Two-Year Results of PROACTIVE-HF Trial Stratified by Left Ventricular Ejection Fraction

Background In the PROACTIVE-HF trial, remote heart failure (HF) management using comprehensive vital signs and seated mean pulmonary artery pressure (mPAP) was safe and resulted in a low reported rate of HF hospitalization (HFH) and all-cause mortality (HFH/D) through 12 months. In this report, we extend the results from the PROACTIVE-HF study through 2 years, stratified by ejection fraction (EF). Methods and Results PROACTIVE-HF was a prospective, multicenter, open-label, single-arm trial evaluating the safety and efficacy of patient management using the Cordella PA pressure sensor system in patients with New York Heart Association class III symptoms, regardless of EF. In the first 24 months, the incidence of HF events (HFE)/D was 0.89 (95% CI 0.81−0.99) events per patient, driven by HFH. Patients with HF with reduced EF had greater HFE/D rates than those with HF with preserved EF (1.0 vs 0.8 events per patient, P = .048). Conclusions For patients with HF experiencing moderate-to-severe symptoms, management using the Cordella PA sensor system was associated with low event rates and improved health status at 2 years, regardless of EF. Comprehensive remote monitoring of vital signs, seated PAP, and patient-reported symptoms via a digital platform supports sustained benefit for high-risk patients with HF.