Author + information
- Received March 30, 2018
- Revision received April 9, 2018
- Accepted April 10, 2018
- Published online January 7, 2019.
- Rebecca T. Hahn, MDa,∗ (, )
- Jonathon Leipsic, MDb,
- Pamela S. Douglas, MDc,
- Wael A. Jaber, MDd,
- Neil J. Weissman, MDe,
- Philippe Pibarot, DVM, PhDf,
- Philipp Blanke, MDb and
- Jae K. Oh, MDg
- aColumbia University Medical Center/New York-Presbyterian Hospital, New York, New York
- bUniversity of British Columbia and St. Paul’s Hospital, Vancouver, Canada
- cDivision of Cardiovascular Medicine, Duke University Medical Center, and Duke Clinical Research Institute, Durham, North Carolina
- dCleveland Clinic Foundation, Cleveland, Ohio
- eMedstar Health Research Institute, Washington, DC
- fInstitut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Department of Medicine, Laval University, Québec, Canada
- gMayo Clinic, Rochester, Minnesota
- ↵∗Address for correspondence:
Dr. Rebecca T. Hahn, Columbia University Medical Center, New York-Presbyterian Hospital, 177 Fort Washington Avenue, New York, New York 10032.
Objectives This study aims to establish parameters for identifying normal function for each of the 3 iterations of balloon-expandable valves and 2 iterations of self-expanding valves.
Background Expected transthoracic echocardiographic Doppler-derived hemodynamic data for transcatheter aortic valves inform pre-implant decision-making and post-implanted monitoring of longitudinal valve function.
Methods We collected the echocardiography core Lab measured mean gradients and effective orifice area (EOA) from discharge or 30-day echocardiograms from randomized trials; the PARTNER (Placement of Aortic Transcatheter Valves) trials for the balloon-expandable valves and the Medtronic CoreValve US Pivotal trial and Medtronic CoreValve Evolut R United States IDE Clinical Study for the self-expanding valves.
Results For all SAPIEN (Edwards Lifesciences, Irvine, California) valve sizes, mean EOA is 1.70 ± 0.49 cm2 with a mean gradient of 9.36 ± 4.13 mm Hg. For all SAPIEN XT valve sizes, mean EOA is 1.67 ± 0.46 cm2 with a mean gradient of 9.52 ± 3.64 mm Hg. For all SAPIEN 3 valve sizes, the mean EOA is 1.66 ± 0.38 cm2 with a mean gradient of 11.18 ± 4.35 mm Hg. For all CoreValve valve sizes, the mean EOA is 1.88 ± 0.56 cm2 with a mean gradient of 8.85 ± 4.14 mm Hg. For all Evolut R valve sizes, the mean EOA is 2.01 ± 0.65 cm2 with a mean gradient of 7.52 ± 3.19 mm Hg. The SAPIEN 3 post-implant EOA was progressively larger for each quintile of baseline annular area by computed tomography (p < 0.001). Similarly, for the Evolut R valve, post-implantation EOA was significantly larger for each quintile of baseline annular perimeter (p < 0.001).
Conclusions Tables of expected mean transcatheter aortic valve hemodynamics by valve type and size are essential in evaluating the function of these transcatheter prosthetic valves. Tables of expected EOA by the native annular anatomy may be useful for pre-implantation decision making. Criteria for defining structural valve dysfunction are proposed.
The PARTNER 1 and PARTNER 2 Trials were sponsored by Edwards Lifesciences. The Medtronic CoreValve US Pivotal trial and Medtronic CoreValve Evolut R United States IDE Clinical Study were sponsored by Medtronic. Drs. Pibarot, Hahn, and Weissman are the Directors of the Echocardiography Core Labs for the P2S3 Trials (sponsored by Edwards Lifesciences) for which they receive no direct compensation. Drs. Blanke and Leipsic are the Co-Directors of the CT Core lab for the P2S3 Trial for which they receive no direct compensation. Dr. Jaber is the Director of the Echocardiography Core Lab for PARTNER II, Cohorts A and B (sponsored by Edwards Lifesciences) for which he receives no direct compensation. Dr. Oh is the Director of the Echocardiography Core Lab for CoreValve/Evolut R; and a consultant for Medtronic. Dr. Leipsic is a consultant for Edwards. Dr. Douglas has received a grant from Edwards Lifesciences. Dr. Weissman has received grants from Boston Scientific, Edwards, Medtronic, Abbott, and LivaNova. Dr. Blanke is a consultant with Edwards Lifesciences.
- Received March 30, 2018.
- Revision received April 9, 2018.
- Accepted April 10, 2018.
- 2019 American College of Cardiology Foundation
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