One-Year Outcomes of Transcatheter Aortic Valve Implantation Using the Direct Aortic Approach.

Abstract

The direct aortic (DA) approach allows for transcatheter aortic valve implantation (TAVI) in patients with difficult peripheral vascular anatomy. The CoreValve ADVANCE Direct Aortic (ADVANCE DA) study was performed to assess the outcomes of DA TAVI with the CoreValve System (Medtronic, Minneapolis, MN) in routine practice. Patients were selected for the DA approach by local cardiac surgical teams, and TAVI was performed with patients under general anesthesia. Safety events were adjudicated according to the Valve Academic Research Consortium-2 definitions by an independent clinical events committee. All imaging data, including that from multislice computed tomography and follow-up echocardiography, were analyzed by an independent core laboratory. From September 2012 to February 2014, 100 patients were enrolled (52.0% male, age 81.9 ± 5.9 years, The Society of Thoracic Surgeons Score 5.9 ± 3.2%) at 9 centers in Europe. Peripheral vascular disease was present in 51.0% of patients, and 38.0% had diabetes. Of the 100 patients enrolled, 92 underwent TAVI. At 30 days after TAVI, 98.1% were free of moderate or severe paravalvular leak. At 1 year, 16 patients had died (Kaplan-Meier rate 17.9%), 1 (1.1%) patient had had a stroke, classified as nondisabling, and 15 (17.0%) patients had received a permanent pacemaker. Most patients experienced improved quality of life as measured by the Kansas City Cardiomyopathy Questionnaire overall summary score (mean change from baseline to 1 year, 39.6 ± 26.3; p < 0.01). The DA approach provides a feasible alternative for patients with challenging anatomic features that may otherwise preclude use of the TAVI procedure.