title: Gender-related clinical and echocardiographic outcomes at 30-day and 12-month follow up after MitraClip implantation in the GRASP registry.
abstract: OBJECTIVE
  To assess the influence of patients' gender on the outcomes of percutaneous edge-to-edge mitral valve repair (PMVR) using the MitraClip system.
  
  
  BACKGROUND
  Although gender-related differences have been extensively documented in patients who undergo surgery for moderate-to-severe (3+) and severe (4+) mitral regurgitation (MR), studies assessing whether these differences exist after PMVR are lacking.
  
  
  METHODS
  Clinical and echocardiographic data through 12-month follow up from 171 consecutive patients whom underwent MitraClip implantation and were dichotomized by the gender (106 males and 65 females) were obtained. The primary safety endpoint was the incidence of major adverse events at 30 days and the primary efficacy endpoint was freedom from death, surgery for mitral valve dysfunction, or grade≥3+ MR at 12-month follow up.
  
  
  RESULTS
  The primary safety endpoint was observed in four males (3.8%) and four females (6.2%) (P=0.358). Remarkable reduction in MR postprocedure was revealed in both groups, and these results were mostly sustained. Furthermore, left ventricle reverse remodeling and New York Heart Association (NYHA) functional class improvement were revealed in both groups, but females tended to demonstrate worse results over time (P=0.083). The primary efficacy endpoint obtained by Kaplan-Meier estimates was observed in 76.3 and 70.2%, respectively (log rank P=0.231).
  
  
  CONCLUSIONS
  MitraClip implantation in patients with 3+ and 4+ MR is safe and efficacious until mid-term follow up, regardless of patients' gender. Despite improvement in NYHA functional class in both groups, female gender demonstrated a trend toward poorer results. Further validation of our findings is warranted.
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; Interventional Cardiology Department, Pitangueiras Hospital, Jundiaí, Brazil; Harrington Heart and Vascular Institute, University Hospitals, Case Medical Center, Cleveland, Ohio.
authors.forename: Guilherme F
authors.initials: GF
authors.lastname: Attizzani
authors.forename: Yohei
authors.initials: Y
authors.lastname: Ohno
authors.forename: Davide
authors.initials: D
authors.lastname: Capodanno
authors.forename: Stefano
authors.initials: S
authors.lastname: Cannata
authors.forename: Fabio
authors.initials: F
authors.lastname: Dipasqua
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Immé
authors.forename: Sarah
authors.initials: S
authors.lastname: Mangiafico
authors.forename: Marco
authors.initials: M
authors.lastname: Barbanti
authors.forename: Margherita
authors.initials: M
authors.lastname: Ministeri
authors.forename: Anna
authors.initials: A
authors.lastname: Cageggi
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Pistritto
authors.forename: Sandra
authors.initials: S
authors.lastname: Giaquinta
authors.forename: Silvia
authors.initials: S
authors.lastname: Farruggio
authors.forename: Marta
authors.initials: M
authors.lastname: Chiarandà
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Ronsivalle
authors.forename: Salvatore
authors.initials: S
authors.lastname: Scandura
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
authors.forename: Piera
authors.initials: P
authors.lastname: Capranzano
authors.forename: Carmelo
authors.initials: C
authors.lastname: Grasso
mesh_terms: D000368:Aged; D004452:Echocardiography; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D008297:Male; D008943:Mitral Valve / Q000601:surgery*; D008944:Mitral Valve Insufficiency / Q000000981:diagnostic imaging / Q000601:surgery*; D011183:Postoperative Complications / Q000453:epidemiology*; D011474:Prosthesis Design; D012042:Registries; D012737:Sex Factors; D013997:Time Factors
keywords: MitraClip; gender; mitral insufficiency; mitral regurgitation; percutaneous mitral valve repair