Journal article
1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve: From the International FORWARD Study.
- Manoharan G Department of Cardiology, Royal Victoria Hospital, Belfast, United Kingdom. Electronic address: gmanoharan@msn.com.
- Van Mieghem NM Department of Interventional Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands.
- Windecker S Department of Cardiology, University Hospital Bern, Bern, Switzerland.
- Bosmans J Department of Cardiology, University Hospital Antwerp, Antwerp, Belgium.
- Bleiziffer S Department of Cardiac Surgery, German Heart Center, Technische Universität, Munich, Germany.
- Modine T Department of Cardiovascular Surgery, Lille University Hospital, Lille, France.
- Linke A Department of Internal Medicine/Cardiology, Herzzentrum Leipzig, Leipzig, Germany.
- Scholtz W Department of Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
- Chevalier B Clinical Research Department, Ramsay Generale de Sante Institut Cardiovasculaire Paris-Sud, Massey, France.
- Gooley R Department of Interventional Cardiology, MonashHeart, Melbourne, Australia.
- Zeng C Structural Heart Clinical, Statistical Services, Medtronic, Minneapolis, Minnesota.
- Oh JK Echocardiography Core Laboratory, Mayo Clinic, Rochester, Minnesota.
- Grube E Department of Innovative Interventions in Cardiology, University of Bonn, Bonn, Germany.
- 2018-11-24
Published in:
- JACC. Cardiovascular interventions. - 2018
FORWARD
self-expanding valve
transcatheter aortic valve implantation
transcatheter aortic valve replacement
transfemoral
Aged
Aged, 80 and over
Aortic Valve
Aortic Valve Stenosis
Female
Heart Valve Prosthesis
Hemodynamics
Humans
Incidence
Male
Postoperative Complications
Product Surveillance, Postmarketing
Prospective Studies
Prosthesis Design
Recovery of Function
Registries
Risk Assessment
Risk Factors
Time Factors
Transcatheter Aortic Valve Replacement
Treatment Outcome
English
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).
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).
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1016/j.jcin.2018.07.032
- PMID 30466832
- Persistent URL
- https://folia.unifr.ch/global/documents/247345
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