RESUMO
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.