Outcomes of patients with severe aortic stenosis at high surgical risk evaluated in a trial of transcatheter aortic valve implantation.

Recent randomized clinical trials have demonstrated that transcatheter aortic valve implantation (TAVI) reduces mortality in high-risk patients with aortic stenosis who are not candidates for aortic valve replacement (AVR). In similar patients who are acceptable candidates for AVR, TAVI provides equivalent outcomes to AVR. In this study, 900 patients with severe aortic stenosis at high surgical risk were evaluated as possible candidates for TAVI. Of these, 595 (66.1%) had neither TAVI nor AVR and constituted the medical arm. In addition to the best available conservative care, 345 patients (39.3%) in this group had balloon aortic valvuloplasty. The AVR arm consisted of 146 patients (16.2%) and the TAVI arm of 159 patients (17.6%). The AVR group had significantly lower clinical risk compared to the medical and TAVI groups, with lower mean age, Society of Thoracic Surgeons score, and logistic European System for Cardiac Operative Risk Evaluation score. Patients in the medical and balloon aortic valvuloplasty group had significantly higher B-type natriuretic peptide levels compared to those in the AVR and TAVI groups and had, on average, lower ejection fractions. The medical and balloon aortic valvuloplasty group was followed for a median of 206 days; the mortality rate was 46.6% (n = 277). The AVR group was followed for 628 days; 39 patients died (26.7%). In 399 days of follow-up, the mortality rate in the TAVI group was 30.8% (n = 49). In conclusion, patients with severe AS who did not undergo TAVI or AVR had high mortality. In properly selected patients, TAVI and AVR improve outcomes. Renal failure is the strongest correlate for adverse outcomes, irrespective of treatment group.