Transcatheter Aortic Valve Replacement (TAVR) with the CoreValve device is safe and effective, according to results presented Oct. 29 at the Transcatheter Cardiovascular Therapeutics (TCT) scientific session in San Francisco.

Jeffrey J. Popma, MD, director of Interventional Cardiology at Beth Israel Deaconess Medical Center in Boston, unveiled trial results from the pivotal CoreValve Extreme Risk Iliofemoral study. In the study, surgeons implanted the CoreValve system in 471 patients with symptomatic severe aortic stenosis during TAVR. The patients were considered too high risk of death or irreversible morbidities to undergo standard open-heart surgery.

The primary endpoint was all-cause mortality or stroke at 12 months.

Key findings include:

• An all-cause mortality or major stroke rates of 9.3 percent at one month and 25.5 percent at 12 months;
• Mortality rates of 7.9 percent at one month and 24 percent at one year;
• Major stroke rate of 2.4 percent at one month and 4.1 percent at one year;
• Improvement from a baseline New York Heart Association class I or II of 8.8 percent to 91 percent at 12 months;
• Major vascular complication rates of 8.3 percent at one month and 8.5 percent at one year;
• Mild paravalvular leak rates of 11.5 percent at one month and 4.1 percent at one year; and
• A permanent pacemaker rate of 22.2 percent at one month. 

Medtronic, manufacturer of the CoreValve system, announced that based on the trial results, the FDA decided it will not need an external expert panel to evaluate the device’s safety and efficacy. Medtronic said it expects to win FDA approval by the end of fiscal year 2014.