• Reinoud E Knops, Fleur V Y Tjong, Petr Neuzil, Johannes Sperzel, Marc A Miller, Jan Petru, Jaroslav Simon, Lucie Sediva, Joris R de Groot, Srinivas R Dukkipati, Jacob S Koruth, Arthur A M Wilde, Josef Kautzner, and Vivek Y Reddy.
• AMC Heart Center, Department of Clinical and Experimental Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. Electronic address: r.e.knops@amc.uva.nl.
• J. Am. Coll. Cardiol. 2015 Apr 21;65(15):1497-504.

BackgroundA leadless cardiac pacemaker (LCP) system was recently introduced to overcome lead-related complications of conventional pacing systems. To date, long-term results of an LCP system are unknown.ObjectivesThe aim of this study was to assess the complication incidence, electrical performance, and rate response characteristics within the first year of follow-up of patients implanted with an LCP.MethodsWe retrospectively assessed intermediate-term follow-up data for 31 of 33 patients from the LEADLESS trial cohort who had an indication for single-chamber pacing and received an LCP between December 2012 and April 2013.ResultsThe mean age of the cohort was 76 ± 8 years, and 65% were male. Between 3 and 12 months of follow-up, there were no pacemaker-related adverse events reported. The pacing performance results at 6- and 12-month follow-up were, respectively, as follows: mean pacing threshold (at a 0.4-ms pulse width), 0.40 ± 0.26 V and 0.43 ± 0.30 V; R-wave amplitude 10.6 ± 2.6 mV and 10.3 ± 2.2 mV; and impedance 625 ± 205 Ω and 627 ± 209 Ω. At the 12-month follow-up in 61% of the patients (n = 19 of 31), the rate response sensor was activated, and an adequate rate response was observed in all patients.ConclusionsThe LCP demonstrates very stable performance and reassuring safety results during intermediate-term follow-up. These results support the use of the LCP as a promising alternative to conventional pacemaker systems. Continued evaluation is warranted to further characterize this system. (Evaluation of a New Cardiac Pacemaker; NCT01700244).Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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