Objective: Tracking changes in hemodynamic congestion and the consequent proactive readjustment of treatment has shown efficacy in reducing hospitalizations for patients with heart failure (HF). However, the cost-prohibitive nature of these invasive sensing systems precludes their usage in the large patient population affected by HF. The objective of this research is to estimate the changes in pulmonary artery mean pressure (PAM) and pulmonary capillary wedge pressure (PCWP) following vasodilator infusion during right heart catheterization (RHC), using changes in simultaneously recorded wearable seismocardiogram (SCG) signals captured with a small wearable patch. Methods: A total of 20 patients with HF (20% women, median age 55 (interquartile range (IQR), 44-64) years, ejection fraction 24 (IQR, 16-43)) were fitted with a wearable sensing patch and underwent RHC with vasodilator challenge. We divided the dataset randomly into a training–testing set ( n = 15) and a separate validation set ( n = 5). We developed globalized (population) regression models to estimate changes in PAM and PCWP from the changes in simultaneously recorded SCG. Results: The regression model estimated both pressures with good accuracies: root-mean-square-error (RMSE) of 2.5 mmHg and R ² of 0.83 for estimating changes in PAM, and RMSE of 1.9 mmHg and R ² of 0.93 for estimating changes in PCWP for the training-testing set, and RMSE of 2.7 mmHg and R ² of 0.81 for estimating changes in PAM, and RMSE of 2.9 mmHg and R ² of 0.95 for estimating changes in PCWP for the validation set respectively. Conclusion: Changes in wearable SCG signals may be used to track acute changes in intracardiac hemodynamics in patients with HF. Significance: This method holds promise in tracking longitudinal changes in hemodynamic congestion in hemodynamically-guided remote home monitoring and treatment for patients with HF.

Monitoring supine pulmonary artery pressures to guide heart failure (HF) management has reduced HF hospitalizations in select patients. 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. 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. 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. 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).

BACKGROUND: A preservation system, the Organ Care System (OCS; TransMedics) uses normothermic pulsatile perfusion during organ transport for heart transplantation. This system has demonstrated favorable outcomes in hearts recovered from extended-criteria donors after brain death (DBD) and donors after circulatory death (DCD). METHODS: The OCS Heart Perfusion Registry collects data on US heart transplantations using the OCS, static cold storage (SCS), or thoracoabdominal normothermic regional perfusion (NRP) and donor hearts recovered from DBD or DCD donors. We analyzed donor and recipient characteristics and posttransplantation outcomes in patients transplanted with OCS donor hearts (either DBD or DCD) compared with SCS hearts, and with OCS hearts from DCD donors compared with those recovered with NRP followed by SCS. Propensity score matching was used in survival analyses to adjust for differences among recipient characteristics. RESULTS: Between 2021 and 2023, 3225 consecutive heart transplantations enrolled from 56 centers were analyzed in the Heart Perfusion Registry. The OCS was used in 854 of 3225 heart transplantations (26.4%), among which 340 (39.8%) were DBD and 514 (60.2%) were DCD donors, whereas 2174 DBD donors were recovered with SCS and another 197 DCD donors with NRP techniques. The OCS-DBD group experienced a greater number of organ offer refusals before final acceptance (13 versus 6; Wilcoxon rank sum, P <0.001) and a longer transport distance (667 miles versus 232 miles; Wilcoxon rank sum, P <0.001) compared with SCS-DBD. Survival at 12 months was similar between the 2 groups (89.9% for OCS-DBD versus 90.6% for SCS-DBD; marginal Cox model, P =0.54). Among the OCS-DCD and SCS-DBD groups, survival at 12 months was also similar (91.0% versus 92.5%, respectively; marginal Cox model, P =0.32). The OCS-DCD and NRP-DCD groups demonstrated similar survival (91.0% versus 91.7%, respectively; log rank, P =0.63), although the transport distance was longer in OCS-DCD compared with DCD with NRP followed by SCS (400 miles versus 223 miles; Wilcoxon rank sum, P <0.001). By 2023, 90% of all OCS donor management and recovery was performed with dedicated organ recovery teams. CONCLUSIONS: We demonstrate that real-world implementation of the OCS for DBD donors (using predominantly a dedicated recovery team) is associated with expanded donor criteria, longer transport distance, and excellent posttransplantation outcomes. In OCS-DCD donors, outcomes parallel those of donors recovered with NRP-DCD and compare favorably with DBD donor organs.

Optimizing guideline-directed medical therapy (GDMT) and monitoring congestion in patients with heart failure (HF) are key to disease management and preventing hospitalizations. A pulmonary artery pressure (PAP)-guided HF management system providing access to body weight, blood pressure, heart rate, blood oxygen saturation, PAP, and symptoms, may provide new insights into the effects of patient engagement and comprehensive care for remote GDMT titration and congestion management. The PROACTIVE-HF study was originally approved in 2018 as a prospective, randomized, controlled, single-blind, multicenter trial to evaluate the safety and effectiveness of the Cordella PAP Sensor in patients with HF and with New York Heart Association (NYHA) functional class III symptoms. Since then, robust clinical evidence supporting PAP-guided HF management has emerged, making clinical equipoise and enrolling patients into a standard-of-care control arm challenging. Therefore, PROACTIVE-HF was changed to a single-arm trial in 2021 with prespecified safety and effectiveness endpoints to provide evidence for a similar risk/benefit profile as the CardioMEMS HF System. The single-arm PROACTIVE-HF trial is expected to further demonstrate the benefits of PAP-guided HF management of patients with NYHA class III HF. The addition of vital signs, patient engagement and self-reported symptoms may provide new insights into remote GDMT titration and congestion management.

Remote hemodynamics-guided management of heart failure (HF) with implantable pulmonary artery pressure sensors has been shown to reduce HF hospitalizations. The widespread clinical adoption of this procedure is constrained by its invasive nature and high cost. We present a noninvasive technology based on a wearable sensor (CardioTag; Cardiosense) and machine learning (ML) for estimating pulmonary capillary wedge pressure (PCWP) in patients with heart failure with reduced ejection fraction (HFrEF). The authors developed and evaluated (against right heart catheterization [RHC]) an ML model to estimate PCWP with the use of electrocardiography, seismocardiography, and photoplethysmography signals from CardioTag. A multicenter prospective study was performed, and 310 patients with HFrEF (EF ≤40%) were recruited in both inpatient and outpatient settings. A blinded core laboratory adjudicated the RHC PCWP tracings to yield criterion-standard PCWP labels against which the model was trained and tested. The data were separated into 2 sets: a training set for model training and fine-tuning, and a held-out testing set unseen until final evaluation. The patients were 61± 13 years of age, 38% female, 44% White, and 39% African American, and had a PCWP of 18.1 ± 9.45 mm Hg. The model estimated PCWP values in the held-out test set with error of 1.04 ± 5.57 mm Hg (limits of agreement of -9.9 to 11.9 mm Hg), with consistent performance across sex, race, ethnicity, and body mass index. The CardioTag and its ML algorithm estimate PCWP with accuracy approaching implantable hemodynamic sensors, potentially offering a more accessible and cost-effective option for hemodynamics-guided management in HFrEF patients.