Publication
Title
1-Year outcomes with the Evolut R self-expanding transcatheter aortic valve from the International FORWARD Study
Author
Abstract
OBJECTIVES This study sought to report the 1-year safety and efficacy outcomes in the FORWARD (CoreValve Evolut R FORWARD) study following transcatheter aortic valve replacement (TAVR) with the next-generation Evolut R device (Medtronic, Minneapolis, Minnesota) in routine clinical practice. BACKGROUND The FORWARD study reported low incidences of mortality, disabling stroke, and significant paravalvular leak following TAVR in routine clinical practice at 30 days. Longer-term results in large patient populations with the Evolut R self-expanding, repositionable transcatheter heart valve (THV) are lacking. METHODS This was a prospective, single-arm, multinational, multicenter, observational study investigating efficacy and safety following TAVR with the next-generation self-expanding THV. Between January and December 2016, 1,040 patients underwent attempted implant of the Evolut R self-expanding repositionable valve at 53 sites worldwide. An independent Clinical Events Committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. RESULTS The mean age was 81.8 +/- 6.2 years, 64.8% were women, and patients had a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.5 +/- 4.5% and EuroSCORE II of 5.7 +/- 5.0%. The 1-year all-cause mortality rate was 8.9%, with a cardiovascular mortality rate of 6.9%. At 1 year, the incidence of disabling stroke was 2.1%, and a pacemaker was implanted in 19.7% of patients. The incidence of more than mild paravalvular leak was 1.2%. CONCLUSIONS TheFORWARDstudydemonstrated goodsafety and efficacy profiles for the next-generation EvolutRTHV up to 1-year follow-up, with very low mortality and adverse events. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369) (c) 2018 by the American College of Cardiology Foundation.
Language
English
Source (journal)
JACC : cardiovascular interventions. - -
Publication
2018
ISSN
1936-8798
1876-7605
Volume/pages
11:22(2018), p. 2326-2334
ISI
000450655400018
Pubmed ID
30466832
Full text (Publisher's DOI)
Full text (publisher's version - intranet only)
UAntwerpen
Faculty/Department
Research group
Publication type
Subject
Affiliation
Publications with a UAntwerp address
External links
Web of Science
Record
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Creation 10.12.2018
Last edited 15.07.2021
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