Abstract

ABSTRACT Objectives This study presents the United Kingdom and Ireland real-world learning curve experience of the EvolutTM R (Medtronic, Minneapolis, Minnesota, USA) transcatheter heart valve. Background The EvolutTM R is a self-expanding, repositionable and fully recapturable second-generation transcatheter heart valve with several novel design features to improve outcome, and reduce complications. Methods Clinical, procedural, and 30-day outcome data were prospectively collected for the first 264 patients to receive an Evolut RTM valve in the United Kingdom and Ireland. Results 264 consecutive EvolutTM R implants were performed across 9 centers. Mean age was 81.1 ± 7.8 years and mean Logistic EuroScore 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 cases 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 0.4%; conversion to sternotomy 0.8%; annular rupture 0.0%; coronary occlusion 0.8%; major vascular 5.3%; acute kidney injury 6.1%; new permanent pacemaker implantation 14.7%; and procedural-related death 0.0%. At 30-day follow-up survival was 97.7%, paravalvular leak was mild or less in 92.3% and stroke rate was 3.8%. Conclusions This registry represents the largest published real-world experience of the EvolutTM R valve. Procedural success rate was high and safety was excellent, comparable to previous studies of the EvolutTM R valve and other second-generation devices. The low rate of complications represents an improvement on first-generation devices.