Ganesh Manoharan1, Nicolas M Van Mieghem2, Stephan Windecker3, Johan Bosmans4, Sabine Bleiziffer5, Thomas Modine6, Axel Linke7, Werner Scholtz8, Bernard Chevalier9, Robert Gooley10, Cathy Zeng11, Jae K Oh12, Eberhard Grube13. 1. Department of Cardiology, Royal Victoria Hospital, Belfast, United Kingdom. Electronic address: gmanoharan@msn.com. 2. Department of Interventional Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands. 3. Department of Cardiology, University Hospital Bern, Bern, Switzerland. 4. Department of Cardiology, University Hospital Antwerp, Antwerp, Belgium. 5. Department of Cardiac Surgery, German Heart Center, Technische Universität, Munich, Germany. 6. Department of Cardiovascular Surgery, Lille University Hospital, Lille, France. 7. Department of Internal Medicine/Cardiology, Herzzentrum Leipzig, Leipzig, Germany. 8. Department of Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany. 9. Clinical Research Department, Ramsay Generale de Sante Institut Cardiovasculaire Paris-Sud, Massey, France. 10. Department of Interventional Cardiology, MonashHeart, Melbourne, Australia. 11. Structural Heart Clinical, Statistical Services, Medtronic, Minneapolis, Minnesota. 12. Echocardiography Core Laboratory, Mayo Clinic, Rochester, Minnesota. 13. Department of Innovative Interventions in Cardiology, University of Bonn, Bonn, Germany.
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: 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. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369).
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 RTHV up to 1-year follow-up, with very low mortality and adverse events. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369).
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