Table 2

VARC-Defined Device Success

Device Success ComponentResult
Successful vascular access, delivery, and deployment of the device and successful retrieval of the delivery system99% (74/75)
Correct position of the device in the proper anatomical location99% (74/75)
Intended performance of the prosthetic heart valve mean aortic valve gradient <20 mm Hg or peak velocity <3 m/s, without moderate or severe prosthetic valve AR93% (71/74)
Only 1 valve implanted100% (75/75)
Combined device success93% (70/75)

Values are % (n/N).

VARC = Valve Academic Research Consortium.

  • Because of the difficulty in adequate echocardiographic images for core lab analysis of aortic valve area, the device success is evaluated without the aortic valve area criteria.