ACURATE neo2 Versus SAPIEN 3 Ultra Transcatheter Heart Valve in Severe Aortic Valve Calcification: A Propensity-Matched Analysis

Clemens Eckel; Won-Keun Kim; Dagmar Sötemann; Christina Grothusen; Vedat Tiyerili; Guido Dohmen; Matthias Renker; Efstratios I Charitos; Christian W Hamm; Yeong-Hoon Choi; Albrecht Elsässer; Helge Möllmann; Johannes Blumenstein

doi:10.1161/CIRCINTERVENTIONS.123.013608

ACURATE neo2 Versus SAPIEN 3 Ultra Transcatheter Heart Valve in Severe Aortic Valve Calcification: A Propensity-Matched Analysis

Circ Cardiovasc Interv. 2024 Mar 26:e013608. doi: 10.1161/CIRCINTERVENTIONS.123.013608. Online ahead of print.

Authors

Clemens Eckel^{1

2}, Won-Keun Kim^{3

4}, Dagmar Sötemann¹, Christina Grothusen^{1

5}, Vedat Tiyerili¹, Guido Dohmen⁶, Matthias Renker^{3

4}, Efstratios I Charitos⁴, Christian W Hamm^{7

8}, Yeong-Hoon Choi⁴, Albrecht Elsässer², Helge Möllmann¹, Johannes Blumenstein^{1

2}

Affiliations

¹ Department of Cardiology, St. Johannes Hospital, Dortmund, Germany (C.E., D.S., C.G., V.T., H.M., J.B.).
² Department of Cardiology, University of Oldenburg, Germany (C.E., A.E., J.B.).
³ Departments of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany. (W.-K.K., M.R.).
⁴ Cardiac Surgery, Kerckhoff Heart Center, Bad Nauheim, Germany. (W.-K.K., M.R., E.I.C., Y.-H.C.).
⁵ Department of Cardiac Surgery, University of Kiel, Germany (C.G.).
⁶ Department of Cardiac Surgery, St. Johannes Hospital, Dortmund, Germany (G.D.).
⁷ Department of Cardiology, University of Giessen, Germany (C.W.H.).
⁸ German Center for Cardiovascular Research, Partner Site RheinMain, Bad Nauheim, Germany (C.W.H.).

PMID: 38529637
DOI: 10.1161/CIRCINTERVENTIONS.123.013608

Abstract

Background: Comparative data on transcatheter self-expanding ACURATE neo2 (NEO2) and balloon-expandable SAPIEN 3 Ultra prostheses in technically challenging anatomy of severe aortic valve calcified aortic annuli are scarce.

Methods: A total of 1987 patients with severe native aortic stenosis treated with the self-expanding NEO2 (n=1457) or balloon-expandable SAPIEN 3 Ultra (n=530) from January 2017 to April 2023 were evaluated. The primary end point was procedural outcome according to the Valve Academic Research Consortium 3 definitions. Propensity matching defined 219 pairs with severe calcification (calcium density cutoff, 758 AU/cm²) of the native aortic valve.

Results: Technical success (90.4% versus 91.8%; risk difference, 1.4% [95% CI, -4.4 to -7.2]; P=0.737) and device success at 30 days (80.8% versus 75.8%; risk difference, -5.0% [95% CI, -13.2 to 3.1]; P=0.246) were comparable between NEO2 and SAPIEN 3 Ultra. The rate of severe prosthesis-patient mismatch (1.1% versus 10.1%; risk difference, 10.0% [95% CI, 4.0-13.9]; P<0.001) and mean transvalvular gradient ≥20 mm Hg (2.8% versus 14.3%; risk difference, 11.5% [95% CI, 5.8-17.1]; P<0.001) was lower with NEO2. The rate of more-than-mild paravalvular leakage or valve-in-valve due to paravalvular leakage was significantly higher (6.2% versus 0.0%; risk difference, 6.2% [95% CI, -10.1 to -2.7]; P=0.002), and there was a tendency for a higher rate of device embolization or migration (1.8% versus 0.0%; risk difference, -1.8% [95% CI, -4.1 to 0.4]; P=0.123) with NEO2. Multivarate regression revealed no independent impact of transcatheter heart valve selection on device success (odds ratio, 0.93 [95% CI, 0.48-1.77]; P=0.817).

Conclusions: In patients with severely calcified annuli, supraannular implantation of NEO2 showed hemodynamic advantages. Nevertheless, NEO2 was associated with a higher incidence of relevant paravalvular leakage and a numerically higher rate of device embolization than SAPIEN 3 Ultra in this particular patient group.

Keywords: aortic valve stenosis; calcium; hemodynamics; incidence; prostheses and implants.