- Recommendation ID
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
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
- Date issued
- August 2018
|Is this a recommendation for the use of a technology only in the context of research?||No|
|Is it a recommendation that suggests collection of data or the establishment of a register?||Yes|