In vitro assessment of the influence of aortic annulus ovality on the hydrodynamic performance of self-expanding transcatheter heart valve prostheses.
BACKGROUND
Although CT-studies as well as intraoperative analyses have described broad anatomic variations of the aortic annulus, which is predominantly found non-circular, commercially available transcatheter aortic heart valve prostheses are circular. In this study, we hypothesize that the in vitro hydrodynamic function of a self-expanding transcatheter heart valve (Medtronic CoreValve) assessed in an oval compartment representing the aortic annulus will differ from the conventionally used circular compartment.


METHODS
Medtronic CoreValve prostheses were tested in specifically designed and fabricated silicone compartments with three degrees of defined ovalities. The measurements were performed in a left heart simulator at three different flow rates. In this setting, regurgitation flow, effective orifice area, and systolic pressure gradient across the valve were determined. In addition, high speed video recordings were taken to investigate leaflet kinematics.


RESULTS
The pressure difference across the prosthesis increased with rising ovality. The effective orifice areas were only slightly impacted. The analyses of the regurgitation showed minor changes and partially lower regurgitation when switching from round to slightly oval settings, followed by strong increases for further ovalization. The high speed videos show minor central leakage and impaired leaflet apposition for strong ovalities, but no leaflet/stentframe contact in any setting.


CONCLUSIONS
This study quantifies the influence of oval expansion of transcatheter heart valve prostheses on their hydrodynamic performance. While slight ovalities were well tolerated by a self-expanding prosthesis, more significant ovality led to worsening of prosthesis function and regurgitation.
Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, RWTH Aachen, University, Aachen, Germany. Electronic address: kuetting@hia.rwth-aachen.de.
Maximilian
M
Kuetting
Med. Klinik und Poliklinik II, Universitätsklinikum Bonn, Rheinische Friedrich-Wilhelms-Universität Bonn, Germany.
Alexander
A
Sedaghat
Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, RWTH Aachen, University, Aachen, Germany.
Marc
M
Utzenrath
Med. Klinik und Poliklinik II, Universitätsklinikum Bonn, Rheinische Friedrich-Wilhelms-Universität Bonn, Germany.
Jan-Malte
JM
Sinning
Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, RWTH Aachen, University, Aachen, Germany.
Christoph
C
Schmitz
Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, RWTH Aachen, University, Aachen, Germany.
Jan
J
Roggenkamp
Med. Klinik und Poliklinik II, Universitätsklinikum Bonn, Rheinische Friedrich-Wilhelms-Universität Bonn, Germany.
Nikos
N
Werner
Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, RWTH Aachen, University, Aachen, Germany.
Thomas
T
Schmitz-Rode
Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, RWTH Aachen, University, Aachen, Germany.
Ulrich
U
Steinseifer
D000369:Aged, 80 and over; D000818:Animals; D001022:Aortic Valve Insufficiency / Q000601:surgery; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001696:Biomechanical Phenomena; D001794:Blood Pressure; D003198:Computer Simulation / Q000592:standards; D005260:Female; D006350:Heart Valve Prosthesis / Q000592:standards*; D006801:Humans; D057446:Hydrodynamics; D008297:Male; D010496:Pericardium / Q000637:transplantation; D011474:Prosthesis Design / Q000592:standards; D013552:Swine; D014741:Video Recording
Aortic valve prosthesis; Aortic valve stenosis; TAVI; Transcatheter aortic valve replacement