Early Real-World Experience with CoreValve Evolut PRO and R Systems for Transcatheter Aortic Valve Replacement.

Publication/Presentation Date

1-1-2019

Abstract

OBJECTIVES: The purpose of this study was to compare the efficacy and safety of the Evolut PRO to the Evolut R valve in a real-world setting.

BACKGROUND: The next-generation self-expanding transcatheter aortic valve replacement (TAVR) system, the CoreValve Evolut PRO was designed with an outer pericardial skirt to improve valve-sealing performance. Safety and efficacy of this valve have not previously been compared to its predecessor, the Evolut R valve.

METHODS: We retrospectively studied 134 patients who underwent TAVR with the Evolut PRO or Evolut R valve over one year at a tertiary center. Endpoints, defined by the Valve Academic Research Consortium-2 criteria, included device success, paravalvular leak (PVL), and a composite safety endpoint including mortality, stroke, major vascular complications, life-threatening bleeding, acute kidney injury, coronary artery obstruction, and repeat procedure for valve-related dysfunction.

RESULTS: 60 Evolut PRO and 56 Evolut R patients met the study criteria. Both groups had similar device success rates (90 vs. 89%,

CONCLUSION: Despite the additional pericardial skirt and larger sheath size of Evolut PRO, outcomes were comparable between the two Evolut systems, supporting adoption of the newest generation valve in the management of severe aortic stenosis as well as continued use of the Evolut R in patients with smaller vasculature warranting a lower profile device.

Volume

2019

First Page

1906814

Last Page

1906814

ISSN

1540-8183

Disciplines

Medicine and Health Sciences

PubMedID

31772515

Department(s)

Fellows and Residents

Document Type

Article

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