TY - JOUR
T1 - 1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve
T2 - From the International FORWARD Study
AU - Manoharan, Ganesh
AU - Van Mieghem, Nicolas M.
AU - Windecker, Stephan
AU - Bosmans, Johan
AU - Bleiziffer, Sabine
AU - Modine, Thomas
AU - Linke, Axel
AU - Scholtz, Werner
AU - Chevalier, Bernard
AU - Gooley, Robert
AU - Zeng, Cathy
AU - Oh, Jae K.
AU - Grube, Eberhard
N1 - Publisher Copyright:
© 2018 American College of Cardiology Foundation
PY - 2018/11/26
Y1 - 2018/11/26
N2 - 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: The FORWARD study demonstrated good safety and efficacy profiles for the next-generation Evolut R THV up to 1-year follow-up, with very low mortality and adverse events.
AB - 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: The FORWARD study demonstrated good safety and efficacy profiles for the next-generation Evolut R THV up to 1-year follow-up, with very low mortality and adverse events.
KW - FORWARD
KW - self-expanding valve
KW - transcatheter aortic valve implantation
KW - transcatheter aortic valve replacement
KW - transfemoral
UR - http://www.scopus.com/inward/record.url?scp=85056196014&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85056196014&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2018.07.032
DO - 10.1016/j.jcin.2018.07.032
M3 - Article
C2 - 30466832
AN - SCOPUS:85056196014
SN - 1936-8798
VL - 11
SP - 2326
EP - 2334
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 22
ER -