Background-The design of a percutaneous implantable prosthetic heart valve has become an important area for investigation. A percutaneously implanted heart valve (PHV) composed of 3 bovine pericardial leaflets mounted within a balloon-expandable stent was developed. After ex vivo testing and animal implantation studies, the first human implantation was performed in a 57-year-old man with calcific aortic stenosis, cardiogenic shock, subacute leg ischemia, and other associated noncardiac diseases. Valve replacement had been declined for this patient, and balloon valvuloplasty had been performed with nonsustained results. Methods and Results-With the use of an antegrade transseptal approach, the PHV was successfully implanted within the diseased native aortic valve, with accurate and stable PHV positioning, no impairment of the coronary artery blood flow or of the mitral valve function, and a mild paravalvular aortic regurgitation. Immediately and at 48 hours after implantation, valve function was excellent, resulting in marked hemodynamic improvement. Over a follow-up period of 4 months, the valvular function remained satisfactory as assessed by sequential transesophageal echocardiography, and there was no recurrence of heart failure. However, severe noncardiac complications occurred, including a progressive worsening of the leg ischemia, leading to leg amputation with lack of healing, infection, and death 17 weeks after PHV implantation. Conclusions-Nonsurgical implantation of a prosthetic heart valve can be successfully achieved with immediate and midterm hemodynamic and clinical improvement. After further device modifications, additional durability tests, and confirmatory clinical implantations, PHV might become an important therapeutic alternative for the treatment of selected patients with nonsurgical aortic stenosis. (Circulation. 2002;106:3006-3008.)Key Words: stenosis, aortic Ⅲ valves, prosthetic Ⅲ prosthesis Ⅲ catheterization P ercutaneous catheter-based systems for the treatment of valvular heart disease have been designed and studied in animal models for several years. [1][2][3][4] Recently, Bonhoeffer et al, 5,6 using a bovine jugular vein valve mounted within a stent, performed the first in-human percutaneous implantations of artificial valves in children with right ventricle to pulmonary prosthetic conduits.The goals of our research project were to develop a biological heart valve, mounted on a specially designed balloon-expandable stent, which could be delivered percutaneously via standard catheter-based techniques and implanted within a diseased aortic valve in calcific aortic stenosis. This concept was based on personal unpublished autopsy observations on calcific aortic stenosis showing that a stent could effectively open while strongly adhering within the native diseased valve without impairing the coronary ostia or the mitral valve.An original percutaneous heart valve (PHV) was developed (Percutaneous Valve Technologies, Inc), which consisted of 3 bovine pericardial leaflets mounted within a tu...

This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option. (Funded by Edwards Lifesciences and Medtronic.).

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Implantation of the PHV can be achieved in patients with end-stage calcific aortic stenosis and might become an important therapeutic option for patients not amenable to surgical valve replacement.

This prospective registry reflects the real-life experience of transcatheter aortic valve implantation in high-risk elderly patients in France. The early results are satisfactory in terms of feasibility, short-term haemodynamic and functional improvement, and safety. Longer term follow-up will be further assessed.

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