Transcatheter aortic valve replacement with the SAPIEN 3: a new balloon-expandable transcatheter heart valve

Binder, Ronald K., Rodés-Cabau, Josep, Wood, David A., Mok, Michael, Leipsic, Jonathon, De Larochellière, Robert, Toggweiler, Stefan, Dumont, Eric, Freeman, Melanie, Willson, Alexander B. and Webb, John G. 2013, Transcatheter aortic valve replacement with the SAPIEN 3: a new balloon-expandable transcatheter heart valve, JACC: cardiovascular interventions, vol. 6, no. 3, pp. 293-300, doi: 10.1016/j.jcin.2012.09.019.

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Title Transcatheter aortic valve replacement with the SAPIEN 3: a new balloon-expandable transcatheter heart valve
Author(s) Binder, Ronald K.
Rodés-Cabau, Josep
Wood, David A.
Mok, MichaelORCID iD for Mok, Michael
Leipsic, Jonathon
De Larochellière, Robert
Toggweiler, Stefan
Dumont, Eric
Freeman, Melanie
Willson, Alexander B.
Webb, John G.
Journal name JACC: cardiovascular interventions
Volume number 6
Issue number 3
Start page 293
End page 300
Total pages 8
Publisher Elsevier
Place of publication Amsterdam, The Netherlands
Publication date 2013-03
ISSN 1936-8798
Keyword(s) Aged
Aged, 80 and over
Aortic Valve Insufficiency
Aortic Valve Stenosis
Balloon Valvuloplasty
British Columbia
Cardiac Catheterization
Feasibility Studies
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation
Multidetector Computed Tomography
Predictive Value of Tests
Prosthesis Design
Radiographic Image Interpretation, Computer-Assisted
Severity of Illness Index
Time Factors
Treatment Outcome
Science & Technology
Life Sciences & Biomedicine
Cardiac & Cardiovascular Systems
Cardiovascular System & Cardiology
transcatheter aortic valve replacement
Summary OBJECTIVES: The aim of this study was to demonstrate the first-in-human feasibility and short-term clinical outcomes with a new balloon-expandable transcatheter heart valve (THV).
BACKGROUND: The SAPIEN 3 (S3) THV incorporates a paravalvular sealing system, an active 3-dimensional coaxial positioning catheter, and is compatible with a 14-F expandable sheath.
METHODS: The S3 THV was implanted in 15 patients with symptomatic severe aortic stenosis via femoral arterial access. Multidetector computed tomography before and after valve implantation allowed assessment of a novel annular area sizing algorithm. Clinical and echocardiographic data were obtained at baseline, discharge, and 30 days.
RESULTS: All 15 device implants were successful. Multidetector computed tomography estimated an aortic annular area of 4.9 ± 0.4 cm(2), predicting 9.7 ± 6.9% THV oversizing. Post-transcatheter aortic valve replacement multidetector computed tomography showed consistently symmetrical and circular THVs. Aortic valve area increased from 0.7 ± 0.2 cm(2) to 1.5 ± 0.2 cm(2) (p < 0.001), and mean transaortic gradient decreased from 42.2 ± 10.3 mm Hg to 11.9 ± 5.3 mm Hg (p < 0.001). No patient had more than mild paravalvular aortic regurgitation. Hospital discharge occurred at a median of 3 (range 2 to 12) hospital days. At 30 days there were no deaths, strokes, vascular complications, bleeds, or transfusions, although 1 patient (6.7%) required a new pacemaker. All patients were in New York Heart Association functional class I or II.
CONCLUSIONS: The S3 THV and delivery system might facilitate fully percutaneous implantation in a broader range of patients with the potential for more accurate positioning and less paravalvular regurgitation.
Language eng
DOI 10.1016/j.jcin.2012.09.019
Field of Research 110201 Cardiology (incl Cardiovascular Diseases)
1102 Cardiovascular Medicine And Haematology
Socio Economic Objective 920103 Cardiovascular System and Diseases
HERDC Research category C1.1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2013, American College of Cardiology Foundation
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Document type: Journal Article
Collections: Faculty of Health
School of Medicine
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