目的:许多文章报道了在腔内主动脉瘤修复术(EVAR)中,CookZenithAlpha内移植物与其他内移植物相比,肢体移植物闭塞(LGO)的发生率增加。本研究旨在评估EVAR后LGO的发生率,特别是在遵守旨在预防肢体相关并发症的标准化协议时,使用CookZenithAlpha设备。
方法:这是在两个大学血管外科中心进行的一项非赞助的回顾性研究,在2016年至2019年的EVAR期间采用相同的预防肢体并发症的方案。该方案包括:(1)在移植物内导航之前,对狭窄>50%的任何总/外动脉进行血管成形术;(2)在与分流器相同的水平处的肢体近端封闭区,重叠最小,比CookZenithAlpha的使用说明更具限制性;(3)肢体半弯曲性亲吻膨胀;(4)在任何残余弯曲/扭结/狭窄的情况下进行肢体支架置入术;(5)在EVAR后进行残余狭窄/夹层的辅助普通和外部髂关节支架置入术。参加本研究的患者接受标准主动脉双髂EVAR治疗。出院时通过临床访视和双工超声检查进行随访,六个月,此后每年。主要终点是评估不同EVAR设备的LGO率(CookZenithAlpha,GoreC3和MedtronicEndurant),并确定与ZenithAlpha相关的LGO的潜在风险因素。
结果:在研究期间,考虑了547种EVAR:233(42.6%)库克天顶阿尔法,196(35.8%)戈尔独家新闻,和118(21.6%)美敦力Endurant。平均随访44±23个月,从LGO的五年自由度为97±3%,组间无差异(97±2%,95±3%,100%和库克天顶阿尔法,美敦力Endurant,和GoreExcluder,分别;p=.080)。在ZenithAlpha群中,术中辅助髂动脉血管成形术,髂动脉支架置入术,或髂肢支架置入术占8%,3.4%,和9.7%,分别。LGO的潜在危险因素分析发现,在随访期间与LGO独立相关的髂外动脉远端着陆和大主体(ZIMB32-36)(风险比[HR]18,95%置信区间[CI]3-130,p=.004;和HR12,95%CI1.2-130,p=.030)。
结论:目前的预防肢体并发症方案的经验使人们在与其他内移植物相似的ZenithAlpha内移植物在五年内获得较低的LGO率。CookZenithAlpha内移植物的具体风险因素是髂外动脉远端着陆和使用大主体(ZIMB32-36)。
OBJECTIVE: Numerous articles have reported an increased incidence of limb graft occlusion (LGO) with the Cook Zenith Alpha endograft compared with other endografts in endovascular aortic aneurysm repair (EVAR). The present study aimed to assess the rate of LGO after EVAR in particular with the Cook Zenith Alpha device when adhering to a standardised protocol designed to prevent limb related complications.
METHODS: This was a non-sponsored retrospective study performed in two university vascular surgery centres employing the same protocol for limb complication prevention during EVAR from 2016 to 2019. The protocol encompassed: (1) angioplasty of any common or external iliac artery with > 50% stenosis before endograft navigation; (2) proximal sealing zone of limbs at the same level of the flow divider with minimum overlap, which is more restrictive than the Cook Zenith Alpha instructions for use; (3) semi-compliant kissing ballooning of limbs; (4) limb stenting for any residual tortuosity, kinking, or stenosis; and (5) adjunctive common and external iliac stenting for residual stenosis or dissection after EVAR. Patients enrolled in this study were treated with standard aortobi-iliac EVAR. Follow up was performed by clinical visit and duplex ultrasonography at discharge, six months, and yearly thereafter. The primary endpoint was to evaluate the LGO rate with different EVAR devices (Cook Zenith Alpha, Gore C3, and Medtronic Endurant) and to determine potential risk factors for LGO associated with the Zenith Alpha.
RESULTS: In the study period, 547 EVARs were considered: 233 (42.6%) Cook Zenith Alpha, 196 (35.8%) Gore Excluder, and 118 (21.6%) Medtronic Endurant. The mean follow up was 44 ± 23 months, and the five year freedom from LGO was 97 ± 3%, without differences between groups (97 ± 2%, 95 ± 3%, and 100% with Cook Zenith Alpha, Medtronic Endurant, and Gore Excluder, respectively; p = .080). In the Zenith Alpha group, intra-operative adjunctive iliac artery angioplasty, iliac artery stenting, or iliac limb stenting was performed in 8%, 3.4%, and 9.7% of cases, respectively. Analysis of potential risk factors for LGO identified external iliac artery distal landing and large main bodies (ZIMB 32 - 36) to be independently associated with LGO during follow up (hazard ratio [HR] 18, 95% confidence interval [CI] 3 - 130, p = .004; and HR 12, 95% CI 1.2 - 130, p = .030, respectively).
CONCLUSIONS: The present experience with a protocol for limb complication prevention allows achievement of a low rate of LGO at five years with Zenith Alpha endografts similar to other endografts. Specific risk factors for the Cook Zenith Alpha endograft are external iliac artery distal landing and the use of a large main body (ZIMB 32 - 36).