Long-term outcomes in leadless Micra transcatheter pacemakers with elevated thresholds at implantation: Results from the Micra Transcatheter Pacing System Global Clinical Trial

for the, Micra Transcatheter Pacing Study Group

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23 Citations (Scopus)

Abstract

Background Device repositioning during Micra leadless pacemaker implantation may be required to achieve optimal pacing thresholds. Objective The purpose of this study was to describe the natural history of acute elevated Micra vs traditional transvenous lead thresholds. Methods Micra study VVI patients with threshold data (at 0.24 ms) at implant (n = 711) were compared with Capture study patients with de novo transvenous leads at 0.4 ms (n = 538). In both cohorts, high thresholds were defined as >1.0 V and very high as >1.5 V. Change in pacing threshold (0–6 months) with high (1.0 to ≤1.5 V) or very high (>1.5 V) thresholds were compared using the Wilcoxon signed-rank test. Results Of the 711 Micra patients, 83 (11.7%) had an implant threshold of >1.0 V at 0.24 ms. Of the 538 Capture patients, 50 (9.3%) had an implant threshold of >1.0 V at 0.40 ms. There were no significant differences in patient characteristics between those with and without an implant threshold of >1.0 V, with the exception of left ventricular ejection fraction in the Capture cohort (high vs low thresholds, 53% vs 58%; P =.011). Patients with an implant threshold of >1.0 V decreased significantly (P <.001) in both cohorts. Micra patients with high and very high thresholds decreased significantly (P <.01) by 1 month, with 87% and 85% having 6-month thresholds lower than the implant value. However, when the capture threshold at implant was >2 V, only 18.2% had a threshold of ≤1 V at 6 months and 45.5% had a capture threshold of >2 V. Conclusions Pacing thresholds in most Micra patients with elevated thresholds decrease after implant. Micra device repositioning may not be necessary if the pacing threshold is ≤2 V.

Original languageEnglish
Pages (from-to)685-691
Number of pages7
JournalHeart Rhythm
Volume14
Issue number5
DOIs
Publication statusPublished - máj. 1 2017

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Clinical Trials
Equipment and Supplies
Nonparametric Statistics
Natural History
Stroke Volume

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

@article{ad6ff710de8e49f590cfa9598dd0d866,
title = "Long-term outcomes in leadless Micra transcatheter pacemakers with elevated thresholds at implantation: Results from the Micra Transcatheter Pacing System Global Clinical Trial",
abstract = "Background Device repositioning during Micra leadless pacemaker implantation may be required to achieve optimal pacing thresholds. Objective The purpose of this study was to describe the natural history of acute elevated Micra vs traditional transvenous lead thresholds. Methods Micra study VVI patients with threshold data (at 0.24 ms) at implant (n = 711) were compared with Capture study patients with de novo transvenous leads at 0.4 ms (n = 538). In both cohorts, high thresholds were defined as >1.0 V and very high as >1.5 V. Change in pacing threshold (0–6 months) with high (1.0 to ≤1.5 V) or very high (>1.5 V) thresholds were compared using the Wilcoxon signed-rank test. Results Of the 711 Micra patients, 83 (11.7{\%}) had an implant threshold of >1.0 V at 0.24 ms. Of the 538 Capture patients, 50 (9.3{\%}) had an implant threshold of >1.0 V at 0.40 ms. There were no significant differences in patient characteristics between those with and without an implant threshold of >1.0 V, with the exception of left ventricular ejection fraction in the Capture cohort (high vs low thresholds, 53{\%} vs 58{\%}; P =.011). Patients with an implant threshold of >1.0 V decreased significantly (P <.001) in both cohorts. Micra patients with high and very high thresholds decreased significantly (P <.01) by 1 month, with 87{\%} and 85{\%} having 6-month thresholds lower than the implant value. However, when the capture threshold at implant was >2 V, only 18.2{\%} had a threshold of ≤1 V at 6 months and 45.5{\%} had a capture threshold of >2 V. Conclusions Pacing thresholds in most Micra patients with elevated thresholds decrease after implant. Micra device repositioning may not be necessary if the pacing threshold is ≤2 V.",
keywords = "Bradycardia, Capture threshold, Clinical trial, Leadless pacemaker, Outcomes, Pacemaker, VVI",
author = "{for the} and {Micra Transcatheter Pacing Study Group} and Piccini, {Jonathan P.} and Kurt Stromberg and Jackson, {Kevin P.} and Verla Laager and G. Duray and Mikhael El-Chami and Ellis, {Christopher R.} and John Hummel and Jones, {D. Randy} and Kowal, {Robert C.} and Calambur Narasimhan and Razali Omar and Philippe Ritter and Roberts, {Paul R.} and Kyoko Soejima and Shu Zhang and Dwight Reynolds",
year = "2017",
month = "5",
day = "1",
doi = "10.1016/j.hrthm.2017.01.026",
language = "English",
volume = "14",
pages = "685--691",
journal = "Heart Rhythm",
issn = "1547-5271",
publisher = "Elsevier",
number = "5",

}

TY - JOUR

T1 - Long-term outcomes in leadless Micra transcatheter pacemakers with elevated thresholds at implantation

T2 - Results from the Micra Transcatheter Pacing System Global Clinical Trial

AU - for the

AU - Micra Transcatheter Pacing Study Group

AU - Piccini, Jonathan P.

