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

• Published in: JACC. Cardiovascular interventions Vol. 6; no. 3; pp. 293 - 300
• Main Authors: 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, Webb, John G
• Format: Journal Article
• Language: English
• Published: United States 01-03-2013
• Subjects: Aged; Aged, 80 and over; Algorithms; Aortic Valve Insufficiency - etiology; Aortic Valve Stenosis - diagnosis; Aortic Valve Stenosis - therapy; Balloon Valvuloplasty; British Columbia; Cardiac Catheterization - adverse effects; Cardiac Catheterization - instrumentation; Echocardiography; Feasibility Studies; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation - adverse effects; Heart Valve Prosthesis Implantation - instrumentation; Heart Valve Prosthesis Implantation - methods; Humans; Male; Multidetector Computed Tomography; Predictive Value of Tests; Prosthesis Design; Quebec; Radiographic Image Interpretation, Computer-Assisted; Severity of Illness Index; Time Factors; Treatment Outcome; British Columbia; Quebec
• ISSN: 1876-7605
• DOI: 10.1016/j.jcin.2012.09.019

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).
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.
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.
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.
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.