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    Description

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    1 Recommendations

    Single-chamber pacing

    1.1

    Leadless cardiac pacemaker implantation can be used as an option for single-chamber pacing in people with bradyarrhythmias.

    Dual-chamber pacing

    1.2

    More research is needed on leadless pacemakers for bradyarrhythmias for people who need dual-chamber pacing before it can be used in the NHS.

    1.3

    For people who need dual-chamber pacing, this procedure should only be done as part of formal research and a research ethics committee needs to have approved its use.

    What research is needed

    More research, in the form of observational studies or registry data, is needed on dual-chamber pacing:

    • patient selection including age, comorbidities and cause of bradyarrhythmias

    • implantation site

    • clinical outcomes such as adverse events, symptom relief and quality of life, in the short and long term.

    • device durability.

    What this means in practice

    Single-chamber pacing

    There is enough evidence on the safety and efficacy of this procedure for clinicians to consider single-chamber leadless pacemaker implantation as an option for single-chamber pacing.

    Clinicians should always discuss the available options with the person with bradyarrhythmias before a joint decision is made (see NICE's page on shared decision making).

    Hospital trusts will have their own policies on funding procedures and monitoring results. NHS England may also have policies on funding of procedures.

    Dual-chamber pacing

    There is not enough evidence to know if this procedure is safe and effective for dual-chamber pacing. Dual-chamber leadless pacemaker implantation should only be done as part of formal research.

    For everyone having the procedure

    Auditing of outcomes

    Clinicians doing this procedure should collect data on safety and outcomes of the procedure. Enter details about everyone having leadless pacemaker implantation for bradyarrhythmias into the National Audit of Cardiac Rhythm Management database, managed by the National Institute for Cardiovascular Outcomes Research (NICOR), and regularly review the data on outcomes and safety.

    Who should be involved in the procedure

    The procedure should only be done in specialist centres by clinicians with specific training on inserting the device.

    Why the committee made these recommendations

    For single-chamber pacing, the evidence includes large observational studies comparing single-chamber leadless pacemakers with conventional transvenous cardiac pacemakers. It shows that leadless pacemaker implantation for bradyarrhythmias is effective at detecting abnormal heart rhythms and restoring normal pacing. The evidence also shows that it improves quality of life. The risk of infection and other complications is lower after leadless pacemaker implantation than after conventional transvenous cardiac pacemaker implantation.

    For dual-chamber pacing, there is not enough evidence on the safety and efficacy of the procedure. So, it should only be used in research.