A Novel Fenestrating Device: Quick Fenestrater for Reconstructing Supra-aortic Arteries In Situ During Thoracic Endovascular Aortic Repair
A Novel Fenestrating Device: Quick Fenestrater for Reconstructing Supra-aortic Arteries In Situ During Thoracic Endovascular Aortic Repair
复制标题
一种新型开窗装置：胸主动脉腔内修复术中用于原位重建主动脉上动脉的快速开窗器
DOI：
10.1016/j.cjca.2021.04.024
复制
发表时间：
2021-11-19
影响因子：
6.2
通讯作者：
Qu, Lefeng
中科院分区：
文献类型：
--
作者：
Bai, Jun;Wang, Chao;Qu, Lefeng
背景：原位开窗(ISF)是胸主动脉腔内修复术(TEVAR)中重建主动脉上支的有效方法。ISF需要一种专用装置。方法：Quick Fenestrater(QF)进行了体外、动物实验和初步临床试验。在体外，使用QF对聚四氟乙烯和涤纶主动脉内移植物进行开窗，并对移植物的结构、开窗孔和脱落颗粒材料进行评估。8头白猪采用QF辅助的ISF联合TEVAR和桥式支架植入术。通过术中血管造影术和活体组织检查来评估结果。最后，对13例患者进行QF辅助ISF联合TEVAR治疗，记录成功率、技术细节及术中、术后并发症。结果：体外试验未见内膜结构破坏。开窗孔是干净的，没有检测到颗粒物质。在动物研究中，所有动物都存活下来，主动脉上动脉通畅，内移植物和桥支架形态正常。在临床研究中，技术成功率为100%，没有发生与开窗相关的神经并发症或死亡。1例患者围手术期出现局部血肿，经保守治疗后痊愈。3名患者出现III型内漏，无需额外治疗即可痊愈。平均随访22.1+/-6个月，未发现胸腔并发症，桥接支架通畅，无内漏。无不良脑血管事件、心血管事件及死亡。结论：QF辅助ISF是TEVAR中重建主动脉上支的一种安全有效的方法。中期随访结果验证了新型开窗装置的应用。
Background: In situ fenestration (ISF) is an effective approach for reconstructing supra-aortic branches during thoracic endovascular aortic repair (TEVAR). A dedicated device is needed for ISF.Methods: The Quick Fenestrater (QF) underwent in vitro, animal based, and initial clinical testing. In vitro, the polytetrafluoroethylene and Dacron aortic endografts were fenestrated using the QF, and the structure of the graft, fenestration hole, and shed particulate material were evaluated. Eight white swine had QF-aided ISF combined with TEVAR and bridge-stent implantation. The outcomes were assessed using intraoperative angiography and biopsy. Finally, 13 patients were treated with QF-assisted ISF combined with TEVAR, and the success rate, technical details, and intra-and postoperative complications were recorded.Results: The endograft structure was not damaged during in vitro testing. The fenestration hole was clean, and no particulate material was detected. In animal studies, all animals survived, the supra-aortic arteries were patent, and the endografts and bridge stents had normal morphology. In clinical studies, the technical success rate was 100%, and no fenestration-related neurologic complications or death occurred. One patient had a local access-related hematoma perioperatively and recovered after conservative treatment. Three patients had type III endoleaks, which resolved with no additional treatment. During a mean follow-up of 22.1 +/- 6 months, no thoracic complications were identified, and the bridge stents were patent with no endoleaks. No adverse cerebrovascular events, cardiovascular events, or death occurred.Conclusions: QF-assisted ISF is a safe and effective method for the reconstruction of supra-aortic branches during TEVAR. Intermediate term follow-up results validate the application of the novel fenestration device.