1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve: From the International FORWARD Study

Ganesh Manoharan, Nicolas M. Van Mieghem, Stephan Windecker, Johan Bosmans, Sabine Bleiziffer, Thomas Modine, Axel Linke, Werner Scholtz, Bernard Chevalier, Robert Gooley, Cathy Zeng, Jae Kuen Oh, Eberhard Grube

Research output: Contribution to journalArticle

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)

LanguageEnglish (US)
Pages2326-2334
Number of pages9
JournalJACC: Cardiovascular Interventions
Volume11
Issue number22
DOIs
StatePublished - Nov 26 2018

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Aortic Valve
Heart Valves
Mortality
Safety
Incidence
Stroke
Multicenter Studies
Observational Studies
Equipment and Supplies
Research
Population
Transcatheter Aortic Valve Replacement

Keywords

  • FORWARD
  • self-expanding valve
  • transcatheter aortic valve implantation
  • transcatheter aortic valve replacement
  • transfemoral

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Manoharan, G., Van Mieghem, N. M., Windecker, S., Bosmans, J., Bleiziffer, S., Modine, T., ... Grube, E. (2018). 1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve: From the International FORWARD Study. JACC: Cardiovascular Interventions, 11(22), 2326-2334. https://doi.org/10.1016/j.jcin.2018.07.032

1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve : From the International FORWARD Study. / Manoharan, Ganesh; Van Mieghem, Nicolas M.; Windecker, Stephan; Bosmans, Johan; Bleiziffer, Sabine; Modine, Thomas; Linke, Axel; Scholtz, Werner; Chevalier, Bernard; Gooley, Robert; Zeng, Cathy; Oh, Jae Kuen; Grube, Eberhard.

In: JACC: Cardiovascular Interventions, Vol. 11, No. 22, 26.11.2018, p. 2326-2334.

Research output: Contribution to journalArticle

Manoharan, G, Van Mieghem, NM, Windecker, S, Bosmans, J, Bleiziffer, S, Modine, T, Linke, A, Scholtz, W, Chevalier, B, Gooley, R, Zeng, C, Oh, JK & Grube, E 2018, '1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve: From the International FORWARD Study' JACC: Cardiovascular Interventions, vol. 11, no. 22, pp. 2326-2334. https://doi.org/10.1016/j.jcin.2018.07.032
Manoharan, Ganesh ; Van Mieghem, Nicolas M. ; Windecker, Stephan ; Bosmans, Johan ; Bleiziffer, Sabine ; Modine, Thomas ; Linke, Axel ; Scholtz, Werner ; Chevalier, Bernard ; Gooley, Robert ; Zeng, Cathy ; Oh, Jae Kuen ; Grube, Eberhard. / 1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve : From the International FORWARD Study. In: JACC: Cardiovascular Interventions. 2018 ; Vol. 11, No. 22. pp. 2326-2334.
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