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Frailty response in patients with aortic stenosis undergoing transcatheter aortic valve implantation: a pilot, cluster-randomised controlled trial (FRAIL-AS Response Trial)

Australian Catholic University

  • Cardiovascular Early-Mid Career Researcher Grant
Date Funded:
  • 28 November, 2023
Chief Investigator/s:
  • Dr. Nicola Straiton

What is the issue for NSW?

Aortic stenosis, which affects 1 in 8 older adults, narrows the heart valve and causes symptoms of breathlessness, chest pain, and heart failure. In 2021, more than 97,000 Australians over 55 had it, with 26,000 of those people being in NSW. This is expected to rise 25% by 2027. Left untreated, this condition has a 50% 2-year survival rate.

Traditional treatment is open-heart surgery, but since 2002 a less invasive procedure called transcatheter aortic valve implantation (TAVI) has become an alternative, especially for frail patients with aortic stenosis. Since then, the number of people undergoing a TAVI procedure has increased significantly, especially in NSW.

Frailty is present in 3 out of 10 people who undergo TAVI. However, there’s limited evidence for managing frailty in people with aortic stenosis, which worsens outcomes for patients post TAVI procedures. Frail patients with aortic stenosis undergoing TAVI procedures have higher mortality, more complications, longer hospital stays, and lower quality of life. Yet, heart valve treatment programs lack early frailty management strategies to support these patients.

What does the research aim to do and how?

This research aims to examine the feasibility of implementing a Frailty Response Program intervention for frail patients with aortic stenosis undergoing TAVI. Using a cluster-randomised controlled trial design, the study will compare the Frailty Response Program intervention to standard care in ten selected NSW hospitals. This multi-component program comprises of nutritional assessment, geriatrician review, rehabilitation, and education, all tailored to the patient’s frailty status. The Frailty Response Program intervention will commence pre-TAVI and then patients will be followed up for 12-months post procedure.

The aspiration of the research team is to close the gap between identifying frailty in patients with aortic stenosis undergoing TAVI and implementing evidence-based frailty management practices, ultimately improving patient outcomes and enhancing care quality.