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Automatic measurement of atrial pacing thresholds in dual-chamber pacemakers: Clinical experience with atrial capture management

Sperzel, J; Milasinovic, G; Smith, T W; Mead, H; Brandt, Johan LU ; Haisty, W K; Bailey, J R; Roelke, M; Simonson, J and Englund, J, et al. (2005) In Heart Rhythm 2(11). p.1203-1210
Abstract
BACKGROUND The Medtronic EnPulse (TM) pacemaker incorporates the new atrial capture management (ACM) algorithm to automatically measure atrial capture thresholds and subsequently manage atrial pacing outputs. OBJECTIVES The purpose of this study was to evaluate the clinical performance of ACM. METHODS Two hundred patients with an indication for a dual-chamber pacemaker underwent implantation. ACM thresholds and manually measured atrial pacing thresholds were assessed at follow-up visits. Clinical equivalence was defined as the ACM-measured threshold being within -0.25 V to +0.5 V of the manually measured threshold. The clinician analyzed all ACM measurements performed in-office for evidence of proarrhythmia. RESULTS All 200 implanted... (More)
BACKGROUND The Medtronic EnPulse (TM) pacemaker incorporates the new atrial capture management (ACM) algorithm to automatically measure atrial capture thresholds and subsequently manage atrial pacing outputs. OBJECTIVES The purpose of this study was to evaluate the clinical performance of ACM. METHODS Two hundred patients with an indication for a dual-chamber pacemaker underwent implantation. ACM thresholds and manually measured atrial pacing thresholds were assessed at follow-up visits. Clinical equivalence was defined as the ACM-measured threshold being within -0.25 V to +0.5 V of the manually measured threshold. The clinician analyzed all ACM measurements performed in-office for evidence of proarrhythmia. RESULTS All 200 implanted patients had a 1-month visit, and validated manual and in-office ACM threshold data were available for 123 patients. The ACM threshold was 0.595 +/- 0.252 V, and the manual threshold was 0.584 +/- 0.233 V. The mean difference was 0.010 V with a 95% confidence interval of (-0.001, 0.021). The mean difference over all visits was 0.011 V. For all patients, the individual threshold differences were within the range of clinical equivalence at all visits. No atrial arrhythmias were observed during 892 ACM tests in 193 patients. CONCLUSION This study demonstrated that the ACM algorithm is safe, accurate, and reliable over time. ACM was demonstrated to be clinically equivalent to the manual atrial threshold test in all patients at 1 month and over the entire follow-up period of up to 6 months. ACM ensures atrial capture, may save time during follow-up, and can be used to manage atrial pacing outputs. (Less)
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type
Contribution to journal
publication status
published
subject
keywords
atrioventricular conduction, atrial chamber reset, automatic atrial threshold measurement, atrial capture management, atrial threshold, test, dual-chamber pacemaker
in
Heart Rhythm
volume
2
issue
11
pages
1203 - 1210
publisher
Elsevier
external identifiers
  • pmid:16253910
  • wos:000233102900007
  • scopus:27744529238
ISSN
1547-5271
DOI
10.1016/j.hrthm.2005.07.023
language
English
LU publication?
yes
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9de392bc-eb2a-4c8f-abb6-45160b91a64d (old id 213882)
date added to LUP
2007-08-06 09:33:54
date last changed
2017-07-30 03:41:22
@article{9de392bc-eb2a-4c8f-abb6-45160b91a64d,
  abstract     = {BACKGROUND The Medtronic EnPulse (TM) pacemaker incorporates the new atrial capture management (ACM) algorithm to automatically measure atrial capture thresholds and subsequently manage atrial pacing outputs. OBJECTIVES The purpose of this study was to evaluate the clinical performance of ACM. METHODS Two hundred patients with an indication for a dual-chamber pacemaker underwent implantation. ACM thresholds and manually measured atrial pacing thresholds were assessed at follow-up visits. Clinical equivalence was defined as the ACM-measured threshold being within -0.25 V to +0.5 V of the manually measured threshold. The clinician analyzed all ACM measurements performed in-office for evidence of proarrhythmia. RESULTS All 200 implanted patients had a 1-month visit, and validated manual and in-office ACM threshold data were available for 123 patients. The ACM threshold was 0.595 +/- 0.252 V, and the manual threshold was 0.584 +/- 0.233 V. The mean difference was 0.010 V with a 95% confidence interval of (-0.001, 0.021). The mean difference over all visits was 0.011 V. For all patients, the individual threshold differences were within the range of clinical equivalence at all visits. No atrial arrhythmias were observed during 892 ACM tests in 193 patients. CONCLUSION This study demonstrated that the ACM algorithm is safe, accurate, and reliable over time. ACM was demonstrated to be clinically equivalent to the manual atrial threshold test in all patients at 1 month and over the entire follow-up period of up to 6 months. ACM ensures atrial capture, may save time during follow-up, and can be used to manage atrial pacing outputs.},
  author       = {Sperzel, J and Milasinovic, G and Smith, T W and Mead, H and Brandt, Johan and Haisty, W K and Bailey, J R and Roelke, M and Simonson, J and Englund, J and Farges, E and Compton, S},
  issn         = {1547-5271},
  keyword      = {atrioventricular conduction,atrial chamber reset,automatic atrial threshold measurement,atrial capture management,atrial threshold,test,dual-chamber pacemaker},
  language     = {eng},
  number       = {11},
  pages        = {1203--1210},
  publisher    = {Elsevier},
  series       = {Heart Rhythm},
  title        = {Automatic measurement of atrial pacing thresholds in dual-chamber pacemakers: Clinical experience with atrial capture management},
  url          = {http://dx.doi.org/10.1016/j.hrthm.2005.07.023},
  volume       = {2},
  year         = {2005},
}