Abstract
Implantable cardioverter defibrillator (ICD) lead monitoring diagnostic alerts (LMA) facilitate diagnosis of structural lead failure (LF). A prespecified WRAP-IT study was conducted to prospectively study LMA in ICD patients. To assess the real-world performance of LMA in detecting structural LF. We studied ICD patients with all LMAs enabled. At each study visit, investigators reported possible lead system events (LSEs), and device/clinical data were reviewed. LMAs, programming changes, adverse events and system modifications were recorded. An independent committee classified events as a LF, other LSE or non-lead event (NLE). In 4942 patients with a right ventricle defibrillation lead followed for 19.4 ± 8.7 mo, there were 124 LMA (65 LSEs, 59 NLEs) and 19 LSEs that did not trigger LMA. Of 84 LSEs, 48 were structural LFs. LMA had 100% sensitivity for the 48 LFs (95%, confidence interval: 92.6-100%) and also for the 10 events adjudicated as either possible LF or connection issue. The positive predictive value of LMA for LF was 38.7% (48/124). However, sensitivity was only 13.6% (3/22) for lead dislodgements or perforations, which comprised all LSEs that did not trigger LMA. For the 34 pace-sense LFs, the Lead Integrity Alert™ (LIA) was more sensitive than the pacing impedance-threshold alert (33 patients, 97.1% vs. 9 patients, 26.5%, p < 0.0001). Inappropriate shocks occurred in 2 patients with pace-sense LF (5.9%). Of 59 LMAs activated by NLEs, 23 (39.0%) were impedance alerts and 36 (61.0%) were LIA oversensing alerts, triggered by rapid cardiac activation in ventricular tachyarrhythmias (n=17) or oversensing of either electromagnetic interference (n=11) or physiologic signals (n=8). No patient had unnecessary lead replacement for an LMA unrelated to LF. In this first, real-world prospective study, LMA had 100% sensitivity for structural LFs. Although positive predictive value was modest, no false-positive alert resulted in unnecessary lead replacement. For diagnosis of pace-sense LF, an alert that incorporates oversensing was more sensitive than a pacing impedance-threshold alert. Present LMA are insensitive for lead dislodgements and perforations.
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