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Transcatheter aortic valve replacement with the St. Jude Medical Portico valve: first-in-human experience.

Abstract：

OBJECTIVES:The purpose of this study was to demonstrate the feasibility and procedural outcomes with a new self-expanding and repositionable transcatheter heart valve. BACKGROUND:Transcatheter aortic valve replacement is a viable option for selected patients with severe symptomatic aortic stenosis. However, suboptimal prosthesis positioning may contribute to paravalvular regurgitation, atrioventricular conduction block, and mitral or coronary compromise. METHODS:The repositionable Portico valve (St. Jude Medical, Minneapolis, Minnesota) was implanted in 10 patients with severe aortic stenosis utilizing percutaneous femoral arterial access. Patients underwent transthoracic and transesophageal echocardiography and multidetector computed tomography before and after valve implantation. Clinical and echocardiographic follow-up was obtained at 30 days. RESULTS:Device implantation was successful in all patients. Prosthesis recapture and repositioning was performed in 4 patients. Intermittent prosthetic leaflet dysfunction in 1 patient required implantation of a second transcatheter valve. There was 1 minor stroke. At 30-day follow-up, echocardiographic mean transaortic gradient was reduced from 44.9 ± 16.7 mm Hg to 10.9 ± 3.8 mm Hg (p < 0.001), and valve area increased from 0.6 ± 0.1 cm(2) to 1.3 ± 0.2 cm(2) (p < 0.001). Paravalvular regurgitation was mild or less in 9 patients (90%) and moderate in 1 patient (10%). There were no major strokes, major vascular complications, major bleeds, or deaths. No patient required pacemaker implantation. All patients were in New York Heart Association functional class II or less. CONCLUSIONS:Transcatheter aortic valve replacement with the repositionable Portico transcatheter heart valve is feasible, with good short-term clinical and hemodynamic outcomes.

journal_name

J Am Coll Cardiol

journal_title

Journal of the American College of Cardiology

authors

Willson AB,Rodès-Cabau J,Wood DA,Leipsic J,Cheung A,Toggweiler S,Binder RK,Freeman M,DeLarochellière R,Moss R,Nombela-Franco L,Dumont E,Szummer K,Fontana GP,Makkar R,Webb JG

doi

10.1016/j.jacc.2012.02.045

subject

Has Abstract

pub_date

2012-08-14 00:00:00

pages

581-6

issue

eissn

0735-1097

issn

1558-3597

pii

S0735-1097(12)01253-3

journal_volume

pub_type

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Transcatheter aortic valve replacement with the St. Jude Medical Portico valve: first-in-human experience.