A comparative study of the two leadless pacemakers in clinical practice

Abstract

IntroductionAVEIR‐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.MethodsThe 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.ResultsIn 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.ConclusionOur 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.

Late cardiac tamponade after a helix‐based active fixation leadless pacemaker implantation

“… 1 In this case, the patient was on hemodialysis and was at medium risk. Medium‐risk cases are associated with a risk of pericardiac effusion because of the increased number of deployments, and the Aveir‐VR™ had more successful single‐attempt deployments than the Micra™ 2 ; thus, we should have aimed for successful single‐attempt deployment. In addition, it is difficult to implant the Aveir‐VR™ on the septum because the Aveir‐VR™ is 38 mm long, which is too long to be implanted in the right ventricle without interfering with the tricuspid valve, especially in the Japanese population.…”