1.1 Evidence on the safety of leadless cardiac pacemaker implantation for bradyarrhythmias shows that there are serious but well-recognised complications. The evidence on efficacy is inadequate in quantity and quality:
For people who can have conventional cardiac pacemaker implantation, leadless pacemakers should only be used in the context of research.
For people in whom a conventional cardiac pacemaker implantation is contraindicated following a careful risk assessment by a multidisciplinary team, leadless cardiac pacemakers should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to do leadless cardiac pacemaker implantation for bradyarrhythmias in people who cannot have conventional cardiac pacemaker implantation should:
Inform the clinical governance leads in their NHS trusts.
Ensure that patients and their carers understand the uncertainty about the procedure's safety and efficacy compared with conventional pacemaker implantation, and provide them with clear written information. In addition, the use of NICE's information for the public is recommended.
1.3 Further research in people who could have conventional cardiac pacemaker implantation should report the patient selection criteria and compare leadless pacemakers with conventional pacemakers. Follow‑up should be for at least 5 years and outcomes should include adverse events, symptom relief, quality of life and device durability in the long‑term.
1.4 Clinicians should enter details about all patients having leadless cardiac pacemaker implantation for bradyarrhythmias onto the National Institute for Cardiovascular Outcomes Research database and review local clinical outcomes.
1.5 The procedure should only be done in specialist centres by clinicians with specific training on, and supervised experience in, inserting the device. Centres where this procedure is done should have both cardiac and vascular surgical support for emergency treatment of complications.
1.6 NICE advises clinicians to follow the Medicines and Healthcare products Regulatory Agency's (MHRA) Expert Advisory Group recommendations on leadless cardiac pacemaker therapy.
1.7 NICE may review this procedure on publication of further evidence.