Device dislodgement and embolization associated with a new leadless pacemaker.

INTRODUCTION

Currently, there are two approved single chamber leadless pacemakers (LP) in the United States (US), Micra VR™; approved since 2016 and AVEIR VR™; approved in 2022. A potential complication of LPs is dislodgement and/or embolization (D/E) during or after implant. According to the IDE trials, there appears to be a significant difference in D/E rates between the two LPs that have different fixation mechanisms; Micra uses nitinol tines, while AVEIR uses an active screw helix. The aim of this study was to determine if the AVEIR VR LP has continued to exhibit D/E in the United States since it was approved by the Food and Drug Administration (FDA) in April 2022.

METHODS

The FDA Manufacturer and User Facility Device Experience (MAUDE) database was searched for US D/E reports communicated by the manufacturers of both LP devices. For AVEIR VR we reviewed reports from approval till December 2023, and for Micra VR we looked at reports from approval to April 2024. Excluded were reports based on information indirectly obtained from registries, journals, social media, or volunteers. Total number of US implants was acquired from the manufacturers' product performance reports.

RESULTS

During a period of 21 months, 5990 AVEIR VR implants had been registered in the United States, of which 53 (0.88%) encountered D/E both during and after the procedure. More D/E (32; 60.4%) occurred during the implantation procedure, with device release problems being the most prominent procedural issue involved with these events. Within a 8-year period, 72 237 Micra VR implants have been registered in the United States, of which 211 (0.29%) showed D/E. The rate of D/E since the US approval of both devices was significantly higher for AVEIR VR compared to Micra VR (0.88% vs 0.29%; p < .0001).

CONCLUSION

AVEIR VR implants may be complicated by dislodgement with or without embolization. Currently, the estimated incidence is about 0.9%, which is significantly higher than Micra VR. Fixation issues and separation problems of the device from the delivery catheter appear to be responsible for most of these D/E events.