1.1
Leadless cardiac pacemaker implantation can be used as an option for right ventricular pacing for bradyarrhythmias.
Leadless cardiac pacemaker implantation for bradyarrhythmias
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1 Recommendations
Dual-chamber pacing when transvenous pacing is not an option
1.2
When transvenous pacing is not an option, leadless cardiac pacemaker implantation can be used during the evidence generation period for dual-chamber pacing for bradyarrhythmias. There must be enhanced informed consent and auditing of outcomes.
Dual-chamber pacing when transvenous pacing is an option
1.3
When transvenous pacing is an option, more research is needed on leadless cardiac pacemaker implantation for dual-chamber pacing for bradyarrhythmias.
1.4
This procedure should only be done as part of formal research and a research ethics committee needs to have approved its use.
Atrial pacing
1.5
More research is needed on leadless cardiac pacemaker implantation for atrial pacing for bradyarrhythmias before it can be used in the NHS.
1.6
What this means in practice
Right ventricular pacing
There is enough evidence on the safety and efficacy of this procedure for right ventricular pacing for healthcare professionals to consider it as an option for bradyarrhythmias.
Healthcare professionals should always discuss the available options with the person with a bradyarrhythmia 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 when transvenous pacing is not an option
There are uncertainties around the safety and efficacy of this procedure for dual-chamber pacing. When transvenous pacing is not an option for bradyarrhythmias, dual-chamber pacing can be used if needed while more evidence is generated.
After this, the evidence base will be reviewed by NICE periodically and the guidance will only be reconsidered by the committee if there is reason to do so.
Healthcare professionals do not have to offer leadless cardiac pacemaker implantation for dual-chamber pacing when transvenous pacing is not an option for bradyarrhythmias. They should always discuss the available options with the person with a bradyarrhythmia 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.
Enhanced informed consent
Because there are uncertainties about whether this procedure is safe and effective for dual-chamber pacing when transvenous pacing is not an option, there must be an emphasis on informed consent. Healthcare professionals must make sure that people (and their families and carers as appropriate) understand the uncertainty and lack of evidence around a procedure's safety and efficacy using NICE's advice on shared decision making and NICE's information for the public. Healthcare professionals must also inform the clinical governance leads in their organisation if they want to do the procedure.
Dual-chamber pacing when transvenous pacing is an option and atrial pacing
There are uncertainties around the safety and efficacy of this procedure for dual-chamber pacing when transvenous pacing is an option. There is not enough evidence on the safety and efficacy of this procedure for atrial pacing for bradyarrhythmias. For both of these scenarios it should only be done as part of formal research.
For everyone having the procedure
Auditing of outcomes
Healthcare professionals doing this procedure should collect data on safety and outcomes of the procedure. Enter details about everyone having leadless cardiac pacemaker implantation for bradyarrhythmias into the National Institute for Cardiovascular Outcomes Research (NICOR) National Audit of Cardiac Rhythm Management and regularly review the data on outcomes and safety.
Who should be involved in the procedure
This procedure should only be done in specialist centres by healthcare professionals with specific training on inserting the devices.
What evidence generation and research is needed
Healthcare professionals must collect data specifically around the safety and efficacy of dual-chamber pacing when transvenous pacing is not an option. More evidence generation and research, in the form of observational studies or registry data, is needed for dual-chamber and atrial pacing on:
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.
Why the committee made these recommendations
For right ventricular pacing, the evidence includes large observational studies comparing right ventricular leadless cardiac pacemakers with conventional transvenous cardiac pacemakers. It shows that leadless cardiac pacemaker implantation for right ventricular pacing 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 cardiac pacemaker implantation than after conventional transvenous cardiac pacemaker implantation. So, it can be used.
For dual-chamber pacing, the available evidence is limited in quality and quantity and is mainly from observational studies with short term follow-up (12 months or less). So, it is unclear how well the procedure works in the long term, and high-quality evidence on efficacy and safety outcomes is needed. There are some people who cannot have transvenous dual-chamber pacing and have no other options. For these people, the procedure can be used in the NHS while further evidence is generated. When transvenous pacing is a suitable option, leadless cardiac pacemaker implantation for dual-chamber pacing should only be used in research.
For atrial pacing, there is not enough evidence on the safety and efficacy of the procedure. So, it should only be used in research.
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