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Translational Rabbit Model of Chronic Cardiac Pacing

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Device dislodgement and embolization associated with a new leadless pacemaker.

Ali Bahbah¹, Jay Sengupta¹, Dawn Witt¹

¹The Joseph F. Novogratz Family Heart Rhythm Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, USA.

Journal of Cardiovascular Electrophysiology

|October 30, 2024

Summary

This summary is machine-generated.

The AVEIR VR leadless pacemaker (LP) shows a higher dislodgement/embolization (D/E) rate (0.88%) compared to Micra VR (0.29%). Fixation and detachment issues contribute to AVEIR VR D/E events.

Keywords:

device problems dislodgement leadless permanent pacemaker procedural outcomes

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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation

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Published on: February 28, 2012

Area of Science:

Cardiology
Medical Devices
Biomedical Engineering

Background:

Two single-chamber leadless pacemakers (LPs), Micra VR and AVEIR VR, are approved in the US.
Dislodgement and/or embolization (D/E) is a potential complication of LPs.
Different fixation mechanisms (nitinol tines for Micra, active screw helix for AVEIR) may influence D/E rates.

Purpose of the Study:

To evaluate the incidence of D/E for the AVEIR VR LP in the US post-FDA approval.
To compare the D/E rates of AVEIR VR and Micra VR leadless pacemakers.

Main Methods:

The FDA MAUDE database was searched for US D/E reports for AVEIR VR (approval to Dec 2023) and Micra VR (approval to Apr 2024).
Reports indirectly obtained were excluded.
Total US implant numbers were sourced from manufacturer reports.

Main Results:

Over 21 months, 5990 AVEIR VR implants had a D/E rate of 0.88% (53/5990), with 60.4% occurring during implantation.
Over 8 years, 72,237 Micra VR implants had a D/E rate of 0.29% (211/72237).
The D/E rate for AVEIR VR was significantly higher than Micra VR (0.88% vs 0.29%; p < .0001).

Conclusions:

AVEIR VR implants have a significant risk of dislodgement and/or embolization, with an estimated incidence of 0.9%.
This incidence is significantly higher compared to Micra VR.
Fixation issues and device separation from the delivery catheter are implicated in AVEIR VR D/E events.