Comparing two transcatheter aortic valves from Edwards Lifesciences, researchers found that the new Sapien XT has a lower risk of major vascular complications than the Sapien THV.
The new valve's NovaFlex delivery system uses smaller catheters, the Italian research team notes.
The valves have been available in Europe for years but weren't approved in the U.S. until just this week. The Sapien XT is now set to become the first transcatheter aortic valve sold in the U.S. Its projected cost is $30,000.
In the July issue of JACC: Cardiovascular Interventions, Dr. Marco Mussardo from San Raffaele Scientific Institute, Milan, Italy and colleagues present their experience with transfemoral implantation of the two prosthetic valves in a retrospective study of 120 patients.
Fifty-four received the Sapien XT (SXT), with a success rate of 96.3%, and 66 received the Sapien THV (ESV), with a similarly good success rate of 92.4%.
The overall rate of major vascular events was significantly lower in the SXT group (11.1% vs. 33.3%; p=0.004). At a recent FDA hearing just prior to approval, however, Edwards' researchers presented raw data showing that mortality and stroke rates may rise after two or more years.
Minor vascular effects, life-threatening bleeding, and major bleeding occurred with similar frequency in the two groups, although the need for blood transfusion trended lower in the SXT group.
Two patients died within 30 days, both in the SXT group. Even so, the 30-day combined safety endpoint was lower in the SXT group (20.4% vs. 45.5%; p=0.004), mainly because of the lower rate of major vascular events.
Prosthesis performance, as assessed by echocardiography at 30 days, was similar for both valves.
"The new SXT valve has the same short-term performance as the ESV but seems to be associated with a lower risk of major vascular complications and thus has a broader clinical application," the researchers conclude.
J Am Coll Cardiol Intv 2011;4:743-750. Abstract
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