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 having an interior and a plurality of prosthetic valve leaflets mounted within the interior to provide unidirectional flow of blood through the prosthetic aortic valve, the method comprising:
 loading the prosthetic aortic valve into a delivery system in a collapsed condition in an orientation relative to an axis of the delivery system by reference to a radiopaque marker on the delivery system;   placing the prosthetic aortic valve mounted in the delivery system into a sheath in a femoral artery of the patient with the axis of the delivery system in a rotational orientation relative to the sheath that ensures the prosthetic aortic valve will be at least substantially aligned in a desired orientation with respect to the native aortic valve after the prosthetic aortic valve has been advanced up the aorta and around the substantially U-shaped turn of the aortic arch;   moving the prosthetic aortic valve to a position above the native aortic valve in the aorta,   rotating the delivery system about its axis to align the prosthetic aortic valve in the desired orientation relative to the native aortic valve,   lowering the prosthetic aortic valve inside the annulus of the native aortic valve, and   deploying the prosthetic aortic valve into an implanted state inside the annulus with the prosthetic aortic valve aligned in the desired orientation with respect to the native aortic valve.   
     
     
         2 . The method of  claim 1 , wherein the desired orientation with respect to the native aortic valve is with respect to the right coronary artery. 
     
     
         3 . The method of  claim 1 , wherein the desired orientation with respect to the native aortic valve is with respect to a junction of cusps of the native aortic valve. 
     
     
         4 . The method of  claim 3 , wherein the junction is the junction of the non-coronary cusp and the right coronary cusp. 
     
     
         5 . The method of  claim 1 , wherein the desired orientation is relative to a native cusp. 
     
     
         6 . The method of  claim 5 , wherein the desired orientation is relative to the nadir of a native cusp. 
     
     
         7 . The method of  claim 1 , wherein the rotating the delivery system includes visualizing the radiopaque marker under fluoroscopy. 
     
     
         8 . The method of  claim 1 , wherein the stent frame has a lower margin or edge and a cut-out, opening, or recess located along the lower margin or edge, and wherein the desired orientation is selected to dispose the cut-out, opening, or recess will in least substantial alignment with to a junction of the right and non-coronary cusps of the native aortic valve. 
     
     
         9 . The method of  claim 1 , wherein the stent frame includes a portion at a lower edge thereof, and the desired orientation is selected so that when the prosthetic aortic valve is in its expanded condition inside the native aortic valve, the portion of the stent frame is disposed adjacent to the location of conduction tissue of the native aortic valve so that the frame does not damage the conduction tissue. 
     
     
         10 . The method of  claim 9 , wherein the portion includes a cut-out, recess, or opening. 
     
     
         11 . A method of delivering a prosthetic aortic valve to a native aortic valve of a patient, the prosthetic aortic valve having a frame and being movable between a collapsed condition and an expanded condition, the prosthetic aortic valve being disposed in its collapsed condition in a delivery system for delivery to the native aortic valve, the delivery system having a radiopaque marker and an axis, the prosthetic aortic valve being disposed in an orientation relative to the axis of the delivery system by reference to the radiopaque marker, the native aortic valve having native cusps, adjacent cusps having a commissure junction therebetween, the method comprising:
 delivering the prosthetic aortic valve in the collapsed condition to the aorta of the patient above the native aortic valve;   imaging the prosthetic aortic valve and the delivery system, including the radiopaque marker, within the aorta, an aortic root of the patient, and the native aortic valve;   rotating the delivery system about its axis with reference to the radiopaque marker to align the prosthetic aortic valve in a desired orientation relative to a portion of the native aortic valve or the aortic root;   introducing the prosthetic aortic valve inside the native cusps; and   moving the prosthetic aortic valve into its expanded condition inside the native aortic valve.   
     
     
         12 . The method of  claim 11 , wherein the desired orientation is relative to the right coronary artery. 
     
     
         13 . The method of  claim 11 , wherein the desired orientation is relative to a commissure junction of the cusps of the native aortic valve. 
     
     
         14 . The method of  claim 13 , wherein the commissure junction is the commissure junction of the non-coronary cusp and the right coronary cusp of the native aortic valve. 
     
     
         15 . The method of  claim 11 , wherein the desired orientation is relative to a native cusp. 
     
     
         16 . The method of  claim 15 , wherein the desired orientation is relative to the nadir of a native cusp. 
     
