JACC. Heart failure · 2026
Seated Pulmonary Artery Pressure Management in Patients With Heart Failure: 12-Month Outcomes of the PROACTIVE-HF Trial.
СтатьяМногоцентровое исследованиеКлиническое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Guichard Jason L, Bonno Eric L, Nassif Michael E, Khumri Taiyeb M, Miranda David, Jonsson Orvar, Shah Hirak, Alexy Tamas, Macaluso Gregory P, Sur James, Hickey Gavin, McCann Patrick, Cowger Jennifer A, Badiye Amit, Old Wayne D, Raza Yasmin, Masha Luke, Kunavarapu Chandra, Bennett Mosi, Sharif Faisal, Kiernan Michael, Mullens Wilfried, Chaparro Sandra V, Mahr Claudius, Amin Rohit R, Hiivala Nicholas J, Owens Max M, Sauerland Andrea, Forouzan Omid, Klein Liviu
Аннотация
BACKGROUND: In the 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, remote heart failure (HF) management using seated mean pulmonary artery pressure (mPAP) and vital signs was safe and resulted in a low rate of HF hospitalizations and mortality through 6 months.
OBJECTIVES: The authors evaluated the effect of managing seated mPAP with the Cordella system on outcomes in patients with HF through 12 months.
METHODS: In a single-arm, open-label trial, conducted in 75 European and U.S. centers, the authors enrolled HF patients with NYHA functional class III symptoms, irrespective of ejection fraction, and recent HF hospitalization and/or elevated natriuretic peptides. The prespecified, powered, secondary effectiveness endpoint at 12 months required the HF hospitalization or all-cause mortality rate to be lower than a performance goal of 0.70 events/patient/12 months, established from previous hemodynamic monitoring trials. Device/system-related complications, pressure sensor failure, and serious adverse events were examined.
RESULTS: Between February 7, 2020, and March 31, 2023, 456 patients were implanted in a modified intent-to-treat cohort. The 12-month event rate was 0.36 (95% CI: 0.31-0.42), which was significantly lower than the performance goal (0.36 vs 0.70; P < 0.0001). There were no device/system-related complications or pressure sensor failures beyond the 6-month primary results (0.8% and 0.2%, respectively).
CONCLUSIONS: Remote HF management using seated mPAP and vital signs in NYHA functional class III patients is safe and results in a low rate of HF hospitalizations and mortality over 12 months. These results support the use of seated mPAP monitoring and extend the evidence that pulmonary artery pressure-guided management improves HF outcomes. (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 [PROACTIVE-HF Trial]; NCT04089059).
OBJECTIVES: The authors evaluated the effect of managing seated mPAP with the Cordella system on outcomes in patients with HF through 12 months.
METHODS: In a single-arm, open-label trial, conducted in 75 European and U.S. centers, the authors enrolled HF patients with NYHA functional class III symptoms, irrespective of ejection fraction, and recent HF hospitalization and/or elevated natriuretic peptides. The prespecified, powered, secondary effectiveness endpoint at 12 months required the HF hospitalization or all-cause mortality rate to be lower than a performance goal of 0.70 events/patient/12 months, established from previous hemodynamic monitoring trials. Device/system-related complications, pressure sensor failure, and serious adverse events were examined.
RESULTS: Between February 7, 2020, and March 31, 2023, 456 patients were implanted in a modified intent-to-treat cohort. The 12-month event rate was 0.36 (95% CI: 0.31-0.42), which was significantly lower than the performance goal (0.36 vs 0.70; P < 0.0001). There were no device/system-related complications or pressure sensor failures beyond the 6-month primary results (0.8% and 0.2%, respectively).
CONCLUSIONS: Remote HF management using seated mPAP and vital signs in NYHA functional class III patients is safe and results in a low rate of HF hospitalizations and mortality over 12 months. These results support the use of seated mPAP monitoring and extend the evidence that pulmonary artery pressure-guided management improves HF outcomes. (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 [PROACTIVE-HF Trial]; NCT04089059).