Ruiter Kanamori Lucas, Dias-Neto Marina, Porras-Colon Jesus, Lima Guilherme B, Huang Ying, Figueroa Andres, Han Sukgu M, Mendes Bernardo C, Macedo Thanila A, Saqib Naveed, Maximus Steven, Timaran Carlos H, Oderich Gustavo S
Advanced Endovascular Aortic Research Program, Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Baylor College of Medicine, Houston, TX.
Angiology and Vascular Surgery, Centro Hospitalar Universitário de São João, Porto, Portugal; Department of Surgery and Physiology, Faculdade de Medicina da Universidade do Porto, Porto, Portugal.
J Vasc Surg. 2025 Jul 17. doi: 10.1016/j.jvs.2025.06.112.
Type IIIb endoleak (T3bE) owing to fabric tears or integrity issues is infrequent, but has been poorly described among patients undergoing fenestrated-branched endovascular aortic repair (FB-EVAR). This study aimed to describe the incidence, management, and outcomes of T3bE after FB-EVAR for the treatment of complex abdominal aortic aneurysms (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs).
Clinical data, imaging, and outcomes of consecutive patients enrolled in prospective, nonrandomized physician-sponsored investigational device exemption studies evaluating company-manufactured devices for FB-EVAR at three centers were reviewed from 2013 to 2024. Patients with unequivocal diagnosis of T3bE affecting the main fenestrated-branched aortic device component, confirmed by contrast-enhanced ultrasound examination, standard or dynamic computed tomography angiography (CTA), and/or diagnostic angiography, were included. The primary end point was the cumulative incidence of T3bE. Secondary end points included treatment approaches, mortality, major adverse events, secondary interventions, and aneurysm rupture.
A total of 717 patients (69% male; mean age, 74 ± 8 years old) were treated by FB-EVAR in the two centers. After a median follow-up of 37 months (interquartile range [IQR], 25-40 months), eight patients (1.1%) had unequivocal diagnosis of T3bE affecting the main component of a fenestrated-branched device. Cumulative incidence of T3bE at 3 and 5 years was 1.1% (95% confidence interval, 0.0%-2.2%) and 2.4% (95% confidence interval, 0.6%-4.3%), respectively. All patients had prior imaging showing no T3bE. Surveillance imaging with a final diagnosis of T3bE was established by angiography in three patients, contrast-enhanced ultrasound examination in two, dynamic CTA in two, and CTA in one. Of the eight patients, seven underwent endovascular repair with redo fenestrated-branch device in three, and parallel stent graft, cuff extension, or endovascular plug/coils in one each. Seven secondary interventions successfully resolved the T3bE with one patient presenting with an aneurysm rupture leading to mortality. One patient was managed conservatively with clinical surveillance and had spontaneous resolution of the endoleak. The overall median follow-up was 55 months (IQR, 42-62 months), and the median follow-up after T3bE reintervention was 20 months (IQR, 5-28 months).
T3bEs from fabric tears or integrity issues are uncommon after FB-EVAR, but pose diagnostic and treatment challenges, particularly when the affected segment involves fenestrations and directional branches. Redo endovascular repair is effective in selected patients. Persistent leaks may lead to aneurysm sac expansion and rupture, emphasizing the need for vigilant surveillance and timely intervention.
因人工血管撕裂或完整性问题导致的Ⅲb型内漏(T3bE)并不常见,但在接受开窗分支型血管腔内主动脉修复术(FB-EVAR)的患者中,对此描述甚少。本研究旨在描述FB-EVAR治疗复杂腹主动脉瘤(CAAA)和胸腹主动脉瘤(TAAA)后T3bE的发生率、处理方法及结局。
回顾了2013年至2024年在三个中心进行的前瞻性、非随机、医生发起的研究性器械豁免研究中连续纳入的患者的临床资料、影像学检查及结局,这些研究评估了公司生产的用于FB-EVAR的器械。纳入经对比增强超声检查、标准或动态计算机断层扫描血管造影(CTA)和/或诊断性血管造影确诊的明确诊断为T3bE且影响主要开窗分支型主动脉器械组件的患者。主要终点是T3bE的累积发生率。次要终点包括治疗方法、死亡率、主要不良事件、二次干预及动脉瘤破裂情况。
两个中心共有717例患者(69%为男性;平均年龄74±8岁)接受了FB-EVAR治疗。中位随访37个月(四分位间距[IQR],25 - 40个月)后,8例患者(1.1%)被明确诊断为T3bE,影响开窗分支型器械的主要组件。T3bE在3年和5年时的累积发生率分别为1.1%(95%置信区间,0.0% - 2.2%)和2.4%(95%置信区间,0.6% - 4.3%)。所有患者既往影像学检查均未显示T3bE。最终诊断为T3bE的监测影像学检查,3例通过血管造影确定,2例通过对比增强超声检查确定,2例通过动态CTA确定,1例通过CTA确定。8例患者中,7例接受了血管腔内修复,其中3例使用了再次开窗分支器械修复,1例分别使用了平行支架移植物、袖带延长装置或血管腔内封堵器/弹簧圈修复。7次二次干预成功解决了T3bE,1例患者出现动脉瘤破裂导致死亡。1例患者采用临床监测保守治疗,并出现内漏自发消失。总体中位随访时间为55个月(IQR,42 - 62个月),T3bE再次干预后的中位随访时间为20个月(IQR,5 - 28个月)。
FB-EVAR术后因人工血管撕裂或完整性问题导致的T3bE并不常见,但带来了诊断和治疗挑战,尤其是当受影响节段涉及开窗和定向分支时。再次血管腔内修复对部分患者有效。持续渗漏可能导致动脉瘤瘤腔扩大和破裂,强调了需要进行密切监测和及时干预。