Ganesh Manoharan1, Antony S Walton2, Stephen J Brecker3, Sanjeevan Pasupati4, Daniel J Blackman5, Hongyan Qiao6, Ian T Meredith7. 1. Regional Cardiology Department, Royal Victoria Hospital, Belfast, United Kingdom. Electronic address: gmanoharan@msn.com. 2. Victorian Heart Centre, Epworth Hospital, Melbourne, Australia. 3. Cardiology and Interventional Cardiology Services, St. George's Hospital, London, United Kingdom. 4. Department of Cardiology, Waikato Hospital, Hamilton, New Zealand. 5. Department of Cardiology, Leeds General Infirmary, Leeds, United Kingdom. 6. Statistical Services, Medtronic, Inc., Minneapolis, Minnesota. 7. Monash Cardiovascular Research Centre, MonashHEART, Monash Health, and Department of Medicine, Monash University, Melbourne, Australia.
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).
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 stenosispatients. 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).
Authors: Giuseppe D'Ancona; Stephan Kische; Mohamed El-Mawardy; Martin Dißmann; Helmut Heinze; Dietlind Zohlnhöfer-Momm; Hakan Gürer; Hüseyin Ince Journal: Heart Vessels Date: 2019-05-27 Impact factor: 2.037
Authors: Sabine Bleiziffer; Johan Bosmans; Stephen Brecker; Ulrich Gerckens; Peter Wenaweser; Corrado Tamburino; Axel Linke Journal: Clin Res Cardiol Date: 2017-05-08 Impact factor: 5.460