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

IF 6.1 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Circulation: Cardiovascular Interventions Pub Date : 2024-05-01 Epub Date: 2024-03-26 DOI:10.1161/CIRCINTERVENTIONS.123.013608

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

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引用次数: 0

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.

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ACURATE neo2 与 SAPIEN 3 Ultra 经导管心脏瓣膜在严重主动脉瓣钙化中的应用：倾向匹配分析

背景：经导管自膨化ACURATE neo2（NEO2）和球囊扩张SAPIEN 3 Ultra假体在重度主动脉瓣钙化主动脉瓣环的高难度解剖中的比较数据很少：对2017年1月至2023年4月期间使用自膨胀NEO2（n=1457）或球囊扩张SAPIEN 3 Ultra（n=530）治疗的1987例重度原发性主动脉瓣狭窄患者进行了评估。主要终点是根据瓣膜学术研究联盟 3 定义的手术结果。倾向匹配定义了219对原发性主动脉瓣严重钙化（钙密度临界值为758 AU/cm2）的患者：NEO2和SAPIEN 3 Ultra的技术成功率（90.4%对91.8%；风险差异为1.4% [95% CI, -4.4 to -7.2]；P=0.737）和30天的装置成功率（80.8%对75.8%；风险差异为-5.0% [95% CI, -13.2 to 3.1]；P=0.246）相当。NEO2 的假体与患者严重不匹配率（1.1% 对 10.1%；风险差异，10.0% [95% CI，4.0-13.9]；PPP=0.002）和器械栓塞或移位率（1.8% 对 0.0%；风险差异，-1.8% [95% CI，-4.1 至 0.4]；P=0.123）有上升趋势。多变量回归显示，经导管心脏瓣膜的选择对装置的成功率没有独立影响（几率比，0.93 [95% CI，0.48-1.77]；P=0.817）：结论：在钙化严重的瓣环患者中，NEO2瓣环上植入显示出血流动力学优势。尽管如此，与 SAPIEN 3 Ultra 相比，NEO2 在这一特殊患者群体中的相关瓣膜旁漏发生率更高，器械栓塞率也更高。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Circulation: Cardiovascular Interventions CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

10.30

自引率

1.80%

发文量

221

审稿时长

6-12 weeks

期刊介绍： Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.