The AFR-PRELIEVE trial: a prospective, non-randomised, pilot study to assess the Atrial Flow Regulator (AFR) in heart failure patients with either preserved or reduced ejection fraction.

Abstract

Reducing elevated left atrial pressure with an atrial septum shunt device is a possible treatment option in symptomatic heart failure patients. This study aimed to investigate the safety and feasibility of the Atrial Flow Regulator (AFR) in heart failure patients. AFR-PRELIEVE is a prospective, non-randomised, open-label, multicentre study in patients with symptomatic heart failure NYHA Class III or IV and pulmonary capillary wedge pressure (PCWP) ≥15 mmHg at rest or ≥25 mmHg at exercise irrespective of left ventricular ejection fraction (EF ≥15%). Here we report on procedural and three-month follow-up data for a total of thirty-six enrolled patients. Sixteen (44.5%) patients with reduced EF (HFrEF: EF 15-39%) and twenty (55.5%) patients with preserved EF (HFpEF: EF ≥40%) were enrolled. Implantation success rate and device patency with left-right shunt was 100% (post procedure and at three months) in both patient groups, with one SADE in the HFpEF group which completely resolved. Three (3/36, 8.3%) patients were hospitalised for worsening of heart failure (two HFrEF patients, one HFpEF patient). Individual patients from both the HFrEF and HFpEF groups showed improvement in symptoms and surrogate parameters of heart failure (NYHA class, six-minute walking distance, Kansas City Cardiomyopathy Questionnaire, PCWP, NT-proBNP). Implantation of the AFR device in heart failure patients is feasible and safe; shunt patency at three months was confirmed in the study. The atrial shunt improved symptoms and surrogate parameters of heart failure in some but not all patients in both the HFpEF and HFrEF groups.