The bioprosthetic versus mechanical valve debate: Unwinnable and increasingly irrelevant?

Patient‐specific in vitro testing for evaluating TAVR clinical performance—A complementary approach to current ISO standard testing

“…15,[17][18][19] Testing a TAVR device performance under patient-specific conditions would yield clinically relevant information that current ISO testing guidelines cannot provide. We evaluated the performance of a novel polymeric TAVR device, advocated as the future of TAVR technology by addressing many TAVR's clinical complications, 10,20,21 in order to optimize its design for better clinical performance prior to clinical trials. The deployment and hemodynamic performance of TAVR valves were studied in custom fabricated patient-specific calcified aortic valve replicas, reconstructed from CT scans of presurgical TAVR patients.…”