Gouveia E Melo Ryan, Fernández Prendes Carlota, Khanafer Adib, Wanhainen Anders, Mani Kevin, Rouhani Guido, Chao Victor, Tay Kiang Hiong, Chong Tze Tec, Adam Donald, Dias Nuno, Agaev Arzou, Tsilimparis Nikolaos
Department of Vascular Surgery, Ludwig Maximilian University Hospital, Munich, Germany.
University of Otago, Christchurch, Christchurch Hospital, Christchurch, New Zealand.
J Endovasc Ther. 2025 Apr;32(2):481-489. doi: 10.1177/15266028231179593. Epub 2023 Jun 9.
To analyze device designs, similarities and overlaps of custom-made fenestrated arch endografts intended for mid/distal arch thoracic endovascular aortic repair.
A multicenter cross-sectional study analyzing custom-made anonymized graft plans was performed. Graft plans were included from a cohort of mid/distal aortic arch repairs using custom-made fenestrated aortic endografts treated at 8 centers. Grafts targeting >2 arteries were excluded. No patient/clinical data were analyzed. A descriptive analysis was performed followed by an analysis of overlap of the designs to reach a common design in which the greatest number of grafts would overlap.
One hundred thirty-one graft plans were included. All grafts were custom-made grafts from the COOK Medical Fenestrated arch platform. Ninety-four (71.8%) had a scallop-and-single-fenestration design, 33 (25.2%) had a single fenestration and 4 (4.3%) a single scallop. For analysis purposes, these latter 4 grafts were excluded. Two main graft plans () were proposed after analysis with similar configuration (1 scallop with 30 mm width, 20 mm height, 12:00 position; 1 preloaded fenestration with 8 mm diameter, 26 mm from the top of the graft and 12:00 position; tapered, with a 193 mm length and 32 mm distal diameter) but with 2 different proximal diameters of 38 mm () and 44 mm (), reaching an overall feasibility of 85.8% (n=109), being 47.2% (n=60) and 38.6% (n=49) for each design, respectively.
The degree of overlap between the studied fenestrated and/or scalloped thoracic endovascular aneurysm repair (TEVAR) graft designs was high. Future studies analyzing these designs in a real-world cohort of patients are needed to further address off-the-shelf feasibility.Clinical ImpactIn a multicenter study analyzing 127 fenestrated aortic arch endograft plans from 9 aortic centers, we found that the degree of overlap between the studied fenestrated and/or scalloped arch graft designs was high and that 2 proposed graft designs would be theoretically applicable in 85.8% of cases. Future studies analyzing these designs in a real-world cohort of patients are needed to further address off-the-shelf feasibility.
分析用于胸主动脉中/远段腔内修复的定制开窗型主动脉弓内支架移植物的装置设计、异同点及重叠情况。
开展一项多中心横断面研究，分析定制的匿名移植物方案。纳入了8个中心采用定制开窗型主动脉内支架移植物治疗的中/远段主动脉弓修复队列中的移植物方案。排除了针对超过2条动脉的移植物。未分析患者/临床数据。先进行描述性分析，然后分析设计重叠情况，以得出能使最多移植物重叠的通用设计。
共纳入131个移植物方案。所有移植物均为库克医疗公司开窗型主动脉弓平台的定制移植物。94个（71.8%）采用用用有扇贝形和单开窗设计，33个（25.2%）有单开窗设计，4个（4.3%）有单扇贝形设计。为便于分析，后4个移植物被排除。分析后提出了两种主要的移植物方案（），其构型相似（1个扇贝形，宽30毫米，高20毫米，位于12:00位置；1个预载开窗，直径8毫米，距移植物顶部26毫米，位于12:00位置；呈锥形，长193毫米，远端直径32毫米），但近端直径不同，分别为38毫米（）和44毫米（），总体可行性为85.8%（n = 109），每种设计的可行性分别为47.2%（n = 60）和38.6%（n = 49）。
所研究的开窗型和/或带扇贝形的胸主动脉腔内动脉瘤修复（TEVAR）移植物设计之间的重叠程度较高。未来需要在真实患者队列中分析这些设计，以进一步探讨现成产品的可行性。临床影响在一项分析9个主动脉中心127个开窗型主动脉弓内支架移植物方案的多中心研究中，我们发现所研究的开窗型和/或带扇贝形的主动脉弓移植物设计之间的重叠程度较高，并且两种提出的移植物设计理论上在85.8%的病例中适用。未来需要在真实患者队列中分析这些设计，以进一步探讨现成产品的可行性。
