AUTHOR=Butera Gianfranco , Piccinelli Enrico , Kolesnik Adam , Averin Konstantin , Seaman Cameron , Castaldi Biagio , Cuppini Elena , Fraisse Alain , Bautista-Rodriguez Carles , Hascoet Sebastien , D'Amore Carmen , Baruteau Alban-Elouen , Blasco Pedro Betrián , Bianco Lisa , Eicken Andreas , Jones Matthew , Kuo James A. , Rajszys Grazyna Brzezinska 

TITLE=Implantation of atrial flow regulator devices in patients with congenital heart disease and children with severe pulmonary hypertension or cardiomyopathy—an international multicenter case series

JOURNAL=Frontiers in Cardiovascular Medicine

VOLUME=Volume 10 - 2023

YEAR=2024

URL=https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2023.1332395

DOI=10.3389/fcvm.2023.1332395

ISSN=2297-055X

ABSTRACT=Background: The Occlutech Atrial Flow Regulator (AFR®) is a self-expandable double-disc nitinol device with a central fenestration. Its use has been approved in the adult population with heart failure and described for pulmonary hypertension (PH). Only case reports and small series have been published about its use in the pediatric population and congenital heart disease (CHD). 
Objectives: The authors sought to investigate the feasibility, safety and short-term follow-up of AFR implantation in patients with CHD or children with PH or cardiomyopathy.
Methods: This is a multicenter retrospective study involving ten centres worldwide. Patients of any age with CHD or patients aged < 18 years with PH or cardiomyopathy needing AFR implantation were included.
Results: A total of 40 patients underwent AFR implantation. The median age of the population at the time of procedure was 58.5 months (IQR 31.5 – 142.5) and the median weight was 17 Kg (IQR 10 – 46). 26 (65.0%) patients had CHD, 9 (22.5%) children a cardiomyopathy and 5 (12.5%) a structurally normal heart. The implantation success rate was 100%. There were two early and one late device thrombosis. Two patients (5.0%) with dilated cardiomyopathy on ECMO died during the hospital stay. At a median follow-up of 330 days (IQR 125 – 593), 37 (92.5%) patients were alive. At follow-up 20 patients improved their NYHA class, 12 patients did not change their NYHA class and one patient with idiopathic PH worsened.
Conclusions: AFR implantation in patients with CHD and children with severe PH or cardiomyopathy is promising and seems to have beneficial effects at short-term follow-up.