Simons Jessica P, Podder Sourav, Dossabhoy Shernaz S, Wyman Allison S, Arous Edward J, Judelson Dejah R, Aiello Francesco A, Schanzer Andres
UMass Memorial Center for Complex Aortic Disease, University of Massachusetts Medical School, Worcester, MA.
UMass Memorial Center for Complex Aortic Disease, University of Massachusetts Medical School, Worcester, MA.
Ann Vasc Surg. 2020 Jan;62:213-222. doi: 10.1016/j.avsg.2019.04.051. Epub 2019 Aug 2.
Fenestrated/branched endovascular aneurysm repair (F/B-EVAR) achieves more extensive proximal seal than conventional infrarenal devices, thereby increasing aneurysm exclusion durability. Optimal seal zone length remains undefined. We assessed relative risks and benefits of extending the proximal seal above the celiac artery.
The prospective database of all complex endovascular aortic aneurysm repairs at a single institution (institutional review board-approved, physician-sponsored investigational device exemption trial, 10/2010-6/2017) was used to classify repairs according to the number of target visceral-renal arteries incorporated: 4-vessel versus <4-vessel. Comparisons of aneurysm characteristics, perioperative details, and postoperative complications were performed, stratified by repair type. One-year survival, target artery patency, freedom from type 1 or 3 endoleak, and freedom from reintervention were estimated with Kaplan-Meier analysis.
Among 175 F/B-EVARs, 38% (n = 67) were 4-vessel and 62% (n = 108) were <4-vessel. Intraoperatively, there was no difference in mean contrast use (76 mL vs. 74 mL, P = non significant [NS]) or dose area product (63,428 mGy cm vs. 96,015 mGy cm), but there was increased median procedure time (4.8 hr, interquartile range [IQR] = 4.1-5.8 versus 3.6 hr, IQR = 2.9-4.1, P < 0.0001) and mean operating room direct costs ($52,532, standard deviation [SD] = 18,640 versus $40,128, SD = 15,135, P < 0.0001) in 4-vessel repairs. There were no differences in mortality (1.9% vs. 4.5%), paraparesis (0% vs. 3.0%), or paralysis (0.9% vs. 0%), all P = NS. There were no differences in one-year survival, target artery patency, or freedom from reintervention. There was a lower 1-year freedom from type 1 or 3 endoleak with 4-vessel repairs (82% vs. 94%, log-rank P = 0.02), driven by an increased rate of type 3 endoleaks. Endoleak resolution after treatment was equivalent in both groups (4-vessel, 10 of 12, 83% resolved; <4-vessel, 7 of 7, 100% resolved, P = NS).
With F/B-EVAR, utilization of a supraceliac seal zone, compared with an infraceliac seal zone, is associated with statistical differences in operative characteristics/resource utilization, but with negligible clinical significance. Further innovation to eliminate type 3 endoleaks at fenestrations/branches remains an unmet need. To achieve adequate F/B-EVAR proximal seal zone length, one should have a low threshold to incorporate the celiac artery.
开窗/分支型血管腔内动脉瘤修复术（F/B-EVAR）比传统的肾下装置能实现更广泛的近端密封，从而提高动脉瘤排除的耐久性。最佳密封区长度仍未明确。我们评估了将近端密封延伸至腹腔干动脉上方的相对风险和益处。
使用单一机构所有复杂血管腔内主动脉瘤修复术的前瞻性数据库（机构审查委员会批准，医生发起的研究性器械豁免试验，2010年10月 - 2017年6月），根据纳入的目标内脏 - 肾动脉数量对修复进行分类：4支血管与少于4支血管。按修复类型分层，对动脉瘤特征、围手术期细节和术后并发症进行比较。采用Kaplan-Meier分析评估1年生存率、目标动脉通畅率、无1型或3型内漏率以及无需再次干预率。
在175例F/B-EVAR中，38%（n = 67）为4支血管，62%（n = 108）为少于4支血管。术中，平均造影剂用量（76 mL对74 mL，P = 无显著差异[NS]）或剂量面积乘积（63,428 mGy cm对96,015 mGy cm）无差异，但4支血管修复的中位手术时间增加（4.8小时，四分位数间距[IQR] = 4.1 - 5.8对3.6小时，IQR = 2.9 - 4.1，P < 0.0001），平均手术室直接成本增加（52,532美元，标准差[SD] = 18,640对40,128美元，SD = 15,135，P < 0.0001）。死亡率（1.9%对4.5%）、截瘫（0%对3.0%）或瘫痪（0.9%对0%）均无差异，所有P = NS。1年生存率、目标动脉通畅率或无需再次干预率无差异。4支血管修复的1年无1型或3型内漏率较低（82%对94%，对数秩检验P = 0.02），原因是3型内漏率增加。两组治疗后内漏的解决情况相当（4支血管，12例中的10例，83%得到解决；少于4支血管，7例中的7例，100%得到解决，P = NS）。
对于F/B-EVAR，与肾下密封区相比，使用腹腔干上密封区在手术特征/资源利用方面存在统计学差异，但临床意义可忽略不计。消除开窗/分支处3型内漏的进一步创新仍未满足需求。为实现足够的F/B-EVAR近端密封区长度，应降低纳入腹腔干动脉的阈值。
