评估一种综合设备诊断算法以对心力衰竭患者进行危险分层 - SCAN-HF 研究结果。

Evaluation of an Integrated Device Diagnostics Algorithm to Risk Stratify Heart Failure Patients　- Results From the SCAN-HF Study.

机构信息

Division of Cardiology, Saiseikai Kumamoto Hospital.

Department of Cardiology, Hirosaki University Graduate School of Medicine.

出版信息

Circ J. 2020 Jun 25;84(7):1118-1123. doi: 10.1253/circj.CJ-19-1143. Epub 2020 May 23.

DOI:10.1253/circj.CJ-19-1143

PMID:32448844

Abstract

BACKGROUND

Integrated device diagnostics, Triage-HF, is useful in risk stratifying patients with heart failure (HF), but its performance for Japanese patients remains unknown. This is a prospective study of Japanese patients treated with a cardiac resynchronization therapy defibrillator (CRT-D), with a Medtronic OptiVol 2.0 feature.

METHODS AND RESULTS

A total of 320 CRT-D patients were enrolled from 2013 to 2017. All received HF treatment in the prior 12 months. Following enrollment, they were followed every 6 months for 48 months (mean, 22 months). Triage-HF-stratified patients at low, medium and high risk statuses at every 30-day period, and HF-related hospitalization occurring for the subsequent 30 days, were evaluated and repeated. The primary endpoint was to assess Triage-HF performance in predicting HF-related hospitalization risk. All device data were available for 279 of 320 patients (NYHA class II or III in 93%; mean left ventricular ejection fraction, 31%). During a total of 5,977 patient-month follow-ups, 89 HF-related hospitalization occurred in 72 patients. The unadjusted event numbers for Low, Medium and High statuses were 19 (0.7%), 42 (1.6%) and 28 (4.1%), respectively. Relative risk of Medium to Low status was 2.18 (95% CI 1.23-3.85) and 5.78 (95% CI 3.34-10.01) for High to Low status. Common contributing factors among the diagnostics included low activity, OptiVol threshold crossing, and elevated night heart rate.

CONCLUSIONS

Triage-HF effectively stratified Japanese patients at risk of HF-related hospitalization.

摘要

背景

综合设备诊断，即 Triage-HF，在对心力衰竭（HF）患者进行风险分层方面非常有用，但它在日本患者中的表现尚不清楚。这是一项前瞻性研究，纳入了 2013 年至 2017 年间接受心脏再同步治疗除颤器（CRT-D）治疗的 320 例日本 HF 患者，这些患者均在过去 12 个月内接受了 HF 治疗。入组后，每 6 个月随访 48 个月（平均 22 个月）。在每个 30 天期间，对 Triage-HF 低、中、高风险分层的患者进行评估，并重复评估 HF 相关住院情况。主要终点是评估 Triage-HF 在预测 HF 相关住院风险方面的表现。279 例患者（93%为 NYHA Ⅱ或Ⅲ级；平均左心室射血分数为 31%）的所有设备数据均可用。在总共 5977 患者月的随访期间，72 例患者发生 89 例 HF 相关住院事件。低、中、高状态的未调整事件数分别为 19 例（0.7%）、42 例（1.6%）和 28 例（4.1%）。中危与低危状态的相对风险为 2.18（95%CI 1.23-3.85），高危与低危状态的相对风险为 5.78（95%CI 3.34-10.01）。诊断中常见的共同因素包括活动量低、OptiVol 阈值跨越和夜间心率升高。