title: Hydrodynamic Performance of the Medtronic CoreValve and the Edwards SAPIEN XT Transcatheter Heart Valve in Surgical Bioprostheses: An In Vitro Valve-in-Valve Model.
abstract: BACKGROUND
  Valve-in-valve transcatheter aortic valve replacement (TAVR) is becoming a valuable option with promising clinical results in failed bioprosthetic heart valves. Sizing recommendations are based on size compatibility rather than on broad clinical data, in vitro measurements, or biomechanical evidence. The hemodynamic performance of transcatheter heart valves within degenerated surgical heart valves is unknown.
  
  
  METHODS
  We evaluated the in vitro hydrodynamic performance of two commercially available transcatheter heart valves (Medtronic CoreValve [Medtronic, Minneapolis, MN] and Edwards SAPIEN XT [Edwards Lifesciences, Irvine, CA]) in two different bioprosthetic aortic valves (Edwards Perimount [Edwards Lifesciences] and St. Jude Trifecta [St. Jude Medical, St. Paul, MN]).
  
  
  RESULTS
  Within the Edwards Perimount (23 mm) prosthesis, pressure gradients were higher for the SAPIEN XT compared with the CoreValve (11.2 ± 0.1 mm Hg versus 10.1 ± 0.1 mm Hg, p < 0.01), whereas effective orifice area (1.99 ± 0.01 cm(2) versus 1.80 ± 0.01 cm(2), p < 0.01) and total paravalvular leakage (9.0% ± 1.0% versus 5.4% ± 1.3%, p < 0.01) were increased when using the CoreValve. Similarly, measurements in the St. Jude Trifecta revealed higher transvalvular pressure gradients (13.0 ± 0.2 mm Hg versus 10.9 ± 0.3 mm Hg, p < 0.01) and lower effective orifice area for the SAPIEN XT compared with the CoreValve. However, total relative regurgitation was higher with SAPIEN XT as compared with the CoreValve in St. Jude Trifecta prostheses (11.2% ± 1.4% versus 8.3% ± 0.9%, p < 0.01).
  
  
  CONCLUSIONS
  Both transcatheter heart valve prostheses performed well in the described valve-in-valve settings. Hydrodynamic results were in line with the International Organization for Standardization standards for all configurations. The observed differences indicate a necessity for preclinical valve-in-valve tests in addition to clinical long-term data about longevity.
authors.affiliation: Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Rheinische Friedrich-Wilhelms-Universität Bonn, Bonn, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Sedaghat
authors.affiliation: Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Rheinische Friedrich-Wilhelms-Universität Bonn, Bonn, Germany.
authors.forename: Jan-Malte
authors.initials: JM
authors.lastname: Sinning
authors.affiliation: Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, Rheinisch-Westfälische Technische Hochschule Aachen University, Aachen, Germany.
authors.forename: Marc
authors.initials: M
authors.lastname: Utzenrath
authors.affiliation: Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, Rheinisch-Westfälische Technische Hochschule Aachen University, Aachen, Germany.
authors.forename: Pejman Farhadi
authors.initials: PF
authors.lastname: Ghalati
authors.affiliation: Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, Rheinisch-Westfälische Technische Hochschule Aachen University, Aachen, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Schmitz
authors.affiliation: Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Rheinische Friedrich-Wilhelms-Universität Bonn, Bonn, Germany.
authors.forename: Nikos
authors.initials: N
authors.lastname: Werner
authors.affiliation: Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Rheinische Friedrich-Wilhelms-Universität Bonn, Bonn, Germany.
authors.forename: Georg
authors.initials: G
authors.lastname: Nickenig
authors.affiliation: Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Rheinische Friedrich-Wilhelms-Universität Bonn, Bonn, Germany.
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.affiliation: Herz- und Diabeteszentrum Bad Oeynhausen, Bad Oeynhausen, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Ensminger
authors.affiliation: Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, Rheinisch-Westfälische Technische Hochschule Aachen University, Aachen, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Steinseifer
authors.affiliation: Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, Rheinisch-Westfälische Technische Hochschule Aachen University, Aachen, Germany. Electronic address: max@kuetting.de.
authors.forename: Maximilian
authors.initials: M
authors.lastname: Kuetting
mesh_terms: D001021:Aortic Valve / Q000601:surgery*; D000082882:Bicuspid Aortic Valve Disease; D001705:Bioprosthesis; D006330:Heart Defects, Congenital / Q000601:surgery*; D006349:Heart Valve Diseases / Q000601:surgery*; D006350:Heart Valve Prosthesis; D006801:Humans; D057446:Hydrodynamics; D008422:Materials Testing; D008954:Models, Biological; D011312:Pressure; D011474:Prosthesis Design; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation*