May 27, 2010 – New European data from five national clinical registries presented this week at EuroPCR in Paris report positive clinical outcomes for the transcatheter aortic valve implantation for treatment of severe aortic stenosis. The registries’ results demonstrate encouraging clinical outcomes for more than 2,000 patients treated with CoreValve percutaneous aortic valve system from Medtronic.
“We welcome the abundance of positive data, which shows that transcatheter aortic valve therapy is a successful treatment option for a patient population who is at high risk or unable to undergo surgical valve replacement,” said Eberhard Grube, M.D., chief of the division of structural heart disease, International Heart Center Rhein–Ruhr, Essen, Germany. “The breadth and results of these post-market evaluations suggest that CoreValve is successfully transitioning into general clinical practice. It also shows that patient outcomes largely transcend physician specialties, countries and clinical settings.”
Data presented during the “TAVI Facts, Figures and National Registries” session included findings from registries in Belgium, France, Germany, Italy and the United Kingdom. Overall the results demonstrate sustained positive patient outcomes following the procedure – at six months and, in some studies, at one year. These new data reaffirm findings from previous clinical trials that demonstrate high procedure success rates and positive clinical outcomes in patients who have received the CoreValve system.
The Italian Experience
The Italian Registry in particular, with more than 750 patients, provides a deeper look at the performance of CoreValve. There was a highly significant and long-term improvement in symptoms, including heart failure improvement with a reduction in New York Heart Association (NHYA) functional class in a majority of patients. In addition, all hemodynamic performance indicators improved, and left ventricle hypertrophy (excessive wall thickness) decreased six months after implant.
“The overall results of the Italian Registry were quite impressive, indicating superb device performance and patient outcomes, as well as relatively low complication rates,” said Sonia Petronio, M.D., associate professor of cardiology and head of the catheterization lab of the Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. “We were especially pleased to see early reduction in LV hypertrophy, similar to what is seen with surgical aortic valve replacement. These results suggest that CoreValve is not only a suitable aortic replacement valve but may also improve the overall pumping function of the heart.”
The CoreValve System
The CoreValve system, designed to replace a diseased aortic valve without open-heart surgery or surgical removal of the native valve, has now been implanted in more than 10,000 patients worldwide in 32 countries outside the United States. Typically delivered through the femoral artery, CoreValve is used in 75 percent of transarterial transcatheter valve replacement procedures.
The CoreValve system received CE (Conformité Européenne) mark in March 2007. It is not yet available in the United States for clinical trial or commercial sale or use.
For more information: www.medtronic.com