Impact of a Telematic Intervention Based on Exercise, Nutrition and Education on Frailty Reversion and Prognosis Among Older Patients with Aortic Stenosis Undergoing Transcatheter Aortic Valve Intervention: the TELE-FRAIL TAVI Clinical Trial

**Introduction** Degenerative aortic stenosis (AS) is the most common valvular disease in Western countries, largely due to increased life expectancy and the progressive aging of the population. Percutaneous aortic valve replacement (TAVI) has revolutionized the treatment of AS, demonstrating its effectiveness in inoperable patients, high-risk patients, and recently even in patients with low or intermediate surgical risk. This increasing evidence has led to a steady rise in TAVI procedures annually, generating a need for healthcare systems to adapt and optimize healthcare pathways and hospital stays.

AS is a disease predominantly associated with aging. The presence of frailty, comorbidities, and other geriatric syndromes is strongly linked to complications, the need for readmissions, and mortality both in conservatively treated patients and those undergoing surgery or TAVI. Frailty and comorbidity burden are also associated with a higher incidence of procedure-related complications, despite technological advances making TAVI increasingly less invasive. Previous data suggest that patients with greater comorbidity burden have higher rates of readmission and extracardiac mortality, which can limit the benefit of TAVI and even negate it in some highly comorbid patients. Therefore, optimizing patient selection to avoid the futility of the procedure remains a key clinical challenge.

Frailty is a phenotype characterized by vulnerability to potential external stressors, and it may be reversible. In patients with cardiovascular diseases, a significant part of frailty is due to heart disease itself, and therefore potentially reversible with its specific treatment. However, in patients with a higher comorbidity burden, it can be challenging to determine what proportion of frailty is due to other health conditions. It has been suggested that managing frail patients requires a comprehensive approach for frailty reversal, including physical exercise, proper nutrition, and strict control of comorbidities that may accelerate frailty progression. Some publications have shown that physical exercise programs can partially reverse frailty in various cardiovascular settings, including AS patients. However, implementing these strategies in clinical practice presents significant challenges, including the cost of enrolling a growing number of patients in cardiac rehabilitation programs and the difficulty in achieving sustained adherence to these programs.

Telemedicine presents potential advantages, especially in managing elderly patients with frailty and cardiovascular diseases, by enabling proper follow-up while avoiding logistical barriers such as transportation and suboptimal adherence, particularly relevant in this context. Different telemedicine-related tools have proven useful in improving outcomes for patients with heart failure by detecting early decompensation and preventing hospital admissions and other complications. However, there is no experience with applying telemedicine to frail patients with AS undergoing TAVI.

The primary objective of the TELE-FRAIL TAVI clinical trial is to analyze the effect of a comprehensive telehealth intervention on frailty reversal at 3 months post-TAVI compared to standard management in patients with AS undergoing TAVI.