%0 Journal Article
%T Feasibility, Safety, and Efficacy of the Atrial Flow Regulator in Pediatric Patients: A Single-Center Experience.
%A Castaldi B
%A Cuppini E
%A Sirico D
%A Cattapan I
%A Fumanelli J
%A Pozza A
%A Di Salvo G
%J J Soc Cardiovasc Angiogr Interv
%V 2
%N 6
%D 2023 Nov-Dec
%M 39131063
暂无%R 10.1016/j.jscai.2023.101209
%X <B>UNASSIGNED: </B>The Atrial Flow Regulator (AFR; Occlutech) can be used to create interatrial communication with a predetermined diameter in various pathophysiological settings. In the pediatric population, the experience is limited to a few case reports. We aim to report the initial single-center experience of AFR implantation in children with congenital and acquired heart disease.<BR><B>UNASSIGNED: </B>From December 2021 to June 2023, we enrolled 10 patients (aged 6 months-16 years). Indications to treatment were: left ventricular systolic dysfunction (n = 6), restrictive cardiomyopathy with pulmonary hypertension (n = 2), postoperative right ventricle dysfunction after surgical repair of a native Tetralogy of Fallot in a 12-year-old child (n = 1), and failure Fontan (n = 1). AFR implantation was successfully performed in all patients. Transseptal puncture was needed in 8 cases; in the other 2 cases, preexisting patent foramen ovale and fenestrated atrial septal defect were used. Balloon predilation was performed in 9 cases. An 8 mm device was implanted in all cases. The mean time of the procedure was 50 minutes, the median fluoroscopy time was 17 minutes, and median radiation exposure dose was 2.3 Gy × cm2.<BR><B>UNASSIGNED: </B>No complications were reported during the procedure. Three patients died during the follow-up: 1 due to sepsis (16 days after the procedure), 1 due to disease progression (8 months after), and 1 due to failure of ECMO decannulation 7 days after the atrial venting. In the remaining patients, a reduction of LA dilation, postcapillary pulmonary hypertension, and heart failure symptoms were observed.<BR><B>UNASSIGNED: </B>AFR is safe and feasible in children and critical settings, allowing right/left cavities unloading and improvement of hemodynamics and symptoms.