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• W3208807498 abstract "HomeCirculation: Arrhythmia and ElectrophysiologyVol. 14, No. 11Remote Monitoring of Implantable Loop Recorders: False-Positive Alert Episode Burden Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyRedditDiggEmail Jump toFree AccessLetterPDF/EPUBRemote Monitoring of Implantable Loop Recorders: False-Positive Alert Episode Burden Catherine J. O’Shea, MBBS, Melissa E. Middeldorp, PhD, Jeroen M. Hendriks, PhD, Anthony G. Brooks, PhD, Curtis Harper, CCDS, Gijo Thomas, PhD, Mehrdad Emami, MD, Anand Thiyagarajah, MBBS, Suzanne Feigofsky, MD, Rakesh Gopinathannair, MD, MA, Niraj Varma, MD, PhD, Kevin Campbell, MD, Dennis H. Lau, MBBS, PhD and Prashanthan Sanders, MBBS, PhD Catherine J. O’SheaCatherine J. O’Shea https://orcid.org/0000-0002-5068-6106 Centre for Heart Rhythm Disorders, University of Adelaide, Australia (C.J.O., M.E.M., J.M.H., A.G.B., G.T., M.E., A.T., D.H.L., P.S.). Department of Cardiology, Royal Adelaide Hospital, Australia (C.J.O., M.E.M., J.M.H., M.E., A.T., D.H.L., P.S.). Search for more papers by this author , Melissa E. MiddeldorpMelissa E. Middeldorp https://orcid.org/0000-0002-4106-9771 Centre for Heart Rhythm Disorders, University of Adelaide, Australia (C.J.O., M.E.M., J.M.H., A.G.B., G.T., M.E., A.T., D.H.L., P.S.). Department of Cardiology, Royal Adelaide Hospital, Australia (C.J.O., M.E.M., J.M.H., M.E., A.T., D.H.L., P.S.). Search for more papers by this author , Jeroen M. HendriksJeroen M. Hendriks https://orcid.org/0000-0003-4326-9256 Centre for Heart Rhythm Disorders, University of Adelaide, Australia (C.J.O., M.E.M., J.M.H., A.G.B., G.T., M.E., A.T., D.H.L., P.S.). Department of Cardiology, Royal Adelaide Hospital, Australia (C.J.O., M.E.M., J.M.H., M.E., A.T., D.H.L., P.S.). College of Nursing and Health Sciences, Flinders University, Adelaide, Australia (J.M.H.). Search for more papers by this author , Anthony G. BrooksAnthony G. Brooks Centre for Heart Rhythm Disorders, University of Adelaide, Australia (C.J.O., M.E.M., J.M.H., A.G.B., G.T., M.E., A.T., D.H.L., P.S.). Search for more papers by this author , Curtis HarperCurtis Harper https://orcid.org/0000-0002-1995-669X PaceMate, Bradenton, FL (C.H.). Search for more papers by this author , Gijo ThomasGijo Thomas https://orcid.org/0000-0002-2307-1560 Centre for Heart Rhythm Disorders, University of Adelaide, Australia (C.J.O., M.E.M., J.M.H., A.G.B., G.T., M.E., A.T., D.H.L., P.S.). Search for more papers by this author , Mehrdad EmamiMehrdad Emami https://orcid.org/0000-0003-2093-6909 Centre for Heart Rhythm Disorders, University of Adelaide, Australia (C.J.O., M.E.M., J.M.H., A.G.B., G.T., M.E., A.T., D.H.L., P.S.). Department of Cardiology, Royal Adelaide Hospital, Australia (C.J.O., M.E.M., J.M.H., M.E., A.T., D.H.L., P.S.). Search for more papers by this author , Anand ThiyagarajahAnand Thiyagarajah Centre for Heart Rhythm Disorders, University of Adelaide, Australia (C.J.O., M.E.M., J.M.H., A.G.B., G.T., M.E., A.T., D.H.L., P.S.). Department of Cardiology, Royal Adelaide Hospital, Australia (C.J.O., M.E.M., J.M.H., M.E., A.T., D.H.L., P.S.). Search for more papers by this author , Suzanne FeigofskySuzanne Feigofsky https://orcid.org/0000-0002-3645-4093 Iowa Heart Center, Iowa City, IA (S.F.). Search for more papers by this author , Rakesh GopinathannairRakesh Gopinathannair https://orcid.org/0000-0003-4611-3687 Kansas City Heart Rhythm Institute, Kansas City, MO (R.G.). Search for more papers by this author , Niraj VarmaNiraj Varma https://orcid.org/0000-0003-2296-2596 Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH (N.V.). Search for more papers by this author , Kevin CampbellKevin Campbell Health First Heart and Vascular, Melbourne, FL (KC). Search for more papers by this author , Dennis H. LauDennis H. Lau https://orcid.org/0000-0001-7753-1318 Centre for Heart Rhythm Disorders, University of