PMID- 38288053 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240131 IS - 2297-055X (Print) IS - 2297-055X (Electronic) IS - 2297-055X (Linking) VI - 10 DP - 2023 TI - 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. PG - 1332395 LID - 10.3389/fcvm.2023.1332395 [doi] LID - 1332395 AB - 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 paediatric population and for 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 10 centers 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 the procedure was 58.5 months (IQR: 31.5-142.5) and the median weight was 17 kg (IQR: 10-46). A total of 26 (65.0%) patients had CHD, nine (22.5%) children, a cardiomyopathy, and five (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 extracorporeal membrane oxygenator (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 New York Heart Association (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. CI - (c) 2024 Butera, Piccinelli, Kolesnik, Averin, Seaman, Castaldi, Cuppini, Fraisse, Bautista-Rodriguez, Hascoet, D'Amore, Baruteau, Blasco, Bianco, Eicken, Jones, Kuo and Rajszys. FAU - Butera, Gianfranco AU - Butera G AD - Cardiology, Cardiac Surgery and Heart Lung Transplantation, ERN GUARD HEART, Bambino Gesu Hospital and Research Institute, IRCCS, Rome, Italy. FAU - Piccinelli, Enrico AU - Piccinelli E AD - Cardiology, Cardiac Surgery and Heart Lung Transplantation, ERN GUARD HEART, Bambino Gesu Hospital and Research Institute, IRCCS, Rome, Italy. AD - Department of Mechanical and Aerospace Engineering, Politecnico di Torino, Torino, Italy. FAU - Kolesnik, Adam AU - Kolesnik A AD - Cardiovascular Interventions Laboratory, The Children's Memorial Health Institute, Varsavia, Poland. FAU - Averin, Kostantin AU - Averin K AD - Division of Cardiology, Department of Pediatrics, Stollery Children's Hospital, Edmonton, AB, Canada. FAU - Seaman, Cameron AU - Seaman C AD - Division of Cardiology, Department of Pediatrics, Stollery Children's Hospital, Edmonton, AB, Canada. FAU - Castaldi, Biagio AU - Castaldi B AD - Pediatric Cardiology Department, Padova University, Padova, Italy. FAU - Cuppini, Elena AU - Cuppini E AD - Pediatric Cardiology Department, Padova University, Padova, Italy. FAU - Fraisse, Alain AU - Fraisse A AD - Pediatric Cardiology Department, Royal Brompton Hospital, London, United Kingdom. FAU - Bautista-Rodriguez, Carles AU - Bautista-Rodriguez C AD - Pediatric Cardiology Department, Royal Brompton Hospital, London, United Kingdom. FAU - Hascoet, Sebastien AU - Hascoet S AD - Pediatric Cardiology Department, Royal Brompton Hospital, London, United Kingdom. FAU - D'Amore, Carmen AU - D'Amore C AD - Epidemiology, Clinical Pathways and Clinical Risk Unit, Medical Direction, Bambino Gesu Children's Hospital, IRCCS, Rome, Italy. FAU - Baruteau, Alban-Elouen AU - Baruteau AE AD - Nantes Universite, CHU Nantes, Department of Pediatric Cardiology and Pediatric Cardiac Surgery, FHU PreciCare, Nantes, France. FAU - Blasco, Pedro Betrian AU - Blasco PB AD - Pediatric Interventional Cardiology Unit, Vall d'Hebron Hospital, Barcellona, Spain. FAU - Bianco, Lisa AU - Bianco L AD - Cardiology, Cardiac Surgery and Heart Lung Transplantation, ERN GUARD HEART, Bambino Gesu Hospital and Research Institute, IRCCS, Rome, Italy. AD - Pediatric Interventional Cardiology Unit, Vall d'Hebron Hospital, Barcellona, Spain. FAU - Eicken, Andreas AU - Eicken A AD - Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum Munchen, Munchen, Germany. FAU - Jones, Matthew AU - Jones M AD - Department of Paediatric Cardiology and Adults with Congenital Heart Diseases, Evelina Children's Hospital, London, United Kingdom. FAU - Kuo, James A AU - Kuo JA AD - Division of Cardiology, Children's Healthcare of Atlanta, Atlanta, GA, United States. FAU - Rajszys, Grazyna Brzezinska AU - Rajszys GB AD - Cardiovascular Interventions Laboratory, The Children's Memorial Health Institute, Varsavia, Poland. LA - eng PT - Journal Article DEP - 20240115 PL - Switzerland TA - Front Cardiovasc Med JT - Frontiers in cardiovascular medicine JID - 101653388 PMC - PMC10822980 OTO - NOTNLM OT - Fontan circulation OT - atrial flow regulator device OT - congenital heart disease OT - extracorporeal membrane oxygenation OT - pulmonary hypertension COIS- AF and A-EB are consultants and proctors for Occlutech. MJ is a consultant for Occlutech. BC was a proctor for Occlutech. PB has been Occlutech medical advisor. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The handling editor CA declared a past coauthorship with the author AE. EDAT- 2024/01/30 06:42 MHDA- 2024/01/30 06:43 PMCR- 2023/01/01 CRDT- 2024/01/30 03:37 PHST- 2023/11/02 00:00 [received] PHST- 2023/12/22 00:00 [accepted] PHST- 2024/01/30 06:43 [medline] PHST- 2024/01/30 06:42 [pubmed] PHST- 2024/01/30 03:37 [entrez] PHST- 2023/01/01 00:00 [pmc-release] AID - 10.3389/fcvm.2023.1332395 [doi] PST - epublish SO - Front Cardiovasc Med. 2024 Jan 15;10:1332395. doi: 10.3389/fcvm.2023.1332395. eCollection 2023.