     
         17 . The method of  claim 11 , wherein the frame has a portion configured to avoid damage to conduction tissue of the heart, and wherein the rotating the delivery system is to align the portion with respect to a junction of the right and non-coronary cusps of the native aortic valve. 
     
     
         18 . The method of  claim 11 , wherein the imaging the prosthetic aortic valve includes imaging with a fluoroscopy camera movable through a range of coordinates for camera positioning, and further comprising, before the imaging the prosthetic aortic valve:
 taking a baseline CT image of the native aortic valve to predict the camera positioning coordinates for the fluoroscopy camera for the imaging the prosthetic aortic valve.   
     
     
         19 . The method of  claim 11 , wherein the imaging the prosthetic aortic valve includes imaging with a fluoroscopy camera positioned to image a commissure junction of the native aortic valve. 
     
     
         20 . The method of  claim 11 , wherein the rotating the delivery system includes matching the prosthetic aortic valve with the native aortic valve. 
     
     
         21 . The method of  claim 11 , wherein the rotating the delivery system includes matching at least one commissure of the prosthetic valve with a commissure of the native aortic valve. 
     
     
         22 . The method of  claim 11 , further comprising, before the delivering the prosthetic aortic valve:
 placing the prosthetic aortic valve mounted in the delivery system into a sheath in the femoral artery of the patient with the axis of the delivery system in a rotational orientation relative to the sheath that ensures the prosthetic aortic valve will be at least substantially aligned in the desired orientation after the prosthetic aortic valve has been advanced up the aorta and around the substantially U-shaped turn of the aortic arch.   
     
     
         23 . The method of  claim 22 , further comprising, before the placing the prosthetic aortic valve, imaging the aorta of the patient to determine the rotational orientation relative to the sheath. 
     
     
         24 . The method of  claim 11 , further comprising, before the delivering the prosthetic aortic valve, loading the prosthetic aortic valve into the delivery system in the collapsed condition in the orientation relative to an axis of the delivery system by reference to the radiopaque marker on the delivery system. 
     
     
         25 . The method of  claim 11 , wherein the frame includes a portion at a lower edge thereof, and the desired orientation is selected so that when the prosthetic aortic valve is in its expanded condition inside the native aortic valve, the portion of the frame is disposed adjacent to the location of conduction tissue of the native aortic valve so that the frame does not damage the conduction tissue. 
     
     
         26 . The method of  claim 25 , wherein the portion includes a cut-out, recess, or opening. 
     
     
         27 . A method of delivering a prosthetic aortic valve to a native aortic valve of a patient to avoid contact between the prosthetic aortic valve and conduction tissue of the heart of the patient, the prosthetic aortic valve having a frame with an inflow end and being movable between a collapsed condition and an expanded condition, the prosthetic aortic valve being disposable in its collapsed condition in a delivery system having an axis for delivery to the native aortic valve, the native aortic valve having native cusps, adjacent cusps having a commissure junction therebetween, the method comprising:
 delivering the prosthetic aortic valve in the collapsed condition to the aorta of the patient above the native aortic valve;   imaging the prosthetic aortic valve and the delivery system within the aorta, an aortic root of the patient, and the native aortic valve;   rotating the delivery system about its axis to match the prosthetic aortic valve to the native aortic valve;   introducing the prosthetic aortic valve inside the native cusps; and   moving the prosthetic aortic valve into its expanded condition inside the native aortic valve with the lower edge of the frame disposed above the location of the conduction tissue.   
     
     
         28 . The method of  claim 27 , wherein the inflow end of the frame is non-planar, and wherein the rotating includes rotating the delivery system so that the highest point on the inflow end of the frame is aligned with the conduction tissue and wherein the moving includes disposing the highest point of the lower edge of the frame above the location of the conduction tissue. 
     
     
         29 . The method of  claim 27 , wherein the stent frame includes a portion at a lower edge thereof, and the desired orientation is selected so that when the prosthetic aortic valve is in its expanded condition inside the native aortic valve, the portion of the stent frame is disposed adjacent to the location of conduction tissue of the native aortic valve so that the frame does not damage the conduction tissue, wherein the portion includes a cut-out, opening, or recess. 
     
     
         30 . The method of  claim 29 , wherein the inflow end of the frame is planar, and the portion includes a recess.