A comparative study of the two leadless pacemakers in clinical practice

Area of Science:

• Cardiology
• Medical Devices
• Electrophysiology

Background:

• The AVEIR-VR leadless pacemaker (LP) is a new device recently approved for clinical use.
• While initial trial data for the AVEIR-VR LP were promising, real-world data on its effectiveness and safety are limited.
• Comparative studies with existing leadless pacemakers are crucial for understanding its clinical utility.

Purpose of the Study:

• To report the early clinical experience with the AVEIR-VR LP.
• To evaluate the effectiveness and safety of the AVEIR-VR LP in a real-world setting.
• To compare the performance of the AVEIR-VR LP with the MICRA-VR device.

Main Methods:

• A retrospective comparison of the first 25 patients implanted with AVEIR-VR LP and 25 age- and sex-matched patients who received MICRA-VR implants.
• Data collected included implantation success rates, procedure times, periprocedural complications, and device parameters.
• Follow-up assessments at 2 and 8 weeks evaluated device stability and battery life.

Main Results:

• Both AVEIR-VR and MICRA-VR achieved 100% implantation success.
• While implantation and procedure times were numerically longer for AVEIR-VR, no significant complications were observed in either group.
• The AVEIR-VR group showed a higher incidence of ventricular arrhythmias (20% vs. 0%), but had a significantly longer estimated battery life (15 years vs. 8 years).

Conclusions:

• The AVEIR-VR LP demonstrates comparable effectiveness and safety to the MICRA-VR in early clinical experience.
• The learning curve for AVEIR-VR implantation appears to stabilize after 3-4 cases.
• Larger studies are warranted to validate these findings and further assess the long-term performance of the AVEIR-VR LP.