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Apr 04, 2014

CoreValve a Promising Alternative for the Treatment of Aortic Stenosis

Device proves effective for patients considered high-risk for surgical valve replacement.

Patients with a severe narrowing of their aortic valve, known as aortic stenosis, may benefit from treatment with a self-expanding transcatheter aortic valve replacement with the Medtronic CoreValve device, according to research presented at the American College of Cardiology’s 63rd Annual Scientific Session. Previously, patients suffering from aortic stenosis—typically the elderly with many medical problems—had only surgical options that were associated with high surgical risks. Recently, however, transcatheter aortic valve replacement (TAVR) procedures to replace the narrowed aortic valve are being offered as an alternative for a select group of patients deemed too sick to undergo an open surgical procedure.

The CoreValve study enrolled 795 patients across 45 U.S. medical centers that were considered high-risk for a surgical aortic valve replacement and were randomized to either open surgery or TAVR. At one year of follow-up, TAVR was superior to surgery with a lower risk of death (14% vs. 19%). Testing with echocardiography showed that the TAVR with the CoreValve was not inferior to open-valve surgeries, with preservation of good valve function over a year of follow-up. In fact, the studies suggest that the CoreValve may be superior to open surgical aortic valve replacement.

Previously, patients had to be at extreme risk with an estimated surgical mortality score of more than 10% to be considered for TAVR. This trial possibly expands the role of TAVR for patients at high surgical risk. Future studies are underway to see if patients at intermediate risk for surgery would similarly benefit from these less invasive procedures.

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