The National Institute for Clinical Excellence is examining stent placement for vena caval obstruction 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 stent placement for vena caval obstruction.

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• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.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 Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 23 March 2004

Target date for publication of guidance: June 2004

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 stent placement for vena caval obstruction appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance.

Vena caval obstruction is narrowing or occlusion of the caval veins (the inferior vena cava or the superior vena cava), which return blood from the body to the heart. It is most commonly caused by cancer, especially lung cancer. Patients with malignant vena caval obstruction are very unwell and have a short life expectancy.

Standard treatments for malignant caval obstruction include radiotherapy and chemotherapy. These can cause severe adverse events and response to treatment may take several weeks. Stent placement can replace or supplement these treatments.

Stent placement for vena caval obstruction is a minimally invasive procedure that involves inserting a catheter into a large vein, usually in the groin, and passing it into the narrowed area under X-ray control. A stent, which may be self-expanding or balloon-dilated, is then positioned across the area of narrowing to relieve it.

A systematic review on the treatment of superior vena caval obstruction in lung cancer identified 23 non-randomised studies (159 patients) examining the use of stents. The review reported 90% (151/159) relief from obstruction and although recurrence occurred in 11% (17/159) of patients during follow-up (up to 8 months), long-term patency was achieved in 92% (146/159). This compared to a complete relief rate of 77.4% (377/487), which was an overall rate for patients treated with any combination of chemotherapy and/or radiotherapy. Median survival ranged from 1.5 to 6.5 months in the 13 studies that reported on survival outcomes. For more details, refer to the Sources of evidence (see Appendix).

The evidence showed that the response to treatment was more rapid for patients receiving stents than for patients receiving radiotherapy or chemotherapy. One historical controlled study reported relief of obstruction immediately or within 48 hours in patients receiving stents, compared to no change before 2 weeks in patients receiving radiotherapy. For more details, refer to the Sources of evidence (see Appendix).

The Specialist Advisors considered stenting to be highly effective. The only concern they raised was possible inappropriate stenting in some young patients with a mediastinal mass on chest X-ray that may disappear quickly with chemotherapy.

Few adverse events were reported. In the largest study reporting complications, 2.6% (2/76 patients) had misplaced stents, 1.3% (1/76) required anticoagulation, 1.3% (1/76) experienced transient chest pain and 1.3% (1/76) required blood transfusion. Adverse events in another study included stent obstruction 11.5% (6/52) and stent migration 1.9% (1/52). For more details, refer to the Sources of evidence (see Appendix).

The Specialist Advisors had few concerns about the safety of this procedure, provided that it was undertaken in specialised cardiology units by fully trained clinicians. They considered the main potential adverse events to be rupture of the caval vein requiring emergency surgery, perforation of the vein, stent migration and embolisation.

The Advisory Committee noted that the majority of evidence relates to adults with malignant carcinoma of the lung.

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

• Interventional procedure overview of stent placement for vena caval obstruction, April 2003.

Available from: www.nice.org.uk/ip152overview