Author + information
- Received July 19, 2016
- Revision received October 24, 2016
- Accepted November 17, 2016
- Published online February 6, 2017.
- Sundeep S. Kalra, MAa,
- Sami Firoozi, MBBSa,
- James Yeh, PhDb,
- Daniel J. Blackman, MBBS, MDc,
- Shabnam Rashid, MBChB, BScc,
- Simon Davies, MAc,
- Neil Moat, MBBSc,
- Miles Dalby, MDc,
- Tito Kabir, PhDc,
- Saib S. Khogali, MDd,
- Richard A. Anderson, MBBS, BSc, MDe,
- Peter H. Groves, MDe,
- Darren Mylotte, MBBS, MDf,
- David Hildick-Smith, MBBS, MDg,
- Rajiv Rampat, MBBSg,
- Jan Kovac, MDh,
- Ashan Gunarathne, MBBSh,
- Jean-Claude Laborde, MDa and
- Stephen J. Brecker, MDa,∗ ()
- aCardiology Clinical Academic Group, St. George’s University Hospitals NHS Foundation Trust & St. George’s University of London, London, United Kingdom
- bCardiology Department, Royal Brompton and Harefield NHS Trust, London, United Kingdom
- cCardiology Department, Leeds Teaching Hospital, Leeds, United Kingdom
- dCardiology Department, The Royal Wolverhampton Hospitals, Wolverhampton, United Kingdom
- eCardiology Department, University Hospital of Wales, Cardiff, United Kingdom
- fCardiology Department, University Hospital Galway, Galway, Ireland
- gCardiology Department, Brighton and Sussex University Hospitals, Brighton, United Kingdom
- hCardiology Department, Glenfield Hospital, Leicester, United Kingdom
- ↵∗Address for correspondence:
Dr. Stephen J. Brecker, Cardiology Clinical Academic Group, St. George’s University Hospitals NHS Foundation Trust & St. George’s University of London, Blackshaw Road, Tooting, London SW17 0QT, United Kingdom.
Objectives The authors present the UK and Irish real-world learning curve experience of the Evolut R transcatheter heart valve.
Background 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.
Methods 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.
Results 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%.
Conclusions 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.
- aortic stenosis
- Evolut R
- transcatheter aortic valve replacement
- transcatheter heart valve
Dr. Blackman is a proctor and consultant for Medtronic and Boston Scientific. Dr. Khogali is a proctor for Medtronic and Boston Scientific. Dr. Hildick-Smith is a proctor for Boston Scientific and Medtronic. Dr. Kovac is a proctor for Medtronic, Boston Scientific, and Edward Lifesciences. Dr. Jean-Claude Laborde is a proctor and consultant for Medtronic. Dr. Brecker is a proctor and consultant for Medtronic; and a member of a steering committee for Boston Scientific. Dr. Mylotte is a proctor and consultant for Medtronic and Microport. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 19, 2016.
- Revision received October 24, 2016.
- Accepted November 17, 2016.
- American College of Cardiology Foundation