Transcatheter aortic valve implantation

The patient was a 57-year-old man with calcific aortic stenosis who was in cardiogenic shock and judged unsuitable for surgery. Alain Cribier, Helene Eltchaninoff and their colleagues used a catheter to place a valve made of bovine pericardial leaflets mounted inside a balloon-expandable stent, reaching the aortic valve by an antegrade route across the atrial septum.

The valve sat stably without blocking the coronary arteries or disturbing the mitral valve, and the improvement in the patient's circulation held through four months. His existing leg ischemia worsened, however, leading to amputation, and he died 17 weeks after the procedure. Reporting the case in Circulation in December 2002, the authors concluded that implanting a valve without surgery was feasible but needed refinement and further clinical testing.

That testing came in the PARTNER trial. At 21 centers, 17 of them in the United States, 358 patients with severe aortic stenosis whom surgeons considered unsuitable for surgery were randomly assigned to standard therapy, which included balloon aortic valvuloplasty, or to transfemoral implantation of a balloon-expandable bovine pericardial valve. At one year, 30.7 percent of the implant group had died against 50.7 percent of the standard therapy group (hazard ratio 0.55). Major strokes and major vascular complications were more common with the implant. Martin Leon, who had also co-written the 2002 case report, was first author of the results, published in the New England Journal of Medicine in September 2010.

An FDA advisory panel reviewed the device on 20 July 2011, and on 2 November 2011 FDA approved the Edwards SAPIEN transcatheter heart valve for patients with severe aortic stenosis who were inoperable for open valve replacement.