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

Study Questions:

What are the feasibility and procedural outcomes with a new self-expanding and repositionable transcatheter heart valve?

Methods:

The authors reported the results of implantation of the repositionable Portico valve (St. Jude Medical, Minneapolis, MN) in 10 patients with severe aortic stenosis utilizing percutaneous femoral arterial access. Patients underwent transthoracic and transesophageal echocardiography (TEE) and multidetector computed tomography before and after valve implantation.

Results:

Device implantation was successful in all patients. Prosthesis recapture and repositioning were performed in four patients due to suboptimal initial positioning. Intermittent prosthetic leaflet dysfunction in one patient required implantation of a second transcatheter valve. There was one minor stroke. At 30-day follow-up, echocardiographic mean transaortic gradient was reduced from 44.9 mm Hg to 10.9 mm Hg (p < 0.001), and valve area increased from 0.6 cm2 to 1.3 cm2 (p < 0.001). Paravalvular regurgitation was absent or trace in five patients, mild in four patients and moderate in one patient. No patient had more than trivial valvular regurgitation. 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 at follow-up.

Conclusions:

The authors concluded that transcatheter aortic valve replacement with the repositionable Portico transcatheter heart valve is associated with good short-term clinical and hemodynamic outcomes.

Perspective:

This study provides the first clinical experience with a fully repositionable transcatheter heart valve. The ability to reposition the valve provides another margin of safety, and should lead to further improvement in safety and efficacy. Larger studies are needed to establish the clinical significance of this advantage and to study the comparative efficacy of this valve in relation to the two currently available transcatheter valve systems.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound

Keywords: Prostheses and Implants, Follow-Up Studies, Cardiology, Heart Valve Diseases, Heart Valve Prosthesis Implantation, Angioplasty, New York, Hemodynamics, Echocardiography


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