中文摘要

第一部分

 Z2区TEVAR中直接覆盖与开窗技术在单发左椎动脉患者中的疗效比较：一项回顾性研究

目的：为了获得足够的近端定区，Z2区胸主动脉腔内修复术（thoracic endovascular aortic repair，TEVAR）中覆盖单发左椎动脉（isolated left vertebral artery，ILVA）是获取近端锚定区的常规策略。ILVA作为一种常见的先天性血管畸形，是否需要保留血流仍存争议。本研究旨在比较Z2区TEVAR中直接覆盖与开窗技术的疗效。

方法：本研究回顾性分析了2010年9月至2023年8月期间阜外医院接受Z2区TEVAR治疗的ILVA患者的临床数据。根据治疗方式不同，以上患者分为覆盖组（N=23）和开窗组（N=33）。本研究对比分析了两组患者的基线特征、手术结果，以及手术前后左右椎动脉直径变化的情况。

结果：本研究队列患者的平均年龄为54.48 ± 10.31岁，男性占比为89.29%，平均体重指数为25.88 ± 3.5 kg/m²。开窗组患者年龄较大（56.82 ± 8.78岁 vs 51.13 ± 11.56岁，P=0.04）。两组患者的TEVAR技术成功率均为100%，围术期无死亡。开窗组的同期左锁骨下动脉支架植入比例较高（57.58% vs 21.74%，P=0.008）。出院时，覆盖组患者的左椎动脉直径缩小幅度显著大于开窗组（3.03% [0, 13.61%] vs 0 [-3.29%, 5.13%]，P<0.001）。覆盖组的狭窄率明显高于开窗组（39.13% vs 6.06%，P<0.01）。随访计算机断层扫描血管造影结果显示，覆盖组的左椎动脉狭窄率较高（52.94% vs 14.29%，P=0.02），但两组的闭塞率相似（29.41% vs 4.76%，P=0.07）。

结论：与直接覆盖相比，开窗技术在Z2区TEVAR术后显著减少了ILVA的狭窄程度，强调了术中保留ILVA血流在手术中的重要性。

第二部分

  CSkirt主动脉弓分支支架系统治疗B型主动脉夹层疗效：多中心

1年随访结果分析

目的：评估新型CSkirt主动脉弓分支支架系统（简称CSkirt系统）治疗累及主动脉弓且需重建左锁骨下动脉的B型主动脉夹层（type B aortic dissection，TBAD）的中期疗效及安全性。

方法：本研究为前瞻性、单臂、多中心临床研究（全国26家中心协作），纳入2021年7月至2022年10月接受CSkirt系统治疗的需重建左锁骨下动脉的TBAD患者。主要终点为术后12个月治疗成功率和术后30无主要不良事件（major adverse events，MAE）发生率，次要终点包括即刻手术成功率、I/III型内漏发生率和分支通畅率等。采用SAS 9.4进行统计分析，正态分布计量资料以均数±标准差表示，分类变量以频数（%）描述，假设检验采用Z检验及Clopper-Pearson精确法。

结果：120例患者，平均年龄54.43 ± 11.01岁，男性占89.17%，85%合并高血压。即刻手术成功率为97.46%（115/118），平均手术时间为137.28 ± 52.24分钟，术中失血量48.00 ± 38.31 mL。主体支架均成功释放（143个），定位准确率99.30%；117例（97.50%）完成左锁骨下动脉分支支架植入。术后12个月治疗成功率达99.09%（109/110）。术后12个月假腔最大直径从术前38.31 ± 8.58 mm降至5.26 ± 12.95 mm，假腔完全血栓化率达80.00%（88/110）；真腔直径从11.57 ± 6.13 mm扩增至27.09 ± 3.64 mm。术后30天MAE发生率为2.50%（3/120），包括1例主动脉相关死亡及2例缺血性脑梗死；12个月全因死亡率5.00%（6/120），均与器械或手术无关。12个月Ⅰ/Ⅲ型内漏仅3.64%（4/110）。

结论：CSkirt系统通过优化原位开窗技术和双层裙边密封设计，在需要重建左锁骨下动脉的TBAD治疗中展现出优异的疗效：技术成功率高达97.46%，12个月治疗成功率高达99.09%，体现了该器械良好的解剖适配性。同时，80%假腔血栓化率及较低的Ⅰ/Ⅲ型内漏发生率（3.64%），也证实了该系统在保证分支通畅性及预防内漏的有效性。

第三部分

CS系统治疗复杂主动脉弓病变的解剖适用性研究

目的：回顾性分析接受开发手术、杂交手术或烟囱/开窗技术治疗主动脉动脉瘤或穿透性溃疡患者的影像资料，评估C-S一体化主动脉弓部三分支重建系统（concave supra-arch branched stent-graft，CS系统）在这些患者中的解剖适用性。

