Jubouri Matti, Surkhi Abedalaziz O, Tan Sven Z C P, Bailey Damian M, Williams Ian M, Bashir Mohamad
Hull York Medical School, University of York, York, United Kingdom.
Faculty of Medicine, Al-Quds University, Jerusalem, Palestine.
Front Cardiovasc Med. 2022 Jul 14;9:959149. doi: 10.3389/fcvm.2022.959149. eCollection 2022.
Since the introduction of endovascular aortic repair (EVAR), it has demonstrated excellent clinical outcomes and has replaced open surgical repair (OSR) in the treatment of abdominal aortic aneurysms (AAA). AAA is a life-threatening abnormal dilation of the abdominal aorta to 1.5 times its normal diameter. Several commercial EVAR devices exist on the global market, with the Terumo Aortic Fenestrated Anaconda™ graft showing superiority. In this study, we sought to provide an international perspective using multicenter-multinational data on the Anaconda™ device characteristics, design, and delivery, and discuss relevant literature.
This study represents a cross-sectional international analysis of custom-made fenestrated Anaconda™ device. Ethical and legal approval for data collection was obtained from each of the local authorities. For the statistical analysis, SPSS 28 for Windows and R were utilized. Pearson's chi-square analysis was used to assess differences in cumulative distribution frequencies between select variables. Statistical significance for all two-tailed tests was set at < 0.05.
A total of 5,030 Anaconda™ devices were implanted during the 9-year study period in 27 countries spanning 6 continents. The predominant device category was bifurcate (83.6%), whereas the most common proximal ring stent configuration being standard (64.5%). All devices were delivered within 8 weeks of diagnosis, with most being implanted within 6-8 weeks (55.4%). The Anaconda™ was indicated in the 3,891 (77.4%) patients due to competitor rejection/inability to treat unsuitable/complex aortic anatomy. In the remaining 1,139 (22.6%) patients, it was utilized based on surgeon preference. Almost all devices (95%) were delivered along with a prototype. Of the total 5,030 Anaconda™ devices, 438 (8.7%) used 0-1 fenestrations, 2,349 (46.7%) used 2-3, while 2,243 (44.6%) utilized 4, 5, or 6 fenestrations.
The Terumo Aortic Fenestrated Anaconda™ device features a highly unique and innovative design that enables it to treat highly complex aortic anatomy while achieving excellent results. The Anaconda™'s custom-made approach allows it to be tailored to individual patient anatomy, in addition to the device prototype provided by Terumo Aortic optimize clinical outcomes. Finally, the fenestrated Anaconda™ is a highly versatile device offering a wide range of device categories, configurations, and sizes.
自血管内主动脉修复术（EVAR）引入以来，它已展现出出色的临床效果，并在腹主动脉瘤（AAA）的治疗中取代了开放手术修复（OSR）。AAA是腹主动脉异常扩张至正常直径的1.5倍，会危及生命。全球市场上有几种商用EVAR装置，其中泰尔茂带开窗Anaconda™移植物表现出优越性。在本研究中，我们试图利用多中心、多国数据，从国际视角分析Anaconda™装置的特性、设计和输送情况，并讨论相关文献。
本研究是对定制带开窗Anaconda™装置的横断面国际分析。已获得各地方当局对数据收集的伦理和法律批准。统计分析使用了适用于Windows的SPSS 28和R软件。采用Pearson卡方分析评估选定变量之间累积分布频率的差异。所有双侧检验的统计学显著性设定为<0.05。
在为期9年的研究期间，六大洲27个国家共植入了5030个Anaconda™装置。主要的装置类型是分叉型（83.6%），而最常见的近端环形支架配置是标准型（64.5%）。所有装置均在诊断后8周内输送，大多数在6 - 8周内植入（55.4%）。3891例（77.4%）患者使用Anaconda™是因为竞争对手的产品被拒用/无法治疗不合适的/复杂的主动脉解剖结构。在其余1139例（22.6%）患者中，使用该装置是基于外科医生的偏好。几乎所有装置（95%）都是与一个原型一起输送的。在总共5030个Anaconda™装置中，438个（8.7%）使用0 - 1个开窗，2349个（46.7%）使用2 - 3个，而2243个（44.6%）使用4、5或6个开窗。
泰尔茂带开窗Anaconda™装置具有高度独特和创新的设计，使其能够治疗高度复杂的主动脉解剖结构，同时取得优异的效果。Anaconda™的定制方法使其能够根据个体患者的解剖结构进行定制，此外，泰尔茂主动脉提供的装置原型可优化临床结果。最后，带开窗的Anaconda™是一种用途广泛的装置，提供多种装置类型、配置和尺寸。
