Department of Medicine, Division of Cardiology, Section for Advanced Heart Failure, Pulmonary Hypertension, and Mechanical Circulatory Support, Prisma Health-Upstate, Greenville, South Carolina, USA.
Saint Luke's Mid-American Heart Institute, Kansas City, Missouri, USA.
JACC Heart Fail. 2024 Nov;12(11):1879-1893. doi: 10.1016/j.jchf.2024.05.017. Epub 2024 Aug 14.
Monitoring supine pulmonary artery pressures to guide heart failure (HF) management has reduced HF hospitalizations in select patients.
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.
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.
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.
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).
监测仰卧位肺动脉压以指导心力衰竭（HF）管理已减少了特定患者的 HF 住院率。
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 HF 患者结局的影响。
在 GUIDE-HF（血流动力学指导的心力衰竭试验）之后，在美国食品和药物管理局的参与下，PROACTIVE-HF（一项前瞻性、多中心、开放标签、单臂临床试验，评估 Cordella 肺动脉传感器系统在 NYHA 分级 III 心力衰竭患者中的安全性和疗效）从随机对照试验改为单臂、开放标签试验，在美国和欧洲的 75 个中心进行。符合条件的患者为 NYHA 功能分级 III 级症状的慢性 HF，无论射血分数如何，且近期有 HF 住院和/或升高的利钠肽。6 个月时的主要有效性终点要求 HF 住院或全因死亡率低于从以前的血流动力学监测试验中建立的 0.43 事件/患者的绩效目标。6 个月时的主要安全性终点是无器械或系统相关并发症或压力传感器故障。
在 2020 年 2 月 7 日至 2023 年 3 月 31 日期间，456 例患者成功植入改良意向治疗队列。6 个月时的事件发生率为 0.15（95%CI：0.12-0.20），明显低于绩效目标（0.15 比 0.43；P<0.0001）。6 个月时，器械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%。
远程管理坐位 mPAP 是安全的，HF 住院和死亡率较低。这些结果支持使用坐位 mPAP 监测，并扩展了越来越多的证据，即肺动脉压指导的管理可改善心力衰竭的结局。（多中心、开放标签、单臂临床试验，评估 Cordella 肺动脉传感器系统在 NYHA 分级 III 心力衰竭患者中的安全性和疗效 [PROACTIVE-HF]；NCT04089059）。
