Magnetic retrieval of prosthetic heart valves for redo-TAVI

Abstract

Bioprosthetic aortic heart valves are known to degenerate within 7–15 years of implantation. Currently, the options for treating a failing valve are (a) redo surgical aortic valve replacement or, increasingly, (b) valve-in-valve transcatheter aortic valve implantation (ViV-TAVI). The ViV-TAVI procedure is referred to as redo-TAVI when the failing valve is a TAVI device. Repeated procedures, such as two or three valve-in-valves, significantly reduce the effective valve flow area, putting a limit on recurrent treatments. With increasing life expectancy and the use of TAVI in younger, lower-risk patients, the demand for multiple replacement procedures will inevitably increase. Against this background, we describe a novel valve system named exchangeable-TAVI (e-TAVI) in which an electromagnetic catheter is used to remove and retrieve a failed exchangeable valve, followed by the immediate deployment of a new valve. The e-TAVI system comprises (i) an exchangeable valve, (ii) a permanent holding member that anchors the exchangeable valve and (iii) a dedicated catheter with electromagnets for removal of the exchangeable valve. Simulations have been performed to determine the forces, frame design and electromagnetic parameters required to crimp and retrieve a 26 mm diameter valve. An optimum configuration was found to comprise a 12 cell self-expanding frame with circular ferromagnetic regions of 1 mm radius and 0.5 mm thickness, along with eight electromagnets of 1 mm radius and 2 mm thickness. A force of 2.87 N and a current of 2.52 A per electromagnet were required to partially crimp the frame to an envelope radius of 11 mm. While this amount of force allowed the frame to be crimped solely through magnetic attraction, re-sheathing of the frame was not possible due to the weaker shear holding force of the magnets. Also, the current was close to the fusing current of the copper wire needed to fit sufficient windings into the available volume. These issues led to the conclusion that, in addition to the magnetic coupling, a mechanical mating between the removal catheter and the exchangeable valve is needed. This would decrease both the force that the electromagnets had to exert during crimping and the current required to generate this force.