Gender-specific outcomes post transcatheter aortic valve implantation
Research type
Research Study
Full title
Gender-specific outcomes post transcatheter aortic valve implantation
IRAS ID
283163
Contact name
Ghada Mikhail
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
Duration of Study in the UK
2 years, 2 months, 0 days
Research summary
Severe aortic stenosis (AS) is the commonest form of valvular abnormality in the developed world and accounts for more than 40% of patients with native valvular disease with an approximately equal prevalence in males and females.
Transcatheter aortic valve implantation (TAVI) is now widely practiced with treatment of over 300,000 patients worldwide. Many centres now regularly implant devices in patients for whom conventional aortic valve replacement (AVR) is deemed high or intermediate risk. Several studies have shown that females have an apparent better outcome with TAVI than males.
There are numerous possible reasons as to the apparent favourable benefit of TAVI in women including: having both lower rates of moderate / severe aortic regurgitation and peri-procedural mortality, lower rates of bleeding and renal failure, better patient prosthesis match and recovery of left ventricular function with more favourable left ventricular remodelling.
Rationale for proposal:
Newer devices have reduced the introducer French size and are hence associated with reduced rates of vascular and bleeding complications. This may translate to an even higher survival benefit in female versus male patients with severe aortic stenosis treated with transfemoral TAVI. In the current study we will aim to investigate gender temporal survival trends, and complications including stroke and heart attack in aortic stenosis patients treated with current versus older generation transcatheter valves. We have already been successful in obtaining the periprocedural data from NICOR but need to link the procedural data to outcome. This will be obtained from NHS digital after ethics submission and approval form Imperial College Healthcare NHS Trust and Imperial College,London.Objectives
The current study will aim to:
1. Compare the mid-long term survival of females versus males in patients with AS treated with current versus older TAVI technologies.Study design
In the current study, all patients undergoing transfemoral TAVI in the UK (between 2007 and 2017) will be included.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
20/YH/0242
Date of REC Opinion
3 Sep 2020
REC opinion
Favourable Opinion