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 K; Grube, Eberhard (2018). 1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve: From the International FORWARD Study. JACC. Cardiovascular Interventions, 11(22), pp. 2326-2334. Elsevier 10.1016/j.jcin.2018.07.032

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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).

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1876-7605

Publisher:

Elsevier

Language:

English

Submitter:

Nadia Biscozzo

Date Deposited:

27 Feb 2019 11:28

Last Modified:

05 Dec 2019 06:28

Publisher DOI:

10.1016/j.jcin.2018.07.032

PubMed ID:

30466832

Uncontrolled Keywords:

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

BORIS DOI:

10.7892/boris.125198

URI:

https://boris.unibe.ch/id/eprint/125198

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