Which is the Optimal Frozen Elephant Trunk? A Systematic Review and Meta-Analysis of Outcomes in 2161 Patients Undergoing Thoracic Aortic Aneurysm Surgery Using E-vita OPEN PLUS Hybrid Stent Graft versus Thoraflex™ Hybrid Prosthesis

Abstract Objective: To systematically review the rate of morbidity and mortality associated with the use of E-vita hybrid stent graft and ThoraflexTM in patients undergoing complex aortic surgery. Methods: A comprehensive search was undertaken among the four major databases to identify published data about E-vita or Thoraflex™ in patients undergoing repair of thoracic aortic aneurysms. Results: In total, 28 papers were included in the study, encompassing a total of 2,161 patients (1,919 E-vita and 242 Thoraflex™). Patients undergoing surgery with E-vita or Thoraflex™ were of similar age and sex. The number of patients undergoing non-elective repair with Thoraflex™ was higher than with E-vita (35.2% vs. 28.7%, respectively). Cardiopulmonary bypass time was associated with increasing mortality in E-vita patients, however a meta-analysis of proportions showed higher 30-day mortality, permanent neurological deficit, and one-year mortality for Thoraflex™ patients. Direct statistical comparisons between E-vita and Thoraflex™ was not possible due to heterogeneity of studies. Conclusion: Although there are limited studies available, the available data suggests that mortality and morbidity are lower for the E-vita device in thoracic aortic aneurysm surgery than for Thoraflex™. Long-term data of comparative studies do not yet exist to assess viability of these procedures.摘要：本研究旨在系统评价接受复杂主动脉手术的患者使用E-vita混合型覆膜支架（E-vita hybrid stent graft）与Thoraflex™支架相关的发病率与死亡率。研究方法：在四大核心数据库中开展全面检索，筛选已发表的、关于E-vita或Thoraflex™用于胸主动脉瘤修复患者的研究数据。研究结果：最终纳入28篇文献，共计2161例患者（其中1919例使用E-vita支架，242例使用Thoraflex™支架）。两组手术患者的年龄与性别分布无显著差异。使用Thoraflex™支架接受非择期修复手术的患者比例高于E-vita支架组（分别为35.2%与28.7%）。体外循环时长与E-vita支架使用者的死亡率升高相关；然而荟萃分析结果显示，Thoraflex™支架使用者的30天死亡率、永久性神经功能缺损发生率及一年死亡率均更高。由于各研究间存在异质性，无法直接对E-vita与Thoraflex™进行统计学对比。研究结论：尽管现有研究数量有限，但现有数据表明，在胸主动脉瘤手术中，E-vita支架的死亡率与发病率均低于Thoraflex™支架。目前尚无针对上述两种手术方式的长期对比研究数据，无法评估其临床适用性。