Devices, systems and methods to improve placement and/or prevent heart block with percutaneous aortic valve replacement

Abstract

Devices, systems and methods to position a prosthetic heart valve such that the prosthetic valve is more accurately positioned. Guide devices promote positioning the prosthetic valve within a native aortic valve and, optionally, to center the prosthetic valve within the native heart valve. Prosthetic valves may include one or more cut-outs, openings or recesses configured to align with the conduction tissue so that the conduction tissue is not contacted in a way that would lead to higher incidents of complete heart block.

1 . A method of implanting a prosthetic aortic valve, the prosthetic aortic valve including a stent frame formed from wire, the stent frame including an upper margin or edge, a lower margin or edge, and an interior, and a plurality of prosthetic valve leaflets mounted within the interior of the stent frame to provide unidirectional flow of blood through the prosthetic aortic valve, the method comprising:
 selecting an orientation of the prosthetic valve relative to a native aortic valve in a patient,   identifying a location on the native aortic valve as a reference target for orientating the prosthetic valve during implantation,   using a visualization system to identify the reference target,   mounting the prosthetic valve on a delivery system including a radiopaque marker such that the prosthetic valve is orientated relative to the radiopaque marker,   delivering the prosthetic valve in a collapsed condition through a delivery sheath in a femoral artery of the patient,   moving the prosthetic valve through the aorta and around the substantially U-shaped turn of the aortic arch to a position above the native aortic valve in the aorta,   rotating the prosthetic valve using the delivery system to precisely align the radiopaque marker on the delivery system with the preselected reference target on the native aortic valve so that the prosthetic valve will be aligned with the preselected target on the native aortic valve, lowering the prosthetic valve inside the annulus of the native aortic valve, and   deploying the prosthetic valve into an implanted state inside the annulus in the preselected orientation of the prosthetic valve relative to the native aortic valve.   
     
     
         2 . The method of  claim 1 , wherein the prosthetic valve is rotated relative to the axis of the delivery system prior to entry in the patient and/or as the prosthetic valve is advanced in the patient to ensure that the prosthetic valve will be substantially aligned with native aortic valve in the preselected orientation after the prosthetic valve has been advanced up the aorta and around the substantially U-shaped turn of the aortic arch. 
     
     
         3 . The method of  claim 1 , wherein the step of using a visualization system further comprises performing an angiogram to identify the reference target.