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

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

Research output: Contribution to journalArticle

4 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 - Feb 1 2019

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Renal Dialysis
Registries
Infection
Device Removal
Equipment and Supplies
Pericardial Effusion
Bacteremia
Acidosis
Blood Vessels
Coronary Artery Disease
Dialysis
Heart Failure
Hypertension
Physicians
Safety

Keywords

  • bradycardia
  • hemodialysis
  • leadless pacemaker
  • permanent pacemaker

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Leadless Pacemaker Implantation in Hemodialysis Patients : Experience With the Micra Transcatheter Pacemaker. / El-Chami, Mikhael F.; Clementy, Nicolas; Garweg, Christophe; Omar, Razali; Duray, G.; Gornick, Charles C.; Leyva, Francisco; Sagi, Venkata; Piccini, Jonathan P.; Soejima, Kyoko; Stromberg, Kurt; Roberts, Paul R.

In: JACC: Clinical Electrophysiology, Vol. 5, No. 2, 01.02.2019, p. 162-170.

Research output: Contribution to journalArticle

El-Chami, MF, Clementy, N, Garweg, C, Omar, R, Duray, G, Gornick, CC, Leyva, F, Sagi, V, Piccini, JP, Soejima, K, Stromberg, K & Roberts, PR 2019, 'Leadless Pacemaker Implantation in Hemodialysis Patients: Experience With the Micra Transcatheter Pacemaker', JACC: Clinical Electrophysiology, vol. 5, no. 2, pp. 162-170. https://doi.org/10.1016/j.jacep.2018.12.008
El-Chami, Mikhael F. ; Clementy, Nicolas ; Garweg, Christophe ; Omar, Razali ; Duray, G. ; Gornick, Charles C. ; Leyva, Francisco ; Sagi, Venkata ; Piccini, Jonathan P. ; Soejima, Kyoko ; Stromberg, Kurt ; Roberts, Paul R. / Leadless Pacemaker Implantation in Hemodialysis Patients : Experience With the Micra Transcatheter Pacemaker. In: JACC: Clinical Electrophysiology. 2019 ; Vol. 5, No. 2. pp. 162-170.
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AU - El-Chami, Mikhael F.

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AU - Omar, Razali

AU - Duray, G.

AU - Gornick, Charles C.

AU - Leyva, Francisco

AU - Sagi, Venkata

AU - Piccini, Jonathan P.

AU - Soejima, Kyoko

AU - Stromberg, Kurt

AU - Roberts, Paul R.

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N2 - 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)

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