SORA

Advancing, promoting and sharing knowledge of health through excellence in teaching, clinical practice and research into the prevention and treatment of illness

Initial experience of a second generation self expanding transcatheter aortic valve. The Uk & Ireland Evolut R Implanters' Registry

Brecker, S; Kalra, SS; Firoozi, S; Yeh, J; Blackman, DJ; Rashid, S; Davies, S; Moat, N; Dalby, M; Kabir, T; et al. Brecker, S; Kalra, SS; Firoozi, S; Yeh, J; Blackman, DJ; Rashid, S; Davies, S; Moat, N; Dalby, M; Kabir, T; Khogali, SS; Anderson, RA; Groves, PH; Mylotte, D; Hildick-Smith, D; Rampat, R; Kovac, J; Gunarathne, A; Laborde, JC (2017) Initial experience of a second generation self expanding transcatheter aortic valve. The Uk & Ireland Evolut R Implanters' Registry. JACC: Cardiovascular Interventions, 10 (3). pp. 276-282. ISSN 1876-7605 https://doi.org/10.1016/j.jcin.2016.11.025
SGUL Authors: Brecker, Stephen

[img] Microsoft Word (.doc) Accepted Version
Available under License Creative Commons Attribution Non-commercial No Derivatives.

Download (142kB)

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.

Item Type: Article
Additional Information: © 2016. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/
Keywords: 1102 Cardiovascular Medicine And Haematology
SGUL Research Institute / Research Centre: Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Journal or Publication Title: JACC: Cardiovascular Interventions
ISSN: 1876-7605
Dates:
DateEvent
13 February 2017Published
6 February 2017Published Online
17 November 2016Accepted
Publisher License: Creative Commons: Attribution-Noncommercial-No Derivative Works 4.0
URI: http://openaccess.sgul.ac.uk/id/eprint/108443
Publisher's version: https://doi.org/10.1016/j.jcin.2016.11.025

Actions (login required)

Edit Item Edit Item