Leadless cardiac pacemaker implantation for bradyarrhythmias

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 the natural ageing process, 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:

• NICE's technology appraisal guidance on dual-chamber pacemakers for symptomatic bradycardia due to sick sinus syndrome and/or atrioventricular block

• NICE's technology appraisal guidance on dual-chamber pacemakers for symptomatic bradycardia due to sick sinus syndrome without atrioventricular block

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. Leadless cardiac pacemaker implantation provides an option for people who cannot have conventional transvenous cardiac pacemaker implantation. Leadless cardiac pacemakers may be particularly beneficial for some people, such as people with previous device infection or endocarditis, immunosuppression, vascular access issues or high risk of infection.

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 a transvenous cardiac 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 transvenous pacemakers can be associated with 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. There are several devices available, not all offer dual-chamber leadless pacing.

The dual-chamber pacing system with atrial sensing has been associated with slightly reduced battery life compared with single chamber pacing.

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.