Results:

TAVI was performed at 34 centers in 3,195 patients who were at high surgical risk for surgical aortic valve replacement. The average age of the cohort was 82 years and roughly half (49%) of the patients were female. The Edwards SAPIEN valve was used in 66.9% and the Medtronic CoreValve device was used in 33.1% of the patients. Most procedures were performed in a catheterization laboratory (74.7%), with 15.3% performed in a hybrid room and 10% in an operating room (10.0%). The procedure was performed using the transfemoral approach in 74.6%; subclavian approach in 5.8%, and a transapical approach in 17.8%. The procedural success rate was 96.9%. One-month mortality was 9.7%, and the death rate at 1 year was 24.0%. Mortality was significantly lower with the transfemoral approach than with the transapical approach (8.5% vs. 13.9% at 30 days and 17.2% vs. 22.4% at 6 months). The incidence of stroke was 3.4% at 30 days, 3.8% at 6 months, and 4.1% at 1 year, and the rates of major stroke were 1.9%, 2.1%, and 2.2%, respectively. A new, permanent pacemaker was required more frequently in patients receiving CoreValve devices than in those receiving the SAPIEN devices (24.2% vs. 11.5%). Major vascular complications occurred in 156 patients (4.7%). The independent predictors of mortality were a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical approach, and significant periprosthetic regurgitation.