Leadless Pacemaker Implantation in Hemodialysis Patients: Experience With the Micra Transcatheter Pacemaker

Mikhael F. El-Chami, Nicolas Clementy, Christophe Garweg, Razali Omar, Gabor Z. Duray, Charles C. Gornick, Francisco Leyva, Venkata Sagi, Jonathan P. Piccini, Kyoko Soejima, Kurt Stromberg, Paul R. Roberts

Research output: Article

9 Citations (Scopus)

Abstract

Objectives: This study sought to report periprocedural outcomes and intermediate-term follow-up of hemodialysis patients undergoing Micra implantation. Background: Leadless pacemakers may be preferred in patients with limited vascular access and high-infection risk, such as patients on hemodialysis. Methods: Patients on hemodialysis at the time of Micra implantation attempt (n = 201 of 2,819; 7%) from the Micra Transcatheter Pacing Study investigational device exemption trial, Micra Transcatheter Pacing System Continued Access Study Protocol, and Micra Transcatheter Pacing System Post-Approval Registry were included in the analysis. Baseline characteristics, periprocedural outcomes, and intermediate-term follow-up were summarized. Results: Patients on hemodialysis at the time of Micra implantation attempt were on average 70.5 ± 13.5 years of age and 59.2% were male. The dialysis patients commonly had hypertension (80%), diabetes (61%), coronary artery disease (39%), and congestive heart failure (27%), and 72% had a condition that the implanting physician felt precluded the use of a transvenous pacemaker. Micra was successfully implanted in 197 patients (98.0%). Reasons for unsuccessful implantation included inadequate thresholds (n = 2) and pericardial effusion (n = 2). The median implantation time was 27 min (interquartile range: 20 to 39 min). There were 3 procedure-related deaths: 1 due to metabolic acidosis following a prolonged procedure duration in a patient undergoing concomitant atrioventricular nodal ablation and 2 deaths occurred in patients who needed surgical repair after perforation. Average follow-up was 6.2 months (range 0 to 26.7 months). No patients had a device-related infection or required device removal because of bacteremia. Conclusions: Leadless pacemakers represent an effective pacing option in this challenging patient population on chronic hemodialysis. The risk of infection appears low with an acceptable safety profile. (Micra Transcatheter Pacing Study; NCT02004873; Micra Transcatheter Pacing System Continued Access Study Protocol; NCT02488681; Micra Transcatheter Pacing System Post-Approval Registry; NCT02536118)

Original languageEnglish
Pages (from-to)162-170
Number of pages9
JournalJACC: Clinical Electrophysiology
Volume5
Issue number2
DOIs
Publication statusPublished - febr. 2019

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

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    El-Chami, M. F., Clementy, N., Garweg, C., Omar, R., Duray, G. Z., Gornick, C. C., Leyva, F., Sagi, V., Piccini, J. P., Soejima, K., Stromberg, K., & Roberts, P. R. (2019). Leadless Pacemaker Implantation in Hemodialysis Patients: Experience With the Micra Transcatheter Pacemaker. JACC: Clinical Electrophysiology, 5(2), 162-170. https://doi.org/10.1016/j.jacep.2018.12.008