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Leadless Pacemakers at 5-Year Follow-Up
Quick Takes
- Micra leadless pacemaker post-approval registry showed low rates of complications and system revisions (both <5%) at up to 5 years of follow-up.
- The rate of CRT upgrades in the post-approval registry was low (2%) at up to 5 years of follow-up.
- There were no Micra removals due to infection.
Study Questions:
What are the long-term outcomes and performance of the Micra VR leadless pacemaker at 5 years in a worldwide post-approval registry?
Methods:
All Micra post-approval registry patients were included. Endpoints included system- or procedure-related major complications and system revision rate for any cause through 60 months post-implant. Rates were compared through 36 months post-implant to a reference dataset of 2,667 transvenous pacemaker patients using Fine–Gray competing risk models.
Results:
A total of 1,809 patients were enrolled and followed for a median of 51 months. The major complication rate at 36 months was 4.1% at 36 months, which was significantly lower than the 8.5% rate observed for transvenous systems (hazard ratio, 0.47; p < 0.001). The major complication rate at 60 months was 4.5%. The all-cause system revision rate at 60 months was 4.9%. There were no Micra removals due to infection noted. At 36 months, the system revision rate was significantly lower with Micra versus transvenous systems (3.2% vs. 6.6%, p < 0.001).
Conclusions:
The authors conclude that long-term outcomes with the Micra leadless pacemaker have low rates of major complications and system revisions and an extremely low incidence of infection.
Perspective:
There have been prior reports, including from investigational device exemption and post-approval registry, which reported the safety profile of the Micra leadless pacemaker up to 1 year. The current manuscript extends the initial findings from the post-approval registry for up to 5 years. Long-term complications with the leadless Micra pacing system were 53% lower than that with a matched cohort of transvenous systems. The rate of cardiac resynchronization therapy (CRT) upgrades over follow-up was also very low (2%). Additionally, no Micra had to be removed due to infection, which is amazing, and consistent with prior reports. While this study was not randomized, it provides strong evidence of the safety and durability of leadless pacing. Its future is bright.
Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Implantable Devices
Keywords: Cardiac Resynchronization Therapy, Pacemaker, Artificial
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