Journal
JACC-CARDIOVASCULAR INTERVENTIONS
Volume 11, Issue 22, Pages 2326-2334Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jcin.2018.07.032
Keywords
FORWARD; self-expanding valve; transcatheter aortic valve implantation; transcatheter aortic valve replacement; transfemoral
Categories
Funding
- Medtronic
- Abbott Vascular
- Boston Scientific
- Claret Medical
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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.
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