07). At 30 days, major vascular complications were significantly more frequent with TAVR (11.0% versus 3.2%, P <0.001); adverse events that were more frequent after sAVR included major bleeding (9.3% versus 19.5%, P <0.001) and new-onset atrial fibrillation (8.6% versus 16.0%, P=0.006).16 More patients undergoing TAVR had an improvement in symptoms at 30 days, but by 1 year there was not a significant difference between groups.16 The PARTNER II (Cohort B) Trial is designed to determine the safety and effectiveness of the Edwards 18-Fr SAPIEN XT™ device and

NovaFlex delivery system in inoperable patients with symptomatic critical aortic stenosis.17 Patients will be Inhibitors,research,lifescience,medical randomized in a 2:1 fashion to the SAPIEN XT device or the SAPIEN RetroFlex III device.17 The primary noninferiority endpoints are all-cause mortality, major stroke, and repeat hospitalization at 1 year.17 Self-Expanding TAVR Registries and Randomized Clinical Trials Inhibitors,research,lifescience,medical The Medtronic CoreValve ReValving System (Medtronic, Inc., Minneapolis, MN) consists of a trileaflet porcine pericardial valve and a self-expanding Inhibitors,research,lifescience,medical nitinol support frame. The CoreValve is available for clinical study in the United States in 23-mm, 26-mm, 29-mm, and 31-mm sizes. It is placed by means of an 18-Fr sheath from

the femoral artery or subclavian (axillary) arteries or via direct aortic access. The 18-Fr Safety and Efficacy Study included 126 patients (logistic EuroSCORE=23.4%) with severe aortic valve stenosis.18 The overall technical success rate was 83.1%, and the 30-day Inhibitors,research,lifescience,medical all-cause mortality was 15.2%.18 All-cause mortality was 38.1% at 2 years. There was a significant difference in 2-year mortality between moderate-risk and high-risk groups (27.8% versus 45.8%, respectively; P=0.04), mainly attributable to an increased risk of noncardiac mortality among patients in the high-risk groups.18

Hemodynamic results remained unchanged during Inhibitors,research,lifescience,medical follow-up (mean gradient: 8.5±2.5 mmHg at 30 days and 9.0±3.4 mmHg at 2 years).18 Functional class improved in 80% of patients and remained stable over time. There was no incidence of structural valve deterioration. A see more number of national registries have been developed to evaluate the safety and efficacy of the CoreValve TAVR (Table 3).19-25 These registries have included 2,156 patients, and a preliminary meta-analysis of these registries has been reported.19-25 Although there were no consistent definitions, procedure success rates ranged from 92.6 to 98%, and 30-day mortality rates ranged from 84.9 to 92.1%.19-25 Table 3 National registries with self-expanding CoreValve TAVR. The United States CoreValve Extreme Risk Pivotal Registry has completed enrollment of 487 patients Fulvestrant datasheet deemed to have a predicted 30-day surgical mortality risk or irreversible serious morbidity risk that exceeds 50%.