Use of the CoreValve self-expanding transcatheter heart valve in patients with severe aortic stenosis had a low risk of all-cause mortality or major stroke at one year, that compared favorably to a "rigorously defined" objective performance goal (OPG), according to results from the CoreValve Extreme Risk trial presented Oct. 29 as part of Transcatheter Cardiovascular Therapeutics (TCT) 2013 in San Francisco.

According to Jeffrey J. Popma, MD, FACC, who presented on behalf of the CoreValve clinical investigators, the study was based on 471 patients over the age of 83 who underwent extensive demographic evaluation including assessment of co-morbidities, frailty and disability and were deemed to be at extreme risk for surgical aortic valve replacement by two cardiac surgeons and an external surgical review. An OPG was used to estimate the risk of all-cause mortality or major stroke in patients treated with standard therapy (see slides).

Patients in the study had a high frequency of medical co-morbidities including coronary artery disease, peripheral vascular disease, previous myocardial infarction and severe STS Chronic Lung Disease. They were also extremely frail, had a low body mass index, poor grip strength and dependence on home oxygen.

Overall, Popma said the CoreValve Extreme Risk Study achieved its primary endpoint of a low rate of all-cause mortality or major stroke at one year. He also highlighted low rates of major stroke at 1 month (2.4 percent) and one year (4.1 percent), as well as moderate paravalvular regurgitation rates of 11.0 percent at 1 month and 4.1 percent at one year. He noted that "80 percent of patients with moderate PVL at one month who survived to one year experienced a reduction in PVL over time." There was also no association of mild/moderate PVL on late mortality and an acceptable rate of permanent pacemaker placement.

Keywords: Heart Valve Prosthesis, Coronary Artery Disease, Myocardial Infarction, Stroke, Body Mass Index, Oxygen, Hand Strength, Peripheral Vascular Diseases, Lung Diseases