title: The role of sex on VARC outcomes following transcatheter aortic valve implantation with both Edwards SAPIEN™ and Medtronic CoreValve ReValving System® devices: the Milan registry.
abstract: OBJECTIVE
  To assess outcomes after transcatheter aortic valve implantation (TAVI) according to sex, with the two available valves and four recognised delivery approaches.
  
  
  RESULTS
  VARC outcomes are reported according to sex for 305 high-risk patients consecutively treated in our centre, via available access routes utilising the Edwards SAPIEN™/SAPIEN™ XT or the Medtronic CoreValve ReValving System® devices. Three hundred and five patients underwent TAVI: 52.1% male and 47.9% female. Females had a smaller body surface area (1.84±0.16 m² vs. 1.70±0.16 m²; p<0.001) and aortic annulus (24.4±1.6 mm vs. 22.6±1.7 mm; p<0.001) with increased symptoms (NYHA Class III/IV 61.6% vs. 73.6%; p=0.026). Conversely, men had more comorbidities: diabetes mellitus (35.2% vs. 21.9%; p=0.010), chronic kidney disease (41.8% vs. 23.3%; p=0.001), chronic obstructive pulmonary disease (45.3% vs. 30.1%; p=0.006) and previous myocardial infarction (28.3% vs. 14.4%; p=0.003). Thirty-day mortality was 4.7% with no difference between groups. There was a trend for females to develop more major vascular complications (11.9% vs. 19.9%; p=0.058). Notably, females required more blood transfusion (38.4% vs. 50.0%; p=0.041). No differences were observed in device success (92.5%; p=0.667), combined safety endpoint (61.8%; p=0.211) or combined efficacy endpoint (72.0%; p=0.889).
  
  
  CONCLUSIONS
  Female sex was a predictor of major vascular complications with females requiring more transfusion. No differences were noted amongst patients undergoing TAVI in composite safety and efficacy endpoints according to sex.
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Gill Louise
authors.initials: GL
authors.lastname: Buchanan
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
authors.forename: Matteo
authors.initials: M
authors.lastname: Montorfano
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.forename: Cosmo
authors.initials: C
authors.lastname: Godino
authors.forename: Micaela
authors.initials: M
authors.lastname: Cioni
authors.forename: Maria Angela
authors.initials: MA
authors.lastname: Gullace
authors.forename: Annalisa
authors.initials: A
authors.lastname: Franco
authors.forename: Chiara
authors.initials: C
authors.lastname: Gerli
authors.forename: Ottavio
authors.initials: O
authors.lastname: Alfieri
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016009:Chi-Square Distribution; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D016017:Odds Ratio; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D012737:Sex Factors; D013997:Time Factors; D016896:Treatment Outcome; D014652:Vascular Diseases / Q000175:diagnosis / Q000209:etiology* / Q000401:mortality / Q000628:therapy