This article is more than 5 years old. Information may no longer be current.

FRANCE Registry: Trans-catheter aortic valve implantation successful in high risk group

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

American Heart Association Scientific Sessions 2009

Thirty-day results of The French Aortic National CoreValve and Edwards Registry demonstrated a 97% success rate of delivery and deployment of trans-catheter aortic valves in patients at high risk for surgery.

According to Helene Eltchaninoff, MD, of the University of Rouen, France, the primary endpoint of 30-day mortality rate was 12.7% (P=0.32), with failure in seven patients, including one death.

At 16 centers chosen by the French Ministry of Health, 244 consecutive patients were enrolled into the registry between Feb. 1 and Sept. 31, 2009. Two models of trans-catheter aortic valve replacement were used; Edwards Sapien balloon expandable trans-catheter heart valve, both the transfemoral and transapical approaches in two sizes (23 mm and 26 mm) and CoreValve self expandable trans-catheter valve, both the transfemoral and subclavian approaches in two sizes (26 mm and 29mm).

At the time of the presentation, six-month follow-up data was available for 111 patients for the secondary endpoint of hemodynamic and clinical improvement; 86% of patients were NYHA Class I and II and had a mean gradient change of 10.6 mm Hg. In order for registry inclusion, patients had to have NYHA Class II or higher, Euroscore >20% and severe aortic stenosis (effective orfice area <0.6 cm²/m²).

Although the results were comparable between the valves and different approaches, patients receiving the CoreValve device had a higher rate of new pacemaker implantation post-procedure (P<0.001).

The researchers examined more than 30 risk factors and found that prior CABG and Euroscore &ge; 25% were the only predictors of the primary endpoint via multivariate analysis. Patients will be followed up to three years by serial clinical and ECG assessment, Eltchaninoff said. The registry was coordinated by the French Societies of Cardiology and CV Surgery.

“The 97% success rate in a real life registry is really quite extraordinary,” said Peter Block, MD, professor of medicine, division of cardiology, Emory University School of Medicine, and a section editor on Cardiology Today’s Editorial Board. “It’s a wealth of information about what is actually happening with percutaneous valve repair today. This is not made up stuff.” – Judith Rusk

For more information:

• Eltchaninoff H. LB.01. Presented at: American Heart Association Scientific Sessions 2009; Nov 14-18, 2009; Orlando, Fla.