TAVI and Gender Outcomes Aortic Stenosis Undergoing Transfemoral Transcatheter Aortic Valve Implantation.

Brief Title

TAVI and Gender Outcomes Aortic Stenosis Undergoing Transfemoral Transcatheter Aortic Valve Implantation.

Official Title

Gender-specific Temporal Trends in Survival in Patients With Severe Aortic Stenosis Undergoing Transfemoral Transcatheter Aortic Valve Implantation.

Brief Summary

      Severe aortic stenosis (AS) is the commonest form of valvular abnormality in the developed
      world and transcatheter aortic valve implantation (TAVI) is now widely practiced as in many
      cases is the preferred treatment option over conventional aortic surgery. Several studies
      have shown that females have an apparent better outcome with TAVI than males.

      There are a number of 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.

      We aim to explore the long term outcomes of TAVI between males and females to try and
      identify specific tailored treatment options.

      This data will be useful in providing important information regarding gender differences in
      patients who are treated with transcatheter aortic valve implantation. Data provided will
      include long term outcomes and predictors of outcome.

      The study team will then identify and implement strategies to improve outcomes in patients
      being treated with transcatheter aortic valve implantation.

Detailed Description

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 and and mortality data will be linked from NHS
digital.

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.

Study Type

Observational [Patient Registry]

Primary Outcome

All cause mortality

Secondary Outcome

 Major adverse cardiovascular events

Condition

Aortic Stenosis

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

Start Date

January 2007

Completion Date

January 2021

Primary Completion Date

January 2017

Eligibility Criteria

        All comers - retrospective registry

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, ,

Administrative Informations

NCT ID

NCT04915976

Organization ID

Responsible Party

Principal Investigator

Study Sponsor

Imperial College Healthcare NHS Trust

Study Sponsor

, ,

Verification Date

June 2021