方法：纳入2014年1月至2023年12月在阜外医院接受主动脉弓人工血管置换术、杂交手术或烟囱/开窗技术治疗的主动脉动脉瘤和穿透性溃疡患者。根据CS系统全国多中心注册研究中关于疾病类型的纳入标准，并按照病变性质分为动脉瘤组（n = 93）和穿透性溃疡组（n = 95）。基于术前计算机断层扫描血管造影数据，测量升主动脉直径和长度、左颈总动脉/左锁骨下动脉前主动脉直径及分支跨距等解剖学参数，采用CS系统解剖入选标准进行适配性分析。连续变量的正态性通过Shapiro-Wilk检验评估，符合正态分布的变量采用Student t检验，非正态分布的变量采用Mann-Whitney U检验。分类变量比较采用卡方检验或Fisher精确检验。

结果：本研究共纳入188例患者，其中155例（82.4%）符合CS系统解剖标准，平均年龄为65.4±9.2岁，女性占比为6.4%。动脉瘤组与溃疡组基线特征无显著差异（P>0.05）。形态学分析显示，动脉瘤组远端病变直径（40.01 ± 8.58 mm vs 34.94 ± 6.19 mm，P<0.05）、远端锚定区直径（29.49 ± 6.49 mm vs 26.93 ± 4.25 mm，P<0.05）以及左颈总动脉/左锁骨下动脉前主动脉直径均显著大于溃疡组（P<0.05）。此外，动脉瘤组弓上三分支跨距（58.60 ± 15.30 mm vs 53.53 ± 8.82 mm，P<0.05）及左颈总动脉后缘至病变距离（9.30 ± 9.01 vs 7.03 ± 4.66 mm，P<0.05）显著延长。病例筛查失败的原因主要与升主动脉直径或长度异常、弓上分支动脉锚定区参数不符相关，其中因弓上三分支跨距＞80 mm被排除的患者均来自动脉瘤组。

结论：本研究基于解剖学评估发现，82.4%的主动脉弓动脉瘤及穿透性溃疡患者符合CS系统的适用标准。然而，动脉瘤患者中常见因瘤体扩张导致的弓上三分支跨距异常（＞80 mm），提示需通过优化主体支架凹槽段长度设计，以进一步提升其解剖适用性。此外，对于合并升主动脉扩张（直径＞45 mm）或复杂解剖变异的患者，开放手术仍被认为是当前公认的金标准治疗方式。

Abstract

Part I

Outcomes Comparison of Direct Coverage versus Fenestration for Isolated Left Vertebral Artery Management in Zone 2 TEVAR

Objective: Thoracic endovascular aortic repair (TEVAR) in Zone 2 often involves covering the isolated left vertebral artery (ILVA), a common congenital vascular anomaly, to achieve adequate proximal sealing. The necessity of ILVA revascularization remains uncertain. This study compares the outcomes of ILVA coverage and fenestration during Zone 2 TEVAR.

Methods: We retrospectively analyzed clinical data from patients with ILVA at Fuwai Hospital who underwent Zone 2 TEVAR between September 2010 and August 2023. Patients were divided into two groups: Coverage Group (N=23) and Fenestration Group (N=33). Baseline characteristics, surgical outcomes, and changes in left and right vertebral artery diameters pre- and post-operatively were compared.

Results: The cohort had a mean age of 54.48 ± 10.31 years, with 89.29% being male, and a mean BMI of 25.88 ± 3.5 kg/m². The Fenestration Group was older (56.82 ± 8.78 vs 51.13 ± 11.56, P=0.04). The technical success rate of TEVAR was 100% in both groups, with no perioperative mortality. The Fenestration Group had a higher rate of simultaneous left subclavian artery stenting (57.58% vs 21.74%, P=0.008). At discharge, the Coverage Group had a greater reduction in left vertebral artery diameter compared to the Fenestration Group (3.03% [0, 13.61%] vs 0 [-3.29%, 5.13%], P<0.001). The stenosis rate was significantly higher in the Coverage Group (39.13% vs 6.06%, P<0.01). Follow-up CTA revealed higher left vertebral artery stenosis in the Coverage Group (52.94% vs 14.29%, P=0.02), with similar occlusion rates (29.41% vs 4.76%, P=0.07).

Conclusion: Fenestration significantly reduces postoperative ILVA stenosis in Zone 2 TEVAR compared to direct coverage, emphasizing the importance of revascularizing ILVA.

Part II

Efficacy of the CSkirt Aortic Arch Branch Stent-Graft System in the Treatment of Type B Aortic Dissection: A Multi-center Study with One-Year Follow-Up Results

Objective: To evaluate the mid-term efficacy and safety of the novel CSkirt aortic arch branch stent graft system (CSkirt system) in the treatment of type B aortic dissection (TBAD) involving the aortic arch and requiring reconstruction of the left subclavian artery.

Methods: This study is a prospective, single-arm, multi-center clinical trial conducted across 26 centers nationwide. It includes TBAD patients who required left subclavian artery reconstruction and were treated with the CSkirt system from July 2021 to October 2022. The primary endpoints are the treatment success rate at 12 months post-surgery and the incidence of major adverse events (MAEs) within 30 days post-surgery. Secondary endpoints include immediate surgical success rate, incidence of type I/III endoleaks, and branch patency. Statistical analysis was performed using SAS 9.4, with normally distributed continuous variables presented as mean ± standard deviation, categorical variables described as frequency (%), and hypothesis testing conducted using the Z-test and Clopper-Pearson exact method.

