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;

中文翻译：

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植入式心脏复律除颤器导联监测诊断的临床表现

背景

植入式心律转复除颤器 (ICD) 引线监测诊断警报有助于诊断结构性引线故障。

客观的

本研究的目的是前瞻性研究美敦力 ICD 导联监测警报的性能。

方法

在启用所有可用警报的 ICD 患者中进行了一项预先指定的辅助子研究，即全球随机抗生素包膜感染预防试验。调查人员报告了可能的铅系统事件（LSE），有或没有警报。一个独立委员会审查了所有数据并将事件分类为导联失效、其他 LSE 或非导联系统事件 (NLE)。

结果

在随访 19.4 ± 8.7 个月的 4942 名患者中，有 124 名警报（65 名 LSE，59 名 NLE）和 19 名没有警报的 LSE。铅监控警报对 48 次判定的铅故障（95% 置信区间 92.6%–100%）和 10 次判定为铅故障或连接问题的事件具有 100% 的灵敏度。铅故障警报的阳性预测值为 38.7%（124 个中的 48 个）。对于 34 例起搏感应导联故障，包含过感应的警报比起搏阻抗阈值警报更敏感（33 名患者 [97.1%] 对 9 名患者 [26.5%]；P < .0001）。然而，铅脱落或穿孔的灵敏度仅为 13.6%。2 名起搏感应导联失败的患者（5.9%）发生了不适当的电击。没有患者对任何 NLE 进行不必要的铅替代。

结论

在第一项真实世界的前瞻性研究中，铅监测警报对识别铅故障具有 100% 的敏感性。尽管它们的阳性预测值适中，但没有假阳性警报导致不必要的铅更换。对于起搏感应导联故障的诊断，过度感应警报比起搏阻抗阈值警报更敏感。

试用注册

ClinicalTrials.gov 标识符：NCT02277990；