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.).
Circ Cardiovasc Interv. 2024 May;17(5):e013608. doi: 10.1161/CIRCINTERVENTIONS.123.013608. Epub 2024 Mar 26.
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.
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) of the native aortic valve.
Technical success (90.4% versus 91.8%; risk difference, 1.4% [95% CI, -4.4 to -7.2]; =0.737) and device success at 30 days (80.8% versus 75.8%; risk difference, -5.0% [95% CI, -13.2 to 3.1]; =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]; <0.001) and mean transvalvular gradient ≥20 mm Hg (2.8% versus 14.3%; risk difference, 11.5% [95% CI, 5.8-17.1]; <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]; =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]; =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]; =0.817).
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.
关于经导管自膨式 ACURATE neo2（NEO2）和球囊扩张式 SAPIEN 3 Ultra 瓣膜在严重主动脉瓣钙化主动脉瓣环技术挑战性解剖结构中的应用的比较数据较为缺乏。
2017 年 1 月至 2023 年 4 月，共评估了 1987 例患有严重原发性主动脉瓣狭窄的患者，他们接受了自膨式 NEO2（n=1457）或球囊扩张式 SAPIEN 3 Ultra（n=530）治疗。主要终点是根据 Valve Academic Research Consortium 3 定义的手术结果。倾向性匹配定义了 219 对具有严重钙化（原生主动脉瓣钙密度截断值，758 AU/cm）的患者。
技术成功率（90.4%与 91.8%；风险差异，1.4%[95%CI，-4.4 至-7.2]；=0.737）和 30 天器械成功率（80.8%与 75.8%；风险差异，-5.0%[95%CI，-13.2 至 3.1]；=0.246）在 NEO2 和 SAPIEN 3 Ultra 之间无显著差异。严重瓣周漏或瓣中瓣所致瓣周漏的发生率较高（1.1%与 10.1%；风险差异，10.0%[95%CI，4.0-13.9]；<0.001），平均跨瓣压梯度≥20mmHg 的发生率较低（2.8%与 14.3%；风险差异，11.5%[95%CI，5.8-17.1]；<0.001）。NEO2 组的瓣周漏相关的瓣周漏或瓣中瓣所致瓣周漏发生率显著较高（6.2%与 0.0%；风险差异，6.2%[95%CI，-10.1 至-2.7]；=0.002），器械栓塞或迁移的发生率也呈上升趋势（1.8%与 0.0%；风险差异，-1.8%[95%CI，-4.1 至 0.4]；=0.123）。多变量回归显示，经导管心脏瓣膜的选择对器械成功率没有独立影响（比值比，0.93[95%CI，0.48-1.77]；=0.817）。
在严重钙化瓣环的患者中，NEO2 的 supraannular 植入术具有血流动力学优势。然而，与 SAPIEN 3 Ultra 相比，NEO2 与较高的相关瓣周漏发生率和较高的器械栓塞发生率相关，特别是在这一特定患者群体中。
