Risk-Based Nurse-Managed Personalized Heart Failure Interventions: The ALLEVIATE-HF Trial.

This study aims to assess if insertable cardiac monitor (ICM)-based high-risk detection combined with centrally managed, nurse-facilitated, individually protocolized diuretic interventions is safe and improves HF outcomes.

本研究旨在评估基于植入式心脏监测器（ICM）的高风险检测，结合中心管理、护士协助的个性化利尿剂干预措施是否安全并改善心力衰竭的预后。

Methods

A Reveal LINQ (Medtronic) ICM with an investigational HF risk-status software was implanted in participants with HF who were randomized 1:1 to an intervention arm (high-risk HF alert triggering protocolized diuretic regimen) or an observation arm (standard care).

在随机分为干预组（高风险心力衰竭警报触发标准化利尿方案）或观察组（标准护理）的充血性心力衰竭患者中植入了带有研究性心力衰竭风险状态软件的Reveal LINQ（美敦力）植入式心律转复除颤器。

The primary safety endpoint was intervention-related serious adverse events and the primary efficacy endpoint was a 5-component hierarchical composite including cardiovascular death or HF hospitalization or outpatient HF event within 60 days of high-risk onset, Kansas City Cardiomyopathy Questionnaire Clinical Summary Score, and 6-minute walk distance, analyzed using win ratio.

主要的安全终点是与干预相关的严重不良事件，主要的有效终点是一个包含5个组成部分的分层复合终点，包括在高风险开始后60天内的心血管死亡或心力衰竭住院或门诊心力衰竭事件、堪萨斯城心肌病问卷临床总结评分和6分钟步行距离，使用胜率分析。

Results

A total of 711 participants were randomized (357 intervention, 354 observation).

共有711名参与者被随机分配（357名干预组，354名观察组）。

The primary composite endpoint did not significantly differ between groups (win ratio: 0.79; 95% CI: 0.62-1.01; P = 0.06).

主要复合终点在两组间没有显著差异（胜率比：0.79；95% 置信区间：0.62-1.01；P = 0.06）。

Over a mean follow-up of 17.3 ± 8.9 months, the serious adverse events rate was 0.32% (95% CI: 0.10%-0.99%; prespecified safety threshold ≤5%).

在平均随访17.3 ± 8.9个月期间，严重不良事件的发生率为0.32%（95% 置信区间：0.10%-0.99%；预设的安全阈值≤5%）。

The cumulative cardiovascular death and HF events were numerically higher in the intervention group (HR: 1.43; 95% CI: 0.95-2.15; P = 0.091).

干预组的心血管死亡和心力衰竭事件累积发生率在数值上更高（HR: 1.43; 95% 置信区间: 0.95-2.15; P = 0.091）。

In an exploratory sensitivity analysis adjusting for a baseline Kansas City Cardiomyopathy Questionnaire imbalance, the win ratio was 1.02 (95% CI: 0.80-1.31; P = 0.85).

在对基线堪萨斯城心肌病问卷失衡进行调整的探索性敏感性分析中，胜利比为1.02（95% 置信区间：0.80-1.31；P = 0.85）。

Conclusions

ICM-based risk status detection with centrally coordinated diuretic intervention was safe and yielded a neutral result for the primary composite outcome under the tested implementation strategy (ALLEVIATE-HF [Algorithm Using LINQ Sensors for Evaluation and Treatment of Heart Failure]; NCT04452149).

基于ICM（植入式心律转复除颤器）的风险状态检测与中心协调的利尿剂干预是安全的，并且在测试的实施策略下，对于主要复合结果产生了中性结果（ALLEVIATE-HF [使用LINQ传感器评估和治疗心力衰竭的算法]；NCT04452149）。