TAVI in Women Registry
Research type
Research Study
Full title
Women’s INternational Transcatheter Aortic Valve Implantation Registry as part of SCAI-WIN initiative (SCAI, Society for cardiovascular angiography and intervention- Women in Innovations)
IRAS ID
126592
Contact name
Ghada Mikhail
Contact email
Sponsor organisation
Mount Sinai
Research summary
Aortic stenosis (AS) is the most frequently encountered valvular heart disease in the adult population. Up to 33% of patients with severe symptomatic AS are not considered for surgical aortic valve replacement (SAVR)due to presence of multiple co-morbidities which makes them high-risk for the procedure. These patients with medical management tend to have poor outcomes. Transcatheter aortic valve implantation (TAVI) is now considered as an alternative treatment in such high risk patients. The available TAVI data suggests that females are more represented than in previous coronary clinical trials, where the inclusion rate of female patients has historically been low. The higher number of women included in TAVI series could be due to two factors. Firstly, the lower body surface area in the female patients, which is known to be associated with lower survival could have influenced the therapeutic decision and led to TAVI. Secondly, it has been postulated that the left ventricle of women adapt differently to AS, developing more pronounced hypertrophy with a normal ejection fraction, which could have influenced the time of the diagnosis. Female gender is an independent predictor of survival in patients older than 79-years undergoing conventional SAVR. It has been shown on multivariate analysis that female gender is independently associated with better recovery of the left ventricular systolic function following TAVI. Females therefore may be more suited to undergo TAVI in view of their co-existing conditions, and may well have a larger benefit. Furthermore, it has recently been reported that female receiving TAVI have more major vascular complications.
The purpose of this study is to investigate this in a larger patient population, in addition to other factors which may become relevant in the treatment of the female patient with TAVI.
REC name
London - Riverside Research Ethics Committee
REC reference
13/LO/1117
Date of REC Opinion
13 Aug 2013
REC opinion
Further Information Favourable Opinion