The National Institute for Clinical Excellence is examining laser sheath removal of pacing leads 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 laser sheath removal of pacing leads.

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• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.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: 24 February 2004

Target date for publication of guidance: May 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 laser sheath removal of pacing leads appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance.

Laser sheath removal of pacing leads should be used only in patients for whom standard methods of removal are ineffective.

This procedure is used to remove pacemaker leads that have been in place for at least a few months. Pacemaker leads may need to be removed or changed if they malfunction, cause heart rhythm problems or become infected. If the leads have been in place for more than a few months they can become tightly attached by scar tissue to the heart and to the veins through which they pass, making removal difficult and risky.

The standard technique involves inserting locking stylets and telescoping sheaths around the pacing leads to separate them from the surrounding scar tissue. If this fails, open chest surgery may be required. In some cases, the leads may be detached from the pacemaker unit and simply left inside the patient.

Laser sheaths are similar to standard extraction sheaths, but dissolve rather than tear the scar tissue surrounding the pacing leads. The use of laser sheaths involves the passage of a double-layered sheath over the pacing leads. The inner layer of the sheath is made from fibre-optic material which transmits a laser beam; the outer layer is more rigid. The double sheath is passed slowly over the lead and laser energy destroys the scar tissue around the lead as the sheath is advanced over it. When scar tissue has been destroyed up to a point near the heart, the more rigid outer sheath is advanced to provide countertraction for removal of the pacing lead.

In the studies reviewed, complete lead removal ranged from 89% (596/671 leads) to 98% (44/45 leads). In a randomised controlled trial, complete lead removal was 94% (230/244 leads) for patients in the laser group and 64% (142/221 leads) for patients in the non-laser group. In the same study mean operation time per lead was 11 minutes in the laser group compared with 15 minutes in the non-laser group (P < 0.04). For more details, refer to the Sources of evidence (see Appendix).

The Specialist Advisors had no concerns about the efficacy of this procedure. They considered it to be at least as efficacious as, and probably more efficacious than, standard techniques.

In a randomised controlled trial, 3 of the 153 patients randomised to laser sheath removal required subsequent surgery (two patients required a thorocotomy and one patient required a chest tube). One later died after a cardiac tamponade, but this was not directly related to the use of laser energy. In the largest case series, major complications (defined as cardiac tamponade, haemothorax, pulmonary embolism, lead migration and death) were observed in 1.8% (31/1684) of patients, and 0.8% (13/1684) of patients died in hospital. For more details, refer to the Sources of evidence (see Appendix).

The Specialist Advisors considered the complications of laser sheath removal of pacing leads to be similar to those of standard extraction techniques. They commented on the risk of cardiac tamponade caused by rupture of major veins, or of the myocardium, and noted that this could result in the need for emergency surgery and, in some cases, in death.

The Advisory Committee noted that serious complications can occur, which may require cardiac surgery.

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

• Interventional Procedure Overview of laser sheath removal of pacing sheaths, December 2002

Available from: www.nice.org.uk/ip058overview