Performance of the Corevalve Evolut R and PRO in severely calcified anatomies: a propensity-score matched analysis
Authors: Piayda K , Hellhammer K , Veulemans V , Afzal S , Heidari H , Jung C , Kelm M , Zeus T 
Published: November 2020

Abstract

Background
The Corevalve Evolut R and PRO belong to the newer generation of self-expandable valves and are increasingly used to treat patients with severe aortic stenosis. Over the years, technical advancements and increasing experience with the procedure itself are responsible for excellent clinical and hemodynamic results. Patients with severely calcified native aortic valve anatomies still pose a special task to the implanting team since the risk for intraprocedural complications might be increased.

Purpose
To evaluate the hemodynamic and clinical performance of the CoreValve Evolut R and PRO in patients with severely calcified native aortic valve anatomies.

Methods
Baseline characteristics, imaging data and procedural outcome of patients undergoing transfemoral transcatheter aortic valve implantation with the CoreValve Evolut R and PRO from 09/2015 to 03/2018 were prospectively collected. Patients underwent high-resolution multisclice computed tomography (MSCT). A pre-specific threshold of 600 Hounsfield units was set to account for the hyperdensity of the applied contrast medium and to enable comparability with MSCT thresholds, derived by non-contrast enhanced MSCT scans. Patients were divided by the extent of calcification into a severely calcified anatomy group (men &gt;2062AU, woman &gt;1377AU) or a not severely calcified anatomy group (men &lt;2062AU, woman &lt;1377AU). Propensity score matching with the variables log EuroSCORE, LVOT calcium load and the cover index in a 1:2 fashion was performed and clinical and hemodynamic results in accordance with VARC II were collected.

Results
Ninety-eight patients with severely calcified anatomies (SC) could be identified and were matched with 196 patients with lower calcified (LC) anatomies. Patients with severely calcified anatomies were older (SC: 83.1 years vs. LC: 80.3 years, p&lt;0.001) and had a smaller aortic valve area (SC: 0.63cm2 vs. LC: 0.70cm2, p=0.028). The mean implantation depth did not differ (SC 5.4mm±2.4 vs. LC: 5.1±2.2, p=0.554). Pre-dilatation was more often performed in the SC group (SC: 30.6% vs. LC: 15.8%, p=0.003) and the stroke/TIA rate did not differ (SC: 5.1% vs. LC: 3.5%, p=0.532). In SC patients, a permanent pacemaker implantation was significantly more often needed (SC: 28.5% vs. LC:7.6%, p&lt;0.001). The mean pressure gradient after the procedure was effectively reduced (SC: 7.1mmHg±3.9 vs. LC: 7.8±3.7mmHg, p=0.477). No aortic regurgitation (AR) was more often present in patients with SC anatomies (SC: 72.5% vs. LC: 85.2%, p=0.011). The aortic regurgitation index numerically differed between groups without reaching statistical significance (SC: 24.1±7.1 vs. LC: 27.3±6.7, p=0.067).

Conclusion
The CoreValve Evolut R and PRO show a good clinical safety profile and excellent hemodynamic results even in patients with severely calcified anatomies. In those patients, a permanent pacemaker implantation was more often necessary.

Funding Acknowledgement
Type of funding source: None