Clin Res Cardiol (2021)
DOI DOI https://doi.org/10.1007/s00392-021-01843-w
Aortic valve calcification and paravalvular leakage after implantation of the Acurate Neo trans-catheter heart valve
M. Linder1, L. Waldschmidt2, A. Goßling3, S. Ludwig2, L. Voigtländer2, D. Grundmann1, T. J. Demal4, O. Bhadra4, J. Schirmer4, H. Reichenspurner4, S. Blankenberg1, D. Westermann2, L. Conradi4, N. Schofer2, M. Seiffert3, für die Studiengruppe: HARbOR
1Klinik für Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 2Allgemeine und Interventionelle Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 3Klinik und Poliklinik für Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 4Klinik und Poliklinik für Herz- und Gefäßchirurgie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg;

Background: More than mild paravalvular leakage (PVL) is associated with impaired outcomes after transcatheter aortic valve implantation (TAVI). In a recent randomized controlled trial the Acurate NeoTM transcatheter heart valve (THV) failed to demonstrate non-inferiority to the Sapien 3TM THV, largely driven by PVL. We aimed to identify predictors of PVL for the Acurate NeoTM to help select the THV particularly suitable for the individual patient with aortic stenosis.

Methods: 441 consecutive TAVI procedures with the Acurate NeoTM THV from 2014 to 2019 were retrospectively analysed. Baseline variables, aortic valve/root geometry and calcification patterns of the device landing zone were evaluated using a multivariable logistic regression analysis. Calcification severity was additionally assessed with a receiver operating characteristics (ROC) curve.

Results: The incidence of more than mild PVL was 9.9% (moderate: 8.8%, severe: 1.1%). Compared to patients with mild or less PVL, these patients were more often male (52.3% vs. 34.3%; p=0.028) with larger annulus perimeter derived diameters (25.0mm [23.9-26.3] vs. 24.2mm [22.7-25.4]; p=0.017). Calcifications of the aortic valve were more severe (738.6mm³ [305.4-1163.9] vs. 358.2mm³ [199.4-586.2]; p<0.001) and asymmetrically distributed (maximum absolute difference between two cusps: 178.1mm³ [84.2-286.8] vs. 117.4mm³ [60.5-221.4]; p=0.026). Left ventricular outflow tract calcification was likewise increased (18.4mm³ [1.6-97.3] vs. 0.7mm³ [0-25]; p<0.001). No differences were observed in other measures of annulus, root, and LVOT geometry, and the degree of oversizing. Calcification of the aortic valve was identified as independent predictor of more than mild PVL (per mm³: OR 1.0020 [1.0011-1.0030]; p<0.001) and ROC analysis identified >620mm³ [241-700.9] as cut-off value (AUC: 0.692).

Conclusion: Calcification of the aortic valve rather than geometry of the device landing zone was independently associated with more than mild PVL after implantation of the Acurate NeoTM THV. These results may help to steer device choice in patients with aortic stenosis and facilitate comparison with the next-generation Acurate Neo 2TM.
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