Rajesh Khanna

Trans-catheter valve-in-valve implantation: in vitro hydrodynamic performance of the SAPIEN+cloth trans-catheter heart valve in the Carpentier-Edwards Perimount valves.

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.