Focus Issue on Bifurcation Intervention
Structural
Treatment of Symptomatic Severe Aortic Stenosis With a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System

https://doi.org/10.1016/j.jcin.2015.05.015Get rights and content
Under an Elsevier user license
open archive

Abstract

Objectives

The purpose of this study was to prospectively evaluate the safety and clinical performance of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system (Medtronic, Inc., Minneapolis, Minnesota) in a single-arm, multicenter pivotal study in high- or extreme-risk patients with symptomatic aortic valve stenosis.

Background

Although outcomes following TAVR are improving, challenges still exist. The repositionable 14-F equivalent CoreValve Evolut R TAVR system was developed to mitigate some of these challenges.

Methods

Suitable patients (n = 60) underwent TAVR with a 26- or 29-mm Evolut R valve. Primary safety endpoints were mortality and stroke at 30 days. Primary clinical performance endpoints were device success per the VARC-2 (Valve Academic Research Consortium-2) and the percent of patients with mild or less aortic regurgitation 24 h to 7 days post-procedure.

Results

Patients (66.7% female; mean age 82.8 ± 6.1 years; Society of Thoracic Surgeons Score 7.0 ± 3.7%) underwent TAVR via the transfemoral route in 98.3%, using a 29-mm valve in 68.3% of patients. All attempts at repositioning were successful. No death or stroke was observed up to 30 days. The VARC-2 overall device success rate was 78.6%. Paravalvular regurgitation post TAVR was mild or less in 96.6%, moderate in 3.4%, and severe in 0% at 30 days. Major vascular complications occurred in 8.3%, and permanent pacemaker implantation was required in 11.7% of patients.

Conclusions

The repositionable 14-F equivalent Evolut R TAVR system is safe and effective at treating high-risk symptomatic aortic stenosis patients. Repositioning was successful when required in all patients, with low rates of moderate or severe paravalvular aortic regurgitation and low permanent pacemaker implantation. (The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study; NCT01876420)

Key Words

aortic valve stenosis
self-expanding heart valve
transcatheter aortic valve replacement

Abbreviations and Acronyms

BAV
balloon aortic valvuloplasty
DCS
delivery catheter system
LV
left ventricle
MRS
Modified Rankin score
MSCT
multislice computer tomography
NYHA
New York Heart Association
PPM
patient-prosthesis mismatch
PVL
paravalvular leak
SAVR
surgical aortic valve replacement
STS
Society of Thoracic Surgeons
TAV
transcatheter aortic valve
TAVR
transcatheter aortic valve replacement

Cited by (0)

This study was supported by Medtronic, Inc. Dr. Manoharan has received consultant fees and honoraria from Medtronic, St. Jude Medical, and Boston Scientific. Dr. Walton serves as a proctor and advisory board member for Medtronic. Dr. Brecker has received consultant fees from Medtronic and Boston Scientific. Dr. Pasupati serves as a consultant and a proctor for Edwards Lifesciences, Medtronic, and St. Jude Medical. Dr. Blackman has received consultant fees and honoraria from Boston Scientific and Medtronic. Dr. Qiao is an employee and shareholder of Medtronic, Inc. Dr. Meredith has received consultant fees and honoraria from Boston Scientific and Medtronic; and has received proctor fees from Boston Scientific.