The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

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

1. Cardiologicum Hamburg, Cardiology, Hamburg, GERMANY
2. Department of Cardiology, Bezmiâlem Vakıf University, Istanbul, Turkey
3. Department of Cardiology, Pulmonology, Angiology and Intensive Care Medicine, Heart Center University Clinic Köln, Köln, Germany
4. Interventional Cardiology, Cardiologicum Hamburg, Hamburg, Germany, GERMANY
5. Cardiovascular Center, Onze-Lieve-Vrouwziekenhuis Hospital Aalst, Aalst, Belgium
6. Department of Cardiology, Kocaeli University Medical Faculty, Kocaeli, Turkey
7. Department of Cardiology, Charite´ University Clinic Berlin, Berlin, Germany
8. Department of Cardiology and Angiology, University clinic Magdeburg A.ö.R., Magdeburg, Germany
9. Department of Cardiology, Ege University Medical Faculty, Bornova/Izmir, Turkey
10. Department of Cardiology, Charite´ University Clinic Berlin, Berlin, Germany
11. Cardiovascular Center Frankfurt, Frankfurt, Germany
12. Department of Internal Medicine, Cardiology, Angiology and Intensive Care Medicine, University Clinic Saarland, Homburg, Germany

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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.

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