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胸主动脉分支型腔内移植物治疗主动脉弓部病变的早期结果。

Early outcomes of endovascular repairs of the aortic arch using thoracic branch endoprosthesis.

机构信息

Division of Vascular Surgery, University of Washington, Seattle, WA; University of Washington School of Medicine, Seattle, WA.

Division of Vascular Surgery, University of Washington, Seattle, WA; Pacific Northwest University of Health Sciences, Yakima, WA.

出版信息

J Vasc Surg. 2024 Jul;80(1):22-31. doi: 10.1016/j.jvs.2024.02.003. Epub 2024 Feb 11.

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.

摘要

目的

唯一可商业化的治疗主动脉弓的胸主动脉分支型人工血管于 2022 年问世。临床试验结果之外的有限数据已经被报道。本研究描述了在临床试验之外使用胸主动脉分支型人工血管治疗区域 0 至 2 的患者的人口统计学、解剖学细节和结果。

方法

所有使用胸主动脉分支型人工血管治疗区域 0 至 2 的患者均被纳入研究。作为区域 0 至 1 临床试验一部分接受治疗的患者(n=6)被排除。报告了患者的人口统计学、合并症、解剖和手术细节以及结果。然后比较了不同组之间的结果和存活率。

结果

40 例患者中,6 例接受了区域 0 的修复,3 例接受了区域 1 的修复,31 例接受了区域 2 的修复。按治疗区域的不同,患者的人口统计学、合并症或手术细节无差异;然而,遗传主动脉病变的发生率不同(区域 0:0%;区域 1:67%;区域 2:6.4%;P<.01)。73%的患者因夹层而接受治疗,27%的患者因孤立性动脉瘤而接受治疗。患者中,2.5%因破裂而接受治疗,22%因症状性动脉瘤而接受治疗,75%因择期而接受治疗。48%的修复包括近端袖口,83%接受了远端延伸。所有患者均达到技术成功。平均透视时间为 18 分钟,中位数透视剂量为 416mGy。60%的患者有过升主动脉/主动脉弓修复的既往史。45%的患者将胸主动脉分支型人工血管计划作为完整胸腹主动脉修复的一部分。总的 30 天死亡率为 2.5%,1 例区域 0 患者在第 1 天因心肌梗死导致单一死亡。30 天内无再次干预。所有其他结果均相似。30 天的卒中率为 5.0%。卒中发生在第 6 天(区域 1)和第 15 天(区域 2);然而,两者均归因于先前近端手术旁路的闭塞,与胸主动脉分支型人工血管的侧支或栓塞无关。具体来说,两名患者均有先前区域 1 或区域 2 弓部置换的分支闭塞。7.5%的患者在 30 天随访时发生内漏(II 型:5.0%;未知:2.5%)。在平均 6.6 个月的随访中,所有侧支均通畅。

结论

包括胸主动脉分支型人工血管的主动脉弓修复可在可接受的卒中率和死亡率下择期或紧急进行。胸主动脉分支型人工血管为需要完全修复胸腹主动脉瘤的患者提供了有价值的工具。正在进行进一步的研究,以评估临床试验之外的长期安全性和疗效。

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