AU - Stromberg, Kurt

AU - Jackson, Kevin P.

AU - Laager, Verla

AU - Duray, G.

AU - El-Chami, Mikhael

AU - Ellis, Christopher R.

AU - Hummel, John

AU - Jones, D. Randy

AU - Kowal, Robert C.

AU - Narasimhan, Calambur

AU - Omar, Razali

AU - Ritter, Philippe

AU - Roberts, Paul R.

AU - Soejima, Kyoko

AU - Zhang, Shu

AU - Reynolds, Dwight

PY - 2017/5/1

Y1 - 2017/5/1

N2 - Background Device repositioning during Micra leadless pacemaker implantation may be required to achieve optimal pacing thresholds. Objective The purpose of this study was to describe the natural history of acute elevated Micra vs traditional transvenous lead thresholds. Methods Micra study VVI patients with threshold data (at 0.24 ms) at implant (n = 711) were compared with Capture study patients with de novo transvenous leads at 0.4 ms (n = 538). In both cohorts, high thresholds were defined as >1.0 V and very high as >1.5 V. Change in pacing threshold (0–6 months) with high (1.0 to ≤1.5 V) or very high (>1.5 V) thresholds were compared using the Wilcoxon signed-rank test. Results Of the 711 Micra patients, 83 (11.7%) had an implant threshold of >1.0 V at 0.24 ms. Of the 538 Capture patients, 50 (9.3%) had an implant threshold of >1.0 V at 0.40 ms. There were no significant differences in patient characteristics between those with and without an implant threshold of >1.0 V, with the exception of left ventricular ejection fraction in the Capture cohort (high vs low thresholds, 53% vs 58%; P =.011). Patients with an implant threshold of >1.0 V decreased significantly (P <.001) in both cohorts. Micra patients with high and very high thresholds decreased significantly (P <.01) by 1 month, with 87% and 85% having 6-month thresholds lower than the implant value. However, when the capture threshold at implant was >2 V, only 18.2% had a threshold of ≤1 V at 6 months and 45.5% had a capture threshold of >2 V. Conclusions Pacing thresholds in most Micra patients with elevated thresholds decrease after implant. Micra device repositioning may not be necessary if the pacing threshold is ≤2 V.

AB - Background Device repositioning during Micra leadless pacemaker implantation may be required to achieve optimal pacing thresholds. Objective The purpose of this study was to describe the natural history of acute elevated Micra vs traditional transvenous lead thresholds. Methods Micra study VVI patients with threshold data (at 0.24 ms) at implant (n = 711) were compared with Capture study patients with de novo transvenous leads at 0.4 ms (n = 538). In both cohorts, high thresholds were defined as >1.0 V and very high as >1.5 V. Change in pacing threshold (0–6 months) with high (1.0 to ≤1.5 V) or very high (>1.5 V) thresholds were compared using the Wilcoxon signed-rank test. Results Of the 711 Micra patients, 83 (11.7%) had an implant threshold of >1.0 V at 0.24 ms. Of the 538 Capture patients, 50 (9.3%) had an implant threshold of >1.0 V at 0.40 ms. There were no significant differences in patient characteristics between those with and without an implant threshold of >1.0 V, with the exception of left ventricular ejection fraction in the Capture cohort (high vs low thresholds, 53% vs 58%; P =.011). Patients with an implant threshold of >1.0 V decreased significantly (P <.001) in both cohorts. Micra patients with high and very high thresholds decreased significantly (P <.01) by 1 month, with 87% and 85% having 6-month thresholds lower than the implant value. However, when the capture threshold at implant was >2 V, only 18.2% had a threshold of ≤1 V at 6 months and 45.5% had a capture threshold of >2 V. Conclusions Pacing thresholds in most Micra patients with elevated thresholds decrease after implant. Micra device repositioning may not be necessary if the pacing threshold is ≤2 V.

KW - Bradycardia

KW - Capture threshold

KW - Clinical trial

KW - Leadless pacemaker

KW - Outcomes

KW - Pacemaker

KW - VVI

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U2 - 10.1016/j.hrthm.2017.01.026

DO - 10.1016/j.hrthm.2017.01.026

M3 - Article

C2 - 28111349

AN - SCOPUS:85015918459

VL - 14

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EP - 691

JO - Heart Rhythm

JF - Heart Rhythm

SN - 1547-5271

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