Elsevier

The American Journal of Cardiology

Volume 164, 1 February 2022, Pages 111-117
The American Journal of Cardiology

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

https://doi.org/10.1016/j.amjcard.2021.10.021Get rights and content

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.

Section snippets

Methods

The German Aortic Valve Registry (GARY) is a large, prospective, multicenter (78 sides) registry that monitors quality and outcomes in interventional and surgical aortic valve procedures all across Germany. Initiated in 2010, the all-comers registry collects data up to 5 years after the index procedure. Patient participation is voluntary, and the study design has been described in detail previously.7 Standardized electronic case report forms are used to collect baseline information and

Results

During the observation period from 2011 to 2017, valve implantations in extra-large anatomies increased steadily. Overall, a balloon-expandable ES valve was chosen in 311 patients (61.1%), and 198 patients (38.9%) received an MCV (Figure 2). Patients were in their early eighties (large: 80.4 years vs extra-large: 80.3 years, p = 0.787) and predominantly male (large: 92.6% vs extra-large: 91.9%, p = 0.564). Baseline characteristics after propensity score weighting were comparable, except for the

Discussion

Patients with large and extra-large aortic annulus anatomy who underwent TAVI may pose a special task to the interventional team because of the size limitations of currently commercially available transcatheter heart valves. Our study could show that patients presenting with an extra-large anatomy (aortic annulus diameter >29 mm for ES; >30 mm for MCV) have an increased risk for procedure-associated complications and impaired hemodynamic outcome, whereas in-hospital and 30-day mortality are not

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

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Drs. Zeus and Mehdiani contributed equally to this work.

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