Early performance of a miniaturized leadless cardiac pacemaker: The Micra Transcatheter Pacing Study

Philippe Ritter, Gabor Z. Duray, Clemens Steinwender, Kyoko Soejima, Razali Omar, Lluís Mont, Lucas VA Boersma, Reinoud E. Knops, Larry Chinitz, Shu Zhang, Calambur Narasimhan, John Hummel, Michael Lloyd, Timothy Alexander Simmers, Andrew Voigt, Verla Laager, Kurt Stromberg, Matthew D. Bonner, Todd J. Sheldon, Dwight Reynolds

Research output: Contribution to journalArticle

92 Citations (Scopus)

Abstract

Aims Permanent cardiac pacing is the only effective treatment for symptomatic bradycardia, but complications associated with conventional transvenous pacing systems are commonly related to the pacing lead and pocket. We describe the early performance of a novel self-contained miniaturized pacemaker. Methods and results Patients having Class I or II indication for VVI pacing underwent implantation of a Micra transcatheter pacing system, from the femoral vein and fixated in the right ventricle using four protractible nitinol tines. Prespecified objectives were >85% freedom from unanticipated serious adverse device events (safety) and <2 V 3-month mean pacing capture threshold at 0.24 ms pulse width (efficacy). Patients were implanted (n = 140) from 23 centres in 11 countries (61% male, age 77.0 ± 10.2 years) for atrioventricular block (66%) or sinus node dysfunction (29%) indications. During mean follow-up of 1.9 ± 1.8 months, the safety endpoint was met with no unanticipated serious adverse device events. Thirty adverse events related to the system or procedure occurred, mostly due to transient dysrhythmias or femoral access complications. One pericardial effusion without tamponade occurred after 18 device deployments. In 60 patients followed to 3 months, mean pacing threshold was 0.51 ± 0.22 V, and no threshold was ≥2 V, meeting the efficacy endpoint (P < 0.001). Average R-wave was 16.1 ± 5.2 mV and impedance was 650.7 ± 130 ohms. Conclusion Early assessment shows the transcatheter pacemaker can safely and effectively be applied. Long-term safety and benefit of the pacemaker will further be evaluated in the trial.

Original languageEnglish
Pages (from-to)2510-2519
Number of pages10
JournalEuropean heart journal
Volume36
Issue number37
DOIs
Publication statusPublished - Oct 1 2015

Keywords

  • Leadless cardiac pacemaker
  • Miniaturization
  • Transcatheter pacing system

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Ritter, P., Duray, G. Z., Steinwender, C., Soejima, K., Omar, R., Mont, L., Boersma, L. VA., Knops, R. E., Chinitz, L., Zhang, S., Narasimhan, C., Hummel, J., Lloyd, M., Simmers, T. A., Voigt, A., Laager, V., Stromberg, K., Bonner, M. D., Sheldon, T. J., & Reynolds, D. (2015). Early performance of a miniaturized leadless cardiac pacemaker: The Micra Transcatheter Pacing Study. European heart journal, 36(37), 2510-2519. https://doi.org/10.1093/eurheartj/ehv214