NICE provisionally recommends leadless implantable pacemaker in draft guidance
A procedure for people with slow heart rhythms could be used more widely after it was recommended for NHS use in draft guidance.
Our interventional procedures advisory committee has recommended a procedure which sees a leadless pacemaker implanted directly into the internal wall of the heart through a catheter inserted via a large vein in the leg or neck.
Unlike traditional pacemakers, the use of leadless devices eliminates the need for a chest incision in a minimally invasive procedure. The evidence reviewed by the independent committee showed that this approach carries a lower risk of infection and other complications compared with conventional transvenous cardiac pacemakers.
The new draft guidance follows a comprehensive review of evidence, which found that leadless pacemaker implantation is effective at detecting abnormal heart rhythms and restoring normal pacing, while also improving patients' quality of life.
Bradyarrhythmias are abnormal heart rhythms that result in a slow heart rate, usually caused by problems with the heart's electrical system, which affect around one in a thousand people. These conditions are typically managed with conventional transvenous cardiac pacemakers (TVPs), which involve a pacemaker box placed under the skin with leads connecting to the heart.
This draft recommendation provides an important alternative treatment option for people with bradyarrhythmias. The evidence demonstrates that leadless pacemakers can effectively regulate heart rhythm while reducing the risk of complications associated with traditional pacemakers, particularly infections and lead-related issues.
Anastasia continued: "For many patients, especially those with previous device infections or compromised immune systems, leadless pacemakers may offer significant benefits. As always, we recommend that clinicians discuss all available options with patients so they can make informed decisions about their care."
The draft guidance specifies that the procedure should only be performed in specialist centres by clinicians with specific training in inserting these devices. Healthcare providers are also instructed to collect data on safety and outcomes by entering details of all patients receiving leadless pacemaker implantation into the National Audit of Cardiac Rhythm Management database, managed by the National Institute for Cardiovascular Outcomes Research (NICOR).
Around 79,000 pacemaker procedures are carried out each year, costing around £42m according to the NHS Spend Comparison Service.
The committee’s recommendations represents an important step forward in cardiac rhythm management. We carefully considered extensive evidence from large observational studies comparing leadless pacemakers with conventional devices, and we're confident that this technology offers genuine benefits for appropriate patients.
Tom continued: "It's worth noting that the incidence of bradyarrhythmias increases with age, making this guidance particularly relevant to our ageing population."
A consultation on the draft guidance has now begun via the NICE website. Healthcare professionals, commissioners, and patients are encouraged to review the full recommendations to understand how this procedure might be incorporated into treatment pathways and submit comments before Wednesday 23 July 2025.