Transcatheter Aortic Valve Replacement With the St. Jude Medical Portico Valve First-in-Human Experience

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. (J Am Coll Cardiol 2012; 60: 581-6) (C) 2012 by the American College of Cardiology Foundation