence (NICE) is examining bronchoscopic lung volume reduction with airway valves for advanced emphysema 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 bronchoscopic lung volume reduction with airway valves for advanced emphysema.
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- The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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).
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 give suggestions for how it might be improved. 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: 28 July 2009
Target date for publication of guidance: November 2009
1 Provisional recommendation
1.1 Current evidence on the efficacy of bronchoscopic lung volume reduction with airway valves for advanced emphysema shows some improvement in patient-reported quality of life outcomes but there is inadequate evidence on improvement based on objective outcomes of efficacy. There are no major safety concerns in the short term, but there is inadequate evidence on safety in the long term. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to undertake bronchoscopic lung volume reduction with airway valves for advanced emphysema should take the following actions.
- Inform the clinical governance leads in their Trusts.
- Ensure that patients and their carers 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 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 bronchoscopic lung volume reduction with airway valves for advanced emphysema (see section 3.1).
1.3 This procedure should only be carried out by clinicians with specific training and expertise in interventional bronchoscopy, who should perform their initial procedures with an experienced mentor.
1.4 NICE encourages further research into bronchoscopic lung volume reduction with airway valves for advanced emphysema. Research should take the form of studies that allow comparison with the natural history of the disease. They should define patient selection criteria. Outcome measures should include exercise tolerance, ventilation‑perfusion (VQ) mismatch, quality of life and long-term safety. NICE is aware of current clinical trials involving this procedure, and may review the procedure on publication of further evidence.
2 The procedure
2.1 Indications and current treatments
2.1.1 Emphysema is a chronic lung disease, which is usually smoking-related, but may also be inherited. It forms part of chronic obstructive pulmonary disease (COPD).
2.1.2 Common symptoms of emphysema are dyspnoea (shortness of breath), coughing, fatigue and weight loss.
2.1.3 Treatment may include pulmonary rehabilitation (smoking cessation, patient education, exercise and breathing training) and use of inhaled or oral bronchodilators and steroids. Some patients benefit from oxygen treatment.
2.1.4 In advanced disease, lung volume reduction surgery or lung transplantation may be indicated.
2.2 Outline of the procedure
2.2.1 The aim of bronchoscopic lung volume reduction with airway valves for advanced emphysema is to limit airflow to the least functional lung segments in order to improve gas exchange in healthier parts of the lung.
2.2.2 The procedure is undertaken via a bronchoscope with the patient under sedation (or general anaesthesia). Computed tomography (CT) and VQ scans are used to identify parts of the lung(s) with poor function. Using a delivery catheter, a synthetic valve is delivered into the target location and expanded against the bronchial wall. The valves prevent air inflow during inspiration but allow air and mucus to exit during expiration. Several valves may be needed for different lung segments.
2.2.3 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/IP770overview |
2.3 Efficacy
2.3.1 A case series of 98 patients with end-stage emphysema treated by bronchoscopic lung volume reduction with airway valves reported that forced expiratory volume (FEV1) values increased significantly by 10.7% from baseline to 90-day follow-up (absolute values not stated) (p = 0.007). A case series of 19 patients with COPD and dyspnoea despite optimal medical therapy reported a significant improvement after 4 weeks in predicted FEV1 (from 28.4% to 31.5%, p = 0.047) and a non-significant increase in actual FEV1 (from 0.9 to 0.99 litres, p = 0.071). A case series of 57 patients reported no significant difference in FEV1 from baseline to 6-month follow-up (from 0.84 to 0.79 litres, significance not stated).
2.3.2 Case series of 21, 57 and 98 patients reported significant improvement in St. George’s Respiratory Questionnaire (SGRQ) score (ranging from 0 to 100 points; lower values better) from 67.2 to 39.3 points, from 58.2 to 50.0 points, and by 6.8 points at follow-ups of 3, 6 and 6 months and with p values of 0.003, <0.0001 and 0.05 respectively. The case series of 19 patients reported no significant improvement in SGRQ score at 12- or 24-month follow-up (significance not stated).
2.3.3 The Specialist Advisers listed key efficacy outcomes as quality of life (SGRQ score), lung volume and exercise capacity.
2.4 Safety
2.4.1 In the case series of 98 patients, one patient died at 25-day follow-up after pneumonia-related complications. In the case series of 30 patients (66 procedures), pneumonia was reported in 6% (4/66) and bronchitis in 4% (3/66) of procedures at 30-day follow-up.
2.4.2 Bronchospasm occurred shortly after the procedure in 6% (4/66), 5% (1/20), 5% (1/19) and 4% (2/57) of patients.
2.4.3 Periprocedural arrhythmia (not otherwise described) was reported in 9% (6/66) and periprocedural CO2 retention in 3% (2/66) in the series of 66 procedures on 30 patients.
2.4.4 Pneumothorax occurred across four studies in 20% (4/20), 10% (2/19), 7% (4/57), and 5% (1/19) of patients; most resolved spontaneously but one patient needed valve removal and two needed chest tube insertion.
2.4.5 The case series of 19 patients reported that a patient developed bronchial hypersecretion with worsening clinical status; this resolved after removing several valves at 12- and 29-day follow-up. Valve displacement (not otherwise described) occurred in another patient at 1-month follow-up; the valve was removed.
2.4.6 Post-procedural exacerbation of COPD occurred across three case series in 35% (20/57) and 17% (17/98) of patients, and 6% (4/66) of procedures (follow-up period ranged from 30 to 90 days).
2.4.7 The Specialist Advisers listed anecdotal adverse events as pneumonia, pneumothorax and death. Advisers considered theoretical adverse events to include bronchitis, haemoptysis, haemothorax, airway blockage, persistent cough, mucus plugging and exacerbation of COPD.
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
July 2009
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It is the responsibility of consultees to accurately cite academic work in order that they can be validated.