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The impact of learning‐curve‐experience on transcatheter aortic valve replacement outcomes: Insights from the United Kingdom and Ireland all‐comers second‐generation <scp>ACURATE neo™</scp> transcatheter aortic heart valve registry

Authors :
Mark S. Spence
Kamran Baig
Ashan Gunarathne
A. Faour
Ivan P. Casserly
Andrew J Mitchell
Sanjay S Bhandari
Michael S. Cunnington
Kristoffer V. Tanseco
David Hildick-Smith
Richard W Varcoe
Joon Tan
Xavier Armario
Colum G. Owens
Darren Mylotte
Jan Kovac
Source :
Catheterization and Cardiovascular Interventions. 99:1172-1180
Publication Year :
2021
Publisher :
Wiley, 2021.

Abstract

Background The ACURATE neo™ is a novel, second-generation self-expanding supra-annular transcatheter heart valve (THV). The objective of this multi-centre registry is to assess the safety, clinical utility, and impact of &#39;learning-curve-experience&#39; (LCE) on transcatheter aortic valve replacement outcomes in the United Kingdom (UK) and Ireland. Methods We prospectively collected data from seven ACURATE neo™ THV implanting centres (n = 484) between February 2016 and November 2020. We compared mortality rates and outcomes in the LCE group (n = 120) compared to next successive 120 cases. Results The mean age of the cohort was 81.9(SD: 6.1) years and the majority were in the moderate risk category (EuroSCORE-II):3.3(SD: 3). The 97.5% of cases were performed under local anesthetic. The valve was successfully deployed in 98.8% of cases. The survival rate at 30 days was 97.9%. The incidence of stroke was 2.5%. Life threatening bleeding occurred in 0.6% of cases and vascular access complications occurred in 21 (4.3%) patients. Implantation-related conduction abnormalities occurred in 8.3% but only 5.6% required a PPM. The successful valve deployment occurred in 96% of the patients in the LCE group compared to 100% in the other group (p = 0.04; OR-2[CI 1.7-2.3]). The mortality rates at 30 days (1.7% vs. 1.7%) and 1 year (1.9% vs. 2.7%) were comparable between the two groups. Conclusions This study represents the largest published UK and Ireland real-world experience of the ACURATE neo™ valve. The procedural success rates and safety outcomes were excellent and endorse its utility in clinical practice. The LCE appears to have an impact on the successful valve deployment but without translating into short-term or long-term outcomes.

Details

ISSN :
1522726X and 15221946
Volume :
99
Database :
OpenAIRE
Journal :
Catheterization and Cardiovascular Interventions
Accession number :
edsair.doi.dedup.....6f13d1e935dfcc0b01801f38ed715d68