Guideline-defined futility or patient-reported outcomes to assess treatment success after TAVI: What to use? Results from a prospective cohort study with long-term follow-up

Objective Transcatheter aortic valve implantation (TAVI) provides a significant symptom relief and mortality reduction in most patients; however, a substantial group of patients does not experience the same beneficial results according to physician-determined outcomes. Methods Single-centre prospective design; the population comprises all consecutive patients undergoing TAVI in 2012-2017. TAVI futility was defined as the combined endpoint of either no symptomatic improvement or mortality at 1 year. We actively gathered telephone follow-up using a predefined questionnaire. Results Guideline defined TAVI futility was present in 212/741 patients. Multivariate regression showed lower albumin and non-transfemoral approach to be predictive for futility. In addition to these, chronic obstructive pulmonary disease, lower estimated glomerular filtration rate, atrial fibrillation, low-flow-low-gradient aortic stenosis and lower Body Mass Index were predictive for 1-year mortality. Patients who showed symptomatic benefit estimated the percentage in which their symptoms were remedied higher than patients who did not (80% vs 60%, p<0.001). Guideline-defined TAVI futility occurs frequently, contrasting with patient-reported outcome measures (PROMs). The vast majority in both groups would again choose for TAVI treatment. Conclusion Lower albumin and non-transfemoral access route were predictors for guideline-defined TAVI futility, defined as mortality within 1 year or no objective symptomatic improvement in New York Heart Association class. Futility according to this definition occurred frequently in this study, contrasting with much more positive PROMs. The majority of patients would undergo a TAVI again, underlining the patients' experienced value of TAVI and putting the definition of TAVI futility further on debate. In the near future, less-strict criteria for TAVI futility, that is, using a shorter warranted life expectancy and incorporating patients' perceived outcomes, should be used.