[III-JCKAP6-1-6] Autus Size-Adjustable Valve - A Novel Biomimetic Expandable Pediatric Pulmonary Valve
キーワード：Pediatric, surgical, pulmonary valve
Objective: To evaluate a novel size-adjustable pediatric surgical pulmonary valve (Autus Valve) in a 20-week growing ovine model.Methods: The Autus Valve was implanted at 12.7 mm nominal diameter in the native pulmonary valve position of six juvenile sheep (mean weight = 23.4 ±2.4 kg). All animals underwent minimally invasive transcatheter valve balloon expansion at three pre-defined timepoints (30-, 60-, and 90- days post-valve implantation) and were survived to 20 weeks. Results: The Autus Valve was successfully implanted in all six animals, and all survived to term. All animals gained more than 80% in body weight. The Autus Valve was serially balloon expanded to 20 mm ID, without complications. Valve function was preserved in all six animals, across all expansion diameters. At term, the peak transvalvular gradient was 12 ± 10 mmHg, with no pulmonary regurgitation. In all animals, necropsy and histopathology demonstrated healthy right ventricular myocardium, no inflammatory infiltrate, no clinically significant thrombus on the device or device-related distal thrombo-emboli, and no leaflet mineralization. Native pulmonary artery wall integrity was preserved. Conclusion: In an ovine model, the Autus size-adjustable surgical pulmonary valve can be serially balloon-expanded post-implantation to accommodate growth, offering new alternatives to pediatric patients with valve disease.