Why the study?
Long-term clinical outcome data with the Evolut R transcatheter aortic valve replacement platform are scarce in routine clinical practice.
What are the 3-year clinical outcomes of TAVR with the Evolut R system in patients with symptomatic severe aortic stenosis at elevated operative risk?
Observational (n=1,039)
Yes
What are the 3-year clinical outcomes of TAVR with the Evolut R system in patients with symptomatic severe aortic stenosis at elevated operative risk?
The Evolut R transcatheter heart valve demonstrates a favorable safety and effectiveness profile out to 3 years in a real-world, elevated-risk population.
OBJECTIVES: The Evolut R FORWARD study confirmed safety and effectivenesss of the Evolut R THV in routine clinical practice out to 1 year. Herein, we report the final 3-year clinical follow up of the FORWARD study. BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a proven alternative to surgery in elderly patients with symptomatic severe aortic stenosis. Long-term clinical outcome data with the Evolut R platform are scarce. METHODS: FORWARD is a prospective multicenter observational study that evaluated the Evolut R system in routine clinical practice at 53 centres. Eligible patients had symptomatic native aortic valve stenosis or failed surgical aortic bioprosthesis and elevated operative risk per Heart-Team assessment. TAVR was attempted in 1039 patients. RESULTS: Mean age was 81.8 ± 6.2 years, 64.9% were women, STS score was 5.5 ± 4.5% and 34.2% were frail. Rates of all-cause mortality and disabling stroke were 24.8% and 4.8% at 3 years. Early need for a new pacemaker implantation after TAVR (all-cause mortality: with new PPI; 21.0% vs. without; 22.8%, p = 0.55) and the presence of > trace paravalvular regurgitation (all-cause mortality: no or trace; 22.0% vs. ≥ mild; 25.5%, p = 0.29) did not affect survival. Between 1 and 3 years incidence rates of valve related intervention, endocarditis and clinically relevant valve thrombosis were low. CONCLUSIONS: The Evolut R valve maintained a favorable safety profile through 3 years in routine clinical practice. Rates of transcatheter heart valve-related adverse events were low.
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Mieghem et al. (2021) conducted an observational in symptomatic severe aortic stenosis (n=1,039). Transcatheter aortic valve replacement with Evolut R system was evaluated on all-cause mortality.
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