Seated Pulmonary Artery Pressure Monitoring in Patients With Heart Failure: Results of the PROACTIVE-HF Trial.

Autor:	Guichard JL; Department of Medicine, Division of Cardiology, Section for Advanced Heart Failure, Pulmonary Hypertension, and Mechanical Circulatory Support, Prisma Health-Upstate, Greenville, South Carolina, USA., Bonno EL; Department of Medicine, Division of Cardiology, Section for Advanced Heart Failure, Pulmonary Hypertension, and Mechanical Circulatory Support, Prisma Health-Upstate, Greenville, South Carolina, USA., Nassif ME; Saint Luke's Mid-American Heart Institute, Kansas City, Missouri, USA., Khumri TM; Saint Luke's Mid-American Heart Institute, Kansas City, Missouri, USA., Miranda D; Department of Cardiology, Minneapolis Heart Institute, Minneapolis, Minnesota, USA., Jonsson O; Department of Cardiology, Sanford Heart Hospital, Sioux Falls, South Dakota, USA., Shah H; Department of Cardiology, University of Kansas Medical Center, Kansas City, Kansas, USA., Alexy T; Department of Cardiology, University of Minnesota Medical Center, Minneapolis, Minnesota, USA., Macaluso GP; Department of Cardiology, Advocate Christ Medical Center, Oak Lawn, Illinois, USA., Sur J; Department of Cardiology, Advocate Christ Medical Center, Oak Lawn, Illinois, USA., Hickey G; Department of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA., McCann P; Department of Cardiology, Prisma Health, Columbia, South Carolina, USA., Cowger JA; Division of Cardiovascular Medicine, Henry Ford Hospital, Detroit, Michigan, USA., Badiye A; Department of Cardiology, Sentara Healthcare, Norfolk, Virginia, USA., Old WD; Department of Cardiology, Sentara Healthcare, Norfolk, Virginia, USA., Raza Y; Department of Cardiology, Northwestern, Chicago, Illinois, USA., Masha L; Department of Cardiology, Oregon Health and Science University, Portland, Oregon, USA., Kunavarapu CR; Department of Cardiology, Methodist Healthcare, San Antonio, Texas, USA., Bennett M; Department of Cardiology, Minneapolis Heart Institute, Minneapolis, Minnesota, USA., Sharif F; Department of Cardiology, Galway University Hospital, Saolta Group, CURAM and University of Galway, Galway, Ireland., Kiernan M; Cardiovascular Center, Division of Cardiology, Tufts Medical Center, Boston, Massachusetts, USA., Mullens W; Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium and Hasselt University, Hasselt, Belgium., Chaparro SV; Miami Cardiac and Vascular Institute, Division of Cardiology, Baptist Health South Florida, Miami, Florida, USA., Mahr C; Institute for Advanced Cardiac Care, Medical City, Dallas, Texas, USA., Amin RR; Department of Cardiology, Ascension Sacred Heart Hospital, Pensacola, Florida, USA., Stevenson LW; Division of Cardiology, Section of Heart Failure and Cardiac Transplantation, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Hiivala NJ; Clinical Science, Endotronix Inc, Naperville, Illinois, USA., Owens MM; Clinical Science, Endotronix Inc, Naperville, Illinois, USA., Sauerland A; Clinical Science, Endotronix Inc, Naperville, Illinois, USA., Forouzan O; Clinical Science, Endotronix Inc, Naperville, Illinois, USA., Klein L; Advanced Heart Failure Comprehensive Care Center and Division of Cardiology, University of California San Francisco, San Francisco, California, USA. Electronic address: Liviu.Klein@ucsf.edu.
Jazyk:	angličtina
Zdroj:	JACC. Heart failure [JACC Heart Fail] 2024 Aug 02. Date of Electronic Publication: 2024 Aug 02.
DOI:	10.1016/j.jchf.2024.05.017
Abstrakt:	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). Competing Interests: Funding Support and Author Disclosures This work was supported by Endotronix Inc. Drs Miranda, Shah, Macaluso, and Hickey were on the Eligibility Committee of PROACTIVE-HF. Prof Sharif is funded by the Science Foundation Ireland SFI 17/RI/5353. Drs Hiivala, Owens, Sauerland, and Forouzan are employees of Endotronix. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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