Initial Experience of a Second-Generation Self-Expanding Transcatheter Aortic Valve: The UK & Ireland Evolut R Implanters' Registry.
The authors present the UK and Irish real-world learning curve experience of the Evolut R transcatheter heart valve.



The Evolut R is a self-expanding, repositionable, and fully recapturable second-generation transcatheter heart valve with several novel design features to improve outcomes and reduce complications.



Clinical, procedural, and 30-day outcome data were prospectively collected for the first 264 patients to receive the Evolut R valve in the United Kingdom and Ireland.



A total of 264 consecutive Evolut R implantations were performed across 9 centers. The mean age was 81.1 ± 7.8 years, and the mean logistic European System for Cardiac Operative Risk Evaluation score was 19.9 ± 13.7%. Procedural indications included aortic stenosis (72.0%), mixed aortic valve disease (17.4%), and failing aortic valve bioprostheses (10.6%). Conscious sedation was used in 39.8% of patients and transfemoral access in 93.6%. The procedural success rate was 91.3%, and paravalvular leak immediately after implantation was mild or less in 92.3%. Major complications were rare: cardiac tamponade in 0.4%, conversion to sternotomy in 0.8%, annular rupture in 0.0%, coronary occlusion in 0.8%, major vascular in 5.3%, acute kidney injury in 6.1%, new permanent pacemaker implantation in 14.7%, and procedure-related death in 0.0%. At 30-day follow-up, survival was 97.7%, paravalvular leak was mild or less in 92.3%, and the stroke rate was 3.8%.



This registry represents the largest published real-world experience of the Evolut R valve. The procedural success rate was high and safety was excellent, comparable with previous studies of the Evolut R valve and other second-generation devices. The low rate of complications represents an improvement on first-generation devices.
Cardiology Clinical Academic Group, St. George's University Hospitals NHS Foundation Trust & St. George's University of London, London, United Kingdom.
Sundeep S
SS
Kalra
Cardiology Clinical Academic Group, St. George's University Hospitals NHS Foundation Trust & St. George's University of London, London, United Kingdom.
Sami
S
Firoozi
Cardiology Department, Royal Brompton and Harefield NHS Trust, London, United Kingdom.
James
J
Yeh
Cardiology Department, Leeds Teaching Hospital, Leeds, United Kingdom.
Daniel J
DJ
Blackman
Cardiology Department, Leeds Teaching Hospital, Leeds, United Kingdom.
Shabnam
S
Rashid
Cardiology Department, Leeds Teaching Hospital, Leeds, United Kingdom.
Simon
S
Davies
Cardiology Department, Leeds Teaching Hospital, Leeds, United Kingdom.
Neil
N
Moat
Cardiology Department, Leeds Teaching Hospital, Leeds, United Kingdom.
Miles
M
Dalby
Cardiology Department, Leeds Teaching Hospital, Leeds, United Kingdom.
Tito
T
Kabir
Cardiology Department, The Royal Wolverhampton Hospitals, Wolverhampton, United Kingdom.
Saib S
SS
Khogali
Cardiology Department, University Hospital of Wales, Cardiff, United Kingdom.
Richard A
RA
Anderson
Cardiology Department, University Hospital of Wales, Cardiff, United Kingdom.
Peter H
PH
Groves
Cardiology Department, University Hospital Galway, Galway, Ireland.
Darren
D
Mylotte
Cardiology Department, Brighton and Sussex University Hospitals, Brighton, United Kingdom.
David
D
Hildick-Smith
Cardiology Department, Brighton and Sussex University Hospitals, Brighton, United Kingdom.
Rajiv
R
Rampat
Cardiology Department, Glenfield Hospital, Leicester, United Kingdom.
Jan
J
Kovac
Cardiology Department, Glenfield Hospital, Leicester, United Kingdom.
Ashan
A
Gunarathne
Cardiology Clinical Academic Group, St. George's University Hospitals NHS Foundation Trust & St. George's University of London, London, United Kingdom.
Jean-Claude
JC
Laborde
Cardiology Clinical Academic Group, St. George's University Hospitals NHS Foundation Trust & St. George's University of London, London, United Kingdom. Electronic address: sbrecker@sgul.ac.uk.
Stephen J
SJ
Brecker
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D002983:Clinical Competence; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D007494:Ireland; D059032:Learning Curve; D008297:Male; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016896:Treatment Outcome; D006113:United Kingdom
Evolut R; aortic stenosis; complication; outcome; transcatheter aortic valve replacement; transcatheter heart valve