Literature DB >> 28111349

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

Jonathan P Piccini1, Kurt Stromberg2, Kevin P Jackson3, Verla Laager2, Gabor Z Duray4, Mikhael El-Chami5, Christopher R Ellis6, John Hummel7, D Randy Jones8, Robert C Kowal9, Calambur Narasimhan10, Razali Omar11, Philippe Ritter12, Paul R Roberts13, Kyoko Soejima14, Shu Zhang15, Dwight Reynolds16.   

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.
Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Bradycardia; Capture threshold; Clinical trial; Leadless pacemaker; Outcomes; Pacemaker; VVI

Mesh:

Year:  2017        PMID: 28111349     DOI: 10.1016/j.hrthm.2017.01.026

Source DB:  PubMed          Journal:  Heart Rhythm        ISSN: 1547-5271            Impact factor:   6.343


  11 in total

Review 1.  [Leadless pacemakers and subcutaneously implantable cardioverter defibrillators].

Authors:  C Stellbrink; B Hansky; D Meyer Zu Vilsendorf
Journal:  Internist (Berl)       Date:  2018-10       Impact factor: 0.743

Review 2.  Next-generation pacemakers: from small devices to biological pacemakers.

Authors:  Eugenio Cingolani; Joshua I Goldhaber; Eduardo Marbán
Journal:  Nat Rev Cardiol       Date:  2017-11-16       Impact factor: 32.419

3.  Intraoperative sensing increase predicts long-term pacing threshold in leadless pacemakers.

Authors:  Gianfranco Mitacchione; Gianmarco Arabia; Marco Schiavone; Manuel Cerini; Alessio Gasperetti; Francesca Salghetti; Luca Bontempi; Maurizio Viecca; Antonio Curnis; Giovanni B Forleo
Journal:  J Interv Card Electrophysiol       Date:  2022-01-04       Impact factor: 1.900

Review 4.  Leadless Pacing: Current State and Future Direction.

Authors:  Matthias Merkel; Philipp Grotherr; Andrea Radzewitz; Claus Schmitt
Journal:  Cardiol Ther       Date:  2017-07-13

5.  Nanostim leadless pacemaker system: A longer waiting period after active fixation may reduce unnecessary repositioning.

Authors:  Hiro Kawata; Pranav M Patel; Rajesh Banker
Journal:  HeartRhythm Case Rep       Date:  2017-12-16

6.  Implantation of a leadless pacemaker in a pediatric patient with congenital heart disease.

Authors:  Anthony C McCanta; Gira S Morchi; Froilan Tuozo; Farhouch Berdjis; Joanne P Starr; Anjan S Batra
Journal:  HeartRhythm Case Rep       Date:  2018-08-01

7.  The unstable pacing thresholds of the leadless transcatheter pacemaker affected by body positions in subacute phase after implant.

Authors:  Masue Yoh; Masahiko Takagi; Hiroki Takahashi; Takuro Yoshio; Ichiro Shiojima
Journal:  Eur Heart J Case Rep       Date:  2018-12-27

8.  Leadless pacemaker tether failure during recapture attempt leading to device embolization.

Authors:  Tsz Kin Tam; Yat Sun Joseph Chan; Chin Pang Gary Chan; Kin Yin Anna Chan; Chi Yuen Chan
Journal:  HeartRhythm Case Rep       Date:  2019-01-23

9.  Rate-dependent change in capture threshold following implantation of a leadless pacemaker.

Authors:  Alex J Nusbickel; Steven J Ross; William M Miles; Kun Xiang
Journal:  HeartRhythm Case Rep       Date:  2021-12-09

10.  Fluoroscopic predictors of acceptable capture threshold during the implantation of the micra transcatheter pacing system.

Authors:  Ikuko Togashi; Toshiaki Sato; Akiko Maeda; Takato Mohri; Yumi Katsume; Mika Tashiro; Yuichi Momose; Noriko Nonoguchi; Kyoko Hoshida; Yosuke Miwa; Akiko Ueda; Kyoko Soejima
Journal:  J Cardiovasc Electrophysiol       Date:  2022-03-25       Impact factor: 2.942

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