METHODS: All patients treated using TBEs for zone 0 to 2 were included. Patients treated as part of the clinical trial for zone 0 to 1 (n = 6) were excluded. Patient demographics, comorbidities, anatomic and operative details, and outcomes were reported. Outcomes and survival were then compared between groups.
RESULTS: Of 40 patients, six patients underwent repair of zone 0, three of zone 1, and 31 of zone 2. There were no differences in demographics, comorbidities, or operative details by zone of treatment; however, the frequency of genetic aortopathy differed (zone 0: 0%; zone 1: 67%; and zone 2: 6.4%; P < .01). Seventy-three percent of patients were treated for dissection vs 27% with isolated aneurysms. Of the patients, 2.5% were treated for rupture, 22% were treated for symptomatic aneurysms, and 75% were treated electively. Forty-eight percent of repairs included a proximal cuff, and 83% received distal extension. Technical success was achieved in 100% of patients. Mean fluoroscopy time was 18 minutes, and median fluoroscopy dose was 416 mGy. Sixty percent of patients had prior aortic ascending/arch repair. TBE was planned as part of a complete thoracoabdominal repair in 45% of patients. Thirty-day mortality was 2.5% overall, with a single death in a zone 0 patient that occurred at day 1 due to a myocardial infarction. There were no reinterventions within 30 days. All other outcomes were similar. The 30-day stroke rate was 5.0%. The strokes occurred at day 6 (zone 1) and day 15 (zone 2); however, both were due to occlusion of a prior proximal surgical bypass and unrelated to the TBE side branch or embolization. Specifically, both patients had occlusion of a branch of their prior zone 1 or zone 2 arch replacement. An endoleak occurred in 7.5% of patients at 30-day follow-up (type II: 5.0%; unknown: 2.5%). At a mean follow-up of 6.6 months, 100% of side branches were patent.
CONCLUSIONS: Repair of the aortic arch including TBE can be performed electively and urgently with acceptable stroke and death rates. TBE provides a valuable tool for patients requiring complete repair of a thoracoabdominal aneurysm. Continued investigation is underway to assess long-term safety and efficacy outside of the clinical trial.
方法:纳入所有在0至2区使用TBE治疗的患者。作为区域0至1的临床试验的一部分治疗的患者(n=6)被排除。患者人口统计学,合并症,解剖和手术细节,并报告了结果。然后比较两组的预后和生存率。
结果:在40名患者中,6例患者接受了0区修复,1区修复3例,2区修复31例。人口统计学没有差异,合并症,或按治疗区划分的手术细节;然而,遗传性主动脉病变的频率不同(区域0:0%;区域1:67%;区域2:6.4%;P<0.01)。73%的患者接受了夹层治疗,而27%的患者接受了孤立的动脉瘤治疗。在患者中,2.5%的破裂治疗,22%的患者接受了有症状的动脉瘤治疗,75%接受选择性治疗。48%的修复包括近端袖带,83%接受了远端延伸。100%的患者获得了技术成功。平均透视时间为18分钟,中位透视剂量为416mGy。60%的患者先前有主动脉升/弓修复术。计划将TBE作为45%患者的完整胸腹修复的一部分。30天死亡率为2.5%,在第1天因心肌梗死而发生的0区患者中有一人死亡。30天内没有再干预。所有其他结果相似。30天中风率为5.0%。中风发生在第6天(第1区)和第15天(第2区);然而,两者均是由于之前的近端手术旁路闭塞所致,且与TBE侧支或栓塞无关.具体来说,两名患者先前的1区或2区足弓置换的分支均发生闭塞.在30天的随访中,有7.5%的患者发生内漏(II型:5.0%;未知:2.5%)。平均随访6.6个月,100%的侧枝为专利。
结论:主动脉弓修复术包括TBE可以选择性和紧急进行,卒中和死亡率可接受。TBE为需要完全修复胸腹动脉瘤的患者提供了有价值的工具。正在进行持续调查,以评估临床试验之外的长期安全性和有效性。