Author + information
- Received February 18, 2015
- Revision received May 1, 2015
- Accepted May 5, 2015
- Published online August 24, 2015.
- Ganesh Manoharan, MBBCh, MD∗∗ (, )
- Antony S. Walton, MBBS†,
- Stephen J. Brecker, MBBS, MD‡,
- Sanjeevan Pasupati, MBChB§,
- Daniel J. Blackman, MD‖,
- Hongyan Qiao, PhD¶ and
- Ian T. Meredith, AM, MBBS, PhD#
- ∗Regional Cardiology Department, Royal Victoria Hospital, Belfast, United Kingdom
- †Victorian Heart Centre, Epworth Hospital, Melbourne, Australia
- ‡Cardiology and Interventional Cardiology Services, St. George’s Hospital, London, United Kingdom
- §Department of Cardiology, Waikato Hospital, Hamilton, New Zealand
- ‖Department of Cardiology, Leeds General Infirmary, Leeds, United Kingdom
- ¶Statistical Services, Medtronic, Inc., Minneapolis, Minnesota
- #Monash Cardiovascular Research Centre, MonashHEART, Monash Health, and Department of Medicine, Monash University, Melbourne, Australia
- ↵∗Reprint requests and correspondence:
Dr. Ganesh Manoharan, Cardiology Department, Royal Victoria Hospital, 274 Grosvenor Road, Belfast BT12 6BA, United Kingdom.
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)
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.
- Received February 18, 2015.
- Revision received May 1, 2015.
- Accepted May 5, 2015.
- 2015 American College of Cardiology Foundation