Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control

Mikhael F. El-Chami*, Faisal Al-Samadi, Nicolas Clementy, Christophe Garweg, Jose Luis Martinez-Sande, Jonathan P. Piccini, Saverio Iacopino, Michael Lloyd, Xavier Viñolas Prat, Michael Dilou Jacobsen, Philippe Ritter, Jens Brock Johansen, Claudio Tondo, Fang Liu, Dedra H. Fagan, Alyssa K. Eakley, Paul R. Roberts

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Abstrakt

Background: Early results of the Micra Investigational Device Exemption (IDE) study and Micra Post-Approval Registry (PAR) demonstrated excellent safety and efficacy performance; however, intermediate-term results across a large patient population in the real-world setting have not been evaluated. Objectives: We report updated performance of the Micra transcatheter pacemaker from a worldwide PAR and compare it with the IDE study as well as a transvenous historical control. Methods: The safety objective of the analysis was system- or procedure-related major complications through 12 months postimplantation. We compared the major complication rate with that of the 726 patients from the IDE and with a reference data set of 2667 patients with transvenous pacemakers by using a Fine-Gray competing risk model. Results: The Micra device was successfully implanted in 1801 of 1817 patients (99.1%). The mean follow-up period was 6.8 ± 6.9 months. Through 12 months, the major complication rate was 2.7% (95% confidence interval [CI] 2.0%–3.7%). The risk of major complications for Micra PAR patients was 63% lower than that for patients with transvenous pacemakers through 12 months postimplantation (hazard ratio 0.37; 95% CI 0.27–0.52; P < .001). The major complication rate trended lower in the PAR than in the IDE study (hazard ratio 0.71; 95% CI 0.44–1.1; P = .160), driven by the lower pericardial effusion rate in the PAR. There were 3 cases of infection associated with the procedure, but none required device removal and there were no battery or telemetry issues. Pacing thresholds were low and stable through 12 months postimplantation. Conclusion: Performance of the Micra transcatheter pacemaker in international clinical practice remains consistent with previously reported data. Major complications were infrequent and occurred 63% less often compared to transvenous systems. Clinical Trial Registration: Micra Transcatheter Pacing System Post-Approval Registry ClinicalTrials.gov identifier: NCT02536118; Micra Transcatheter Pacing Study ClinicalTrials.gov identifier: NCT02004873.

OriginalsprogEngelsk
TidsskriftHeart Rhythm
Vol/bind15
Udgave nummer12
Sider (fra-til)1800-1807
ISSN1547-5271
DOI
StatusUdgivet - dec. 2018

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