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

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±14.5mmHg at baseline to 7.7±4.0mmHg 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.

Keywords: Aortic valve stenosis; Estenosis valvular aórtica; Evolut R; Fuga paravalvular; Implante de marcapasos; Implante percutáneo de válvula aórtica; Pacemaker implantation; Paravalvular leak; Self-expanding valve; Transcatheter aortic valve implantation; Válvula autoexpandible.