Procedural Results of Patients Undergoing Transcatheter Aortic Valve Implantation With Aortic Annuli Diameter ≥26 mm: insights from the German Aortic Valve Registry.

Patients presenting with severe aortic stenosis and large aortic annuli are challenging to treat because of the size limitations of available transcatheter heart valves. In this study, we aimed to determine clinical and hemodynamic outcomes in patients presenting with large aortic annuli who underwent transcatheter aortic valve implantation (TAVI). Patients from the German Aortic Valve Registry who underwent TAVI either with the Edwards Sapien (ES) or Medtronic CoreValve (MCV) systems from 2011 to 2017 were included. They were further stratified into a large (aortic annulus diameter 26 to 29 mm for ES; 26 to 30 mm for MCV) and extra-large (aortic annulus diameter >29 mm for ES; >30 mm for MCV) group and analyzed using propensity score adjustment. Extra-large was set beyond the sizing limitations according to the manufacturer's instructions for use. Patients in the large (n = 5,628) and extra-large (n = 509) groups were predominantly male (large: 92.6% vs extra-large: 91.9%). The 30-day mortality was comparable (large: 3.9% vs extra-large: 5.0%, p = 0.458). Procedure duration (large: 78.9 minutes ± 0.82 vs extra-large: 86.4 minutes ± 1.9, p <0.001) was longer in the extra-large group. Likewise, vascular complications (large: 6.2% vs extra-large: 12%, p = 0.002) and the need for a permanent pacemaker implantation (large: 18.8% vs extra-large: 26.0%, p = 0.027) were more often present in the extra-large group. Aortic regurgitation ≥II after valve implantation was numerically higher (large: 3.0% vs extra-large: 5.3%, p = 0.082) in patients with extra-large anatomy. In conclusion, patients with large and extra-large aortic annulus diameters who underwent TAVI have comparable 30-day mortality. Beyond the recommended annulus range, there is a higher risk for vascular complications and permanent pacemaker implantation.

Informations de copyright

Copyright © 2021 Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Disclosures Drs. Piayda and Zeus report statistical analysis was provided by German Center for Cardiovascular Disease. Dr. Frerker reports a relation with Universitätsklinikum Schleswig-Holstein that includes consulting or advisory and has received speaker fees from Medtronic, Edwards Lifesciences, Boston Scientific, and Abbott. Dr. Bleiziffer reports a relation with Heart and Diabetes Center North Rhine-Westphalia that includes consulting or advisory and has received speaker fees from Medtronic and Boston Scientific. Dr. Zeus reports a relation with University Hospital Düsseldorf that includes consulting or advisory and has received consulting fees, travel expenses, or study honoraria from Medtronic and Edwards Lifesciences outside of this work. The remaining authors have no conflicts of interest to declare.