Adelaide, Australia (C.J.O., M.E.M., J.M.H., A.G.B., G.T., M.E., A.T., D.H.L., P.S.). Department of Cardiology, Royal Adelaide Hospital, Australia (C.J.O., M.E.M., J.M.H., M.E., A.T., D.H.L., P.S.). Search for more papers by this author and Prashanthan SandersPrashanthan Sanders Correspondence to: Prashanthan Sanders, MBBS, PhD, Department of Cardiology, Centre for Heart Rhythm Disorders, Royal Adelaide Hospital, 1 Port Rd Adelaide, SA 5000, Australia. Email E-mail Address: [email protected] https://orcid.org/0000-0003-3803-8429 Centre for Heart Rhythm Disorders, University of Adelaide, Australia (C.J.O., M.E.M., J.M.H., A.G.B., G.T., M.E., A.T., D.H.L., P.S.). Department of Cardiology, Royal Adelaide Hospital, Australia (C.J.O., M.E.M., J.M.H., M.E., A.T., D.H.L., P.S.). Search for more papers by this author Originally published28 Oct 2021https://doi.org/10.1161/CIRCEP.121.009635Circulation: Arrhythmia and Electrophysiology. 2021;14:e009635Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: October 28, 2021: Ahead of Print Implantable loop recorders (ILRs) are widely recognized as an important diagnostic tool in patients with suspected arrhythmia, providing an opportunity for long-term cardiac rhythm monitoring. The emergence of remote monitoring (RM) for cardiac implantable electronic device follow-up1 has facilitated timely recognition of ILR-detected arrhythmias; however, the volume of alert transmissions is burdensome for clinics and clinicians, with ILRs transmitting disproportionately high-alert quantities in comparison to other cardiac implantable electronic devices.2 By their subcutaneous nature, ILRs are prone to a variety of erroneous activations.3,4 Additionally, ILR alert burden is supplemented by patient-activated alerts, which often do not correspond with significant arrhythmia.5 Although small single-center reports have described false-positive ILR alerts, there is no multicenter experience regarding the RM burden of ILRs and frequency of false-positive alerts. We aimed to characterize ILR alert burden in a large multicenter cohort with the Reveal LINQ device.This was a multicenter cohort study of RM alerts transmitted by the Reveal LINQ device (Medtronic, Inc, Minnesota, MN). RM was undertaken using PaceMate LIVE—a vendor-neutral software system with automatic integration of all RM transmissions, streamlined into a single-user interface, with all alerts managed by the PaceMate RM service. The study was reviewed and approved by the institutional Human Research Ethics Committees. The data that support the findings of this study are available from the corresponding author upon reasonable request.Baseline device episode parameters were programmed at the time of implant as per nominal manufacturer settings, unless programmed otherwise per physician discretion. Alerts arrived in the RM database precategorized as asystole, bradycardia, atrial tachycardia (AT)/atrial fibrillation (AF), tachycardia, or patient activated according to device programming and detection. Alerts were analyzed by the International Board of Heart Rhythm Examiners–certified cardiac device specialists via the PaceMate service, with immediate analysis available 24 hours a day, 7 days a week. Alerts were adjudicated as either true-positive (rhythm strip consistent with true arrhythmia and all patient-activated alerts) or false-positive (all nonpatient-activated alerts without evidence of associated arrhythmia, further classified according to reason for incorrect arrhythmia detection).In total, 1470 patients monitored during a 6-month period (August 2019 to February 2020; Figure), from 21 American and 2 Australian centers, were included in the analysis. Mean age was 70±13 years. A total of 14 086 alerts were transmitted, with median 3 (interquartile range, 1–10) alerts per patient (6 alerts/patient-year). AT/AF alerts were the most common (n=7016; 49.8%), followed by asystole (n=2986; 21.2%), tachycardia (n=2696; 19.1%), patient-activated episodes (n=697; 4.9%), and bradycardia (n=691; 4.9%). Overall, there were 5660 (40.2%) true-positive alerts and 8426 (59.8%) false-positive alerts transmitted.Download figureDownload PowerPointFigure. The number of implantable loop recorders contributing to the remote monitoring alert burden during the 6-mo monitoring period and proportions of true-positive and false-positive alerts in each alert category. AF indicates atrial fibrillation; AT, atrial tachycardia; ILR, implantable loop recorder; and PPV, positive predictive value.Episodes were false-positive in 2292 (76.8%) asystole alerts, 5209 (74.2%) AT/AF alerts, 192 (27.8%) bradycardia alerts, and 733 (27.2%) tachycardia alerts. False-positive AT/AF alerts were due to frequent ectopy (n=4697; 90.2%), noise/artifact (n=490; 9.4%), oversensing (n=10; 0.2%), and undetermined cause (n=12; 0.2%). False-positive tachycardia alerts were due to oversensing (n=713; 97.3%), noise/artifact (n=15; 2.0%), frequent ectopy (n=3; 0.4%), and undetermined cause (n=2; 0.3%). All false-positive asystole and bradycardia alerts were due to undersensing. The 697 patient-activated alerts coincided with normal sinus rhythm (n=302; 43.3%), sinus rhythm with frequent ectopy (n=180; 25.8%), supraventricular tachycardia (n=152; 21.8%), and AF (n=63; 9.0%).Asystole alerts were more likely to be false-positive than AT/AF (P=0.047), tachycardia (P<0.001), and bradycardia (P<0.001) alerts. False-positive alerts in the AT/AF category were more likely than in tachycardia and bradycardia (both P<0.001). There were 387 (26.3%) patients who sent only false-positive alerts, median of 2 (interquartile range, 1–7) false-positive alerts per device. At least 1 false-positive alert was transmitted by 818 patients (55.6%), who had an average 75.8% false-positive alert rate.Limitations of this study include the unavailability of ILR indication. Further, ILR settings were not standardized, with programming as per physician discretion, to reflect real-world ILR management.ILRs have become essential for management of arrhythmia and evaluation of syncope. In this multicenter cohort, 59.8% of all alerts were erroneous, with particularly high false-positive rates for AT/AF (74.2%) and asystole (76.8%) alerts. Rather than a small group of devices being responsible for majority of inaccurate alerts, 55.6% contributed to the false-positive alert burden. The findings of this study highlight the need for strategies to reduce and manage the burden of false-positive ILR alerts. ILR implant positioning, device programming, diligent alert adjudication, and RM response pathways all provide opportunity to do so. ILR positioning at the time of implant is critical, with individual patient body habitus requiring consideration when selecting the optimal position. R-wave amplitude assessment at the time of implant could potentially decrease the likelihood of undersensing events. Device reprogramming for longer detection times before AF alert generation may reduce false positives in this category. Further, ILR alerts require careful assessment given that more than half may not reflect a true arrhythmia; assessment by qualified cardiac device specialists can lessen the proportion of alerts that are unnecessarily escalated to the treating clinician. Finally, management systems can be redesigned with inclusion of features such as third-party alert adjudication and artificial intelligence, to lessen ILR alert burden on current RM response pathways.Article InformationSources of FundingC.J. O’Shea, Dr Emami, and A. Thiyagarajah are supported by postgraduate scholarships from the University of Adelaide. Dr Middeldorp is supported by a postdoctoral fellowship from the University of Adelaide. Dr Hendriks is supported by a Future Leader Fellowship from the Heart Foundation of Australia. Dr Lau is supported by the Robert J. Craig Lectureship from the