title: Thirty-day Outcome Following CoreValve Evolut R Transcatheter Aortic Valve Implantation: An All-comers Prospective Study.
abstract: OBJECTIVE
  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.
authors.affiliation: Division of Cardiology, University Hospital of Geneva, Geneva, Switzerland. Electronic address: nils.perrin@bluewin.ch.
authors.forename: Nils
authors.initials: N
authors.lastname: Perrin
authors.affiliation: Division of Cardiology, University Hospital of Geneva, Geneva, Switzerland.
authors.forename: Marco
authors.initials: M
authors.lastname: Roffi
authors.affiliation: Division of Cardiology, University Hospital of Geneva, Geneva, Switzerland.
authors.forename: Angela
authors.initials: A
authors.lastname: Frei
authors.affiliation: Department of Radiology, University Hospital of Geneva, Geneva, Switzerland.
authors.forename: Anne-Lise
authors.initials: AL
authors.lastname: Hachulla
authors.affiliation: Department of Anesthesiology, University Hospital of Geneva, Geneva, Switzerland.
authors.forename: Christoph
authors.initials: C
authors.lastname: Ellenberger
authors.affiliation: Division of Cardiology, University Hospital of Geneva, Geneva, Switzerland.
authors.forename: Hajo
authors.initials: H
authors.lastname: Müller
authors.affiliation: Division of Cardiovascular Surgery, University Hospital of Geneva, Geneva, Switzerland.
authors.forename: Mustafa
authors.initials: M
authors.lastname: Cikirikcioglu
authors.affiliation: Department of Anesthesiology, University Hospital of Geneva, Geneva, Switzerland.
authors.forename: Marc
authors.initials: M
authors.lastname: Licker
authors.affiliation: Division of Cardiology, University Hospital of Geneva, Geneva, Switzerland.
authors.forename: Stephane
authors.initials: S
authors.lastname: Noble
mesh_terms: D058186:Acute Kidney Injury / Q000453:epidemiology; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001145:Arrhythmias, Cardiac / Q000453:epidemiology* / Q000628:therapy; D001705:Bioprosthesis; D002304:Cardiac Pacing, Artificial / Q000706:statistics & numerical data*; D002423:Cause of Death; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D009026:Mortality; D010138:Pacemaker, Artificial / Q000706:statistics & numerical data*; D011183:Postoperative Complications / Q000453:epidemiology* / Q000628:therapy; D019106:Postoperative Hemorrhage / Q000453:epidemiology; D011446:Prospective Studies; D019919:Prosthesis Implantation; D012720:Severity of Illness Index; D020521:Stroke / Q000453:epidemiology; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation* / Q000379:methods; D016896:Treatment Outcome
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