Department of Cardiothoracic & Vascular Surgery, Advanced Aortic Research Program at the University of Texas Health Science Center at Houston, McGovern Medical School, Houston, TX.
Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, Worcester, MA.
J Vasc Surg. 2023 Jul;78(1):10-28.e3. doi: 10.1016/j.jvs.2023.03.025. Epub 2023 Mar 21.
The purpose of this study was to evaluate the effect of directional branches (DBs) bridging stent choice on target artery (TA) outcomes during fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms.
Patients enrolled in nine prospective physician-sponsored investigational device exemption studies in the United States between 2005 and 2020 were analyzed. All patients who had at least one TA incorporated by DB using either self-expandable (SESGs), balloon-expandable (BESGs), or hybrid stent graft combinations (HSGs). Endpoints were TA patency and freedom from TA endoleak, instability, and reintervention.
There were 800 patients with 2426 renal-mesenteric arteries incorporated by DBs. DB stent selection was SESGs in 1205 TAs (50%), BESGs in 1095 TAs (45%), and HSGs in 126 TAs (5%). SESGs were predominantly used in the first three quartiles of the study period, whereas BESGs comprised 75% of all stents between 2017 and 2020. The median follow-up was 15 months (interquartile range, 6-35 months). At 5 years, BESGs had significantly lower freedom from TA instability (78% ± 4% vs 88% ± 1% vs 96% ± 2%; log-rank P =.010), freedom from TA endoleaks (87% ± 3% vs 97% ± 1% vs 99% ± 1%; log-rank P < .001), and freedom from TA reintervention (83% ± 4% vs 95% ± 1% vs 99% ± 2%; log-rank P <.001) compared with SESGs or HSGs, respectively. For renal arteries, there was no difference in freedom from TA instability for BESGs, SESGs, or HSGs. However, freedom from TA endoleaks and reintervention were lower for renal arteries targeted by BESGs compared with DBs targeted by SESGs and HSGs (83% ± 6% vs 98% ± 1% vs 100%; log-rank P < .001; and 70% ± 10% vs 92% ± 1% vs 96% ± 4%; log-rank P = .022). For mesenteric arteries, DBs targeted by BESGs had lower freedom from TA instability, endoleak, and reintervention than SESGs or HSGs. In stent-specific analysis, iCAST BESGs had the lowest freedom from TA instability either for renal or mesenteric arteries, primarily due to higher rates of TA endoleaks. There was no difference in patency in any scenario. Independent predictors of TA instability were age (+1-year: hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.94-0.99), stent diameter (+1 mm: HR, 0.67; 95% CI, 0.57-0.80), and BESG (HR, 1.8; 95% CI, 1.1-2.9).
DBs incorporated using BESGs had lower freedom from TA instability, TA endoleak, and TA reintervention compared with SESGs and HSGs. The patency of DBs was not affected by the type of stent construction. The observed performance disadvantage associated with BESGs appears to have largely been driven by iCAST usage.
本研究旨在评估分支血管（DB）桥接支架选择对复杂胸腹主动脉瘤腔内修复中靶动脉（TA）结局的影响。
分析了 2005 年至 2020 年期间在美国进行的 9 项前瞻性医生赞助的器械豁免研究中的患者。所有至少有一条 TA 通过 DB 纳入的患者，包括使用自膨式（SESGs）、球囊扩张式（BESGs）或杂交支架移植物组合（HSGs）。终点是 TA 通畅性和免于 TA 内漏、不稳定和再干预。
共有 800 例患者，2426 条肾肠系膜动脉通过 DB 纳入。DB 支架选择为 SESGs 的有 1205 条 TA（50%），BESGs 的有 1095 条 TA（45%），HSGs 的有 126 条 TA（5%）。SESGs 主要在前三个研究期使用，而 BESGs 在 2017 年至 2020 年期间占所有支架的 75%。中位随访时间为 15 个月（四分位距，6-35 个月）。5 年时，BESGs 的 TA 不稳定（78%±4%比 88%±1%比 96%±2%；对数秩 P=0.010）、TA 内漏（87%±3%比 97%±1%比 99%±1%；对数秩 P<0.001）和 TA 再干预（83%±4%比 95%±1%比 99%±2%；对数秩 P<0.001）的无事件率显著降低，分别与 SESGs 或 HSGs 相比。对于肾动脉，BESGs、SESGs 和 HSGs 之间在 TA 不稳定方面无差异。然而，与 SESGs 和 HSGs 相比，BESGs 靶肾动脉的 TA 内漏和再干预率较低（83%±6%比 98%±1%比 100%；对数秩 P<0.001；和 70%±10%比 92%±1%比 96%±4%；对数秩 P=0.022）。对于肠系膜动脉，BESGs 靶 DB 的 TA 不稳定、内漏和再干预率低于 SESGs 或 HSGs。在支架特异性分析中，iCAST BESGs 无论是肾动脉还是肠系膜动脉，TA 不稳定的无事件率均较低，主要是由于 TA 内漏率较高。任何情况下的通畅率均无差异。TA 不稳定的独立预测因素为年龄（每增加 1 岁：风险比 [HR]，0.97；95%置信区间 [CI]，0.94-0.99）、支架直径（每增加 1mm：HR，0.67；95% CI，0.57-0.80）和 BESG（HR，1.8；95% CI，1.1-2.9）。
与 SESGs 和 HSGs 相比，使用 BESGs 构建的 DB 的 TA 不稳定、TA 内漏和 TA 再干预的无事件率较低。DB 的通畅率不受支架结构类型的影响。与 BESGs 相关的观察到的性能劣势似乎主要是由 iCAST 的使用造成的。
