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Revista Española de Cardiología (English Edition) Revista Española de Cardiología (English Edition)
Rev Esp Cardiol. 2017;70:713-9 - Vol. 70 Num.09 DOI: 10.1016/j.rec.2016.11.024

Thirty-day Outcome Following CoreValve Evolut R Transcatheter Aortic Valve Implantation: An All-comers Prospective Study

Nils Perrin a,, Marco Roffi a, Angela Frei a, Anne-Lise Hachulla b, Christoph Ellenberger c, Hajo Müller a, Mustafa Cikirikcioglu d, Marc Licker c, Stephane Noble a

a Division of Cardiology, University Hospital of Geneva, Geneva, Switzerland
b Department of Radiology, University Hospital of Geneva, Geneva, Switzerland
c Department of Anesthesiology, University Hospital of Geneva, Geneva, Switzerland
d Division of Cardiovascular Surgery, University Hospital of Geneva, Geneva, Switzerland

Refers to

Keywords

Transcatheter aortic valve implantation. Aortic valve stenosis. Self-expanding valve. Paravalvular leak. Pacemaker implantation. Evolut R.

Abstract

Introduction and objectives

There are scarce clinical outcomes data on the new generation recapturable and repositionable CoreValve Evolut R.

Methods

Data on all-comer patients undergoing transcatheter aortic valve implantation (TAVI) with the Evolut R for severe symptomatic aortic stenosis at a single center were prospectively collected between February 2015 and April 2016. Clinical endpoints were independently adjudicated according to the Valve Academic Research Consortium-2 criteria. Primary outcomes consisted of early safety composite endpoints and 30-day device success. The incidence of new permanent pacemaker implantation was recorded.

Results

Among the 83 patients undergoing TAVI during this period, 71 (85.5% of the population; median age, 83.0 [interquartile range, 80.0-87.0] years; Society of Thoracic Surgeons scores, 4.8 ± 3.5%) were suitable for Evolut R implantation and were included in the analysis. Repositioning was performed in 26.8% of the procedures. The early safety composite endpoint was observed in 11.3% of patients at 30 days, with 2.8% all-cause mortality. Device success was documented in 90.1% of patients. Paravalvular leakage was less than grade II in 98.4% of patients. The mean transvalvular aortic gradient was reduced from 42.5 ± 14.5 mmHg at baseline to 7.7 ± 4.0 mmHg at discharge (P < .0001 vs baseline). New permanent pacemaker implantation was required in 23.9% of patients.

Conclusions

The new generation Evolut R is suitable for most patients and shows high device success and acceptable mortality in an unbiased, consecutive, all-comer population at a single center performing TAVI exclusively with Medtronic valves.

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1885-5857/© 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved