C45 MULTI–INSTITUTIONAL ITALIAN EXPERIENCE OF ATRIAL FLOW REGULATOR DEVICE IN CONGENITAL AND ACQUIRED HEART DISEASE

Abstract

Abstract The Atrial Flow Regulator is a self–expandable nitinol device implanted into the interatrial septum to establish a communication with a predetermined diameter.The creation of such shunt is advisable in several cardiovascular diseases.In pediatric population,the experience is limited to a few case reports describing patients with failing Fontan,pulmonary hypertension,or severe heart failure.We aim to report the preliminary data of Italian registry of AFR implantation in children with heart failure in congenital and acquired heart disease.The goal is to create a local and national register,to monitoring the safety and efficacy of the AFR in pediatric population.The register is prospective and multi–institutional, with 2 centers involved: Pediatric Cardiology department of Padova Hospital and of Bambino Gesù Hospital in Rome,started on the 27/11/2021 and ongoing.AFR implantation was proposed for all patients with symptomatic heart failure,not responding to maximal medical therapy and a history of complex congenital or acquired cardiac diseases.We enrolled 8 patients (median age 124 months)indications were LV systolic dysfunction in 4 patients,restrictive cardiomyopathy with pulmonary hypertension in one, post–operative RV dysfunction after surgical repair of a native TOF and 2 patients with failing Fontan.AFR implantation was successfully reached in all 8 patients.In one case,it was performed a hybrid procedure during pulmonary artery surgical banding, with peratrial approach through the right atrial free wall.Atrial septostomy was needed in 5 cases, in the other 3 cases pre–existing PFO and ASD were used.Balloon pre–dilation was performed in 4 cases.Mean time of procedure was 50 minutes and median radiation exposure dose was 3 Gy/cm2.No complications were reported during the procedure.No acute or sub–acute shunt occlusion or stroke was observed.One patient died of sepsis not related to the procedure;one patient presented a cardiac arrest due to a cerebral ischemia 24 hours after the procedure.Heparin or aspirin were administered to all patients for at least 6 months.Clinical improvement was observed in all patients with an increase in ejection fraction (p=0.02), reduction in LA dilation(p< 0.05)and in HF symptoms(62% of patients improved their NYHA class).AFR implantation is safe and feasible in children with specific congenital and acquired heart diseases,allowing right/left cavities unloading and improvement of hemodynamics and symptoms.