Predictors of futility outcomes after TAVI: insights from the France TAVI Registry

Abstract Background Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of aortic stenosis and provides a significant symptom relief and mortality reduction. However, a substantial group of patients fail to derive a benefit from TAVI, whether in terms of mortality, quality of life (QoL) or functional benefit. Objectives The aim of the present analysis was to report factors associated with a futility outcome one year after TAVI, in a national real-life registry. Methods This prospectively designed France TAVI-QoL substudy included patients from the national France TAVI registry between February the 12th 2018 and February the 12th 2019. Patient’s QoL was assessed at baseline and one year after TAVI using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Vital status was collected from the SNDS ("Systeme Natiobal des donnees de sante"). Factors associated with a futility outcome, defined by death or significant degradation of QoL one-year after a TAVI, were analyzed through a multivariable logistic regression. Results The mean age of the 3159 included patients was of 83 years old, and 51,1% were male. At follow-up, a total of 1055 patients (33.4%) met the primary outcome of procedure futility: 596 (18.9%) died and 459 (14.5%) had a significant decrease in QoL. The independent factors associated with procedure futility were general conditions (diabetes under insulin (RR 1.7, 95CI[1.2-2.3]; p=0.001), estimated glomerular filtration rate (odds-ratio [OR] 0.9 per 1 ml/min increase, 95CI[0.9-1.0]; p<0.001), chronic pulmonary disease (OR 1.6, 95CI[1.2-1.9]; p<0.001)), geriatric values (severe reduction in mobility (OR 1.5, 95CI[1.1-2.1]; p=0.003)), cardiologic values (supraventricular arrhythmia (OR 1.5, 95CI[1.2-1.8]; p<0.001), anticoagulation therapy at discharge (OR 1.3, 95CI[1.1-1.6]; p=0.01)), and procedural features (immediate complications (OR 1.5, 95CI[1.2-1.7]; p<0.001), and time to discharge (OR 1.1, 95CI[1.1-1.1]; p<0.001)). Conclusion One third of patients treated in the TAVI Qol Substudy presented with a futility outcome. Certain risk factors are potentially reversible (e.g. severe reduction in mobility or supraventricular arrhythmia), and their management might attenuate the risk of treatment futility and improve TAVI outcomes. Futility outcomes should be assessed with the growing number of patients with aortic stenosis and increasing concerns in the allocation of resources.