Intervención telemática sobre la fragilidad en pacientes tratados con TAVI. Diseño del ensayo clínico TELE-FRAIL TAVI

Abstract

Introduction and objectives: Although transcatheter aortic valve implantation (TAVI) is the first-line therapy for aortic stenosis (AS), its benefit could be lower (or even disappear) in frail patients. Physical exercise and nutritional support programs are recommended to address frailty. Data on the application of telemedicine strategies in this context is scarce. The objective of this study is to analyze, in older patients with AS undergoing TAVI, the effect of a telematic intervention on the reversal of frailty vs standard of care. Methods: We will be conducting a randomized multicenter study including patients aged >= 75 years with severe AS (mean aortic gradient > 40 mmHg, or aortic valve area < 0.8 8 cm2 on echocardiogram) with baseline frailty criteria (Short Physical Performance Battery [SPPB ] < 10 and FRAIL scale >= 3) undergoing TAVI. Prior to discharge, patients will be randomized to a) a telematic intervention within the first 3 months (nutritional support plus supervised physical exercise plus health education); or b) standard of care. The primary endpoint will be the percentage of patients with frailty reversal (SPPB >= 10) at 3 months. The estimated sample size is 206 patients (103 in each arm). Conclusions: The hypothesis of this study is that telematic intervention will allow a higher percentage of frailty reversal at 3 months vs standard of care after TAVI. The results of this study may provide novel information on this approach to frail patients with AS undergoing TAVI. ClinicalTrials.gov registered trial (NCT06742970).