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...

Background and Aims: Acute renal failure (ARF) remains a major healthcare problem. Although modern medical therapy has improved its outcome, the syndrome still has high mortality and morbidity rates [Xue et al.: J Am Soc Nephrol 2006;17:1135–1142]. Recently, stem cell (SC) therapies have been proposed as an alternative for the treatment of ARF on the basis of the damaged cells’ replacement or enhanced recovery or regeneration. The aims of this study were to investigate the engraftment of autologous mesenchymal stem cells (MSC) injected into the renal artery in an ovine model of ischemia reperfusion injury (IRI) and to assess the consequence of the delay between injury and cell transplantation on the engraftment. Material and Methods: MSC were transplanted in animals submitted to IRI or in healthy animals not submitted to IRI. Sheep with IRI were grafted at two different time points after injury. Unilateral renal IRI was performed by percutaneous transluminal placement of a balloon catheter in the renal artery. MSC were isolated from bone marrow, cultured, labeled and injected into the renal artery. Results: All ewes showed renal engraftment by MSC, both in tubules and glomeruli. MSC expressed tubular epithelial cell markers and podocyte phenotype. There was a significant increase of engraftment of tubules by MSC when cells were injected early after injury indicating that the delay for cell transplantation after ischemic insult should be short. Conclusions: This is the first report of intra-arterial autologous transplantation of MSC in the kidney, resulting in a successful engraftment into tubular and glomerular structures. The results strongly suggest that the optimal time window for stem cell therapy is during the early phase of the ischemic injury.

Implantation of a semi-lunar valve in the tricuspid position is possible in ewes through a transcatheter approach. A disk-based nitinol stent is needed to allow valve implantation in the atrioventricular position. These studies open new perspectives into tricuspid as well as mitral valve replacement.

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