The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on laser sheath removal of pacing leads.
This procedure is used to remove pacemaker leads that have been in place for more than a few months.
A pacemaker is a device inserted to maintain the rhythm of the heart. During insertion, one or more leads are passed through the veins into the right side of the heart with their other ends are attached to the pacemaker, which is usually placed under the skin of the chest.
Pacemaker leads may need to be removed or changed if they malfunction 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 the veins they pass through, making removal difficult and risky.
Laser assisted removal of pacing leads is claimed to be quicker and less risky than other methods. It involves passing a double layered sheath over the pacing lead, starting with the end that lies outside the body. The inner layer of the sheath is fibreoptic and can transmit a laser beam. The outer layer is more rigid. The double sheath is passed slowly down over the lead while the laser destroys the scar tissue as the sheath advances. Near the heart wall, the more rigid outer sheath is advanced to provide countertraction for removal of the pacing lead.
The procedure is generally carried out under X-ray control. It may take several hours.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.