Several experts at the meeting agreed that despite this difference in performance between CoreValve and SAPIEN XT when each was compared with open surgery, the CoreValve experience better reflected more contemporary performance expectations for TAVR as a class, regardless of device. They cited improvements in valve sizing with imaging, better patient selection, and better TAVR technique as critical in boosting more favorable outcomes, factors that are not valve specific.
They also cited technical factors that may favor the SAPIEN XT device, notably more accurate valve placement using SAPIEN’s balloon-expandable format, compared with the self-expanding CoreValve.
Dr. Ramee said that outside of trials he’s now using SAPIEN XT for about 60% of his cases because of its “more predictable deployment. With CoreValve, you never know exactly where it will end up.” On the other hand, CoreValve works best for a more calcified aortic annulus because self-expanding placement is gentler and less likely to rupture a fragile annulus. That advantage gives CoreValve the edge for about 40% of his patients, Dr. Ramee said in an interview.
“There has been a general forward movement of the TAVR field” in which the focus has been TAVR versus surgery rather than CoreValve versus SAPIEN, Dr. Reardon said in an interview. Some anatomic features favor balloon expandable, others favor self-expanding. New TAVR systems in development by other manufacturers are mostly self-expanding models because of their ability to allow for repositioning, he noted.
Dr. Kodali has an equity interest in Thubrikar Aortic Valve; he has received honoraria from St. Jude; he has served on the steering committee for trials sponsored by Edwards, which markets the SAPIEN systems, Claret Medical, and Meril; and he has received research support from Edwards. Dr. Popma has been a consultant to Abbott, Abiomed, Boston Scientific, Cordis, and Abbott Vascular, and he has received research grants from Medtronic, which markets the CoreValve, and from five other companies. Dr. Reardon has served on an advisory board for Medtronic, Dr. Ramee has received honoraria from Edwards and from Medtronic and has a financial interest in several other companies developing TAVR systems.
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