DOI: 10.1111/jce.16019 ISSN: 1045-3873

A comparative study of the two leadless pacemakers in clinical practice

Ghanshyam Shantha, Jonathan Brock, Matthew J. Singleton, Alexander Joseph Schmitt, Patrick Kozak, George Bodziock, Natalie Bradford, Patrick Whalen, Prashant Bhave
  • Physiology (medical)
  • Cardiology and Cardiovascular Medicine

Abstract

Introduction

AVEIR‐VR leadless pacemaker (LP) was recently approved for clinical use. Although trial data were promising, post‐approval real world data with regard to its effectiveness and safety is lacking. To report our early experience with AVEIR‐VR LP with regard to its effectiveness and safety and compare it with MICRA‐VR.

Methods

The first 25 patients to undergo AVEIR‐VR implant at our institution between June and November 2022, were compared to 25 age‐ and sex‐matched patients who received MICRA‐VR implants.

Results

In both groups, mean age was 73 years and 48% were women. LP implant was successful in 100% of patients in both groups. Single attempt deployment was achieved in 80% of AVEIR‐VR and 60% of MICRA‐VR recipients (p = 0.07). Fluoroscopy, implant, and procedure times were numerically longer in the AVEIR‐VR group compared to MICRA‐VR group (p > 0.05). No significant periprocedural complications were noted in both groups. Incidence of ventricular arrhythmias were higher in the AVEIR‐VR group (20%) compared to the MICRA‐VR group (0%) (p = 0.043). At 2 and 8 weeks follow‐up, device parameters remained stable in both groups with no device dislodgements. The estimated battery life at 8 weeks was significantly longer in the AVEIR‐VR group (15 years) compared to the MICRA‐VR group (8 years) (p = 0.047). With 3−4 AVEIR‐VR implants, the learning curve for successful implantation reached a steady state.

Conclusion

Our initial experience with AVEIR‐VR show that it has comparable effectiveness and safety to MICRA‐VR. Larger sample studies are needed to confirm our findings.

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