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

El-Chami MF 1 , Clementy N 2 , Garweg C 3 , Omar R 4 , Duray GZ 5 , Gornick CC 6 Show all authors , Leyva F 7 , Sagi V 8 , Piccini JP 9 , Soejima K 10 , Stromberg K 11 , Roberts PR 12

Affiliations 

  • 1 Division of Cardiology, Section of Electrophysiology, Emory University Hospital, Atlanta, Georgia. Electronic address: melcham@emory.edu
  • 2 Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours, France
  • 3 Universitaire Ziekenhuizen Leuven-Campus Gasthuisberg, Leuven, Belgium
  • 4 Cardiac Vascular Sentral, Kuala Lumpur, Malaysia
  • 5 Clinical Electrophysiology Department of Cardiology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary
  • 6 Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota
  • 7 Aston Medical Research Institute, Aston Medical School, Aston University, Birmingham, United Kingdom
  • 8 Southern Heart Group, Jacksonville, Florida
  • 9 Duke University Medical Center, Durham, North Carolina
  • 10 Kyorin University Hospital, Tokyo, Japan
  • 11 Medtronic, Mounds View, Minnesota
  • 12 University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom
JACC Clin Electrophysiol, 2019 02;5(2):162-170.
PMID: 30784685 DOI: 10.1016/j.jacep.2018.12.008

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).

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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