First-in-Man Study Supports St. Jude's Repositionable Portico Valve for TAVR

May 30, 2012—Alexander B. Willson, MBBS, et al conducted a first-in-man study that sought to demonstrate the feasibility and procedural outcomes with the self-expanding and repositionable Portico valve (St. Jude Medical, Inc., St. Paul, MN) for transcatheter heart valve replacement (TAVR). The findings were published online ahead of print in the Journal of the American College of Cardiology.

The background for the study was based on TAVR as a viable option for selected patients with severe symptomatic aortic stenosis, but that suboptimal prosthesis positioning could contribute to paravalvular regurgitation, atrioventricular conduction block, and mitral or coronary compromise. The study showed that TAVR with the repositionable Portico transcatheter heart valve is feasible, with good short-term clinical and hemodynamic outcomes.

As summarized in the Journal of the American College of Cardiology, the Portico valve 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.

The investigators stated that device implantation was successful in all patients. Prosthesis recapture and repositioning was performed in four patients. Intermittent prosthetic leaflet dysfunction in one patient required implantation of a second transcatheter valve. There was one minor stroke.

At 30-day follow-up, the investigators found that 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 cm² to 1.3 ± 0.2 cm² (P < 0.001). Paravalvular regurgitation was mild or less in nine patients (90%) and moderate in one 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.