Heart failure with preserved ejection fraction (HFpEF) is a chronic condition affecting 3.1M Americans and 33M people in developed countries. It is considered one of the largest cardiovascular unmet needs owing to a general lack of effective treatments [1]. No device-based therapies have been approved by the FDA and the pharmacological ones have proven ineffective in reducing readmissions as well as mortality. Approximately 500,000 hospitalizations/year are related to HFpEF [2] in the US alone and the readmission rate is the highest in the healthcare system (21%) [3]. The mortality rate for patients after hospitalization hovers around 35% after twelve months and is almost 75% after 5 years
The effects of HFpEF are felt by patients and their caregivers, who might experience detriment to their own health as well as their social and working lives. Although HFpEF accounts for approximately 50% of all HF cases, approximately 70% of HF cases among adults aged 65 to 84 years are classified as HFpEF [5]. Demographic and clinical characteristics common to individuals with HFpEF are an older age, female sex, and comorbidities, such as obesity, hypertension, smoking, atrial fibrillation, coronary artery disease, chronic obstructive pulmonary disease (COPD), anemia, hyperlipidemia, and diabetes mellitus. The high prevalence of comorbidities with this condition makes treatment more challenging given the side effects. The burden of HFpEF, which includes the collective physical, mental/emotional, and financial impact of the disease on patients, caregivers, and the health-care system is high and can be described in terms of morbidity (e.g., hospitalization), mortality, the effect on the patient’s health status (e.g., quality of life), and the patient’s financial/economic situation. The burden extends to caregivers and affect many aspects of a caregiver’s life (e.g., personal, social, financial, and professional), as well as the health-care system through personnel and resource utilization.
The prevalence is expected to increase by almost 50% in the next 10 years due to an aging population. NO device-based treatment for HFpEF has been approved by the FDA and the pharmacological therapies for late-stage patients have proven ineffective, with a rehospitalization rate of 29% within 60 to 90 days of discharge. The optimal treatment for a HFpEF patient would both reduce left atrium (LA) pressure and increase cardiac output (CO), but no such treatment is currently available. Long-term mechanical circulatory support (MCS) devices are currently under development to improve the physiology and hemodynamics of patients with HFpEF given their unique challenge – hypertrophic left ventricle (LV) muscles that reduce its chamber size and, therefore, its ejection fraction.
