@article{e792b047e0b54bfb88249fd06cd8b095,
title = "Clinical performance of implantable cardioverter-defibrillator lead monitoring diagnostics",
abstract = "BACKGROUND: Implantable cardioverter-defibrillator (ICD) lead monitoring diagnostic alerts facilitate the diagnosis of structural lead failure.OBJECTIVE: The purpose of this study was to prospectively study the performance of Medtronic ICD lead monitoring alerts.METHODS: A prespecified ancillary substudy, World-Wide Randomized Antibiotic Envelope Infection Prevention Trial, was conducted in patients with an ICD with all available alerts enabled. The investigators reported possible lead system events (LSEs), with or without an alert. An independent committee reviewed all data and classified events as lead failure, other LSE, or nonlead system events (NLEs).RESULTS: In 4942 patients who were followed for 19.4 ± 8.7 months, there were 124 alerts (65 LSEs, 59 NLEs) and 19 LSEs without an alert. Lead monitoring alerts had 100% sensitivity for the 48 adjudicated lead failures (95% confidence interval 92.6%-100%) and for 10 events adjudicated as either lead failure or connection issue. The positive predictive value of alerts for lead failure was 38.7% (48 of 124). For 34 pace-sense lead failures, an alert that incorporated oversensing was more sensitive than the pacing impedance threshold alert (33 patients [97.1%] vs 9 patients [26.5%]; P < .0001). However, the sensitivity was only 13.6% for lead dislodgments or perforations. Inappropriate shocks occurred in 2 patients with pace-sense lead failure (5.9%). No patient had unnecessary lead replacement for any of the NLEs.CONCLUSION: In this first real-world prospective study, lead monitoring alerts had 100% sensitivity for identifying lead failures. Although their positive predictive value was modest, no false-positive alerts resulted in an unnecessary lead replacement. For the diagnosis of pace-sense lead failure, an alert for oversensing was more sensitive than a pacing impedance threshold alert.TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02277990.",
keywords = "Defibrillators, Implantable/adverse effects, Electric Impedance, Equipment Failure, Humans, Predictive Value of Tests, Prospective Studies, Lead monitoring, Lead failure, Remote monitoring, Defibrillator, Ventricular tachycardi",
author = "Poole, {Jeanne E} and Swerdlow, {Charles D} and Tarakji, {Khaldoun G} and Suneet Mittal and Ellenbogen, {Kenneth A} and Greenspon, {Arnold J} and Charles Kennergren and Philbert, {Berit T} and JoEllyn Moore and Jones, {R Chris} and Schaller, {Robert D} and Riple Hansalia and Timothy Simmers and Attila Mihalcz and Becky DeBus and Lexcen, {Daniel R} and Bruce Gunderson and Wilkoff, {Bruce L}",
note = "Funding Information: Funding Sources: This work was funded by Medtronic Incorporated, Minneapolis, MN. All data were reviewed by the authors who were responsible for the analysis, interpretation of data, writing the report, and decision to submit the article for publication. Funding Information: Funding Sources: This work was funded by Medtronic Incorporated, Minneapolis, MN. All data were reviewed by the authors who were responsible for the analysis, interpretation of data, writing the report, and decision to submit the article for publication.Disclosures: Dr Poole was supported by research funding direct to institution from Kestra Medical, Biotronik, and AtriCure and compensation from the University of Rochester (Rochester, NY) for research committee participation and from the Heart Rhythm Society for Core Concepts Educational Course and for Editor-in-Chief for the Heart Rhythm O2 Journal. Dr Swerdlow has received honoraria from Medtronic and Boston Scientific and consultant fees and patent royalties from Medtronic. Dr Tarakji has received honoraria/consultant fees from Medtronic and AliveCor (outside the submitted work). Dr Mittal has received honoraria/consultant fees from Abbott, Boston Scientific, and Medtronic (outside the submitted work). Dr Ellenbogen has received funding from Medtronic and Boston Scientific; consulting fees from Medtronic, Boston Scientific, Abbott, and Biotronik; and honoraria from Medtronic, Boston Scientific, Biotronik, and Abbott. Dr Greenspon has received honoraria/consultant fees/research grant from Medtronic and Boston Scientific (outside the submitted work). Dr Kennergren has received honoraria/consultant fees from Medtronic (outside the submitted work). Dr Moore has received grants and nonfinancial support from Medtronic (outside the submitted work). Dr Jones has received honoraria/consultant fees from Medtronic and consultant fees from Biosense Webster. Dr Hansalia is a consultant for Boston Scientific. Dr Simmers has received honoraria and consultant fees from Abbott and Medtronic (outside of the submitted work). Ms DeBus, Dr Lexcen, and Mr Gunderson report personal fees from Medtronic (outside the submitted work). Dr Wilkoff has received honoraria/consultant fees from Abbott, Medtronic, and Philips (outside the submitted work). The rest of the authors report no conflicts of interest. Publisher Copyright: {\textcopyright} 2021 Heart Rhythm Society",
year = "2022",
month = mar,
doi = "10.1016/j.hrthm.2021.10.032",
language = "English",
volume = "19",
pages = "363--371",
journal = "Heart Rhythm",
issn = "1547-5271",
publisher = "Elsevier",
number = "3",
}