SAN DIEGO – Long-term outcome results from the trials that compared the first-generation SAPIEN system and the CoreValve system for transcatheter aortic valve replacement (TAVR) have shown that both devices had excellent performance, compared with surgical aortic valve replacement.
The SAPIEN system continued to show similar performance, compared with surgery after 5-year follow-up, and the CoreValve showed even better superiority to surgery after 2 years, compared with first-year results.
But the performance of the two systems for TAVR should not be interpreted to suggest that CoreValve outperforms the SAPIEN system, cautioned Dr. Stephen Ramee during an interview at the annual meeting of the American College of Cardiology.
The CoreValve study began 4 years after the PARTNER trial that studied the SAPIEN valve, and during that intervening period, the cardiologists and cardiac surgeons who collaborate on TAVR learned important lessons on how to better select patients and how to avoid other risks during the procedure, said Dr. Ramee, an interventional cardiologist and director of the John Ochsner Heart and Vascular Institute in New Orleans.
As a consequence, the SAPIEN valve (currently the XT system) remains a very viable option, and Dr. Ramee said he generally used the SAPIEN XT system for about 60% of his cases. The major patient group best suited for CoreValve TAVR are patients with a highly calcified aortic-valve annulus, which is better suited to the self-expanding CoreValve because of a reduced risk for rupture of the annulus during balloon expansion with the SAPIEN valve.
Dr. Ramee has received honoraria from Edwards and Medtronic, the companies that respectively market the SAPIEN and CoreValve systems. He also has a financial interest in several companies developing new TAVR devices.
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