Implante percutáneo de válvula aórtica con Evolut PRO comparada con la SAPIEN 3: estudio comparativo aleatorizado

Introduction and objectives: Advances made in transcatheter aortic valve implantation (TAVI) valvular technology have resulted in better outcomes and fewer complications compared with older generations. We studied the rate and determinants of paravalvular leak (PVL) using Evolut PRO vs SAPIEN 3 valves as well as other perioperative and in-hospital outcomes. Methods: A total of 110 consecutive patients with severe aortic stenosis scheduled for transfemoral TAVI were randomly selected to receive the SAPIEN 3 (N = 59) or the Evolut PRO valve (N = 51). Annular dimensions were determined by transesophageal echocardiography guided balloon sizing. The following postoperative and in-hospital endpoints were assessed: PVL, conduction defects, valve embolization, need for a second valve, annular rupture, stroke, vascular complications, acute kidney injury, and in-hospital mortality. We also studied the possible anatomical determinants of PVL. Results: There were no relevant baseline differences between the 2 groups regarding clinical and echocardiographic characteristics. In-hospital complications were comparable between both valves apart from a significantly higher rate of immediate postoperative PVL and at discharge (≥ grade II) between the Evolut PRO and the SAPIEN 3 valves (19.6% vs 6.8%) and (5.9% vs 1.7%), respectively. Of the anatomical variables described, the left ventricular outflow tract/ascending aorta angle, aortic angulation, and calcification had a significant impact on PVL in the Evolut PRO valves. The left ventricular outflow tract/ascending aorta angle revealed a negative correlation with implantation depth in the Evolut PRO valves but not in the SAPIEN 3 ones. Conclusions: Both valves demonstrated favorable comparable outcomes except for a significantly higher rate of PVL in patients implanted with Evolut PRO valves. Introducción y objetivos: Los avances en la tecnología de implante percutáneo de válvula aórtica (TAVI) han dado lugar a mejores resultados y menos complicaciones en comparación con las generaciones anteriores. Se estudió la incidencia y los determinantes de las fugas periprotésicas (FPP) con las válvulas Evolut PRO y SAPIEN 3, así como otros resultados periprocedimiento y hospitalarios. Métodos: Se seleccionó aleatoriamente a 110 pacientes consecutivos con estenosis aórtica grave programados para TAVI transfemoral para recibir una válvula SAPIEN 3 (n = 59) o una Evolut PRO (n = 51). Las dimensiones anulares se determinaron mediante el