Department of Cardiovascular Surgery, Tokyo Medical University, Tokyo, Japan.
Cardioaortic Center, Takatsuki General (former: Kobe University), Osaka, Japan.
J Thorac Cardiovasc Surg. 2022 Dec;164(6):1681-1692.e2. doi: 10.1016/j.jtcvs.2021.03.079. Epub 2021 Apr 1.
We performed a multicenter prospective comparative study to determine the impact of a Japanese frozen elephant trunk device on total arch replacement compared with conventional repair without it.
Between 2016 and 2019, a total of 684 patients (frozen elephant trunk procedure; n = 369; conventional repair, n = 315) from 41 institutions were enrolled. The 2 procedures were selected according to each center's strategy.
The frozen elephant trunk procedure was applied more for aortic dissection, whereas the conventional repairs were predominantly performed for aneurysms. In the former, only hypothermic circulatory arrest time was reduced among the intraoperative parameters. Although there were no differences in the 30-day and in-hospital mortality rates (0.8% and 1.6%, respectively, for the frozen elephant trunk procedure vs 0.3% and 0.6%, respectively, for conventional repair), the neurologic complication rates were significantly higher in stroke (5.7% vs 2.2%; P = .022) and paraplegia (1.6% vs 0%; P = .023). In the propensity score matching analyses using 11 variables, statistical significance disappeared in the differences for mortality and neurologic morbidity (stroke and paraplegia/paraparesis) rates of 194 patients of each group, although they were still higher for the frozen elephant trunk procedure.
The early outcomes of total arch replacement with the frozen elephant trunk procedure were acceptable despite its higher prevalence of emergency or redo surgery, which was comparable to that of the conventional repair. This procedure had higher rates of spinal cord injury than the conventional repair, which is a disadvantage of this approach.
我们进行了一项多中心前瞻性对比研究，以确定日本冷冻象鼻装置对全主动脉弓置换的影响，与不使用该装置的常规修复相比。
2016 年至 2019 年，共有 684 名患者（冷冻象鼻手术；n=369；常规修复，n=315）来自 41 个机构被纳入研究。这两种手术是根据每个中心的策略选择的。
冷冻象鼻手术更多地用于治疗主动脉夹层，而常规修复主要用于治疗动脉瘤。在前者中，只有术中参数中的低温循环停止时间有所减少。虽然 30 天和住院死亡率（冷冻象鼻手术组分别为 0.8%和 1.6%，常规修复组分别为 0.3%和 0.6%）无差异，但在卒中（5.7%比 2.2%；P=0.022）和截瘫（1.6%比 0%；P=0.023）方面，神经并发症发生率明显更高。在使用 11 个变量进行倾向评分匹配分析后，尽管冷冻象鼻手术组的死亡率和神经并发症（卒中和截瘫/截瘫）发生率仍较高，但在 194 名患者的每个组中，这些差异的统计学意义消失。
尽管冷冻象鼻手术组急诊或再次手术的比例较高，但全主动脉弓置换的早期结果是可以接受的，与常规修复相当。与常规修复相比，该手术脊髓损伤发生率更高，这是该方法的一个缺点。
