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

Background Three in ten severe aortic stenosis patients undergoing transcatheter aortic valve implantation (TAVI) are frail. Frailty correlates with adverse post-procedure patient outcomes, such as higher 1-year mortality, increased adverse events, prolonged hospital stays, and diminished quality of life. Despite the urgency for evidence-based frailty management in this population, research in this area is limited. Methods A pilot, cluster randomised controlled trial to assess the feasibility of implementing a Frailty Response Program intervention in 10 hospital TAVI programs for frail patients with aortic stenosis undergoing valve replacement. The intervention includes an implementation strategy and a Frailty Response Clinical Protocol, focused on malnutrition identification, patient education, general practitioner notification, comprehensive geriatric assessment, and cardiac rehabilitation. Eligible hospitals will be randomised (1:1) to either the intervention or control (standard care). Primary outcome: proportion of patients receiving nutritional assessment upon frailty identification. Secondary outcomes include mortality and hospital admissions, frailty improvement, quality of life, and evidence-based frailty management. Implementation outcomes will be evaluated through a process assessment. Discussion The trial aims to bridge the gap between the recognition of frailty in patients with aortic stenosis undergoing TAVI and the implementation of evidence-based frailty management practices to improve patient outcomes and care quality.