Biagio Castaldi, Elena Cuppini, Domenico Sirico, Irene Cattapan, Jennifer Fumanelli, Alice Pozza, Giovanni Di Salvo
University Hospital of Padova.
Italy
Journal of the Society for Cardiovascular Angiography and Interventions
J Soc Cardiovasc Angiogr Interv 2023; 2(6Part B):
DOI: 10.1016/j.jscai.2023.101209
Abstract
Background: 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.
Methods: 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.
Results: 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.
Conclusions: AFR is safe and feasible in children and critical settings, allowing right/left cavities unloading and improvement of hemodynamics and symptoms.
Category
Class II. Pulmonary Hypertension Associated with Left Ventricular Systolic or Diastolic Dysfunction
Surgical and Catheter-mediated Interventions for Pulmonary Vascular Disease
Age Focus: Pediatric Pulmonary Vascular Disease
Fresh or Filed Publication: Filed (PHiled). Greater than 1-2 years since publication
Article Access
Free PDF File or Full Text Article Available Through PubMed or DOI: Yes