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 @ 200 mmHg); 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 ± 0.5 mmHg. The post-deployment EOA of the valves ranged from 1.7 ± 0.1 to 2.0 ± 0.0 cm². Pulsatile flow regurgitant volume ranged from 2.1 ± 0.7 to 7.6 ± 1.2 ml. Migration during the AWT ranged from 0.01 ± 0.27 to 1.61 ± 0.92 mm. Pressure increase during the tests to quantify migration ranged from >400 to >800 mmHg. 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.