NICE recommends leadless cardiac pacemakers as the standard of care for people with slow heart rhythms.

NICE recommends leadless cardiac pacemakers as the standard of care for people with slow heart rhythms.

NICE has issued final guidance recommending leadless cardiac pacemakers as the standard of care for people with slow heart rhythms (bradyarrhythmias) — a condition affecting more than 2 million people in the UK.

Bradyarrhythmias are abnormal heart rhythms that result in a slow heart rate, usually caused by problems with the heart's electrical system. 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.

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.

Key points from the latest NICE guidance:

·         Leadless cardiac pacemaker implantation can be used as an option for right ventricular pacing alone for bradyarrhythmias.

·         Evidence includes large observational studies involving over one million people, comparing right ventricular leadless cardiac pacemakers with conventional transvenous systems.

·         Evidence 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, and the risk of infection and other complications is lower after leadless cardiac pacemaker implantation than after conventional transvenous cardiac pacemaker implantation. 

An example of this technology:

The guidance includes Abbott’s Aveir VR leadless pacemaker system, a device about the size of a AAA battery that sits directly in the heart’s right ventricle, eliminating the need for surgical pockets and wires (image attached). Benefits of Abbott’s Aveir VR leadless pacemaker system

·         Smaller size – ten times smaller than a traditional pacemaker

·         Lower infection risk – no leads, eliminating lead-related complications (e.g., chest pocket infections, lead breakages)

·         Longer battery life – approximately 18 years vs. 10 years

·         Retrievable – can be removed if a person’s needs change

·         Future-proofed – capacity to be paired with a second leadless device in the atrium

Quotes:

Professor Tom Wong, consultant cardiologist and electrophysiologist at Royal Brompton and Harefield hospitals, Guys and St Thomas’ NHS Trust was one of the first clinicians in the UK to implant leadless pacemakers and is the chief investigator of a five-year, national registry focused on leadless devices like Abbott’s Aveir technology. He said: “Having worked with leadless systems for over a decade, this latest guidance from NICE is a major leap forward in how we treat people living with slow heart rhythms. Leadless pacemaker technology offers a life-saving innovative treatment option that is built for the future and can enhance the lives of people with cardiac rhythm problems and reduce the risk of complications.”

Ross Campbell, Abbott’s general manager, Cardiac Rhythm Management for UK and Ireland said: “More than 50,000 pacemaker procedures are carried out each year and until now, our leadless pacemaker systems have been prioritised for the most complex patients and for research purposes, representing around 500 people in the UK. With NICE’s latest guidance, this pioneering technology will now be accessible to tens of thousands of people nationwide, in the years ahead.”

Trudie Lobban MBE, FRCP, is Founder and CEO of the Arrhythmia Alliance, said: “We’re delighted that the latest technology for heart rhythm conditions like bradyarrhythmia will now be offered to thousands of people across the country, to treat and manage this debilitating condition. Thanks to this NICE approval, many people will be able to return to work and lead active lives. The Arrhythmia Alliance welcomes this news as it means quality of life for so many will be restored, rates of infections will reduce and ultimately savings will be made to our health system and society.”