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Accuracy of arrhythmia detection in implantable cardiac monitors: A prospective randomized clinical trial comparing Reveal LINQ and Confirm Rx

Background Implantable cardiac monitors (ICMs) are increasingly used to detect arrhythmias in various clinical situations. However, the data transmission time and accuracy of detecting cardiac arrhythmias are unclear. Objective The objective of this study was to compare the efficiency of data transm...

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Published in:Pacing and clinical electrophysiology 2020-11, Vol.43 (11), p.1344-1350
Main Authors: Ip, John, Jaffe, Brian, Castellani, Mark, Sheikh, Ali, Castellani, Carson, Ip, Randy
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creator Ip, John
Jaffe, Brian
Castellani, Mark
Sheikh, Ali
Castellani, Carson
Ip, Randy
description Background Implantable cardiac monitors (ICMs) are increasingly used to detect arrhythmias in various clinical situations. However, the data transmission time and accuracy of detecting cardiac arrhythmias are unclear. Objective The objective of this study was to compare the efficiency of data transmission and arrhythmia detection accuracy of the Reveal LINQ with TruRhythm Detection with the Confirm Rx with SharpSense Technology. Methods In this prospective study, 142 patients were randomized 1:1 to receive Reveal LINQ or Confirm Rx ICM system. Arrhythmic events include atrial fibrillation (AF), pauses, and bradycardia. Data transmission time is defined as the time from event occurrence to physician notification. All the arrhythmic events are adjudicated for accuracy. Results A total of 3510 events were transmitted in 61 patients over 7.1 ± 3.5 months. The transmission time both for all events (448 ± 271 vs 610 ± 515 minutes, P = .02) and for patient activated triggers (24 ± 103 vs 475 ± 426 minutes, P 
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However, the data transmission time and accuracy of detecting cardiac arrhythmias are unclear. Objective The objective of this study was to compare the efficiency of data transmission and arrhythmia detection accuracy of the Reveal LINQ with TruRhythm Detection with the Confirm Rx with SharpSense Technology. Methods In this prospective study, 142 patients were randomized 1:1 to receive Reveal LINQ or Confirm Rx ICM system. Arrhythmic events include atrial fibrillation (AF), pauses, and bradycardia. Data transmission time is defined as the time from event occurrence to physician notification. All the arrhythmic events are adjudicated for accuracy. Results A total of 3510 events were transmitted in 61 patients over 7.1 ± 3.5 months. The transmission time both for all events (448 ± 271 vs 610 ± 515 minutes, P = .02) and for patient activated triggers (24 ± 103 vs 475 ± 426 minutes, P &lt; .0001) was significantly shorter in the Confirm Rx group. The total number of events was also higher in the Confirm Rx group (25.5 ± 45.6 vs 0.9 ± 1.1 events per patient‐month, P &lt; .01), which is likely due to event transmission setting differences between the two groups. Kaplan‐Meier analysis showed that the Confirm Rx group detected true arrhythmic episodes sooner with higher percentage of diagnosed patients during 6‐month follow‐up (P = .006). Patient‐averaged true positive detection rates were not statistically significant in the two groups (Reveal LINQ vs Confirm Rx, AF: 52% vs 38%; bradycardia: 67% vs 59%; pause: 24% vs 20%; tachycardia: 81% vs 94%). Conclusion Compared to the Reveal LINQ, Confirm Rx has shorter event transmission time, more frequent event detections, shorter duration to diagnose true arrhythmic events, and higher percentage of diagnosed patients. The accuracy of arrhythmia detection in both ICMs remains suboptimal.</description><identifier>ISSN: 0147-8389</identifier><identifier>EISSN: 1540-8159</identifier><identifier>DOI: 10.1111/pace.14076</identifier><identifier>PMID: 32969518</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Accuracy ; Arrhythmia ; atrial fibrillation ; Bradycardia ; Cardiac arrhythmia ; cryptogenic stroke ; Data transmission ; Devices ; Fibrillation ; Heart ; implantable cardiac monitor ; Monitoring systems ; Patients ; remote monitoring ; Statistical analysis ; syncope ; Tachycardia</subject><ispartof>Pacing and clinical electrophysiology, 2020-11, Vol.43 (11), p.1344-1350</ispartof><rights>2020 The Authors. published by Wiley Periodicals LLC</rights><rights>2020 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.