ES A leadless ventricular pacemaker providing atrioventricular synchronous pacing in the real-world setting: 12-Month results from the Micra AV post-approval registry

Executive Summary

A leadless ventricular pacemaker providing atrioventricular synchronous pacing in the real-world setting: 12-Month results from the Micra AV post-approval registry

Azlan Hussin

Christophe Garweg, Jason S Chinitz, Eloi Marijon, Andreas Haeberlin, Stefan Winter, Saverio Iacopino, Antonio Curnis, Alexander Breitenstein, Azlan Hussin, Theofanie Mela, Mikhael F El-Chami, Paul R Roberts, Jonathan P Piccini, Kurt Stromberg, Dedra H Fagan, Nicolas Clement

Heart Rhythm. Oct 2024;21(10):1939-1947

Background

Pacemakers are devices used to help regulate heartbeats in patients with slow or irregular heart rhythms. Traditional pacemakers use wires (leads) that connect to the heart, but these wires can sometimes cause complications. A newer type, called a leadless pacemaker, is implanted directly into the heart, eliminating the need for wires and reducing potential risks.

The Micra AV leadless pacemaker is an advanced version designed to improve the coordination between the upper and lower chambers of the heart (AV synchrony). This study evaluates how well the Micra AV performs in real-world patients over a 12-month period.

 

Study Details

  • The study involved 801 patients from 19 countries who received the Micra AV pacemaker.
  • Researchers compared the Micra AV to traditional dual-chamber pacemakers with wires.
  • They tracked safety, success rates, and complications for a year.

Key Findings:

 

Successful Implantation:

  • The pacemaker was successfully implanted in 99.4% of patients.
  • The procedure was generally quick and safe.

 

Lower Complication Rate

  • Only 3.7% of patients had major complications, compared to 8.8% in those with traditional pacemakers.
  • Common issues included minor bleeding or fluid build-up around the heart.
  • No cases of lead dislodgment (a common problem with wired pacemakers).

 

Fewer System Revision

  • 5% of Micra AV patients required adjustments or replacements, much lower than the 5.5% rate for traditional pacemakers.
  • Most revisions were due to the need for a different type of pacemaker.

 

Good Heart Synchronization

  • The device successfully helped the heart maintain a coordinated rhythm in most patients.
  • The median synchronization rate was 79.4% in those who depended on the pacemaker for most of their heartbeats.

 

Battery Life

  • The device is expected to last 10-12 years, depending on usage.

 

Conclusion

The Micra AV leadless pacemaker proved to be safe and effective, with fewer complications and device replacements than traditional pacemakers. While it does not fully replace dual-chamber pacemakers in all cases, it offers a reliable, less invasive option for many patients needing heart rhythm support.