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 valve’s 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).