Abstract 13349: Long Term (4 Years) Clinical and Echocardiographic Results of Transcatheter Self-expanding Medtronic Corevalve Device in Patients With Aortic Stenosis

Abstract

Introduction: Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement for patients (pts) with severe aortic stenosis considered inoperable or at high operative risk. However, little is known about long-term outcomes following TAVI. In this study we assessed the 4-year clinical and echocardiographic outcomes of pts undergoing TAVI with the self expanding Medtronic CoreValve prosthesis. Methods: The 4-year outcomes following successful TAVI with the self-expanding aortic valve device (Medtronic CoreValve) were evaluated in 60 pts (mean age 79+6 years, male 47 %, Logistic Euroscore 28.43+10.93%). Principal outcome measures were death from any cause. An echocardiograpic examination was performed at prespecified intervals of 6 and 12 months, and every year afterwards. Categorical variables were compared using X2 test, and continuous variables using t test. Survival curves were also constructed. Results: All cause mortality at 1, 2, 3, and 4 years was 16.7%, 28.3%, 30%, and 40% respectively. Mean aortic valve gradient decreased from 50.96+18.6 mm Hg pre to 9.22+ 4.6 mm Hg after TAVI (P<0.001) and remained at 15.69+6.3 mm Hg at 4 years (p for post-TAVI trend <0.01). Mean aortic valve area increased from 0.66+ 0.14 cm2 pre to 1.87+0.33 cm2 after TAVI (p<0.001) and remained at 1.23+ 0.25 cm2 at 4 years (p for post-TAVI trend <0.01). Paravalvular leak (minimal to moderate) was observed in 61% of pts post-TAVI; however, there was no case of progression to severe regurgitation at 4 years follow-up. Conclusions: TAVI with the Medtronic CoreValve prosthesis is associated with sustained clinical and functional cardiovascular benefits in inoperable or high-risk patients with symptomatic aortic stenosis up to 4-year follow-up.