The National Institute for Clinical Excellence is examining lung volume reduction surgery for advanced emphysema and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. 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 lung volume reduction surgery 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 preliminary recommendation
• 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• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

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

Closing date for comments: 23 November 2004

Target date for publication of guidance: February 2005

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 lung volume reduction surgery for advanced emphysema appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance.

Clinicians wishing to use lung volume reduction surgery for advanced emphysema should ensure that patients are fully informed about the risks of the procedure (including death) and the likelihood of deterioration in the longer term. Use of the Institute's Information for the Public is recommended.

Emphysema is a chronic lung disease. The walls of the air sacs (alveoli) in the lung weaken and disintegrate, leaving behind abnormally large air spaces that remain filled with air even when the patient breathes out. These air spaces may coalesce to form larger air-filled sacs called bullae. The surface area of the alveoli is decreased, so there is less space for the exchange of oxygen and carbon dioxide. This leads to reduced levels of oxygen in the blood. The most common symptoms of emphysema are shortness of breath (dyspnoea), coughing, fatigue and weight loss.

Emphysema often coexists with chronic bronchitis. Both of these conditions may be described by the more general term of chronic obstructive pulmonary disease (COPD).

Lung volume reduction surgery is a palliative treatment that aims to remove the least functional part of the lungs. Computed tomography (CT) and perfusion scanning are used to identify the diseased lung tissue. The diseased part of the lung can be accessed by various techniques including median sternotomy, video assisted thoracoscopy or thoracotomy. The first two are the most common techniques. Median sternotomy involves cutting through the sternum to open the chest. The video assisted procedure involves making a number of small incisions in both sides of the chest to allow the insertion of instruments into the chest between the ribs. A thoracotomy involves making an incision between the ribs on one side of the chest and separating the ribs to access the lung.

Evidence on efficacy indicates that in certain patients lung function, exercise performance and quality of life are improved in the short term after lung volume reduction surgery. These results have been relatively consistent across study designs and confirmed in the National Emphysema Treatment Trial, a recent large-scale randomised controlled trial comparing surgery with medical therapy.

The National Emphysema Treatment Trial randomised 1218 patients of whom 580 underwent surgery. At 24 months, exercise capacity had improved in 15% (54/371) of patients in the surgery group compared with 3% (10/378) of patients in the medical group (p < 0.001). Quality of life had also improved in the surgical group (121/371) as compared with the medical group (34/378) at 24 months (33% versus 9% p < 0.001) However, the trial found no difference in overall mortality between the two groups (0.11 deaths per person-year, risk ratio 1.01, p = 0.90). For more details, refer to the sources of evidence (see Appendix).

The most common complication was persistent air leak from the lung. In one study of 250 patients, 45% of patients (113/250) experienced prolonged air leaks lasting more than 7 days, with 8 of these patients (3%) requiring a subsequent operation. Other complications in this series included pneumonia 10% (24/250), in-hospital mortality 5% (12/250), myocardial infarction 2% (5/250), deep vein thrombosis 2% (4/250), small bowel obstruction 2% (6/250) and phrenic nerve injury < 1% (2/250). For more details, refer to the sources of evidence (see Appendix).

Complications include those that may arise from pre-existing co-morbidities as well as those that are directly due to the surgery.

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

Interventional procedures overview of lung volume reduction surgery for advanced emphysema, June 2004

Available from: www.nice.org.uk/ip236overview