Department of Vascular and Endovascular Surgery, University Hospital, LMU Munich, Munich, Germany.
Department of Vascular and Endovascular Surgery, University Hospital, LMU Munich, Munich, Germany; Department of Cardiothoracic and Vascular Surgery, Evangelismos General Hospital of Athens, Athens, Greece.
J Vasc Surg. 2020 Aug;72(2):716-725.e1. doi: 10.1016/j.jvs.2020.01.049. Epub 2020 Apr 1.
Endovascular treatment of thoracoabdominal aortic aneurysms is becoming increasingly popular in clinical practice, mainly because of its reduced perioperative mortality and morbidity. However, the custom-made stent graft platform that companies offer requires detailed preoperative planning and production time that can take up to 12 weeks. This may delay surgery in elective patients and is not an option for urgent or emergent cases. To surpass this limitation, the t-Branch (Cook Medical, Bloomington, Ind) was launched in 2012 in Europe as the first off-the-shelf standardized multibranched endograft for the endovascular treatment of thoracoabdominal aneurysms. Our aim was to systematically evaluate all published experience with this commercially available off-the-shelf thoracoabdominal stent graft.
We performed a systematic inquiry of the medical databases to identify all published studies that reported on the outcomes of patients treated with the t-Branch stent graft and then conducted a qualitative synthesis and meta-analysis of the results. The main end points studied were technical success, mortality, major stroke, spinal cord ischemia, primary branch patency, and renal insufficiency during the first 30 days along with midterm mortality and reintervention rate. We estimated pooled proportions and 95% confidence intervals (CIs).
We identified seven retrospective studies published between 2014 and 2018, with a total of 197 patients (mean age, 72.3 ± 7 years; 70% male). Among 165 patients, 45% were symptomatic and 19% were treated for a ruptured aortic aneurysm. In 197 patients, pooled technical success was 92.75% (95% CI, 83.9%-98.7%), and in 10% of the cases, an early endoleak was detected (95% CI, 0%-43.7%). Early mortality was 5.8% (95% CI, 2.5%-10%), and major stroke was observed in 4% of the patients (95% CI, 0.96%-8.40%). The rate of spinal cord ischemia was 12.2% (95% CI, 4.1%-23.2%), with the rate of permanent paraplegia at 1.3% (95% CI, 0%-8.7%). Acute renal failure was 18.7% (95% CI, 9.1%-30.4%), whereas primary branch patency was calculated at 98.2% (95% CI, 96.7%-99.2%). Mean follow-up was 15 ± 7 months. During this time, midterm mortality (after 30 days) was 6.9% (95% CI, 2.44%-12.8%) and pooled reintervention rate was 5.7% (95% CI, 1.70%-11.4%).
This pooled analysis indicated good technical success rate after t-Branch endograft implantation, with acceptable mortality and neurologic complications despite a high rate of urgent procedures. Thoracoabdominal endovascular repair with the t-Branch endograft is a feasible and safe therapeutic option for elective and urgent patients.
腔内治疗胸腹主动脉瘤在临床实践中越来越受欢迎，主要是因为其围手术期死亡率和发病率较低。然而，公司提供的定制支架移植物平台需要详细的术前规划和长达 12 周的生产时间。这可能会延迟择期患者的手术时间，并且不适合紧急或紧急情况。为了克服这一限制，2012 年，t-Branch（库克医疗，印第安纳州布鲁明顿）在欧洲推出，作为首个用于胸腹主动脉瘤腔内治疗的现成标准化多分支支架移植物。我们的目的是系统地评估所有已发表的关于这种商业上可用的现成胸腹支架移植物的经验。
我们对医学数据库进行了系统查询，以确定所有报道 t-Branch 支架移植物治疗患者结果的已发表研究，并对结果进行了定性综合和荟萃分析。研究的主要终点包括技术成功率、死亡率、主要卒中、脊髓缺血、一级分支通畅率和 30 天内肾功能不全，以及中期死亡率和再介入率。我们估计了汇总比例和 95%置信区间（CI）。
我们确定了 2014 年至 2018 年期间发表的 7 项回顾性研究，共 197 名患者（平均年龄 72.3±7 岁；70%为男性）。在 165 名患者中，45%有症状，19%因破裂的主动脉瘤而接受治疗。在 197 名患者中，汇总技术成功率为 92.75%（95%CI，83.9%-98.7%），10%的病例检测到早期内漏（95%CI，0%-43.7%）。早期死亡率为 5.8%（95%CI，2.5%-10%），4%的患者发生主要卒中（95%CI，0.96%-8.40%）。脊髓缺血的发生率为 12.2%（95%CI，4.1%-23.2%），永久性截瘫的发生率为 1.3%（95%CI，0%-8.7%）。急性肾衰竭的发生率为 18.7%（95%CI，9.1%-30.4%），而一级分支通畅率为 98.2%（95%CI，96.7%-99.2%）。平均随访时间为 15±7 个月。在此期间，中期死亡率（30 天后）为 6.9%（95%CI，2.44%-12.8%），汇总再介入率为 5.7%（95%CI，1.70%-11.4%）。
这项汇总分析表明，t-Branch 支架移植物植入后的技术成功率较高，尽管紧急手术比例较高，但死亡率和神经并发症可接受。t-Branch 支架移植物用于胸腹主动脉血管内修复是一种可行且安全的治疗选择，适用于择期和紧急患者。
