New York, NY - Forbes magazine turns its attention this week to new developments in the field of aortic valve repair. More specifically, the magazine profiles CoreValve, a new, self-expanding aortic valve prosthesis capable of being delivered percutaneously and retrograde across the aortic valve, as well as the growing need for percutaneous valve delivery in patients too frail for open-heart surgery.

"Some 100 000 elderly Americans receive new aortic valves each year," writes reporter Andy Stone in the October 30, 2006 issue. "And 30 000 more are in need of one but can't get it because the method of replacement—open-heart surgery—might kill them."

One such patient was 85-year-old Klemens Skierka. In March, the retired real-estate broker approached his doctor complaining of shortness of breath. Tests later revealed a damaged aortic valve, with blood seeping back into the heart because the valve would not fully open. Skierka was told he would need a new aortic valve but that the surgery to replace the valve was too risky for his age. He was sent home without treatment. A few months later, however, his daughter took Skierka to the Montreal Heart Institute, where he underwent a successful percutaneous valve replacement procedure with CoreValve.

Forbes notes that the CoreValve procedure has been tested in Europe and Canada since 2004, with possible regulatory approval by 2007, should the trials prove successful.

Founder of CoreValve, Dr Jacques Séguin, a retired cardiac surgeon from France who has performed more than 4000 aortic valve replacement surgeries, believes percutaneous delivery of the aortic valve "can make the brutality of open-heart surgery a thing of the past," reports Stone. Séguin is hoping to raise more money, at least $25 million, to fund the US trial he hopes to start in 2007. An optimistic outlook puts a Food and Drug Administration approval somewhere around 2010, according to Forbes.

"A key feature of Séguin's valve is the hourglass-shape lattice that holds it in place," reports Stone. "It is made of a heat-sensitive nickel-titanium alloy called Nitinol that is used in vascular stents. When the delivery catheter reaches the heart, the tightly folded replacement valve is released from inside. Body heat and the radial force of the Nitinol frame cause [the valve] to spring open, pushing the diseased heart flaps flat against the artery wall."

Forbes reports that Edwards Lifesciences is hoping to bring its catheter-delivered, balloon-inflated valve to market next year, although the company is still working to shrink the size of the catheter to make it easier to thread through the arteries.

Cardiac surgeon Dr Lars Svensson (Cleveland Clinic, OH) said he estimates that in 10 years 10% to 30% of patients undergoing conventional valve replacement will be a candidate for the percutaneous approach. The remaining patients, he told Forbes, would have other problems that will need to be fixed during surgery. According to Dr Carlos Ruiz (Lenox Hill Hospital, New York), who performed the first successful surgery using a CoreValve in Venezuela in 2004, patients might ask for the less-intrusive approach much sooner, as "no one likes to have his chest cracked open."