ABSTRACT
OBJECTIVE: Since 1990, over 1.2 million bioprosthetic valves were implanted for aortic stenosis. Given the risk of structural valve deterioration, the need to redo AVR will likely rise. Recently, SAPIEN valve-in-valve (ViV) has been advocated. We evaluated the in vitro hydrodynamic performance of the Edwards SAPIEN+cloth trans-catheter heart valve (THV) implanted within the Carpentier-Edwards Perimount (CEP) valve. METHODS: Both 23- and 26-mm Edwards SAPIEN+cloth THVs (Model 9000MIS) were deployed within 23- or 25-mm (1) CEP aortic bioprosthesis (Models 2700 and 2800), (2) CEP Magna (Model 3000), and (3) CEP plus pericardial mitral (Model 6900P), respectively. Tests included: (1) mean pressure gradient; (2) pulsatile effective orifice area (EOA); (3) regurgitant volume; (d) migration during accelerated wear testing (AWT; 20 million cycles @ 200mmHg); and (5) valve dislodgement pressure. Values tested per ISO 5840:2005 valve standards; mean±SD. RESULTS: Post-deployment pressure gradient across the combined valves ranges from 2.8±0.3 to 8.7±0.5mmHg. The post-deployment EOA of the valves ranged from 1.7±0.1 to 2.0±0.0cm(2). Pulsatile flow regurgitant volume ranged from 2.1±0.7 to 7.6±1.2ml. Migration during the AWT ranged from 0.01±0.27 to 1.61±0.92mm. Pressure increase during the tests to quantify migration ranged from >400 to >800mmHg. CONCLUSIONS: Compared with the rigorous ISO 5840:2500 valve standards, the Edwards SAPIEN+cloth THV implanted ViV within the CEP valve demonstrated excellent hydrodynamic performance.
