Rational dispersion for the introduction of transcatheter valve therapy.

OMPLEX, HIGH-RISK MEDICAL DEVICES ORDINARILY receiveregulatoryapprovalforuseinclinicalpractice based on results from rigorous randomized controlled trials (RCTs). However, the trial results obtained in a specific population in select centers by expert health care teams and with limited long-term follow-up may not be generalizable in the “real-world setting.” To assess this latter issue, once the device is approved, the Food and Drug Administration (FDA) typically requires postmarketing surveillance studies to detect safety issues in the broader application of the device in expanded, community use. Transcatheter aortic valve replacement (TAVR) is a disruptive new technology with the promise and potential to significantly affect the management of patients with severe aortic stenosis. Transcatheter aortic valve replacement is a new procedure in which a valve is inserted via a catheter and implanted within the diseased aortic valve. Food and Drug Administration approval is expected shortly for the first valve for TAVR for use in patients in the United States who are not considered candidates for traditional aortic valve replacement. This approval was based on the results of a single RCT that compared TAVR with standard therapy including balloon aortic valvuloplasty. 1 By the time the results of this single RCT were available