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Title
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Final 3-year clinical outcomes following transcatheter aortic valve implantation with a supra-annular self-expanding repositionable valve in a real-world setting : results from the multicenter FORWARD study
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Author
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Abstract
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| 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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Language
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English
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Source (journal)
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Catheterization and cardiovascular interventions. - New York, N.Y.
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Publication
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Hoboken
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Wiley
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2022
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ISSN
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1522-1946
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DOI
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10.1002/CCD.29889
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Volume/pages
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99
:1
(2022)
, p. 171-178
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ISI
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000679688000001
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Pubmed ID
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34331844
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Full text (Publisher's DOI)
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Full text (open access)
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