</rights><rights>2020. This article is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). 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However, the data transmission time and accuracy of detecting cardiac arrhythmias are unclear. Objective The objective of this study was to compare the efficiency of data transmission and arrhythmia detection accuracy of the Reveal LINQ with TruRhythm Detection with the Confirm Rx with SharpSense Technology. Methods In this prospective study, 142 patients were randomized 1:1 to receive Reveal LINQ or Confirm Rx ICM system. Arrhythmic events include atrial fibrillation (AF), pauses, and bradycardia. Data transmission time is defined as the time from event occurrence to physician notification. All the arrhythmic events are adjudicated for accuracy. Results A total of 3510 events were transmitted in 61 patients over 7.1 ± 3.5 months. The transmission time both for all events (448 ± 271 vs 610 ± 515 minutes, P = .02) and for patient activated triggers (24 ± 103 vs 475 ± 426 minutes, P &lt; .0001) was significantly shorter in the Confirm Rx group. The total number of events was also higher in the Confirm Rx group (25.5 ± 45.6 vs 0.9 ± 1.1 events per patient‐month, P &lt; .01), which is likely due to event transmission setting differences between the two groups. Kaplan‐Meier analysis showed that the Confirm Rx group detected true arrhythmic episodes sooner with higher percentage of diagnosed patients during 6‐month follow‐up (P = .006). Patient‐averaged true positive detection rates were not statistically significant in the two groups (Reveal LINQ vs Confirm Rx, AF: 52% vs 38%; bradycardia: 67% vs 59%; pause: 24% vs 20%; tachycardia: 81% vs 94%). Conclusion Compared to the Reveal LINQ, Confirm Rx has shorter event transmission time, more frequent event detections, shorter duration to diagnose true arrhythmic events, and higher percentage of diagnosed patients. The accuracy of arrhythmia detection in both ICMs remains suboptimal.</description><subject>Accuracy</subject><subject>Arrhythmia</subject><subject>atrial fibrillation</subject><subject>Bradycardia</subject><subject>Cardiac arrhythmia</subject><subject>cryptogenic stroke</subject><subject>Data transmission</subject><subject>Devices</subject><subject>Fibrillation</subject><subject>Heart</subject><subject>implantable cardiac monitor</subject><subject>Monitoring systems</subject><subject>Patients</subject><subject>remote monitoring</subject><subject>Statistical analysis</subject><subject>syncope</subject><subject>Tachycardia</subject><issn>0147-8389</issn><issn>1540-8159</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><recordid>eNp9kV1rFDEUhoNY7Fq98QdIwBsRpiYz-fRCWJZaC4sfRa9D5kymmzKTjJmZ1fVH-JubdduiXhhCDpw8vJzzvgg9o-SU5vN6sOBOKSNSPEALyhkpFOX6IVoQymShKqWP0eNxvCaECML4I3RclVpoTtUC_VoCzMnCDscW25Q2u2nTe4sbNzmYfAzY59sPnQ2TrTuHwabGW8B9DH6KaXyDl3hIcRz2-NbhZEMTe__TNRg6HzzYDk_J5xdiP9jkwxW-dFuXG-uLD59xxvEqhtanHl_-eIKOWtuN7ultPUFf3519Wb0v1h_PL1bLdQGMKVE0kisAoRXXtbJSK0ldI-uaiGxFqbRiwEilqLKMt1y1oEHZUkKpa9BNyaoT9PagO8x17xpwYUq2M0PyvU07E603f_8EvzFXcWuk5IIxmQVe3gqk-G1242R6P4Lrsk8uzqMpGeNaEk2rjL74B72Ocwp5vUwJQoUSJcnUqwMF2cwxufZ-GErMPmazj9n8jjnDz_8c_x69yzUD9AB8953b_UfKfFquzg6iN3oMtTw</recordid><startdate>202011</startdate><enddate>202011</enddate><creator>Ip, John</creator><creator>Jaffe, Brian</creator><creator>Castellani, Mark</creator><creator>Sheikh, Ali</creator><creator>Castellani, Carson</creator><creator>Ip, Randy</creator><general>Wiley Subscription Services, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TK</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-4444-3383</orcidid></search><sort><creationdate>202011</creationdate><title>Accuracy of arrhythmia detection in implantable cardiac monitors: A prospective randomized clinical trial comparing Reveal LINQ and Confirm Rx</title><author>Ip, John ; Jaffe, Brian ; Castellani, Mark ; Sheikh, Ali ; Castellani, Carson ; Ip, Randy</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4486-d758cc69859b8a79871ed7bb06ace28984c403818a45f58fc9c8a27c29bc9d243</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Accuracy</topic><topic>Arrhythmia</topic><topic>atrial