The AFR-PRELIEVE TRIAL A prospective, non-randomized, pilot study to assess the Atrial Flow Regulator (AFR) in Heart Failure Patients with either preserved or reduced ejection fraction

Aims: Reducing elevated left atrial pressure with a percutaneous delivered atrial septum device is a potential therapeutic strategy in heart failure (HF) patients. The aim of this trial is to investigate the safety of a novel atrial flow regulator (AFR®) device in HF patients.

Methods and results: AFR-PRELIEVE is a prospective, non-randomized, open-label, multicenter study in patients with symptomatic HF (NYHA class III or IV ambulatory) and pulmonary capillary wedge pressure (PCWP) ≥15mmHg at rest or ≥25mmHg at exercise, irrespective of ejection fraction (EF ≥15%). Primary endpoint is the incidence of severe adverse device events (SADEs) up to 3 months following implantation. Here we report on procedural and the 3-month data for a total of 36 enrolled HF patients. 14 (39%) patients with reduced EF (HFrEF: EF15-39%) and 22 (61%) patients with preserved EF (HFpEF: EF≥40%) were enrolled after successful transseptal puncture and balloon atrial septostomy. Implantation success rate and device patency with left-right shunt was 100% (post-procedural and at 3 months) in both patient groups, without SADEs up to 3 months. 1/36 (2.7%) patient had a procedure related bleeding, 3/36 (8.3%) patients (2/14 HFrEF and 1/22 HFpEF) were hospitalised for worsening of HF. 1/36 (2.7%) HFrEF patient died 30 days after implantation (pneumonia). Surrogate endpoints (NYHA class, 6 minute walking distance and Kansas City Cardiomyopathie Score) suggest clinical efficacy for both patient collectives.

Conclusions: Implantation of the atrial flow regulator device in patients with both HFpEF and HFrEF is feasible, safe and possibly effective in reducing HF symptoms.