|Device Success Component||Result|
|Successful vascular access, delivery, and deployment of the device and successful retrieval of the delivery system||99% (74/75)|
|Correct position of the device in the proper anatomical location||99% (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 AR∗||93% (71/74)|
|Only 1 valve implanted||100% (75/75)|
|Combined device success||93% (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.