Bastos Goncalves F, Hoeks S E, Teijink J A, Moll F L, Castro J A, Stolker R J, Forbes T L, Verhagen H J M
Department of Vascular Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands; Department of Angiology and Vascular Surgery, Hospital de Santa Marta, CHLC, Lisbon, Portugal.
Department of Vascular Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands.
Eur J Vasc Endovasc Surg. 2015 Feb;49(2):156-62. doi: 10.1016/j.ejvs.2014.10.003. Epub 2014 Nov 7.
To assess the incidence and risk factors for proximal aneurysm neck related complications with a late generation device for endovascular abdominal aneurysm repair (EVAR).
Data were retrieved from a prospective registry (Endurant Stent Graft Natural Selection Global Postmarket Registry) involving 79 institutions worldwide. The risk factors tested were age, gender, surgical risk profile, proximal neck length (<10 mm), diameter (>30 mm), supra- and infrarenal angulation (>60° and 75°), mural thrombus/calcification (>50%) and taper (>10%), and AAA diameter (>65 mm). Two neck related composite endpoints were used, for intra-operative (type-1a endoleak, conversion, deployment/retrieval complication or unintentional renal coverage) and post-operative (type-1a endoleak or migration) adverse events. Independent risk factors were identified using multivariable backwards modeling.
The study included 1263 patients (mean age 73, 10.3% female) from March 2009 to May 2011. Twenty three (1.8%) intra-operative adverse events occurred. Neck length <10 mm (OR 4.9, 95% CI 1.1-22.6) and neck thrombus/calcification >50% (OR 4.8, 95% CI 1.7-13.5) were risk factors for intra-operative events. The planned 1 year follow up visit was reached for the entire cohort, and the 2 year visit for 431 patients. During this time, 99 (7.8%) events occurred. Female gender (HR 1.9, 95% CI 1.1-3.2), aneurysm diameter >65 mm (HR 2.8, 95% CI 1.9-4.2), and neck length <10 mm (HR 2.8, 95% CI 1.1-6.9) were significant post-operative risk factors. Neck angulation, neck taper, large diameter neck, and presence of thrombus/calcification were not predictors of adverse outcome in this study.
These results support the adequacy of this device in the face of adverse neck anatomy, and confirm neck length as the most relevant anatomical limitation for EVAR. Additionally, the study confirms the decline in early to mid-term intervention rates with a newer generation device in a large patient sample. Lastly, it suggests that neck related risk factors affect outcome and impact on prognosis in varying degrees.
使用新一代血管腔内腹主动脉瘤修复（EVAR）装置评估近端动脉瘤颈部相关并发症的发生率及危险因素。
数据取自一项前瞻性注册研究（Endurant支架移植物自然选择全球上市后注册研究），该研究涉及全球79家机构。所检测的危险因素包括年龄、性别、手术风险概况、近端颈部长度（<10毫米）、直径（>30毫米）、肾动脉上下成角（>60°和75°）、壁血栓/钙化（>50%）和锥度（>10%），以及腹主动脉瘤直径（>65毫米）。使用了两个与颈部相关的复合终点，分别用于术中（1a型内漏、中转开放手术、释放/回收并发症或意外肾动脉覆盖）和术后（1a型内漏或移位）不良事件。采用多变量向后建模确定独立危险因素。
该研究纳入了2009年3月至2011年5月期间的1263例患者（平均年龄73岁，女性占10.3%）。发生了23例（1.8%）术中不良事件。颈部长度<10毫米（比值比4.9，95%置信区间1.1 - 22.6）和颈部血栓/钙化>50%（比值比4.8，95%置信区间1.7 - 13.5）是术中事件的危险因素。整个队列均完成了计划的1年随访，431例患者完成了2年随访。在此期间，发生了99例（7.8%）事件。女性（风险比1.9，95%置信区间1.1 - 3.2）、动脉瘤直径>65毫米（风险比2.8，95%置信区间1.9 - 4.2）和颈部长度<10毫米（风险比2.8，95%置信区间1.1 - 6.9）是显著的术后危险因素。在本研究中，颈部成角、颈部锥度、颈部大直径以及血栓/钙化的存在并非不良结局的预测因素。
这些结果支持了该装置在面对不良颈部解剖结构时的适用性，并确认颈部长度是EVAR最相关的解剖学限制因素。此外，该研究证实了在大量患者样本中，使用新一代装置后早期至中期干预率有所下降。最后，研究表明与颈部相关的危险因素对结局有影响，并在不同程度上影响预后。
