Two-in-one aortic valve sizing and valvuloplasty conductance balloon catheter.
Two-in-one aortic valve sizing and valvuloplasty conductance balloon catheter.
复制标题
二合一主动脉瓣尺寸确定和瓣膜成形术电导球囊导管。
DOI：
10.1002/ccd.25774
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发表时间：
2015
期刊：
影响因子：
--
通讯作者：
Kassab,Ghassan
中科院分区：
文献类型：
--
作者：
Svendsen,MarkC;Sinha,AnjanK;Berwick,ZacharyC;Combs,William;Teague,ShawnD;Lefevre,Thierry;Babaliaros,Vasilis;Kassab,Ghassan
背景：主动脉瓣尺寸和选择不准确与经导管主动脉瓣置换术（TAVR）中的瓣周漏有关。在这里，一种新的尺寸瓣膜成形术电导球囊（SVCB）导管被证明是准确的，可重复的，无偏见的，并提供真实的‐时间工具，主动脉瓣大小，适合在标准valvuloplasty procedure.Methods和ResultsThe SVCB导管是一种瓣膜成形术设备，使用真实的‐时间电导测量的基础上欧姆定律大小的球囊反对主动脉瓣在任何给定的膨胀压力。SVCB导管的准确性和可重复性在实验室已知尺寸的体模中进行，并在三个家猪主动脉瓣环中离体进行，与计算机断层扫描（CT）和扩张器测量结果进行比较。在另外3头家猪体内证明了手术工作流程和安全性。SVCB导管测量的工作台准确度偏差或误差可忽略不计，被视为金标准（偏差：−0.11 ± 0.26 mm;误差：1.2%），但离体与扩张器（偏差：−0.3 ± 1.1 mm;误差：4.5%）和离体与CT（偏差：−1.0 ± 1.6 mm;误差：8.7%）的差异更大。扩张器与CT准确度显示出相似的一致性（偏差：-0.9 ± 1.5 mm;误差：7.3%）。在实验室（偏倚：0.02 ± 0.12 mm;误差：0.5%）和离体（偏倚：-0.4 ± 0.9 mm;误差：4.6%）上的重复性极佳。在动物研究中，该器械在手术工作流程中配合良好，无不良事件或并发症。ConclusionsDue的临床相关性，这种准确的，可重复的，无偏见的，和真实的时间尺寸测量，SVCB导管可以提供一个有用的工具之前，TAVR。这些发现值得未来的人类研究。© 2015威利期刊公司.
BackgroundInaccurate aortic valve sizing and selection is linked to paravalvular leakage in transcatheter aortic valve replacement (TAVR). Here, a novel sizing valvuloplasty conductance balloon (SVCB) catheter is shown to be accurate, reproducible, unbiased, and provides real‐time tool for aortic valve sizing that fits within the standard valvuloplasty procedure.Methods and ResultsThe SVCB catheter is a valvuloplasty device that uses real‐time electrical conductance measurements based on Ohm's Law to size the balloon opposed against the aortic valve at any given inflation pressure. Accuracy and repeatability of the SVCB catheter was performed on the bench in phantoms of known dimension and ex vivo in three domestic swine aortic annuli with comparison to computed tomography (CT) and dilator measurements. Procedural workflow and safety was demonstrated in vivo in three additional domestic swine. SVCB catheter measurements had negligible bias or error for bench accuracy considered as the gold standard (Bias: −0.11 ± 0.26 mm; Error: 1.2%), but greater disagreement in ex vivo versus dilators (Bias: −0.3 ± 1.1 mm; Error: 4.5%), and ex vivo versus CT (Bias: −1.0 ± 1.6 mm; Error: 8.7%). The dilator versus CT accuracy showed similar agreement (Bias: −0.9 ± 1.5 mm; Error: 7.3%). Repeatability was excellent on the bench (Bias: 0.02 ± 0.12 mm; Error: 0.5%) and ex vivo (Bias: −0.4 ± 0.9 mm; Error: 4.6%). In animal studies, the device fit well within the procedural workflow with no adverse events or complications.ConclusionsDue to the clinical relevance of this accurate, repeatable, unbiased, and real‐time sizing measurement, the SVCB catheter may provide a useful tool prior to TAVR. These findings merit a future human study. © 2015 Wiley Periodicals, Inc.