title: Treatment of Symptomatic Severe Aortic Stenosis With a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System.
abstract: OBJECTIVE
  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).
authors: Regional Cardiology Department, Royal Victoria Hospital, Belfast, United Kingdom. Electronic address: gmanoharan@msn.com.
authors: Ganesh
authors: G
authors: Manoharan
authors: Victorian Heart Centre, Epworth Hospital, Melbourne, Australia.
authors: Antony S
authors: AS
authors: Walton
authors: Cardiology and Interventional Cardiology Services, St. George's Hospital, London, United Kingdom.
authors: Stephen J
authors: SJ
authors: Brecker
authors: Department of Cardiology, Waikato Hospital, Hamilton, New Zealand.
authors: Sanjeevan
authors: S
authors: Pasupati
authors: Department of Cardiology, Leeds General Infirmary, Leeds, United Kingdom.
authors: Daniel J
authors: DJ
authors: Blackman
authors: Statistical Services, Medtronic, Inc., Minneapolis, Minnesota.
authors: Hongyan
authors: H
authors: Qiao
authors: Monash Cardiovascular Research Centre, MonashHEART, Monash Health, and Department of Medicine, Monash University, Melbourne, Australia.
authors: Ian T
authors: IT
authors: Meredith
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000503:physiopathology; D001022:Aortic Valve Insufficiency / Q000209:etiology; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D001145:Arrhythmias, Cardiac / Q000209:etiology / Q000628:therapy; D001315:Australia; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D062906:Cardiac Catheters; D002304:Cardiac Pacing, Artificial; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006801:Humans; D008297:Male; D009520:New Zealand; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D012720:Severity of Illness Index; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
keywords: aortic valve stenosis; self-expanding heart valve; transcatheter aortic valve replacement