JACC. Heart failure最新文献

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).

Background: Younger patients (18-49 years of age) with advanced heart failure (HF) face unique challenges in decision-making for advanced HF therapies. Although heart transplantation (HT) offers excellent survival, it is associated with finite graft longevity. The HeartMate 3 (HM3) left ventricular assist device (LVAD) has demonstrated promising outcomes, but direct comparisons with those listed for or undergoing HT in this age group remain limited.

Objectives: This study sought to compare survival and adverse event (AE) outcomes between younger patients receiving HM3 LVAD support and those listed for or undergoing HT.

Methods: The authors analyzed patients 18-49 years of age from the MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) portfolio (HM3 cohort; n = 420) and the UNOS (United Network for Organ Sharing) registry (HT listing cohort; n = 1,955) (HT recipients; n = 1,176) from 2014-2018. Propensity score matching was performed to adjust for baseline differences. Outcomes included 2-year survival from time of treatment or time of listing, freedom from death or delisting for deterioration, and 1-year incidence of major AEs (ie, stroke, renal dysfunction, infection).

Results: After propensity score matching, 2-year survival from treatment was similar for HM3 and HT (88.7% vs 90.2%; HR: 1.18; P = 0.53). When comparing outcomes from time of transplant listing vs LVAD implantation, HM3 was associated with higher freedom from death compared with freedom from death or delisting due to deterioration in UNOS (90.1% vs 76.7%; HR: 0.38; P < 0.0001). AE analysis showed lower 1-year rates of renal dysfunction requiring dialysis (5.0% vs 10.4%; P = 0.016) and fewer infection-related hospitalizations (24.8% vs 34.2%; P = 0.012) in HM3 recipients, but a higher incidence of debilitating stroke (3.4% vs 0.3%; P = 0.027).

Conclusions: Contemporary data suggest that durable LVAD therapy may offer survival outcomes comparable to HT in adults <50 years of age. These findings support the consideration of an LVAD-first strategy as a viable initial approach to heart replacement therapy in appropriately selected patients. (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 Investigational Device Exemption [MOMENTUM 3 IDE]; NCT02224755) (MOMENTUM 3 Continued Access Protocol [MOMENTUM 3 CAP]; NCT02892955).