Oliveira-Pinto José, Oliveira Nelson, Bastos-Gonçalves Frederico, Hoeks Sanne, VAN Rijn Marie Josee, Ten Raa Sander, Mansilha Armando, Verhagen Hence J
Department of Vascular Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands; Department of Angiology and Vascular Surgery, Centro Hospitalar São João, Porto, Portugal; Department of Surgery and Physiology, Faculty of Medicine, Porto University, Porto, Portugal.
Department of Vascular Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands.
J Cardiovasc Surg (Torino). 2017 Apr;58(2):252-260. doi: 10.23736/S0021-9509.16.09830-X. Epub 2016 Dec 19.
Endovascular aneurysm repair (EVAR) has progressively expanded to more complex anatomies, frequently outside manufacturer's instructions for use (IFU). However, the long term results of off-label use of EVAR remain largely undocumented. The aim of this paper is to examine the long term results of outside IFU EVAR.
English literature was searched to identify publications on long term results for outside IFU EVAR. A follow-up extending for at least 5 years was the minimum required as inclusion criteria. The outcomes measured were: overall mortality, aneurysm-related mortality (ARM), freedom from postimplant aneurysm rupture, aneurysm sac enlargement, type I endoleaks and secondary interventions. Results were compared to randomized clinical trials (RCTs) with long term results published (EVAR-1, DREAM, OVER and ACE Trial).
Thirteen studies were included. 7 studies described outcomes associated to a specific breached IFU, while 6 studies presented general outside IFU results. In patients outside IFU, 3 to 8 years estimates of overall mortality ranged from 21.5% to 40% (RCTs:13.7-46%) and ARM from 0-11% (RCTs: 1.2-7%). Five-year estimates of sac enlargement was approximately 43%. Type I endoleak rates for outside IFU (follow-up 5-12 years) ranged from 3.8-15%, which is higher than found in RCT-derived data (6.6-6.9%). Comparable results are seen for postimplant rupture and secondary interventions.
The long term results of off-label use of EVAR are scarcely published. Although overall mortality and ARM does not seem to differ significantly at long-term, higher rates of type I endoleaks may be expected, mainly in short necks. However, for patients with severe angulation or high thrombus load in the proximal neck, results of outside IFU EVAR seem to match the results of inside IFU.
血管内动脉瘤修复术（EVAR）已逐渐扩展至更复杂的解剖结构，常常超出制造商的使用说明（IFU）范围。然而，EVAR超说明书使用的长期结果在很大程度上仍未得到记录。本文旨在研究超说明书使用EVAR的长期结果。
检索英文文献以确定关于超说明书使用EVAR长期结果的出版物。纳入标准要求至少5年的随访。测量的结果包括：总死亡率、动脉瘤相关死亡率（ARM）、植入后动脉瘤破裂的发生率、动脉瘤囊扩大、I型内漏和二次干预。将结果与已发表长期结果的随机临床试验（RCT）（EVAR-1、DREAM、OVER和ACE试验）进行比较。
纳入了13项研究。7项研究描述了与特定违反IFU相关的结果，而6项研究呈现了一般的超说明书使用结果。在超说明书使用的患者中，3至8年的总死亡率估计范围为21.5%至40%（RCT为13.7 - 46%），ARM为0至11%（RCT为1.2 - 7%）。5年的动脉瘤囊扩大估计约为43%。超说明书使用（随访5至12年）的I型内漏率范围为3.8%至15%，高于RCT得出的数据（6.6 - 6.9%）。植入后破裂和二次干预的结果类似。
EVAR超说明书使用的长期结果鲜有发表。尽管长期来看总死亡率和ARM似乎没有显著差异，但可能预期I型内漏率更高，主要发生在短瘤颈患者中。然而，对于近端瘤颈严重成角或血栓负荷高的患者，超说明书使用EVAR的结果似乎与符合IFU使用的结果相当。
