定制髂支装置治疗合并和不合并腹主动脉瘤的髂总动脉瘤的中期结果。
Midterm result of custom-made iliac branch device for common iliac aneurysm with and without abdominal aortic aneurysm.
机构信息
Division of Cardiovascular Surgery, Department of Surgery, Taipei Veterans General Hospital, Taipei, Taiwan.
Institute of Clinical Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.
出版信息
Interact Cardiovasc Thorac Surg. 2021 Jan 1;32(1):97-105. doi: 10.1093/icvts/ivaa229.
OBJECTIVES
Although commercial iliac branch devices offer a new and valid endovascular approach to treating iliac aneurysm and effectively preserve antegrade flow of the internal iliac artery, their use may not be suited for all types of challenging anatomy, especially isolated common iliac artery aneurysm. Our custom-made iliac bifurcation device has a unique design and excludes both combined and isolated iliac branch aneurysm. This study validated the efficacy and safety of the custom device by comparing clinical outcomes between groups receiving commercial and custom devices.
METHODS
Data of consecutive patients receiving iliac bifurcation device implantation for iliac aneurysm with or without concomitant endovascular repair for abdominal aortic aneurysm from January 2010 to May 2019 were reviewed.
RESULTS
Iliac bifurcation device implantation with or without concomitant abdominal aortic aneurysm stent grafting was completed in 46 patients (commercial, n = 35; custom, n = 11). No significant differences were observed regarding postoperative complications, occlusion or endoleak. Comparisons of primary (80.8% vs 85.7%, P = 0.88) and secondary (86.5% vs 85.7%, P = 0.85) patency and freedom from reintervention (88.2% vs 100%, P = 0.33), all-cause mortality (78.6% vs 100%, P = 0.25) and aneurysm-related mortality (100% vs 100%, P = 1.00) also indicated no differences at a 5-year surveillance point. Furthermore, the iliac aneurysms of the groups displayed similar shrinkage 1 year after procedures.
CONCLUSIONS
For iliac aneurysm, the novel custom-made iliac bifurcation device is an adaptable design not inferior to commercial devices with regard to postoperative complications, bridge occlusion, endoleak and short-term aneurysm remodelling. It provides an alternative for treatment, particularly when certain anatomic challenges are present.
CLINICAL TRIAL REGISTRATION
2018-07-050BC, 2017-01-023ACF.
目的
尽管商用髂分支装置为治疗髂动脉瘤提供了一种新的有效血管内治疗方法，并能有效维持髂内动脉的前向血流，但它们的使用可能并不适合所有类型的具有挑战性的解剖结构，尤其是孤立的髂总动脉瘤。我们定制的髂分叉装置具有独特的设计，可排除髂分支合并及孤立性动脉瘤。本研究通过比较接受商用和定制设备治疗的患者的临床结果，验证了定制设备的疗效和安全性。
方法
回顾了 2010 年 1 月至 2019 年 5 月期间，因髂动脉瘤接受髂分叉装置植入术（伴或不伴腹主动脉瘤腔内修复术）的连续患者的资料。
结果
46 例患者接受了髂分叉装置植入术（商用组 35 例，定制组 11 例），伴或不伴腹主动脉瘤支架植入术。术后并发症、闭塞或内漏无显著差异。主要通畅率（80.8% vs 85.7%，P=0.88）和次要通畅率（86.5% vs 85.7%，P=0.85）以及免于再次干预率（88.2% vs 100%，P=0.33）、全因死亡率（78.6% vs 100%，P=0.25）和动脉瘤相关死亡率（100% vs 100%，P=1.00）的比较均表明，5 年随访时无差异。此外，两组的髂动脉瘤在术后 1 年均有相似的缩小。
结论
对于髂动脉瘤，新型定制髂分叉装置是一种适应性设计，与商用装置相比，在术后并发症、桥接闭塞、内漏和短期动脉瘤重塑方面并无差异。当存在某些解剖学挑战时，它为治疗提供了一种替代方案。
临床试验注册
2018-07-050BC，2017-01-023ACF。
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