Khan Jaffar M, Rogers Toby, Weissman Gaby, Torguson Rebecca, Rodriguez-Weisson Fernando J, Chezar-Azerrad Chava, Greenspun Benjamin, Gupta Neha, Medvedofsky Diego, Zhang Cheng, Gordon Paul, Ehsan Afshin, Wilson Sean R, Goncalves John, Levitt Robert, Hahn Chiwon, Parikh Puja, Bilfinger Thomas, Butzel David, Buchanan Scott, Hanna Nicholas, Garrett Robert, Shults Christian, Buchbinder Maurice, Garcia-Garcia Hector M, Kolm Paul, Satler Lowell F, Hashim Hayder, Ben-Dor Itsik, Asch Federico M, Waksman Ron
Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America; Cardiovascular Branch, Division of Intramural Research, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD, United States of America.
Department of Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.
Cardiovasc Revasc Med. 2021 Jun;27:1-6. doi: 10.1016/j.carrev.2020.09.034. Epub 2020 Sep 25.
BACKGROUND/PURPOSE: This sub-analysis of the prospective Low Risk TAVR (LRT) trial determined anatomical characteristics associated with hypoattenuated leaflet thickening (HALT), which may contribute to early transcatheter heart valve (THV) degeneration.
METHODS/MATERIALS: The LRT trial enrolled 200 low-risk patients between February 2016 and February 2018. All subjects underwent baseline and 30-day CT studies, analyzed by an independent core laboratory. Additional measurements, namely THV expansion, eccentricity, depth, and commissural alignment, were made by consensus of three independent readers. HALT was observed only in the Sapien 3 THV, so Evolut valves were excluded from this analysis.
In the LRT trial, 177 subjects received Sapien 3 THVs, of whom 167 (94.3%) had interpretable 30-day CTs and were eligible for this analysis. Twenty-six subjects had HALT (15.6%). Baseline characteristics were similar between groups. There was no difference in THV size implanted and baseline aortic-root geometry between groups. In patients who developed HALT, THV implantation depth was shallower than in patients who did not develop HALT (2.6 ± 1.1 mm HALT versus 3.3 ± 1.8 mm no-HALT, p = 0.03). There were more patients in the HALT group with commissural malalignment (40% vs. 28%; p = 0.25), but this did not reach statistical significance. In a univariable regression model, no predetermined variables were shown to independently predict the development of HALT.
This study did not find anatomical or THV implantation characteristics that predicted the development of HALT at 30 days. This study cannot exclude subtle effects or interaction between factors because of the small number of events.
背景/目的：这项对前瞻性低风险经导管主动脉瓣置换术（LRT）试验的亚分析确定了与瓣叶低密度增厚（HALT）相关的解剖学特征，这可能导致早期经导管心脏瓣膜（THV）退变。
方法/材料：LRT试验在2016年2月至2018年2月期间招募了200名低风险患者。所有受试者均接受了基线和30天的CT研究，由独立的核心实验室进行分析。另外的测量，即THV扩张、偏心度、深度和瓣叶交界对齐情况，由三位独立阅片者共同确定。仅在Sapien 3 THV中观察到HALT，因此Evolut瓣膜被排除在本分析之外。
在LRT试验中，177名受试者接受了Sapien 3 THV，其中167名（94.3%）有可解读的30天CT图像并符合本分析条件。26名受试者出现HALT（15.6%）。两组之间的基线特征相似。两组之间植入的THV尺寸和基线主动脉根部几何形状没有差异。发生HALT的患者中，THV植入深度比未发生HALT的患者浅（HALT组为2.6±1.1mm，无HALT组为3.3±1.8mm，p = 0.03）。HALT组中瓣叶交界未对齐的患者更多（40%对28%；p = 0.25），但未达到统计学意义。在单变量回归模型中，没有预先确定的变量被证明能独立预测HALT的发生。
本研究未发现能预测30天时HALT发生的解剖学或THV植入特征。由于事件数量较少，本研究不能排除因素之间的细微影响或相互作用。
