Comparison of Automatic and Manual Threshold Testing in Patients with Permanent Pacemakers: Results from COMET Study

Background: Automaticity of cardiac devices is designed to reduce the burden on physicians while securing patient safety. The aim of this study is to elucidate accuracy of automatic adjustment algorithm of pacing output and effectiveness of this feature for time reduction during clinic visits. Metho...

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Main Authors: Kenji Ando, MD, Fumiharu Miura, MD, Fumiaki Masani, MD, Hiroyuki Kakugawa, MD, Tomoyuki Tejima, MSc, Kentaro Doi, PhD
Format: Article
Language:English
Published: Wiley 2011-01-01
Series:Journal of Arrhythmia
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S1880427611800323
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author Kenji Ando, MD
Fumiharu Miura, MD
Fumiaki Masani, MD
Hiroyuki Kakugawa, MD
Tomoyuki Tejima, MSc
Kentaro Doi, PhD
author_facet Kenji Ando, MD
Fumiharu Miura, MD
Fumiaki Masani, MD
Hiroyuki Kakugawa, MD
Tomoyuki Tejima, MSc
Kentaro Doi, PhD
author_sort Kenji Ando, MD
collection DOAJ
description Background: Automaticity of cardiac devices is designed to reduce the burden on physicians while securing patient safety. The aim of this study is to elucidate accuracy of automatic adjustment algorithm of pacing output and effectiveness of this feature for time reduction during clinic visits. Methods and Results: Patients implanted with pacemakers capable of automatically adjusting the pacing output were enrolled. During their routine device follow-ups, pacing thresholds were compared between manual measurements and most recently recorded data in the device, which had been measured automatically at prespecified timing. Difference betwee n −0.25 and 0.5 volts were predefined as equivalent. Time required for conventional follow-up was also compared to device interrogation and data assessment. A total of 359 patients from 32 centers were enrolled. Calculated 95% confidence interval of difference in volts for atrium was (−0.0625, 0) and the difference for ventricle was nonsignificant. These results met the equivalence criteria. Observed time to interrogate and assess device-stored pacing threshold was shorter by average of 3.3 minutes compared to manual method. Conclusions: The pacing threshold determined by the automatic measurement algorithm was accurate. Follow-up time was shorter when utilizing automaticity of pacemakers. The system is safe and time efficient.
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spelling doaj.art-e0809058695d4068bd222b7be400e0cb2022-12-22T00:23:44ZengWileyJournal of Arrhythmia1880-42762011-01-0127430731310.1016/S1880-4276(11)80032-3Comparison of Automatic and Manual Threshold Testing in Patients with Permanent Pacemakers: Results from COMET StudyKenji Ando, MD0Fumiharu Miura, MD1Fumiaki Masani, MD2Hiroyuki Kakugawa, MD3Tomoyuki Tejima, MSc4Kentaro Doi, PhD5Department of Cardiology, Kokura Memorial Hospital, Kita-Kyushu, JapanDepartment of Cardiology, Hiroshima City Hospital, Hiroshima, JapanDepartment of Cardiology, Niigata Prefectural Central Hospital, Johetsu, JapanDepartment of Cardiology, National Hospital Organization Hamada Medical Center, Hamada, JapanCardiac Rhythm Disease Management, Medtronic Japan Co., Ltd., Tokyo, JapanCardiac Rhythm Disease Management, Medtronic Japan Co., Ltd., Tokyo, JapanBackground: Automaticity of cardiac devices is designed to reduce the burden on physicians while securing patient safety. The aim of this study is to elucidate accuracy of automatic adjustment algorithm of pacing output and effectiveness of this feature for time reduction during clinic visits. Methods and Results: Patients implanted with pacemakers capable of automatically adjusting the pacing output were enrolled. During their routine device follow-ups, pacing thresholds were compared between manual measurements and most recently recorded data in the device, which had been measured automatically at prespecified timing. Difference betwee n −0.25 and 0.5 volts were predefined as equivalent. Time required for conventional follow-up was also compared to device interrogation and data assessment. A total of 359 patients from 32 centers were enrolled. Calculated 95% confidence interval of difference in volts for atrium was (−0.0625, 0) and the difference for ventricle was nonsignificant. These results met the equivalence criteria. Observed time to interrogate and assess device-stored pacing threshold was shorter by average of 3.3 minutes compared to manual method. Conclusions: The pacing threshold determined by the automatic measurement algorithm was accurate. Follow-up time was shorter when utilizing automaticity of pacemakers. The system is safe and time efficient.http://www.sciencedirect.com/science/article/pii/S1880427611800323PacemakerAutomaticityPacing threshold
spellingShingle Kenji Ando, MD
Fumiharu Miura, MD
Fumiaki Masani, MD
Hiroyuki Kakugawa, MD
Tomoyuki Tejima, MSc
Kentaro Doi, PhD
Comparison of Automatic and Manual Threshold Testing in Patients with Permanent Pacemakers: Results from COMET Study
Journal of Arrhythmia
Pacemaker
Automaticity
Pacing threshold
title Comparison of Automatic and Manual Threshold Testing in Patients with Permanent Pacemakers: Results from COMET Study
title_full Comparison of Automatic and Manual Threshold Testing in Patients with Permanent Pacemakers: Results from COMET Study
title_fullStr Comparison of Automatic and Manual Threshold Testing in Patients with Permanent Pacemakers: Results from COMET Study
title_full_unstemmed Comparison of Automatic and Manual Threshold Testing in Patients with Permanent Pacemakers: Results from COMET Study
title_short Comparison of Automatic and Manual Threshold Testing in Patients with Permanent Pacemakers: Results from COMET Study
title_sort comparison of automatic and manual threshold testing in patients with permanent pacemakers results from comet study
topic Pacemaker
Automaticity
Pacing threshold
url http://www.sciencedirect.com/science/article/pii/S1880427611800323
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