Author + information
- Received May 31, 2018
- Revision received July 23, 2018
- Accepted July 25, 2018
- Published online November 19, 2018.
- Ganesh Manoharan, MBBCh, MDa,∗ (, )
- Nicolas M. Van Mieghem, MD, PhDb,
- Stephan Windecker, MDc,
- Johan Bosmans, MD, PhDd,
- Sabine Bleiziffer, MDe,
- Thomas Modine, MD, PhDf,
- Axel Linke, MDg,
- Werner Scholtz, MDh,
- Bernard Chevalier, MDi,
- Robert Gooley, MBBS, PhDj,
- Cathy Zeng, MSk,
- Jae K. Oh, MDl and
- Eberhard Grube, MD, PhDm
- aDepartment of Cardiology, Royal Victoria Hospital, Belfast, United Kingdom
- bDepartment of Interventional Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands
- cDepartment of Cardiology, University Hospital Bern, Bern, Switzerland
- dDepartment of Cardiology, University Hospital Antwerp, Antwerp, Belgium
- eDepartment of Cardiac Surgery, German Heart Center, Technische Universität, Munich, Germany
- fDepartment of Cardiovascular Surgery, Lille University Hospital, Lille, France
- gDepartment of Internal Medicine/Cardiology, Herzzentrum Leipzig, Leipzig, Germany
- hDepartment of Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany
- iClinical Research Department, Ramsay Generale de Sante Institut Cardiovasculaire Paris-Sud, Massey, France
- jDepartment of Interventional Cardiology, MonashHeart, Melbourne, Australia
- kStructural Heart Clinical, Statistical Services, Medtronic, Minneapolis, Minnesota
- lEchocardiography Core Laboratory, Mayo Clinic, Rochester, Minnesota
- mDepartment of Innovative Interventions in Cardiology, University of Bonn, Bonn, Germany
- ↵∗Address for correspondence:
Dr. Ganesh Manoharan, Cardiology Department, Royal Victoria Hospital, Grosvenor Road, Belfast BT12 6BA, United Kingdom.
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)
- self-expanding valve
- transcatheter aortic valve implantation
- transcatheter aortic valve replacement
Since December 2017, Dr. Linke has served as the Chief Physician at the Department of Internal Medicine and Cardiology at the Heart Center Dresden University Hospital, Dresden, Germany. Medtronic funded the Evolut R FORWARD Study. Dr. Manoharan has served as a proctor for Boston Scientific, Medtronic, and St. Jude Medical. Dr. Van Mieghem has received grant support from Abbott Vascular, Boston Scientific, Claret Medical, and Medtronic. Dr. Windecker has received grant support from Biotronik, Edwards Lifesciences, and Medtronic; grant support and personal fees from Boston Scientific; and personal fees from Daiichi Sankyo outside of the submitted work. Dr. Bleiziffer has served as a consultant and proctor for Medtronic; served as a proctor for JenaValve and Boston Scientific; and received travel expenses from Medtronic. Dr. Bosmans has served as a proctor for Medtronic. Dr. Modine has served as a proctor for Medtronic. Prof. Linke has received speaker honoraria or served as a consultant for Medtronic, St. Jude Medical, Claret Medical, Boston Scientific, Edwards Lifesciences, Symetis, and Bard; holds stock options from Claret Medical; and has received grant support from Medtronic and Claret Medical. Dr. Scholtz has received honoraria and travel expense reimbursements from Medtronic.
Dr. Chevalier has served as a consultant and proctor for Medtronic. Dr. Gooley has served as a proctor for Medtronic and a proctor and consultant for Boston Scientific. Ms. Zeng is an employee and shareholder of Medtronic. Dr. Oh has received research support for the echocardiographic core laboratory from and served as a consultant for Medtronic. Prof. Grube has served as a consultant for Medtronic.
- Received May 31, 2018.
- Revision received July 23, 2018.
- Accepted July 25, 2018.
- 2018 American College of Cardiology Foundation