Arrhythmia Burden and Clinical Responses Under Continuous Monitoring in Heart Failure: Observations From the ALLEVIATE-HF Trial.

The goal was to assess whether arrhythmia burden differed between randomized congestion-management strategies and characterize the occurrences and associations of insertable cardiac monitor (ICM)-detected arrhythmias with therapeutic actions and clinical events.

该研究的目标是评估随机充血管理策略之间的心律失常负担是否存在差异，并描述可植入心脏监测器（ICM）检测到的心律失常的发生情况及其与治疗行为和临床事件的关联。

Methods

In ALLEVIATE-HF, patients with NYHA functional class II-III HF with any ejection fraction (EF) and a recent HF event, without prior CIEDs, underwent ICM implantation and were randomized to ICM-guided, physician-directed, nurse-facilitated congestion management or usual care.

在ALLEVIATE-HF研究中，患有纽约心脏病协会(NYHA)功能II-III级心力衰竭、任何射血分数(EF)且近期有心力衰竭事件的患者，且之前未植入心脏植入装置(CIEDs)，接受了植入式心律转复除颤器(ICM)植入，并被随机分配到ICM指导下的、医生主导的、护士协助的充血管理或常规护理。

In both arms, arrhythmia data were accessible to investigators, and arrhythmia-related management was clinician directed.

在两个治疗组中，心律失常数据对研究者是可获取的，且心律失常相关的管理是由临床医生指导的。

Arrythmia occurrence was estimated using Kaplan-Meier methods.

使用Kaplan-Meier方法估计心律失常的发生率。

Associations with therapeutic interventions and clinical events were evaluated using time-varying Cox models.

使用时变Cox模型评估治疗干预与临床事件之间的关联。

Results

The analysis included 711 patients (mean age 70.5 ± 10.4 years; 45.7% women; mean follow-up 17.3 ± 8.9 months); 67.9% had HF with preserved EF, and 60.2% were NYHA functional class II at baseline.

分析包括711名患者（平均年龄70.5 ± 10.4岁；45.7%为女性；平均随访时间17.3 ± 8.9个月）；67.9%的患者有射血分数保留的心力衰竭，60.2%在基线时为纽约心脏病协会（NYHA）功能II级。

During the 13-month randomized phase, arrhythmia occurrence rate did not differ between the study arms.

在13个月的随机化阶段，研究组之间心律失常的发生率没有差异。

The 3-year overall occurrence of atrial fibrillation (AF) was 66.6%, with an incidenceof new-onset AF of 25.4%.

3年房颤（AF）总发生率为66.6%，新发房颤发生率为25.4%。

Bradyarrhythmia occurred in 47.1% of patients, and ventricular tachycardia or fibrillation (VT/VF) in 20.1%.

47.1%的患者出现缓慢性心律失常，20.1%的患者出现室性心动过速或室颤（VT/VF）。

ICM-recorded arrhythmia was associated with subsequent increase in arrhythmia-related interventions (HR: 3.81; VT/VF and VT/VF-related interventions, HR: 7.04; AF and AF-related interventions, HR: 3.28; bradyarrhythmia and bradyarrhythmia-related interventions, HR: 7.22; all P < 0.001).

ICM记录的心律失常与随后心律失常相关干预措施的增加有关（HR: 3.81; VT/VF和VT/VF相关干预，HR: 7.04; AF和AF相关干预，HR: 3.28; 缓慢性心律失常和缓慢性心律失常相关干预，HR: 7.22; 所有P < 0.001）。

ICM-recorded arrhythmia was associated with increased risk of all-cause hospitalization (HR: 1.79; P < 0.001) and HF events (HR: 1.69; P = 0.003).

ICM记录的心律失常与全因住院风险增加有关（HR: 1.79; P < 0.001）和心力衰竭事件（HR: 1.69; P = 0.003）。

Therapeutic CIED implantation and ablation occurred in 22.7% and 26.1%, respectively.

治疗性心脏植入电子装置（CIED）植入和消融分别发生在22.7%和26.1%的患者中。

Bradyarrhythmias were more common in patients with EF ≥50%, whereas VT/VF occurred more frequently in EF <50%; AF occurrence was similar between EF groups.

EF（射血分数）≥50%的患者中，缓慢性心律失常更为常见，而在EF <50%的患者中，室性心动过速/心室颤动的发生更为频繁；两组EF之间房颤的发生率相似。

Conclusions

In ambulatory patients with recent symptomatic HF events, arrhythmia burden was not modified by the study protocol-directed, congestion-management strategy.

在最近出现症状性心力衰竭事件的门诊患者中，研究方案指导的充血管理策略并未改变心律失常的负担。

Continuous ICM monitoring revealed a high burden of clinically meaningful arrhythmias that were associated with clinical events and therapeutic interventions.

连续的ICM监测揭示了与临床事件和治疗干预相关的高负荷的临床意义重大的心律失常。

(Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure [ALLEVIATE-HF]; NCT04452149).

(使用LINQ传感器评估和治疗心力衰竭的算法[ALLEVIATE-HF]; NCT04452149).