Individual research recommendation details

Recommendation ID

IPG626/1

Question

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.

Any explanatory notes
(if applicable)

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.

Source guidance details

Comes from guidance

Leadless cardiac pacemaker implantation for bradyarrhythmias

Number

IPG626

Date issued

August 2018

Other details