Anatomic feasibility of a novel modular triple-branched endograft for patients with aortic arch pathologies.

Expert review of medical devices Pub Date : 2024-12-01 Epub Date: 2024-11-24 DOI:10.1080/17434440.2024.2433718
Zelin Niu, Long Cao, Wei Guo, Hongpeng Zhang
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Abstract

Objectives: This study aimed to assess the anatomical feasibility of a novel modular triple-branched endograft for aortic arch diseases.

Methods: A cross-sectional study was conducted on 314 patients with aortic arch pathologies treated at a single center from January 2018 to December 2023. Preoperative computed tomography angiography images were analyzed with three-dimensional reconstruction to quantify anatomical features. Feasibility was based on endograft anatomical criteria, and logistic regression identified risk factors for unsuitability.

Results: Out of 132 patients included in the study, 67.4% were deemed anatomically suitable for the triple-branched device. A total of 36 (27.3%) patients were deemed inapplicable due to a large diameter of the proximal landing zone, 12 (9%) patients due to a small diameter of the left common carotid artery, and 1 (0.8%) patient due to a small diameter of the left subclavian artery. Logistic regression identified large proximal landing zone diameter and small left common carotid artery diameter were significant factors for unsuitability (p < 0.001 and p = 0.002, respectively).

Conclusions: The novel triple-branched endograft demonstrated promising anatomical feasibility in two-thirds of patients. However, anatomical constraints limited its applicability. Future device iterations should focus on accommodating a broader range of anatomical variations.

用于主动脉弓病变患者的新型模块化三分支内移植物的解剖可行性。
研究目的本研究旨在评估一种新型模块化三分支内植物治疗主动脉弓疾病的解剖可行性:从2018年1月至2023年12月,对在一个中心接受治疗的314例主动脉弓病变患者进行了横断面研究。通过三维重建分析术前计算机断层扫描血管造影图像,量化解剖特征。可行性基于内植物解剖学标准,逻辑回归确定了不适合的风险因素:在纳入研究的 132 名患者中,67.4% 的患者被认为在解剖学上适合使用三分支装置。共有 36 例(27.3%)患者因近端着床区直径过大而不适用,12 例(9%)患者因左侧颈总动脉直径过小而不适用,1 例(0.8%)患者因左侧锁骨下动脉直径过小而不适用。逻辑回归发现,近端着床区直径大和左侧颈总动脉直径小是不适合的重要因素(P P = 0.002):结论:新型三分支内植物移植在三分之二的患者中显示出良好的解剖可行性。结论:新型三分支内移植物在三分之二的患者中显示出良好的解剖可行性,但解剖限制限制了其适用性。未来的装置迭代应侧重于适应更广泛的解剖变异。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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