Micra clinical evidence
COVERAGE WITH EVIDENCE DEVELOPMENT (CED) STUDY - Two-Year Outcomes2
The largest claims-based evaluation of leadless pacemakers to date.1
analysis design
This study facilitates national Medicare coverage while generating evidence about the real-world effectiveness of the Micra VR* leadless pacing system using the Centers for Medicare and Medicaid Services (CMS) administrative claims data. The study evaluates complications, utilization, and outcomes of the Micra VR leadless pacing system. Patients receiving a transvenous VVI pacemaker (TV-VVI) during the study period, regardless of manufacturer, were included as a contemporaneous control group (Micra VR n = 6219, TV-VVI n = 10212).
LEADLESS VS. TRANSVENOUS SINGLE-CHAMBER VENTRICULAR PACING IN THE MICRA CED STUDY: 2-YEAR FOLLOW-UP.
Results
- Significant 38% reduction in the rate of reintervention for patients receiving Micra VR vs. TV-VVI (adjusted HR, 0.62, 95% CI, 0.45–0.85, P = 0.003)
- Significant 31% reduction in chronic complication rate at two years with Micra VR vs. TV-VVI (adjusted HR, 0.69, 95% CI, 0.60–0.81, P = < .0001)
ESC Guidelines now recommend Leadless Pacing for defined patients populations4
Download ESC 2021 Guidelines
*
The single chamber Micra™ Transcatheter Pacing System is being described herein as Micra™ VR in order to distinguish it from Micra™ AV product.
References
1
Nippoldt D, Whiting J. Micra Transcatheter Pacing System Device Volume Characterization Comparison. November 2014. Medtronic data on file.
2
El Chami MF, Bockstedt L, Longacre C, Higuera L, Stromberg K, Crossley G, Kowal RC, Piccini JP. Leadless vs. transvenous single-chamber ventricular pacing in the Micra CED study: 2-year follow-up. Eur Heart J. 2021; https://doi.org/10.1093/eurheartj/ehab767
3
Akatsu, Susumu. 100,000 Micra Patients Implanted. May 2021. Medtronic Data on File.
4
Glikson, M. et al. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. October 2021. European Heart Journal.