Leadless Pacemaker Implantation in Hemodialysis Patients

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

Research output: Contribution to journalArticle

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)
LanguageEnglish
Pages162-170
Number of pages9
JournalJACC: Clinical Electrophysiology
Volume5
Issue number2
Early online date30 Jan 2019
DOIs
Publication statusPublished - 19 Feb 2019

Fingerprint

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

Keywords

  • bradycardia
  • hemodialysis
  • leadless pacemaker
  • permanent pacemaker

Cite this

El-chami, M. F., Clementy, N., Garweg, C., Omar, R., Duray, G. Z., Gornick, C. C., ... Roberts, P. R. (2019). Leadless Pacemaker Implantation in Hemodialysis Patients. 5(2), 162-170. https://doi.org/10.1016/j.jacep.2018.12.008
El-chami, Mikhael F. ; Clementy, Nicolas ; Garweg, Christophe ; Omar, Razali ; Duray, Gabor Z. ; Gornick, Charles C. ; Leyva-Leon, Francisco ; Sagi, Venkata ; Piccini, Jonathan P. ; Soejima, Kyoko ; Stromberg, Kurt ; Roberts, Paul R. / Leadless Pacemaker Implantation in Hemodialysis Patients. 2019 ; Vol. 5, No. 2. pp. 162-170.
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title = "Leadless Pacemaker Implantation in Hemodialysis Patients",
abstract = "ObjectivesThis study sought to report periprocedural outcomes and intermediate-term follow-up of hemodialysis patients undergoing Micra implantation.BackgroundLeadless pacemakers may be preferred in patients with limited vascular access and high-infection risk, such as patients on hemodialysis.MethodsPatients 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.ResultsPatients 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.ConclusionsLeadless 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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El-chami, MF, Clementy, N, Garweg, C, Omar, R, Duray, GZ, Gornick, CC, Leyva-Leon, F, Sagi, V, Piccini, JP, Soejima, K, Stromberg, K & Roberts, PR 2019, 'Leadless Pacemaker Implantation in Hemodialysis Patients' vol. 5, no. 2, pp. 162-170. https://doi.org/10.1016/j.jacep.2018.12.008

Leadless Pacemaker Implantation in Hemodialysis Patients. / El-chami, Mikhael F.; Clementy, Nicolas; Garweg, Christophe; Omar, Razali; Duray, Gabor Z.; Gornick, Charles C.; Leyva-Leon, Francisco; Sagi, Venkata; Piccini, Jonathan P.; Soejima, Kyoko; Stromberg, Kurt; Roberts, Paul R.

Vol. 5, No. 2, 19.02.2019, p. 162-170.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Leadless Pacemaker Implantation in Hemodialysis Patients

AU - El-chami, Mikhael F.

AU - Clementy, Nicolas

AU - Garweg, Christophe

AU - Omar, Razali

AU - Duray, Gabor Z.

AU - Gornick, Charles C.

AU - Leyva-Leon, Francisco

AU - Sagi, Venkata

AU - Piccini, Jonathan P.

AU - Soejima, Kyoko

AU - Stromberg, Kurt

AU - Roberts, Paul R.

PY - 2019/2/19

Y1 - 2019/2/19

N2 - ObjectivesThis study sought to report periprocedural outcomes and intermediate-term follow-up of hemodialysis patients undergoing Micra implantation.BackgroundLeadless pacemakers may be preferred in patients with limited vascular access and high-infection risk, such as patients on hemodialysis.MethodsPatients 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.ResultsPatients 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.ConclusionsLeadless 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)

AB - ObjectivesThis study sought to report periprocedural outcomes and intermediate-term follow-up of hemodialysis patients undergoing Micra implantation.BackgroundLeadless pacemakers may be preferred in patients with limited vascular access and high-infection risk, such as patients on hemodialysis.MethodsPatients 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.ResultsPatients 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.ConclusionsLeadless 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)

KW - bradycardia

KW - hemodialysis

KW - leadless pacemaker

KW - permanent pacemaker

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El-chami MF, Clementy N, Garweg C, Omar R, Duray GZ, Gornick CC et al. Leadless Pacemaker Implantation in Hemodialysis Patients. 2019 Feb 19;5(2):162-170. https://doi.org/10.1016/j.jacep.2018.12.008