Sundeep S Kalra1, Sami Firoozi1, James Yeh2, Daniel J Blackman3, Shabnam Rashid3, Simon Davies3, Neil Moat3, Miles Dalby3, Tito Kabir3, Saib S Khogali4, Richard A Anderson5, Peter H Groves5, Darren Mylotte6, David Hildick-Smith7, Rajiv Rampat7, Jan Kovac8, Ashan Gunarathne8, Jean-Claude Laborde1, Stephen J Brecker9. 1. Cardiology Clinical Academic Group, St. George's University Hospitals NHS Foundation Trust & St. George's University of London, London, United Kingdom. 2. Cardiology Department, Royal Brompton and Harefield NHS Trust, London, United Kingdom. 3. Cardiology Department, Leeds Teaching Hospital, Leeds, United Kingdom. 4. Cardiology Department, The Royal Wolverhampton Hospitals, Wolverhampton, United Kingdom. 5. Cardiology Department, University Hospital of Wales, Cardiff, United Kingdom. 6. Cardiology Department, University Hospital Galway, Galway, Ireland. 7. Cardiology Department, Brighton and Sussex University Hospitals, Brighton, United Kingdom. 8. Cardiology Department, Glenfield Hospital, Leicester, United Kingdom. 9. 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.
Abstract
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.
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.
Authors: Renuka Jain; Daniel P O'Hair; Tanvir K Bajwa; Denise Ignatowski; Daniel Harland; Amanda M Kirby; Tracy Hammonds; Suhail Q Allaqaband; Jonathan Kay; Bijoy K Khandheria Journal: Echo Res Pract Date: 2017-11-03