The impact of atrial flow regulator implantation on hemodynamic parameters in patients with heart failure.

Abstract

Background Left atrial decompression has emerged a new option to treat patients with heart failure and dyspnea at rest or during exercise. Here we report the impact of atrial flow regulator (AFR) implantation on hemodynamic parameters in patients at our center with heart failure and with reduced (HFrEF) or with preserved left ventricular ejection fraction (HFpEF).Material and methods The PRELIEVE trial is designed to assess the safety and efficacy of the AFR in patients with HFrEF or HFpEF. Patients with left ventricular end-diastolic pressure ≥15 mmHg at rest or ≥25 mmHg during exercise and with an ejection fraction ≥15 % were enrolled. Echocardiographic data, 6‑min walking distance, Kansas City Cardiomyopathy Questionnaire, and brain natriuretic peptide levels were assessed pre- and post-AFR implantation and at 3 mos. Invasive hemodynamic assessments were also performed pre- and post-AFR implantation and at 3 mos.Results 27 (69.2 %) patients with HFrEF and 12 (30.8 %) patients with HFpEF at our center were enrolled in this study. A significant decrease was observed in pulmonary arterial wedge pressure regardless of EF (p=0.007 for HFrEF and p=0.03 for HFpEF). No significant difference of mean pulmonary arterial pressure, right arterial pressure and cardiac output (CO) existed at 3 months compared with pre-implantation baseline values.Conclusion AFR implantation led to decrease in left ventricle filling pressure without the deleterious impact on CO and right heart function regardless of ejection fraction.