TY - JOUR
T1 - Seated Pulmonary Artery Pressure Monitoring in Patients With Heart Failure
T2 - Results of the PROACTIVE-HF Trial
AU - Guichard, Jason L.
AU - Bonno, Eric L.
AU - Nassif, Michael E.
AU - Khumri, Taiyeb M.
AU - Miranda, David
AU - Jonsson, Orvar
AU - Shah, Hirak
AU - Alexy, Tamas
AU - Macaluso, Gregory P.
AU - Sur, James
AU - Hickey, Gavin
AU - McCann, Patrick
AU - Cowger, Jennifer A.
AU - Badiye, Amit
AU - Old, Wayne D.
AU - Raza, Yasmin
AU - Masha, Luke
AU - Kunavarapu, Chandra R.
AU - Bennett, Mosi
AU - Sharif, Faisal
AU - Kiernan, Michael
AU - Mullens, Wilfried
AU - Chaparro, Sandra V.
AU - Mahr, Claudius
AU - Amin, Rohit R.
AU - Stevenson, Lynne Warner
AU - Hiivala, Nicholas J.
AU - Owens, Max M.
AU - Sauerland, Andrea
AU - Forouzan, Omid
AU - Klein, Liviu
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2024/11
Y1 - 2024/11
N2 - 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.
AB - 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.
KW - GDMT
KW - heart failure
KW - pulmonary artery pressure
KW - remote monitoring
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U2 - 10.1016/j.jchf.2024.05.017
DO - 10.1016/j.jchf.2024.05.017
M3 - Article
C2 - 39152983
AN - SCOPUS:85203019621
SN - 2213-1779
VL - 12
SP - 1879
EP - 1893
JO - JACC: Heart Failure
JF - JACC: Heart Failure
IS - 11
ER -
