Laser sheath removal of pacing leads

# Guidance
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.# The procedure

# Indications
This procedure is used to remove pacemaker leads that have been in place for 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. This procedure may also be used to remove defibrillator leads.
The conventional technique for removing pacing leads 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. Alternatively, in some cases, the leads may be detached from the pacemaker unit and simply left inside the patient.

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

# Efficacy
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 section.
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.

# Safety
In a randomised controlled trial, 3 of 153 patients randomised to laser sheath removal required subsequent surgery (two patients required a thorocotomy and one patient required a chest tube). One patient 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 2% (31/1684) of patients, and 1% (13/1684) of patients died in hospital. For more details, refer to the Sources of evidence section.
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 small risk of cardiac tamponade caused by rupture of major veins or the myocardium, and noted that this could result in the need for emergency surgery and, in some cases, cause death.

# Other comments
Removal of pacing leads can cause serious complications, requiring cardiac surgery, regardless of the extraction technique used.
Andrew DillonChief ExecutiveJune 2004# Further information 

# Sources of evidence
The evidence considered by the Interventional Procedures Advisory Committee is described in the following document.
'Interventional procedure overview of laser sheath removal of pacing leads', December 2002.

# Information for patients
NICE has produced information on this procedure for patients and carers ('Understanding NICE guidance'). It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind.# About this guidance
NICE interventional procedure guidance makes recommendations on the safety and efficacy of the procedure. It does not cover whether or not the NHS should fund a procedure. Funding decisions are taken by local NHS bodies after considering the clinical effectiveness of the procedure and whether it represents value for money for the NHS. It is for healthcare professionals and people using the NHS in England, Wales, Scotland and Northern Ireland, and is endorsed by Healthcare Improvement Scotland for implementation by NHSScotland.
This guidance was developed using the NICE interventional procedure guidance process.
We have produced a summary of this guidance for patients and carers. Information about the evidence it is based on is also available.
Changes since publication
January 2012: minor maintenance.
Your responsibility
This guidance represents the views of NICE and was arrived at after careful consideration of the available evidence. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of healthcare professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties.
Copyright
 National Institute for Health and Clinical Excellence 2004. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
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