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基于植入式设备的心力衰竭患者多参数远程监测与带有或不带有心脏再同步治疗选项的除颤器:IN-TIME 试验的亚组分析。

Implant-based multi-parameter telemonitoring of patients with heart failure and a defibrillator with vs. without cardiac resynchronization therapy option: a subanalysis of the IN-TIME trial.

机构信息

Arrhythmia and Invasive Electrophysiology Section, Division of Cardiology, Zentralklinik Bad Berka, Bad Berka, Germany.

Otto-von-Guericke University School of Medicine, Magdeburg, Germany.

出版信息

Clin Res Cardiol. 2019 Oct;108(10):1117-1127. doi: 10.1007/s00392-019-01447-5. Epub 2019 Mar 14.

Abstract

AIMS

In the IN-TIME trial, automatic daily implant-based multiparameter telemonitoring significantly improved clinical outcomes in patients with chronic systolic heart failure and implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). We compared IN-TIME results for ICD and CRT-D subgroups.

METHODS

Patients with LVEF ≤ 35%, NYHA class II/III, optimized drug treatment, no permanent atrial fibrillation, and a dual-chamber ICD (n = 274) or CRT-D (n = 390) were randomized 1:1 to telemonitoring or no telemonitoring for 12 months. Primary outcome measure was a composite clinical score, classified as worsened if the patient died or had heart failure-related hospitalization, worse NYHA class, or a worse self-reported overall condition.

RESULTS

The prevalence of worsened score at study end was higher in CRT-D than ICD patients (26.4% vs. 18.2%; P = 0.014), as was mortality (7.4% vs. 4.1%; P = 0.069). With telemonitoring, odds ratios (OR) for worsened score and hazard ratios (HR) for mortality were similar in the ICD [OR = 0.55 (P = 0.058), HR = 0.39 (P = 0.17)] and CRT-D [OR = 0.68 (P = 0.10), HR = 0.35 (P = 0.018)] subgroups (insignificant interaction, P = 0.58-0.91).

CONCLUSION

Daily multiparameter telemonitoring has a potential to reduce clinical endpoints in patients with chronic systolic heart failure both in ICD and CRT-D subgroups. The absolute benefit seems to be higher in higher-risk populations with worse prognosis.

摘要

目的

在 IN-TIME 试验中,基于植入式设备的自动每日多参数远程监测显著改善了慢性收缩性心力衰竭合并植入式心脏复律除颤器(ICD)或心脏再同步治疗除颤器(CRT-D)患者的临床结局。我们比较了 IN-TIME 试验中 ICD 和 CRT-D 亚组的结果。

方法

将 LVEF≤35%、NYHA 心功能 II/III 级、优化药物治疗、无永久性心房颤动且具有双腔 ICD(n=274)或 CRT-D(n=390)的患者按 1:1 随机分为远程监测组或无远程监测组,进行 12 个月的随访。主要观察终点为复合临床评分,若患者死亡或因心力衰竭住院、NYHA 心功能恶化或自我报告整体状况恶化则定义为评分恶化。

结果

与 ICD 患者(26.4% vs. 18.2%;P=0.014)相比,CRT-D 患者在研究结束时出现评分恶化的比例更高(26.4% vs. 18.2%;P=0.014),死亡率也更高(7.4% vs. 4.1%;P=0.069)。在 ICD(比值比[OR]:0.55,P=0.058;风险比[HR]:0.39,P=0.17)和 CRT-D(OR:0.68,P=0.10;HR:0.35,P=0.018)亚组中,远程监测的 OR 和 HR 对评分恶化和死亡率的影响相似(无显著交互作用,P=0.58-0.91)。

结论

每日多参数远程监测可能降低慢性收缩性心力衰竭患者的临床终点事件发生率,在 ICD 和 CRT-D 亚组中均有获益。在预后较差的高危人群中,其绝对获益似乎更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f76f/6753058/06b0140cb4cc/392_2019_1447_Fig1_HTML.jpg

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