Gender in the ACCESS-EU registry: a prospective, multicentre, non-randomised post-market approval study of MitraClip® therapy in Europe.
OBJECTIVE
Gender has been an important factor in outcomes after mitral valve surgery; however, its effect on percutaneous mitral valve repair is not well known. We aimed to report the effect of gender on outcomes in a large European prospective, multicentre, non-randomised post-approval study of percutaneous mitral valve repair.


RESULTS
Two hundred and five female and 362 male patients with significant mitral regurgitation underwent percutaneous repair at 14 European sites from October 2008 to April 2011. Women and men had similar baseline risk scores, but women had a higher rate of degenerative disease (32% vs. 18%). Women were more likely to have one clip implanted (72% vs. 54%), but had a similar length of stay in the intensive care unit (2.6±4.1 days) and overall length of stay (8.0±6.9 days) compared to men. They were also less likely to be discharged home: more women than men went to skilled nursing facilities (25% vs. 15%) and fewer women went home compared to men (71.9% vs. 83.9%). Thirty-day and 12-month safety results were similar between genders, as was 12-month efficacy (echocardiographic and clinical). Multivariate analysis showed no effect of gender on 12-month survival.


CONCLUSIONS
In a real-world, post-approval experience in Europe, female patients who underwent percutaneous mitral valve repair experienced safety and efficacy results similar to those of males. However, the discharge rates to skilled nursing facilities rather than home may indicate a need for better optimisation of the female patient's physical and social comorbidities prior to intervention and during the hospitalisation period.
CardioVascular Center Frankfurt, Frankfurt, Germany.
Sameer
S
Gafoor
Horst
H
Sievert
Francesco
F
Maisano
Stephan
S
Baldus
Ulrich
U
Schaefer
Joerg
J
Hausleiter
Christian
C
Butter
Gian Paolo
GP
Ussia
Volker
V
Geist
Julian D
JD
Widder
Tiziano
T
Moccetti
Wolfgang
W
Schillinger
Olaf
O
Franzen
D000368:Aged; D000369:Aged, 80 and over; D004452:Echocardiography / Q000379:methods; D005060:Europe; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery*; D008944:Mitral Valve Insufficiency / Q000601:surgery*; D011446:Prospective Studies; D012042:Registries; D012727:Sex Characteristics; D013525:Surgical Instruments / Q000009:adverse effects; D016896:Treatment Outcome