Safety and Efficacy of Aveir Leadless Pacemaker in Chinese Patients

Aveir无导线起搏器在中国患者中的安全性和有效性

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Abstract

BACKGROUND: Aveir, as a newly approved leadless pacemaker (LP), has been increasingly adopted in clinical practice. However, its application in the Chinese population remains limited. This retrospective study aimed to evaluate the safety and efficacy of the Aveir LP in Chinese patients. METHODS: A retrospective analysis was conducted on patients who underwent LP implantation at the First Affiliated Hospital of Xiamen University between June 2024 and October 2024. Implantation sites included the right ventricular septum and the right ventricular free wall. Parameters were collected preoperatively and at 1-month post-implantation. RESULTS: A total of 16 patients were included, and all cases achieved successful implantation. At the 1-month follow-up, the pacing threshold improved from 0.68 ± 0.42 to 0.59 ± 0.27 V, impedance decreased from 740.00 ± 268.53 to 557.5 ± 129.69 Ω, and R-wave sensing increased from 8.51 ± 3.83 to 11.4 ± 4.22 mV. No complications were observed. There were no significant differences in measurements of the aorta, ascending aorta, left atrium, right atrium, left ventricular end-diastolic diameter, interventricular septal thickness, left ventricular end-systolic diameter, or ejection fraction between preoperative and 1-month post-implantation. Similarly, no significant changes in tricuspid regurgitation were noted between preoperative and 1-month post-implantation. CONCLUSION: This study demonstrated the safety and efficacy of Aveir VR implantation in the Chinese population, with no complications or adverse effects on right heart function. Both the right ventricular free wall and septum were shown to be safe implantation sites with satisfactory device performance, highlighting the free wall as a viable alternative.

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