Results: A total of 120 patients were included, with a mean age of 54.43 ± 11.01 years, and 89.17% were male. Hypertension was present in 85% of patients. The immediate surgical success rate was 97.46% (115/118), with an average operation time of 137.28 ± 52.24 minutes and intraoperative blood loss of 48.00 ± 38.31 mL. All 143 main stents were successfully deployed, with a positioning accuracy of 99.30%. A total of 117 patients (97.50%) had left subclavian artery branch stents successfully implanted. The treatment success rate at 12 months post-surgery was 99.09% (109/110). At 12 months, the maximum diameter of the false lumen decreased from 38.31 ± 8.58 mm preoperatively to 5.26 ± 12.95 mm, with a complete false lumen thrombosis rate of 80.00% (88/110); the true lumen diameter increased from 11.57 ± 6.13 mm to 27.09 ± 3.64 mm. The incidence of MAE at 30 days was 2.50% (3/120), including 1 aortic-related death and 2 ischemic strokes. The 12-month all-cause mortality rate was 5.00% (6/120), all unrelated to the device or procedure. The incidence of type I/III endoleaks at 12 months was 3.64% (4/110).

Conclusion: The CSkirt system, by optimizing the in situ fenestration technique and utilizing a dual-layer skirt sealing design, demonstrates excellent efficacy in the treatment of TBAD requiring left subclavian artery reconstruction. The technical success rate was as high as 97.46%, with a treatment success rate of 99.09% at 12 months, reflecting the system's good anatomical compatibility. Furthermore, the 80% false lumen thrombosis rate and low incidence of type I/III endoleaks (3.64%) confirm the system's effectiveness in maintaining branch patency and preventing endoleaks.

Part III

Anatomical Suitability of the CSkirt System in the Treatment of Complex Aortic Arch Pathologies

Objective: To retrospectively analyze the imaging data of patients with aortic aneurysms or penetrating ulcers treated with open surgery, hybrid surgery, or chimney/fenestration techniques, and evaluate the anatomical suitability of the C-S integrated aortic arch three-branch reconstruction system (concave supra-arch branched stent-graft, CSkirt system) in these patients.

Methods: Patients who underwent aortic arch graft replacement, hybrid surgery, or chimney/fenestration techniques for aortic aneurysms and penetrating ulcers at Fuwai Hospital from January 2014 to December 2023 were included. Based on the inclusion criteria for disease types in the national multi-center registration study of the CSkirt system, patients were divided into the aneurysm group (n = 93) and the penetrating ulcer group (n = 95). Anatomical parameters, including ascending aortic diameter and length, left common carotid artery/left subclavian artery anterior aortic diameter, and supra-arch branch distance, were measured based on preoperative CT angiography data. The compatibility with the CSkirt system’s anatomical inclusion criteria was analyzed. The normality of continuous variables was assessed using the Shapiro-Wilk test. Normally distributed variables were analyzed using the Student’s t-test, and non-normally distributed variables were analyzed using the Mann-Whitney U test. Categorical variables were compared using the chi-square test or Fisher’s exact test.

Results: A total of 188 patients were included in this study, of whom 155 (82.4%) met the anatomical criteria for the CSkirt system. The mean age was 65.4 ± 9.2 years, with 6.4% female participants. There were no significant differences in baseline characteristics between the aneurysm group and the ulcer group (P > 0.05). Morphological analysis showed that the aneurysm group had significantly larger distal lesion diameters (40.01 ± 8.58 mm vs. 34.94 ± 6.19 mm, P < 0.05), distal landing zone diameters (29.49 ± 6.49 mm vs. 26.93 ± 4.25 mm, P < 0.05), and left common carotid/left subclavian artery anterior aortic diameters compared to the ulcer group (P < 0.05). Additionally, the aneurysm group had a significantly longer supra-arch branch distance (58.60 ± 15.30 mm vs. 53.53 ± 8.82 mm, P < 0.05) and a longer distance from the posterior edge of the left common carotid artery to the lesion (9.30 ± 9.01 mm vs. 7.03 ± 4.66 mm, P < 0.05). The reasons for screening failure were mainly related to abnormal ascending aortic diameter or length and non-compliance with the parameters for the supra-arch branch artery anchoring zone. Among the patients excluded due to a supra-arch branch distance >80 mm, all were from the aneurysm group.

Conclusion: Based on anatomical evaluation, this study found that 82.4% of patients with aortic arch aneurysms and penetrating ulcers met the anatomical suitability criteria for the CSkirt system. However, in aneurysm patients, the commonly observed supra-arch branch distance abnormalities (> 80 mm) due to aneurysm expansion suggest that further optimization of the main stent groove section length is needed to improve anatomical compatibility. Furthermore, for patients with concurrent ascending aortic dilation (diameter >45 mm) or complex anatomical variations, open surgery remains the gold standard treatment.