Description

Bradyarrhythmias are abnormal heart rhythms that can result in 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 AV 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 technology appraisal guidance on dual-chamber pacemakers for symptomatic bradycardia due to sick sinus syndrome and/or atrioventricular block and dual-chamber pacemakers for symptomatic bradycardia due to sick sinus syndrome without atrioventricular block. Dual-chamber pacing is recommended for symptomatic bradycardia caused by sick sinus syndrome, AV block, or both. Single-chamber ventricular pacemakers may be used for AV block alone or with sick sinus syndrome in people with continuous atrial fibrillation, or 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 pacemaker (TVPs). But these are associated with lead and generator-related complications, including infection and lead failure, which contribute to long-term morbidity. Leadless pacemaker implantation provides an option for people who cannot have conventional TVP implantation. Leadless pacemakers may be particularly beneficial for some people, such as those 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 16 sources, which was discussed by the committee. The evidence included a randomised controlled trial, 4 systematic reviews with meta-analyses, 5 registry studies, 4 prospective studies and 2 retrospective studies. 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.

The professional experts and the committee considered the key efficacy outcomes to be: adequate pacing performance and 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 and 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 pacemakers may be particularly beneficial for people who have a higher risk of complications with a conventional TVP or when a TVP 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.

The committee heard that companies offer comprehensive training programmes on the implantation procedure.

The incidence of bradyarrhythmias increases with age, due to more frequent underlying causes.

People with bradyarrhythmias may be covered by the Equality Act if the condition has a long-term impact on their daily life. Disability is a protected characteristic under the Equality Act (2010).