Cardiovascular Implantable Electronic Devices -> Bradycardia Devices: -> Device Technology D-PO02 - Poster Session II (ID 47) Poster

D-PO02-089 - Need For System Revision With Leadless Pacemakers In Extended Follow-up:updated Results From The Micra Transcatheter Pacing System Post-approval Registry (ID 1009)

Abstract

Background: The investigational trials of Micra leadless pacing demonstrated excellent safety and efficacy; however, longer-term outcomes in general clinical practice, including need for system revision, remain unknown.
Objective: We report updated performance of the Micra transcatheter pacemaker and long-term outcomes from the worldwide post-approval registry (PAR).
Methods: All Micra PAR patients (n=1816) undergoing implant attempt were included. Endpoints included system revision rate for any cause and system- or procedure-related major complications through 36 months post-implant. We compared these rates to a reference dataset of 2667 patients implanted with a transvenous pacemaker using Fine-Gray competing risk models.
Results: Patients were followed for an average of 19.7 ± 10.7 months. The major complication rate at 36 months was 4.1% (95% CI: 3.0%-5.3%) and was 57% lower than that for patients with transvenous pacemakers (HR: 0.43, 95% CI: 0.32-0.57). The all-cause system revision rate at 36 months was 3.6% (95% CI: 2.2% - 5.3%) in the 1799 successfully implanted patients. System revisions were mostly for elevated thresholds (41.5%) or device upgrades (36.6%) and the most frequent action was to turn the device OOO or decrease the lower rate limit (76%). Risk of system revision for Micra PAR patients was 56% lower compared to transvenous pacemakers at 36 months (HR: 0.44, 95% CI: 0.31 - 0.63, P<0.001, Figure).
Conclusion: Extended performance data of the Micra transcatheter pacemaker in international clinical practice remains consistent with previously reported data. System revisions were infrequent and occurred 56% less often compared to transvenous systems.

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