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 shows that leadless cardiac pacemaker implantation for right ventricular pacing for bradyarrhythmias is effective at detecting abnormal heart rhythms and restoring normal pacing
- Eevidence 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.
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. Benefits of Abbott's Aveir VR leadless pacemaker system include:
- Smaller size – 10 times smaller than a traditional pacemaker
- Lower infection risk – no leads, eliminating lead-related complications
- Longer battery life – approximately 18 years compared to 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.
Professor Tom Wong, consultant cardiologist and electrophysiologist at Royal Brompton and Harefield hospitals, Guys and St Thomas' NHS Trust, 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.'
Trudie Lobban, founder and chief executive at the Arrhythmia Alliance, said: ‘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.'
