Department of Cardiology, Amsterdam UMC, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division. University of Campinas, Campinas, Brazil.
Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands.
JACC Cardiovasc Interv. 2020 Jun 8;13(11):1303-1311. doi: 10.1016/j.jcin.2020.03.002. Epub 2020 Mar 16.
The aim of this study was to assess acute regurgitation following transcatheter aortic valve replacement, comparing different implanted transcatheter heart valves.
Regurgitation following transcatheter aortic valve replacement influences all-cause mortality. Thus far, no quantitative comparison of regurgitation among multiple commercially available transcatheter heart valves has been performed.
Aortograms from a multicenter cohort of consecutive 3,976 transcatheter aortic valve replacements were evaluated in this pooled analysis. A total of 2,258 (58.3%) were considered analyzable by an independent academic core laboratory using video densitometry. Results of quantitative regurgitation are shown as percentages. The valves evaluated were the ACURATE (n = 115), Centera (n = 11), CoreValve (n = 532), Direct Flow Medical (n = 21), Evolut PRO (n = 95), Evolut R (n = 295), Inovare (n = 4), Lotus (n = 546), Lotus Edge (n = 3), SAPIEN XT (n = 239), and SAPIEN 3 (n = 397). For the main analysis, only valves with more than 50 procedures (7 types) were used.
The Lotus valve had the lowest mean regurgitation (3.5 ± 4.4%), followed by Evolut PRO (7.4 ± 6.5%), SAPIEN 3 (7.6 ± 7.1%), Evolut R (7.9 ± 7.4%), SAPIEN XT (8.8 ± 7.5%), ACURATE (9.6 ± 9.2%) and CoreValve (13.7 ± 10.7%) (analysis of variance p < 0.001). The only valves that statistically differed from all their counterparts were Lotus (as the lowest regurgitation) and CoreValve (the highest). The proportion of patients presenting with moderate or severe regurgitation followed the same ranking order: Lotus (2.2%), Evolut PRO (5.3%), SAPIEN 3 (8.3%), Evolut R (8.8%), SAPIEN XT (10.9%), ACURATE (11.3%), and CoreValve (30.1%) (chi-square p < 0.001).
In this pooled analysis stemming from daily clinical practice, the Lotus valve was shown to have the best immediate sealing. This analysis reflects the objective evaluation of regurgitation by an academic core laboratory (nonsponsored) in a real-world cohort of patients using a quantitative technique.
本研究旨在比较不同植入式经导管主动脉瓣置换术后急性反流，评估经导管主动脉瓣置换术后的急性反流。
经导管主动脉瓣置换术后的反流会影响全因死亡率。迄今为止，尚未对多种商业上可获得的经导管心脏瓣膜的反流进行定量比较。
本荟萃分析评估了来自多中心连续 3976 例经导管主动脉瓣置换术患者的主动脉造影。共有 2258 例（58.3%）由独立的学术核心实验室使用视频密度测定法进行了可分析。反流的定量结果以百分比表示。评估的瓣膜包括 ACURATE（n=115）、Centera（n=11）、CoreValve（n=532）、Direct Flow Medical（n=21）、Evolut PRO（n=95）、Evolut R（n=295）、Inovare（n=4）、Lotus（n=546）、Lotus Edge（n=3）、SAPIEN XT（n=239）和 SAPIEN 3（n=397）。主要分析中，仅使用超过 50 例（7 种类型）的瓣膜。
Lotus 瓣膜的平均反流率最低（3.5±4.4%），其次是 Evolut PRO（7.4±6.5%）、SAPIEN 3（7.6±7.1%）、Evolut R（7.9±7.4%）、SAPIEN XT（8.8±7.5%）、ACURATE（9.6±9.2%）和 CoreValve（13.7±10.7%）（方差分析 p<0.001）。唯一与所有其他瓣膜统计学上有差异的瓣膜是 Lotus（反流率最低）和 CoreValve（反流率最高）。中度或重度反流患者的比例遵循相同的排序顺序：Lotus（2.2%）、Evolut PRO（5.3%）、SAPIEN 3（8.3%）、Evolut R（8.8%）、SAPIEN XT（10.9%）、ACURATE（11.3%）和 CoreValve（30.1%）（卡方检验 p<0.001）。
在这项源于日常临床实践的汇总分析中，Lotus 瓣膜表现出最佳的即刻密封效果。该分析反映了使用定量技术由学术核心实验室（非赞助）对真实世界患者队列中反流进行的客观评估。
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