Abstract
Implantable cardioverter-defibrillator (ICD) lead monitoring diagnostic alerts facilitate the diagnosis of structural lead failure. The purpose of this study was to prospectively study the performance of Medtronic ICD lead monitoring alerts. 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). 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 forlead failure was 38.7% (48 of 124). For 34 pace-sense lead failures,an alert that incorporated oversensing was more sensitivethan thepacing 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 shocksoccurred in 2 patients with pace-sense lead failure (5.9%). No patient had unnecessary lead replacement for any of the NLEs. 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. ClinicalTrials.gov identifier: NCT02277990.
Highlights
Automated, device-based, lead-monitoring alerts were developed to improve the early detection of defibrillation lead failure.[1,2,3,4,5] In retrospective studies, alerts reduced inappropriate shocks in patients with recalled Sprint Fidelis
In 4942 patients who were followed for 19.4 6 8.7 months, there were 124 alerts (65 lead system events (LSEs), 59 nonlead system events (NLEs)) and 19 LSEs without an alert
Dr Hansalia is a consultant for Boston Scientific
Summary
Device-based, lead-monitoring alerts were developed to improve the early detection of defibrillation lead failure.[1,2,3,4,5] In retrospective studies, alerts reduced inappropriate shocks in patients with recalled Sprint Fidelis (Medtronic, Inc. Minneapolis, MN) leads[6] and facilitated the diagnosis of lead failure in patients with other leads.[3,7,8] No lead performance diagnostic has been studied prospectively. The World-Wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT) assessed an absorbable, antibiotic-eluting envelope for reducing infection associated with device implantations.[9] In a prespecified ancillary study, we prospectively assessed the real-world performance of lead monitoring alerts to detect structural lead failure. Implantable cardioverter-defibrillator (ICD) lead monitoring diagnostic alerts facilitate the diagnosis of structural lead failure
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