fibrillation</topic><topic>Bradycardia</topic><topic>Cardiac arrhythmia</topic><topic>cryptogenic stroke</topic><topic>Data transmission</topic><topic>Devices</topic><topic>Fibrillation</topic><topic>Heart</topic><topic>implantable cardiac monitor</topic><topic>Monitoring systems</topic><topic>Patients</topic><topic>remote monitoring</topic><topic>Statistical analysis</topic><topic>syncope</topic><topic>Tachycardia</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ip, John</creatorcontrib><creatorcontrib>Jaffe, Brian</creatorcontrib><creatorcontrib>Castellani, Mark</creatorcontrib><creatorcontrib>Sheikh, Ali</creatorcontrib><creatorcontrib>Castellani, Carson</creatorcontrib><creatorcontrib>Ip, Randy</creatorcontrib><collection>Wiley-Blackwell Open Access Titles (Open Access)</collection><collection>Wiley Free Archive</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Pacing and clinical electrophysiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ip, John</au><au>Jaffe, Brian</au><au>Castellani, Mark</au><au>Sheikh, Ali</au><au>Castellani, Carson</au><au>Ip, Randy</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Accuracy of arrhythmia detection in implantable cardiac monitors: A prospective randomized clinical trial comparing Reveal LINQ and Confirm Rx</atitle><jtitle>Pacing and clinical electrophysiology</jtitle><addtitle>Pacing Clin Electrophysiol</addtitle><date>2020-11</date><risdate>2020</risdate><volume>43</volume><issue>11</issue><spage>1344</spage><epage>1350</epage><pages>1344-1350</pages><issn>0147-8389</issn><eissn>1540-8159</eissn><abstract>Background Implantable cardiac monitors (ICMs) are increasingly used to detect arrhythmias in various clinical situations. However, the data transmission time and accuracy of detecting cardiac arrhythmias are unclear. Objective The objective of this study was to compare the efficiency of data transmission and arrhythmia detection accuracy of the Reveal LINQ with TruRhythm Detection with the Confirm Rx with SharpSense Technology. Methods In this prospective study, 142 patients were randomized 1:1 to receive Reveal LINQ or Confirm Rx ICM system. Arrhythmic events include atrial fibrillation (AF), pauses, and bradycardia. Data transmission time is defined as the time from event occurrence to physician notification. All the arrhythmic events are adjudicated for accuracy. Results A total of 3510 events were transmitted in 61 patients over 7.1 ± 3.5 months. The transmission time both for all events (448 ± 271 vs 610 ± 515 minutes, P = .02) and for patient activated triggers (24 ± 103 vs 475 ± 426 minutes, P &lt; .0001) was significantly shorter in the Confirm Rx group. The total number of events was also higher in the Confirm Rx group (25.5 ± 45.6 vs 0.9 ± 1.1 events per patient‐month, P &lt; .01), which is likely due to event transmission setting differences between the two groups. Kaplan‐Meier analysis showed that the Confirm Rx group detected true arrhythmic episodes sooner with higher percentage of diagnosed patients during 6‐month follow‐up (P = .006). Patient‐averaged true positive detection rates were not statistically significant in the two groups (Reveal LINQ vs Confirm Rx, AF: 52% vs 38%; bradycardia: 67% vs 59%; pause: 24% vs 20%; tachycardia: 81% vs 94%). Conclusion Compared to the Reveal LINQ, Confirm Rx has shorter event transmission time, more frequent event detections, shorter duration to diagnose true arrhythmic events, and higher percentage of diagnosed patients. The accuracy of arrhythmia detection in both ICMs remains suboptimal.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>32969518</pmid><doi>10.1111/pace.14076</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0003-4444-3383</orcidid><oa>free_for_read</oa></addata></record>
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source Wiley; SPORTDiscus with Full Text
subjects Accuracy
Arrhythmia
atrial fibrillation
Bradycardia
Cardiac arrhythmia
cryptogenic stroke
Data transmission
Devices
Fibrillation
Heart
implantable cardiac monitor
Monitoring systems
Patients
remote monitoring
Statistical analysis
syncope
Tachycardia
title Accuracy of arrhythmia detection in implantable cardiac monitors: A prospective randomized clinical trial comparing Reveal LINQ and Confirm Rx
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