Aortic Stenosis (AS) is a condition caused by progressive narrowing of the valve that governs blood flow from the heart to the brain and most other internal organs. About 1.5 million Americans have AS, one-fifth of whom have a severe form that is life-threatening.
Traditionally, the treatment for severe AS involves open heart surgery, an expensive procedure that is associated with its own risks and contraindicated in frail, elderly folks…just the kinds of people that develop the condition in the first place.
Now, scientists have shown that a relatively non-invasive treatment for severe AS may obviate the need for open-heart surgery.
The new approach involves attaching a replacement valve to a catheter, and then threading it through blood vessels to a place where it can serve the role of the malfunctioning valve.
The replacement valve is produced from cow tissue and is housed within a metal frame.
A study of the new device was published 2 weeks ago in the New England Journal of Medicine. In the study, a group of elderly patients received the catheter-placed device while others received various other non-surgical interventions.
The one-year mortality rate for people that received the replacement-valve was 31%. This was lower than the 51% mortality observed in controls. Of note, the study also revealed a higher incidence of early strokes (5% vs. 1%) in patients who received the new device. The increased stroke risk was nevertheless deemed “an acceptable price to pay” by Craig Smith, a study co-author.
The study was funded by Edwards Lifesciences, the same company that designed the valve. Several authors have financial ties to the company. Catheter-delivered valves “should be the new standard of care” for patients with severe AS that can’t tolerate open-heart surgery, they concluded.
Edwards hopes to gain FDA approval for its device in 2011.