Study device
The J-Valve is a self-expandable, porcine aortic valve stitched within a
nitinol frame with 3 U-shape anatomically orientating claspers (Figure
1A). All procedures were performed with the patient under general
anesthesia delivered via a transapical route. Details of the
implantation procedure were previously reported 9. The
stent implantation was performed in two-stages during the procedure.
The graspers can be fully released and wholly seated in each sinus of
the tricuspid aortic valve before valve deployment (Figure 1B),
enabling correct valve fixation in a supra annular position. Precise
positioning of the clasper can also be applied to the bicuspid aortic
valve (BAV) (Figure 1C).
The valveās prosthesis is then retrieved into the aortic sinus and
released without rapid ventricular pacing (Figure 1D). Five valve
sizes were available during the study (21-, 23-, 25 -, 27- and 29-mm).
The diameter was measured as the largest possible diameter during
systole using the Multidetector computed tomography (MDCT) perimeter15.
Multidetector computed tomography (MDCT) perimeter-based diameters
determined the choice of valve size (21 mm, 18 to 20.9 mm; 23 mm, 21 to
22.9 mm; 25 mm, 23 to 24.9 mm; 27 mm, 25 to 26.9 mm; and 29 mm, 27 to 29
mm). MDCT was performed on all of the patients both before and after the
procedure (Figure 2).