The progression of a transcatheter aortic valve program: a decision analysis of more than 680 patient referrals.

Background: A ground-breaking, US Food and Drug Administration clinical trial for the treatment of critical aortic stenosis commenced at our institution in November 2007 with our first transcatheter aortic valve repair (TAVR). This novel procedure created a new treatment option for high-risk patients with aortic stenosis. Although the pivotal trial completed enrollment in 2009, continued access was implemented by the Food and Drug Administration in response to an unprecedented demand for this new procedure by patients and physicians.