New Study Published in JACC: Heart Failure Reveals that Despite Significant Efforts to Improve Acute Heart Failure Treatment Over the Past 20 Years, Management Remains Unchanged

Reprieve Cardiovascular, Inc. (?Reprieve'), a development stage company focused on pioneering an intelligent approach to acute decompensated heart failure (ADHF) treatment, today highlighted the publication of TREAT-AHF study results in JACC: Heart Failure.

Heart failure (HF) is a leading cause of hospitalization in the United States. Decongestion remains a central goal of inpatient management, but contemporary decongestion practices and associated weight loss are not well described. Nearly 20 years ago, the Acute Decompensated Heart Failure National Registry (ADHERE) was published¹ and described inpatient HF treatment patterns and decongestion outcomes in a prospective national database of HF hospitalizations across 275 community and academic medical centers.

As a national community-based cohort, Trajectory and Response to Emergently Administered Therapy for Acute Heart Failure (TREAT-AHF) is a contemporary registry that characterizes a diverse population of 262,673 patients with HF from 2015 to 2022. In the TREAT-AHF study, the distribution of inpatient body weight change was similar to those reported from ADHERE nearly two decades ago. Discharge weight was higher than admission weight in 20% of HF hospitalizations, highlighting the challenges facing physicians and patients to effectively remove excess fluid. Furthermore, there was considerable variation in weight loss from diuretic use related to differences in patient characteristics and clinical practices. The TREAT-AHF study also demonstrated the median length of stay was 5.8 days (ranging from 3.7 to 9.7 days), which underscores the extended, variable duration of inpatient decongestion treatment. This unpredictability manifests in resource and scheduling challenges for patients, physicians and administrators.

"Decongestion therapy is a critical part of acute heart failure management. The TREAT-AHF analysis provides a contemporary understanding of the state of decongestion therapy across a broad set of health systems across the United States. We found there has been little change in diuretic management compared with prior cohort studies. There needs to be a call to action for developing and testing novel strategies for improving decongestion for patients hospitalized with heart failure," stated Dr. Alexander Sandhu, Division of Cardiovascular Medicine and Stanford Prevention Research Center, Department of Medicine at Stanford University.

Additional Heart Failure Research Presented

Acute HF hospitalization represents a critical opportunity for the rapid initiation of evidence-based medications. However, data on GDMT use at discharge are mostly derived from national quality improvement registries. At the American College of Cardiology 2024 scientific sessions, a TREAT-AHF subset was presented that looked at guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF).

The study findings: Inpatient utilization of GDMT among diverse community-based health systems was lower than rates observed in national quality improvement registries where participation is voluntary. Discontinuation of GDMT before discharge, contrary to the guidelines, occurred in a substantial proportion of hospitalizations despite previous inpatient administration. Hypotension, hyperkalemia, and worsening renal function were strong factors associated with discontinuation, but discontinuation was unexplained by clinical factors in many hospitalizations. Implementation of novel strategies to achieve comprehensive use of GDMT is urgently needed among acute HF hospitalizations.

"Guideline-directed medical therapy underuse and discontinuation during hospitalization for heart failure results in poor quality of care and worse outcomes for patients. We need to develop in-hospital management strategies including for clinical decongestion that allow restoration of euvolemia while also facilitating continuing and new initiation and/or up-titration of GDMT for heart failure," stated Dr. Andrew Ambrosy, Assistant Medical Director for the Clinical Trials Program at the Division of Research and a cardiologist with The Permanente Medical Group.

Advancing Acute Heart Failure Patient Management Through the Analysis of Real-World Data

Reprieve is partnering with industry-leading heart failure researchers and Truveta to understand and advance acute heart failure patient outcomes. Truveta delivers the most complete, timely, and clean electronic health record data, including images, clinician notes, and labs from more than 30 health systems linked with social drivers of health (SDOH), claims, and mortality data, empowering researchers with scientifically rigorous analytics. Truveta Data provides daily updated, regulatory-grade data from more than 100 million de-identified patients in all 50 states from more than 800 hospitals and 20,000 clinics to provide a timely and representative view of patient care in the US.

Through this partnership, Reprieve is providing heart failure researchers access to Truveta Data to facilitate the understanding of contemporary care of patients with ADHF. The partnership with Truveta contributed to the TREAT-AHF analysis and the publication of the manuscripts.

"Reprieve is committed to understanding the ADHF patient journey. The clinical evidence from the TREAT-HF study demonstrates that heart failure decongestion management has not substantially changed in 20 years," said Mark Pacyna, chief executive officer of Reprieve Cardiovascular. "The data highlights the opportunities to improve care, but it will take a sustained partnership among hospital systems, physicians, nurses, and industry partners to solve this. Reprieve is committed to building these partnerships."

About Acute Decompensated Heart Failure

ADHF is the sudden or gradual onset of the signs or symptoms of heart failure (difficulty breathing, leg or feet swelling, and fatigue) requiring unplanned office visits, emergency room visits, or hospitalization. Specifically, ADHF is caused by a rapid onset of fluid volume overload. Five million patients a year are admitted with heart failure diagnoses in the U.S., with 40 percent of these patients being admitted with worsening heart failure. ADHF is one of the leading admission diagnoses around the world. Often, patients are re-admitted to the hospital repeatedly to treat fluid volume overload, and each hospitalization substantially increases a patient's morbidity and mortality.

About Reprieve Cardiovascular, Inc.

Reprieve Cardiovascular, Inc. is developing innovative and groundbreaking therapies that aim to improve the lives of more than 25 million heart failure patients around the world. Reprieve is bringing intelligence to decongestion management to safely accelerate fluid removal for every heart failure patient. In 2022, Reprieve initiated the FASTR Trial (pilot study) to compare decongestive therapy administered by the Reprieve DMS system to Optimal Diuretic Therapy in the treatment of patients diagnosed with acute decompensated heart failure.

Reprieve is a privately held medical device company, headquartered in Milford, Massachusetts, USA.

¹ Adams KF., Fonarow GC., Emerman CL., et al. Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J 2005;149(2):209?16. Doi: 10.1016/j.ahj.2004.08.005.