University of Adelaide and by a Mid-Career Fellowship from The Hospital Research Fund. Dr Sanders is supported by a Practitioner Fellowship from the National Health and Medical Research Council of Australia and by the National Heart Foundation of Australia.DisclosuresDr Hendriks reports that the University of Adelaide has received on his behalf lecture or consulting fees from Medtronic and Pfizer/BMS. Dr Brooks is currently employed by Microport. Dr Fiegofsky reports having served on the advisory board of PaceMate. Dr Gopinathannair reports that he has received consulting fees or honoraria from Abbott Medical, Boston Scientific, Pfizer, and Zoll Medical. Dr Gopinathannair reports having served on the advisory board of HealthTrust PG, Pacemate, and Altathera. Dr Varma reports having consulted for Medtronic, Abbott Medical, Boston Scientific, Biotronik, and Microport and is on the advisory board for PaceMate. Dr Campbell was employed by PaceMate. Dr Lau reports that the University of Adelaide receives on his behalf lecture or consulting fees from Biotronik, Bayer, Medtronic, Abbott Medical, Boehringer Ingelheim, and MicroPort. Dr Sanders reports having served on the advisory board of Medtronic, Abbott Medical, Boston Scientific, PaceMate, and CathRx. Dr Sanders reports that the University of Adelaide receives on his behalf lecture or consulting fees from Medtronic, Abbott Medical, and Boston Scientific. Dr Sanders reports that the University of Adelaide receives on his behalf research funding from Medtronic, Abbott Medical, Boston Scientific, and MicroPort. The other authors report no conflicts.FootnotesFor Sources of Funding and Disclosures, see page 1049.Correspondence to: Prashanthan Sanders, MBBS, PhD, Department of Cardiology, Centre for Heart Rhythm Disorders, Royal Adelaide Hospital, 1 Port Rd Adelaide, SA 5000, Australia. Email prash.[email protected]edu.auReferences1. Slotwiner D, Varma N, Akar JG, Annas G, Beardsall M, Fogel RI, Galizio NO, Glotzer TV, Leahy RA, Love CJ, et al.. HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices.Heart Rhythm. 2015; 12:e69–100. doi: 10.1016/j.hrthm.2015.05.008CrossrefMedlineGoogle Scholar2. O’Shea CJ, Middeldorp ME, Hendriks JM, Brooks AG, Lau DH, Emami M, Mishima R, Thiyagarajah A, Feigofsky S, Gopinathannair R, et al.. Remote monitoring alert burden: an analysis of transmission in >26,000 patients.JACC Clin Electrophysiol. 2021; 7:226–234. doi: 10.1016/j.jacep.2020.08.029CrossrefMedlineGoogle Scholar3. Afzal MR, Mease J, Koppert T, Okabe T, Tyler J, Houmsse M, Augostini RS, Weiss R, Hummel JD, Kalbfleisch SJ, et al.. Incidence of false-positive transmissions during remote rhythm monitoring with implantable loop recorders.Heart Rhythm. 2020; 17:75–80. doi: 10.1016/j.hrthm.2019.07.015CrossrefMedlineGoogle Scholar4. Chorin E, Peterson C, Kogan E, Barbhaiya C, Aizer A, Holmes D, Bernstein S, Schole M, Duraiswami H, Spinelli M, et al.. Comparison of the effect of atrial fibrillation detection algorithms in patients with cryptogenic stroke using implantable loop recorders.Am J Cardiol. 2020; 129:25–29. doi: 10.1016/j.amjcard.2020.05.027CrossrefMedlineGoogle Scholar5. Ermis C, Zhu AX, Pham S, Li JM, Guerrero M, Vrudney A, Hiltner L, Lu F, Sakaguchi S, Lurie KG, et al.. Comparison of automatic and patient-activated arrhythmia recordings by implantable loop recorders in the evaluation of syncope.Am J Cardiol. 2003; 92:815–819. doi: 10.1016/s0002-9149(03)00889-0CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetails November 2021Vol 14, Issue 11Article InformationMetrics Download: 256 © 2021 American Heart Association, Inc.https://doi.org/10.1161/CIRCEP.121.009635PMID: 34708660 Originally publishedOctober 28, 2021 Keywordselectronicscohort studieshumansarrhythmias, cardiacheartPDF download Advertisement SubjectsArrhythmiasAtrial FibrillationVentricular Fibrillation" @default.
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