心力衰竭患者的坐位肺动脉压力监测：PROACTIVE-HF 试验结果。

IF 10.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Heart failure Pub Date : 2024-11-01 DOI:10.1016/j.jchf.2024.05.017

Jason L. Guichard MD, PhD , Eric L. Bonno MD , Michael E. Nassif MD , Taiyeb M. Khumri MD , David Miranda MD , Orvar Jonsson MD , Hirak Shah MD , Tamas Alexy MD, PhD , Gregory P. Macaluso MD , James Sur MD , Gavin Hickey MD , Patrick McCann MD , Jennifer A. Cowger MD, MS , Amit Badiye MD , Wayne D. Old MD , Yasmin Raza MD , Luke Masha MD, MPH , Chandra R. Kunavarapu MD , Mosi Bennett MD, PhD , Faisal Sharif MD, PhD , Liviu Klein MD, MS

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引用次数: 0

摘要

背景：通过监测仰卧位肺动脉压来指导心力衰竭（HF）的治疗，可以减少部分心力衰竭患者的住院治疗：本研究旨在评估使用 Cordella 肺动脉传感器管理坐位平均肺动脉压（mPAP）对心衰患者预后的影响：继 GUIDE-HF（Hemodynamic-GUIDEd Management of Heart Failure Trial）之后，根据美国食品药品管理局的意见，PROACTIVE-HF（A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial）由随机试验改为单臂、开放标签试验，在美国和欧洲的 75 个中心进行。符合条件的患者均为有 NYHA 功能分级 III 级症状的慢性心力衰竭患者，无论射血分数如何，近期均有心力衰竭住院治疗和/或利钠肽升高。6个月时的主要有效性终点要求心房颤动住院率或全因死亡率低于0.43次/人的绩效目标，该目标是根据以往的血液动力学监测试验确定的。6个月时的主要安全性终点为无设备或系统相关并发症或压力传感器故障：2020年2月7日至2023年3月31日期间，456名患者成功植入了修改后的意向治疗队列。6个月事件发生率为0.15（95% CI：0.12-0.20），明显低于绩效目标（0.15 vs 0.43；P < 0.0001）。6个月内，设备或系统相关并发症发生率为99.2%，传感器故障发生率为99.8%：结论：坐式 mPAP 的远程管理是安全的，且高血压住院率和死亡率较低。这些结果支持使用坐姿 mPAP 监测，并扩展了越来越多的证据，证明肺动脉压力指导下的管理可改善心衰的预后。(评估 NYHA III 级心衰患者使用 Cordella 肺动脉传感器系统的安全性和有效性的多中心、开放标签、单臂临床试验[PROACTIVE-HF]；NCT04089059）。

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Seated Pulmonary Artery Pressure Monitoring in Patients With Heart Failure

Background

Monitoring supine pulmonary artery pressures to guide heart failure (HF) management has reduced HF hospitalizations in select patients.

Objectives

The purpose of this study was to evaluate the effect of managing seated mean pulmonary artery pressure (mPAP) with the Cordella Pulmonary Artery sensor on outcomes in patients with HF.

Methods

Following GUIDE-HF (Hemodynamic-GUIDEd Management of Heart Failure Trial), with U.S. Food and Drug Administration input, PROACTIVE-HF (A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial) was changed from a randomized to a single-arm, open label trial, conducted at 75 centers in the USA and Europe. Eligible patients had chronic HF with NYHA functional class III symptoms, irrespective of the ejection fraction, and recent HF hospitalization and/or elevated natriuretic peptides. The primary effectiveness endpoint at 6 months required the HF hospitalization or all-cause mortality rate to be lower than a performance goal of 0.43 events/patient, established from previous hemodynamic monitoring trials. Primary safety endpoints at 6 months were freedom from device- or system-related complications or pressure sensor failure.

Results

Between February 7, 2020, and March 31, 2023, 456 patients were successfully implanted in modified intent-to-treat cohort. The 6-month event rate was 0.15 (95% CI: 0.12-0.20) which was significantly lower than performance goal (0.15 vs 0.43; P < 0.0001). Freedom from device- or system-related complications was 99.2% and freedom from sensor failure was 99.8% through 6 months.

Conclusions

Remote management of seated mPAP is safe and results in a low rate of HF hospitalizations and mortality. These results support the use of seated mPAP monitoring and extend the growing body of evidence that pulmonary artery pressure–guided management improves outcomes in heart failure. (Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial [PROACTIVE-HF]; NCT04089059)

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来源期刊

JACC. Heart failure CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

21.20

自引率

2.30%

发文量

164

期刊介绍： JACC: Heart Failure publishes crucial findings on the pathophysiology, diagnosis, treatment, and care of heart failure patients. The goal is to enhance understanding through timely scientific communication on disease, clinical trials, outcomes, and therapeutic advances. The Journal fosters interdisciplinary connections with neuroscience, pulmonary medicine, nephrology, electrophysiology, and surgery related to heart failure. It also covers articles on pharmacogenetics, biomarkers, and metabolomics.