Transcatheter Aortic Valve Implantation Futility Risk Model Development and Validation Among Treated Patients With Aortic Stenosis

Abstract

Risk-benefit assessment for transcatheter aortic valve implantation (TAVI) is still evolving. A sizeable group of patients do not fully benefit from intervention despite a technically successful procedure. All patients who underwent TAVI with device success and with no Valve Academic Research Consortium (VARC)-2 defined complications were included. Various demographic data, clinical details, and echocardiographic findings were examined. The outcome was defined as 1-year composite of mortality, stroke, lack of functional-class improvement (by New York Heart Association class), and readmissions (≥1 month after the procedure). Logistic regression was used to fit the prediction model. We used a 10-fold cross-validation to validate our results. Of 543 patients, 435 met the inclusion criteria. The mean age was 82 (±6.5) years, 43% were men, and the mean Society of Thoracic Surgeons score was 6.6 (±4.7). At 1 year, 66 of 435 patients (15%) experienced the study end point. The final logistic regression model included diabetes, baseline New York Heart Association functional class, diastolic dysfunction, need for diuretics, mean gradient, hemoglobin level, and creatinine level. The area under the curve was 0.73 and was reduced to 0.71 after validation, with a 97% specificity using a single cutoff. Dividing to low-, medium-, and high-risk groups for futility produced a corresponding prevalence of 6%, 19%, and 59% futility. A web application for the prediction model was developed and provided. In conclusion, this prediction score may provide an important insight and may facilitate identification of patients who, despite a technically successful and uncomplicated procedure, have risk that may outweigh the benefit of a contemplated TAVI.