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

Nicolas M. Van Mieghem*, Stephan Windecker, Ganesh Manoharan, Johan Bosmans, Sabine Bleiziffer, Thomas Modine, Axel Linke, Werner Scholtz, Didier Tchétché, Ariel Finkelstein, Saki Ito, Ruth Eisenberg, Eberhard Grube

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)171-178
Number of pages8
JournalCatheterization and Cardiovascular Interventions
Volume99
Issue number1
DOIs
StatePublished - 1 Jan 2022
Externally publishedYes

Funding

FundersFunder number
Medtronic Bakken Research Center
PulseCath BV, Abiomed and Daiichi Sankyo
Abbott Laboratories
AMGEN
Bristol-Myers Squibb
Bayer
Johnson and Johnson
Medtronic
Edwards Lifesciences
CSL Behring
Boston Scientific Corporation
Abbott Vascular
Cardinal Health
Daiichi-Sankyo
Biotronik

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