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

Autor:	Eckel C; Department of Cardiology, St. Johannes Hospital, Dortmund, Germany (C.E., D.S., C.G., V.T., H.M., J.B.).; Department of Cardiology, University of Oldenburg, Germany (C.E., A.E., J.B.)., Kim WK; Departments of Cardiology (W.-K.K., M.R.), Kerckhoff Heart Center, Bad Nauheim, Germany.; Cardiac Surgery (W.-K.K., M.R., E.I.C., Y.-H.C.), Kerckhoff Heart Center, Bad Nauheim, Germany., Sötemann D; Department of Cardiology, St. Johannes Hospital, Dortmund, Germany (C.E., D.S., C.G., V.T., H.M., J.B.)., Grothusen C; Department of Cardiology, St. Johannes Hospital, Dortmund, Germany (C.E., D.S., C.G., V.T., H.M., J.B.).; Department of Cardiac Surgery, University of Kiel, Germany (C.G.)., Tiyerili V; Department of Cardiology, St. Johannes Hospital, Dortmund, Germany (C.E., D.S., C.G., V.T., H.M., J.B.)., Dohmen G; Department of Cardiac Surgery, St. Johannes Hospital, Dortmund, Germany (G.D.)., Renker M; Departments of Cardiology (W.-K.K., M.R.), Kerckhoff Heart Center, Bad Nauheim, Germany.; Cardiac Surgery (W.-K.K., M.R., E.I.C., Y.-H.C.), Kerckhoff Heart Center, Bad Nauheim, Germany., Charitos EI; Cardiac Surgery (W.-K.K., M.R., E.I.C., Y.-H.C.), Kerckhoff Heart Center, Bad Nauheim, Germany., Hamm CW; Department of Cardiology, University of Giessen, Germany (C.W.H.).; German Center for Cardiovascular Research, Partner Site RheinMain, Bad Nauheim, Germany (C.W.H.)., Choi YH; Cardiac Surgery (W.-K.K., M.R., E.I.C., Y.-H.C.), Kerckhoff Heart Center, Bad Nauheim, Germany., Elsässer A; Department of Cardiology, University of Oldenburg, Germany (C.E., A.E., J.B.)., Möllmann H; Department of Cardiology, St. Johannes Hospital, Dortmund, Germany (C.E., D.S., C.G., V.T., H.M., J.B.)., Blumenstein J; Department of Cardiology, St. Johannes Hospital, Dortmund, Germany (C.E., D.S., C.G., V.T., H.M., J.B.).; Department of Cardiology, University of Oldenburg, Germany (C.E., A.E., J.B.).
Jazyk:	angličtina
Zdroj:	Circulation. Cardiovascular interventions [Circ Cardiovasc Interv] 2024 May; Vol. 17 (5), pp. e013608. Date of Electronic Publication: 2024 Mar 26.
DOI:	10.1161/CIRCINTERVENTIONS.123.013608
Abstrakt:	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/cm 2 ) 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. Competing Interests: Disclosures Dr Kim has received proctor fees and speaker honoraria from Boston Scientific, Edwards Lifesciences, Medtronic, and Abbott. Dr Möllmann has received proctor fees and speaker honoraria from Boston Scientific, Biotronik, and Abbott. Dr Blumenstein has received proctor fees and speaker honoraria from Boston Scientific and Abbott. Dr Hamm is an advisory board member of Medtronic. The other authors report no conflicts.
Databáze:	MEDLINE
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