Abstract：
OBJECTIVE: The only commercially available thoracic branched endoprosthesis (TBE) for treatment of the aortic arch was released in 2022. Limited data outside of clinical trial results have been reported. This study describes the demographics, anatomic details, and outcomes for patients treated for zone 0 to 2 using TBEs outside of a clinical trial.
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.
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.
摘要：
目的：2022年发布了唯一市售的用于治疗主动脉弓的胸分支内置假体（TBE）。临床试验结果之外的数据有限。这项研究描述了人口统计，解剖细节,以及在临床试验之外使用TBE治疗0至2区的患者的结果。
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。
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。
