Three-Year Outcomes of CoreValve TAVR Published

June 9, 2014—Michael Gotzmann, MD, et al published 3-year outcomes after transcatheter aortic valve replacement (TAVR) with the CoreValve prosthesis (Medtronic, Inc.) online ahead of print in the American Journal of Cardiology.

As summarized in the American Journal of Cardiology, this study was composed of 150 consecutive patients with severe aortic stenosis who successfully underwent TAVR with the CoreValve prosthesis. The primary study endpoint was death from any cause after TAVR. The secondary endpoints were defined as cardiovascular death and prosthesis-related mortality and morbidity.

The investigators reported that at 1 to 3 years, all-cause mortality rates were 25%, 32%, and 41%, respectively, and cardiovascular mortality rates were 14%, 21%, and 27%, respectively. Before undergoing TAVR, 95% of patients were in NYHA class III or IV. Of the surviving patients, rates of NYHA class III or IV at 1 to 3 years were 33%, 39%, and 38%, respectively. There was an annual decrease of the valve area of approximately 0.1 cm².

Aortic restenosis occured in two patients. Moderate or severe aortic regurgitation (AR) occurred in 15% of patients immediately after TAVR. Twenty patients (13%) revealed a slight worsening of AR within 3 years. New severe AR did not occur. The incidence of prostheses-related endocarditis was 0.66% per year. Overall, seven patients (incidence of 1.5% per year) revealed a clinically relevant problem of the prosthesis.

The investigators concluded that TAVR with the CoreValve prosthesis had favorable effects on symptoms and outcome even after 3 years, but these results are clouded by side effects such as AR and prosthesis-related mortality and morbidity.