Karaolanis Georgios I, Makaloski Vladimir, Jungi Silvan, Weiss Salome, Kotopoulos Konstantinos, Chaikhouni Basel, Becker Daniel, Kotelis Drosos, Bosiers Michel J
Department of Vascular Surgery, Swiss Aortic Center Bern, Inselspital, University Hospital of Bern, Bern, Switzerland; Vascular Unit, Department of Surgery, University Hospital of Ioannina and School of Medicine, Ioannina, Greece.
Department of Vascular Surgery, Swiss Aortic Center Bern, Inselspital, University Hospital of Bern, Bern, Switzerland.
J Vasc Surg. 2025 Jan;81(1):251-260.e3. doi: 10.1016/j.jvs.2024.08.013. Epub 2024 Aug 13.
During the last years a great progress has been noted in device technology and operator experience in treating complex aortic aneurysms. Fenestrated and branched custom-made devices require detailed preoperative planning and production time that can take ≤12 weeks. During this awaiting period, aortic-related mortality is increased. To overcome this limitation, off-the-shelf standardized multibranched devices were launched in the market for the treatment of pararenal and thoracoabdominal aortic aneurysms (TAAAs). Our aim was to evaluate systematically all the published studies of off-the-shelf endografts for the treatment of pararenal and TAAAs.
We performed a systematic review to identify all the eligible studies that reported outcomes to the off-the-shelf with inner or outer multibranched devices and then conducted a qualitative synthesis and meta-analysis of the results. The main outcomes were technical success, mortality, target visceral vessel instability, major adverse events, and reintervention rates. We estimated pooled proportions and 95% confidence intervals (CIs).
A total of 1605 study titles were identified by the initial search strategy, of which 13 (8 t-Branch, 3 E-nside, 1 We-Flow, and 1 TAMBE) were considered eligible for inclusion in the meta-analysis. A total of 595 patients (70% male) were identified among the eligible studies. In terms of procedures, 64.4% were elective, 19.2% (13.4% outer multibranched group [OMG]; 6.1% inner multibranched group [IMG]) were emergent, and 16.4% (15.6% OMG; 0.8% IMG) were urgent. The pooled technical success was 92.1% (95% CI, 83.8%-96.4%) and 96.9% (95% CI, 92.5%-98.8%) for the outer and inner multibranched endografts, respectively. The pooled 30-day mortality was 10.4 % (95% CI, 6.6%-16.1%,) and 4.2% (95% CI, 2.0%-8.6%) for the OMG and IMG, respectively. The pooled 30-day and late target visceral vessel instability for the OMG was 3.5% (95% CI, 2.0%-6.1%) and 6.2% (95% CI, 4.7%-8.0%) and for the IMG 10.4% (95% CI, 4.5%-22.5%) and 1.6% (95% CI, 0.7%-3.3%) respectively.
This pooled analysis indicated good technical success and mortality rates for both devices despite the high rate of urgent procedures. Pararenal and TAAAs can be treated safely using the included devices. However, further studies are required to draw additional conclusions for the IMG owing to the small sample size.
在过去几年中，治疗复杂主动脉瘤的设备技术和术者经验取得了巨大进展。开窗和分支定制设备需要详细的术前规划和长达12周的生产时间。在此等待期间，主动脉相关死亡率会增加。为克服这一限制，市场上推出了即用型标准化多分支设备用于治疗肾周和胸腹主动脉瘤（TAAA）。我们的目的是系统评估所有已发表的关于即用型腔内移植物治疗肾周和TAAA的研究。
我们进行了一项系统评价，以确定所有报告了使用内置或外置多分支设备的即用型产品结果的合格研究，然后对结果进行定性综合和荟萃分析。主要结局指标为技术成功率、死亡率、目标内脏血管不稳定情况、主要不良事件和再次干预率。我们估计了合并比例和95%置信区间（CI）。
通过初始检索策略共识别出1605个研究标题，其中13项（8项t型分支、3项E型内置、1项We-Flow和1项TAMBE）被认为符合纳入荟萃分析的条件。在合格研究中总共识别出595例患者（70%为男性）。就手术类型而言，64.4%为择期手术，19.2%（外置多分支组[OMG]为13.4%；内置多分支组[IMG]为6.1%）为急诊手术，16.4%（OMG为15.6%；IMG为0.8%）为紧急手术。外置和内置多分支腔内移植物的合并技术成功率分别为92.1%（95%CI，83.8%-96.4%）和96.9%（95%CI，92.5%-98.8%）。OMG和IMG的30天合并死亡率分别为10.4%（95%CI，6.6%-16.1%）和4.2%（95%CI，2.0%-8.6%）。OMG的30天和晚期目标内脏血管不稳定发生率分别为3.5%（95%CI，2.0%-6.1%）和6.2%（95%CI，4.7%-8.0%），IMG分别为10.4%（95%CI，4.5%-22.5%）和1.6%（95%CI，0.7%-3.3%）。
该汇总分析表明，尽管急诊手术率较高，但两种设备的技术成功率和死亡率均良好。使用纳入的设备可以安全地治疗肾周和TAAA。然而，由于IMG样本量较小，需要进一步研究以得出更多结论。
