Department of Cardiovascular Surgery, University Heart Center Freiburg, Faculty of Medicine, Albert Ludwig University of Freiburg, Freiburg, Germany.
GERN Center for Tissue Replacement, Regeneration, and Neogenesis, Department of Orthopedics and Trauma Surgery, Medical Center - Albert Ludwig University of Freiburg, Faculty of Medicine, Albert Ludwig University of Freiburg, Freiburg, Germany.
Ann Thorac Surg. 2020 Oct;110(4):1271-1279. doi: 10.1016/j.athoracsur.2020.02.017. Epub 2020 Mar 16.
This study sought to evaluate the incidence of and identify risk factors for distal stent graft-induced new entries (dSINEs) after the frozen elephant trunk (FET) procedure.
Patient characteristics and radiographic and follow-up data on 126 patients treated for aortic dissections with the Thoraflex (Vascutek Ltd, Inchinnan, United Kingdom) FET device in 2 centers between November 2013 and December 2018 were evaluated. Stress-strain behavior and load-displacement curves of the Thoraflex and the E-Vita Open (Jotec Inc, Hechingen, Germany) FET prosthesis were evaluated by applying axial load to the most distal ring of the prostheses.
dSINEs were diagnosed in 16 patients (13%). There was no difference in the underlying disease, aortic features, or FET stent graft dimension between patients with and without dSINEs. No predictors for dSINE occurrence in patients treated with the Thoraflex device were identified. The risk for dSINE development was 14% (95% confidence interval [CI], 0% to 22%), 16% (95% CI, 0% to 24%), and 25% (95% CI, 0% to 45%) after 12, 24, and 36 months, respectively. When prostheses were loaded axially to 2-mm maximal displacement, the Thoraflex prosthesis exhibited strongly nonlinear behavior with maximal stiffness for minimal displacements, whereas the E-Vita prosthesis showed nearly constant stiffness. In addition, the Thoraflex prosthesis showed an increase in stiffness when confined.
dSINEs may develop at any time after the FET procedure, and the risk for dSINE development is high. No clinical or patient-specific risk factors were identified in this study. The design of the Thoraflex graft with a stiff distal ring may be a potential reason for the occurrence of dSINEs.
本研究旨在评估冷冻象鼻（FET）手术后远端支架移植物诱导新入口（dSINEs）的发生率，并确定其危险因素。
评估了 2013 年 11 月至 2018 年 12 月期间在 2 个中心使用 Thoraflex（Vascutek Ltd， Inchinnan，英国）FET 装置治疗主动脉夹层的 126 名患者的患者特征以及影像学和随访数据。通过对假体的最远端环施加轴向载荷，评估 Thoraflex 和 E-Vita Open（Jotec Inc，Hechingen，德国）FET 假体的应力-应变行为和载荷-位移曲线。
16 名患者（13%）诊断为 dSINEs。dSINEs 患者与无 dSINEs 患者的基础疾病、主动脉特征或 FET 支架移植物尺寸无差异。未确定 Thoraflex 装置治疗患者发生 dSINE 的预测因素。dSINE 发展的风险分别为 12 个月后 14%（95%置信区间[CI]，0%至 22%）、24 个月后 16%（95%CI，0%至 24%）和 36 个月后 25%（95%CI，0%至 45%）。当假体以 2mm 的最大位移轴向加载时，Thoraflex 假体表现出强烈的非线性行为，具有最小位移的最大刚度，而 E-Vita 假体表现出几乎恒定的刚度。此外，当 Thoraflex 假体受到限制时，其刚度会增加。
dSINEs 可能在 FET 手术后的任何时间发生，并且 dSINE 发展的风险很高。本研究未发现临床或患者特异性的危险因素。Thoraflex 移植物带有刚性远端环的设计可能是 dSINEs 发生的一个潜在原因。
