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基于监测与警报的多参数监测以减少心力衰竭恶化事件:SCALE-HF 1研究结果

Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events: Results From SCALE-HF 1.

作者信息

Fudim Marat, Egolum Ugochukwu, Haghighat Amir, Kottam Anupama, Sauer Andrew J, Shah Hirak, Kumar Priya, Rakita Valera, Lopes Renato D, Centen Corey, Ozonat Kivanc, Smith Sarah, Pandit Jay, DeVORE Adam D

机构信息

Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina; Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.

The Heart Center of Northeast Georgia Medical Center, Gainesville, Georgia.

出版信息

J Card Fail. 2025 Apr;31(4):661-675. doi: 10.1016/j.cardfail.2024.08.050. Epub 2024 Sep 17.

Abstract

BACKGROUND

There is a need for better noninvasive remote monitoring solutions that prevent hospitalizations through the early prediction and management of heart failure (HF). SurveillanCe and Alert-Based Multiparameter Monitoring to ReducE Worsening Heart Failure Events (SCALE-HF 1) evaluated the performance of a novel congestion index that alerts to fluid accumulation preceding HF events.

METHODS AND RESULTS

SCALE-HF 1 was a multicenter, prospective, observational study investigating HF event prediction using data from the cardiac scale. Participants with HF took measurements at home by standing barefoot on the scale for approximately 20 seconds each day. The congestion index was applied retrospectively, and an alert was generated when the index exceeded a fixed threshold established in prior studies. HF events were defined as unplanned administration of IV diuretics or admissions with a primary diagnosis of HF. Sensitivity was defined as the ratio of correctly identified HF events to the total number of HF events. We enrolled 329 participants (mean age 64 ± 14 years; 43% women; 32% Black; 56% with reduced ejection fraction) across 8 sites with 238 participant-years of follow-up and 69 usable HF events. The congestion index predicted 48 of the 69 HF events (70%) at 2.58 alerts per participant-year. In contrast, the standard weight rule (weight gain of >3 lb in 1 day or >5 lb in 7 days) predicted only 24 of the 69 HF events (35%) at 4.18 alerts per participant-year. The congestion index alerts had a significantly higher sensitivity (P < .01) at a lower alert rate than the standard weight rule.

CONCLUSIONS

The congestion index alerts demonstrated sensitive prediction of HF events at a low alert rate, significantly exceeding the performance of weight-based monitoring.

GOV IDENTIFIER

NCT04882449.

摘要

背景

需要更好的无创远程监测解决方案,通过对心力衰竭(HF)的早期预测和管理来预防住院。基于监测和警报的多参数监测以减少心力衰竭事件恶化(SCALE-HF 1)评估了一种新型充血指数的性能,该指数可在HF事件之前对液体潴留发出警报。

方法和结果

SCALE-HF 1是一项多中心、前瞻性、观察性研究,利用心脏秤数据调查HF事件预测。患有HF的参与者每天在家中赤脚站在秤上约20秒进行测量。充血指数进行回顾性应用,当指数超过先前研究确定的固定阈值时发出警报。HF事件定义为计划外静脉注射利尿剂或主要诊断为HF的住院治疗。敏感性定义为正确识别的HF事件数与HF事件总数的比率。我们在8个地点招募了329名参与者(平均年龄64±14岁;43%为女性;32%为黑人;56%射血分数降低),随访238人年,有69次可用的HF事件。充血指数预测了69次HF事件中的48次(70%),每位参与者每年发出2.58次警报。相比之下,标准体重规则(1天内体重增加>3磅或7天内体重增加>5磅)预测69次HF事件中的24次(35%),每位参与者每年发出4.18次警报。充血指数警报在较低的警报率下具有显著更高的敏感性(P<.01),高于标准体重规则。

结论

充血指数警报在低警报率下对HF事件表现出敏感预测,显著超过基于体重监测的性能。

政府标识符

NCT04882449。

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