Feasibility, safety, and efficacy of Atrial Flow Regulator in children under 10 kg.

ABSTRACT

INTRODUCTION: The Atrial Flow Regulator (AFR) is a new self-expandable percutaneous-delivered fenestrated device providing an interatrial shunt. Its use in pediatric population has been reported in failing Fontan, pulmonary hypertension, or in patients with cardiomyopathy and venoarterial extracorporeal membrane oxygenator (ECMO) support. Its use in small children under 10 kg has not been reported. METHODS: We report the initial single center experience of the AFR implantation in children below 10 kg. RESULTS: Four children underwent AFR implantation. Patients' age and weight ranged between 9 and 22 months and 5-8.7 kgs. Indications were to unload the left atrium during ECMO support for end-stage cardiomyopathy and to enlarge a restrictive interatrial shunt in two other patients with complex congenital heart diseases. Devices implanted were AFR-6 and AFR-8. Delivery sheaths used via venous femoral access were undersized and ranged from 9 to 11 Fr. Devices were successfully implanted and provided unrestrictive interatrial shunt in all cases. One child developed a nonocclusive thrombus in the inferior vena cava which resolved within 1 month. Clinical improvement and femoral vein patency were observed in all cases. CONCLUSION: AFR implantation is feasible in selected children under 10 kg. The AFR can be safely deployed through sheaths that are 1-2 Fr smaller than the recommended manufacturer size. More studies are needed to confirm safety and efficacy of the device in selected pediatric patients.