Nauta Foeke J H, Kamman Arnoud V, Ibrahim El-Sayed H, Agarwal Prachi P, Yang Bo, Kim Karen, Williams David M, van Herwaarden Joost A, Moll Frans L, Eagle Kim A, Trimarchi Santi, Patel Himanshu J, Figueroa C Alberto
Cardiovascular Center, University of Michigan Health System, Ann Arbor, Michigan, USA.
Department of Vascular Surgery, Thoracic Aortic Research Center, Policlinico San Donato IRCCS, University of Milan, Milan, Italy.
BMJ Open. 2016 Nov 17;6(11):e012270. doi: 10.1136/bmjopen-2016-012270.
Thoracic aortic stent grafts are orders of magnitude stiffer than the native aorta. These devices have been associated with acute hypertension, elevated pulse pressure, cardiac remodelling and reduced coronary perfusion. However, a systematic assessment of such cardiovascular effects of thoracic endovascular aortic repair (TEVAR) is missing. The CardiOvascular Remodelling following Endovascular aortic repair (CORE) study aims to (1) quantify cardiovascular remodelling following TEVAR and compare echocardiography against MRI, the reference method; (2) validate computational modelling of cardiovascular haemodynamics following TEVAR using clinical measurements, and virtually assess the impact of more compliant stent grafts on cardiovascular haemodynamics; and (3) investigate diagnostic accuracy of ECG and serum biomarkers for cardiac remodelling compared to MRI.
This is a prospective, nonrandomised, observational cohort study. We will use MRI, CT, echocardiography, intraluminal pressures, ECG, computational modelling and serum biomarkers to assess cardiovascular remodelling in two groups of patients with degenerative thoracic aneurysms or penetrating aortic ulcers: (1) patients managed with TEVAR and (2) control patients managed with medical therapy alone. Power analysis revealed a minimum total sample size of 20 patients (α=0.05, power=0.97) to observe significant left ventricular mass increase following TEVAR after 1 year. Consequently, we will include 12 patients in both groups. Advanced MRI sequences will be used to assess myocardial and aortic strain and distensibility, myocardial perfusion and aortic flow. ECG, echocardiography and serum biomarkers will be collected and compared against the imaging data. Computational models will be constructed from each patient imaging data, analysed and validated. All measurements will be collected at baseline (prior to TEVAR) and 1-year follow-up. The expected study period is 3 years.
This study has been approved by the University of Michigan IRB. The results will be disseminated through scientific journals and conference presentations.
NCT02735720.
胸主动脉覆膜支架比天然主动脉硬几个数量级。这些装置与急性高血压、脉压升高、心脏重塑和冠状动脉灌注减少有关。然而，目前缺少对胸主动脉腔内修复术（TEVAR）此类心血管效应的系统评估。血管腔内主动脉修复术后心血管重塑（CORE）研究旨在：（1）量化TEVAR术后的心血管重塑，并将超声心动图与作为参考方法的MRI进行比较；（2）使用临床测量结果验证TEVAR术后心血管血流动力学的计算模型，并虚拟评估更柔顺的覆膜支架对心血管血流动力学的影响；（3）与MRI相比，研究心电图和血清生物标志物对心脏重塑的诊断准确性。
这是一项前瞻性、非随机、观察性队列研究。我们将使用MRI、CT、超声心动图、腔内压力、心电图、计算模型和血清生物标志物，评估两组患有退行性胸主动脉瘤或主动脉穿透性溃疡的患者的心血管重塑情况：（1）接受TEVAR治疗的患者；（2）仅接受药物治疗的对照患者。功效分析显示，为观察到TEVAR术后1年左心室质量显著增加，最小总样本量为20例患者（α=0.05，功效=0.97）。因此，我们将每组纳入12例患者。将使用先进的MRI序列评估心肌和主动脉应变及扩张性、心肌灌注和主动脉血流。将收集心电图、超声心动图和血清生物标志物，并与成像数据进行比较。将根据每位患者的成像数据构建计算模型，进行分析和验证。所有测量将在基线（TEVAR术前）和1年随访时收集。预期研究周期为3年。
本研究已获得密歇根大学机构审查委员会的批准。研究结果将通过科学期刊和会议报告进行传播。
NCT02735720。
