A leadless intracardiac transcatheter pacing system

Dwight Reynolds, Gabor Z. Duray, Razali Omar, Kyoko Soejima, Petr Neuzil, Shu Zhang, Calambur Narasimhan, Clemens Steinwender, Josep Brugada, Michael Lloyd, Paul R. Roberts, Venkata Sagi, John Hummel, Maria Grazia Bongiorni, Reinoud E. Knops, Christopher R. Ellis, Charles C. Gornick, Matthew A. Bernabei, Verla Laager, Kurt StrombergEric R. Williams, J. Harrison Hudnall, Philippe Ritter

Research output: Contribution to journalArticle

282 Citations (Scopus)

Abstract

BACKGROUND: A leadless intracardiac transcatheter pacing system has been designed to avoid the need for a pacemaker pocket and transvenous lead. METHODS In a prospective multicenter study without controls, a transcatheter pacemaker was implanted in patients who had guideline-based indications for ventricular pacing. The analysis of the primary end points began when 300 patients reached 6 months of follow-up. The primary safety end point was freedom from system-related or procedure-related major complications. The primary efficacy end point was the percentage of patients with low and stable pacing capture thresholds at 6 months (≤2.0 V at a pulse width of 0.24 msec and an increase of ≤1.5 V from the time of implantation). The safety and efficacy end points were evaluated against performance goals (based on historical data) of 83% and 80%, respectively. We also performed a post hoc analysis in which the rates of major complications were compared with those in a control cohort of 2667 patients with transvenous pacemakers from six previously published studies. RESULTS The device was successfully implanted in 719 of 725 patients (99.2%). The Kaplan-Meier estimate of the rate of the primary safety end point was 96.0% (95% confidence interval [CI], 93.9 to 97.3; P<0.001 for the comparison with the safety performance goal of 83%); there were 28 major complications in 25 of 725 patients, and no dislodgements. The rate of the primary efficacy end point was 98.3% (95% CI, 96.1 to 99.5; P<0.001 for the comparison with the efficacy performance goal of 80%) among 292 of 297 patients with paired 6-month data. Although there were 28 major complications in 25 patients, patients with transcatheter pacemakers had significantly fewer major complications than did the control patients (hazard ratio, 0.49; 95% CI, 0.33 to 0.75; P = 0.001). CONCLUSIONS In this historical comparison study, the transcatheter pacemaker met the prespecified safety and efficacy goals; it had a safety profile similar to that of a transvenous system while providing low and stable pacing thresholds.

Original languageEnglish
Pages (from-to)533-541
Number of pages9
JournalNew England Journal of Medicine
Volume374
Issue number6
DOIs
Publication statusPublished - Feb 11 2016

ASJC Scopus subject areas

  • Medicine(all)

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    Reynolds, D., Duray, G. Z., Omar, R., Soejima, K., Neuzil, P., Zhang, S., Narasimhan, C., Steinwender, C., Brugada, J., Lloyd, M., Roberts, P. R., Sagi, V., Hummel, J., Bongiorni, M. G., Knops, R. E., Ellis, C. R., Gornick, C. C., Bernabei, M. A., Laager, V., ... Ritter, P. (2016). A leadless intracardiac transcatheter pacing system. New England Journal of Medicine, 374(6), 533-541. https://doi.org/10.1056/NEJMoa1511643