The interventional procedures advisory committee considered evidence on leadless cardiac pacemaker implantation for bradyarrhythmias from several sources. This included a review of efficacy and safety evidence, information submitted by 2 companies and responses from stakeholders. Full details are available in the project documents for this guidance.
Bradyarrhythmias are abnormal heart rhythms associated with a slow heart rate (bradycardia), usually defined as less than 60 beats per minute. There are a range of causes including diseases such as sick sinus syndrome or atrioventricular block. The most common causes are age, ischaemic heart disease, heart valve disorders and heart failure. If untreated, bradyarrhythmias may lead to fatigue, fainting, palpitations, dizziness, heart failure and an increased risk of death.
The treatment depends on the underlying cause and the symptoms. If treatment is needed, bradyarrhythmias are usually managed with pacemakers, as described in:
Dual-chamber pacing is used for symptomatic bradycardia caused by sick sinus syndrome, atrioventricular block, or both. Single-chamber ventricular pacemakers may be used for atrioventricular block alone or with sick sinus syndrome for people with continuous atrial fibrillation. It may also be used for people who have specific factors such as frailty or comorbidities that influence the balance of risks and benefits in favour of single-chamber pacing.
Bradyarrhythmias are usually managed with transvenous cardiac pacemakers. But these are associated with lead and generator-related complications, including infection and lead failure, which contribute to long-term morbidity. Transvenous cardiac pacing may be unsuitable for people with previous device infection or endocarditis, immunosuppression, vascular access issues or other factors placing them at high risk of recurrent device-related infection. Leadless cardiac pacemaker implantation provides an option for people who cannot have conventional transvenous cardiac pacemaker implantation.
NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 20 sources, which was discussed by the committee. The evidence included a randomised controlled trial, 4 systematic reviews with meta-analyses, 5 registry studies, 8 prospective studies and 2 retrospective studies. Of these, 15 studies focused on right ventricular pacing, 3 on dual-chamber pacing and 2 on atrial pacing. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.
Several different devices were used in the studies informing this guidance.
The professional experts and the committee considered the key efficacy outcomes to be:
adequate pacing performance
quality of life.
The professional experts and the committee considered the key safety outcomes to be:
cardiac perforation
cardiac tamponade
pericardial effusion
device dislodgement
battery failure
revision rates
duration of device function.
Two submissions were received from patient organisations and 1 patient commentary from a person who had this procedure. These were discussed by the committee.
The committee noted that leadless cardiac pacemakers may be particularly beneficial for people who have a higher risk of complications with a conventional transvenous cardiac pacemaker or when this type of pacemaker is contraindicated. This may include people who:
are on haemodialysis
are having radiotherapy
are at high risk of infection
are immunocompromised
have difficult vascular access
have dementia (because, with transvenous pacemakers, there is a risk of deliberate or unintentional twisting of the pulse generator in the device pocket, resulting in lead dislodgement)
have congenital heart disease so access to their heart chambers may be difficult because of abnormal anatomy or previous surgery.
The committee heard that companies offer comprehensive training programmes on the procedure.
Leadless cardiac pacemaker technology is evolving. Not all offer dual-chamber leadless pacing.
The dual-chamber pacing system with atrial sensing and pacing has been associated with slightly reduced battery life compared with single-chamber pacing, in line with other pacemakers.
The incidence of bradyarrhythmias increases with age because of more frequent underlying causes.
People with bradyarrhythmias may be covered by the Equality Act (2010) if the condition has a long-term impact on their daily life.