Division of Vascular and Endovascular Surgery, Department of Surgery, Universidade de São Paulo, São Paulo, Brazil; McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Tex.
McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Tex; Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minn.
J Vasc Surg. 2021 Nov;74(5):1464-1471.e3. doi: 10.1016/j.jvs.2021.04.048. Epub 2021 May 18.
The purpose of the present study was to assess the outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) using infrarenal aortic vs iliac sealing zones.
We reviewed the clinical data of 430 consecutive patients enrolled in a prospective nonrandomized study to evaluate FB-EVAR from 2013 to 2020. The outcomes were analyzed for patients with extent I to IV thoracoabdominal aortic aneurysms who had undergone FB-EVAR with distal implantation in the native infrarenal aorta. The minimum anatomic criteria for the use of infrarenal aortic seal was a >3-cm length of parallel aorta with a diameter of 18 to 32 mm without excessive thrombus or calcification. A control group matched for the extent of aortic disease with an iliac artery seal was used to compare the following endpoints: 30-day mortality, major adverse events, freedom from type Ib endoleak (TIbE), freedom from secondary interventions, and changes in the infrarenal aortic diameter.
A total of 110 patients (55 men; mean age, 73 ± 8 years) were included in the present study, 55 with an infrarenal aortic distal seal and 55 with the iliac arteries as the sealing zone. Both groups had similar clinical characteristics and aneurysm extent and diameter, except for a greater number of men and higher serum creatinine in the iliac seal group. Technical success was obtained in 106 patients (96%) and was greater for the iliac sealing zone group (100% vs 93%; P = .04). The use of the infrarenal aortic sealing zone was associated with shorter endovascular (148 ± 56 minutes vs 191 ± 61 minutes; P < .001) and fluoroscopy (76 ± 28 minutes vs 96 ± 32 minutes; P < .001) times and lower radiation exposure (cumulative air kerma, 1.4 ± 1.4 Gy vs 2.1 ± 2.0 Gy; P = .02; dose area product, 147 ± 75 Gy ∙ cm vs 208 ± 102 Gy ∙ cm; P = .006). One patient had died (1%) within 30 days. No differences were found in the major adverse events among the patients treated with infrarenal aortic vs iliac sealing zones (22% vs 18%; P = .63), including any spinal cord injury (13% vs 9%; P = .54) and grade 3 spinal cord injury (7% vs 7%; P = 1.0). The mean clinical follow-up was 24 ± 18 months. TIbE occurred in one patient in each group (P = 1.0). The 3-year freedom from TIbE and freedom from secondary intervention rate was 98% ± 2% and 67% ± 8% for the infrarenal aortic seal group and 97% ± 3% and 67% ± 8% for the iliac seal group, respectively (P = NS). Among the patients treated with infrarenal aortic sealing zones, the mean enlargement of the infrarenal aortic diameter was 5 ± 3.2 mm at 3 years. No late TIbE due to disease progression had developed in the infrarenal aorta.
Infrarenal aortic and iliac artery seal zones are safe and effective during FB-EVAR, provided the patients have suitable segments. The use of the infrarenal aortic sealing zone had modest procedural advantages such as shorter endovascular and fluoroscopy times and lower radiation exposure. No differences were found in the clinical outcomes or development of TIbEs.
本研究旨在评估使用肾下主动脉与髂动脉密封区进行腔内分支型主动脉修复(FB-EVAR)的结果。
我们回顾了 2013 年至 2020 年期间,430 例连续患者参与前瞻性非随机研究评估 FB-EVAR 的临床数据。对行 FB-EVAR 治疗的 I 至 IV 型胸腹主动脉瘤患者进行了分析,FB-EVAR 术中远端在原生肾下主动脉内植入。使用肾下主动脉密封的最小解剖标准为具有 18 至 32mm 直径且无过度血栓或钙化的 3cm 以上平行主动脉长度。使用髂动脉密封的对照组与主动脉疾病范围相匹配,用于比较以下终点:30 天死亡率、主要不良事件、Ib 型内漏(TIbE)无复发、无二次干预以及肾下主动脉直径变化。
本研究共纳入 110 例患者(55 例男性;平均年龄 73±8 岁),其中 55 例患者使用肾下主动脉远端密封,55 例患者使用髂动脉作为密封区。两组患者的临床特征和动脉瘤范围及直径相似,但髂动脉密封组的男性更多,血清肌酐更高。106 例患者(96%)获得技术成功,髂动脉密封组的成功率更高(100%比 93%;P=.04)。使用肾下主动脉密封区与较短的腔内(148±56 分钟比 191±61 分钟;P<.001)和透视时间(76±28 分钟比 96±32 分钟;P<.001)以及较低的辐射暴露(累积空气比释动能,1.4±1.4Gy 比 2.1±2.0Gy;P=.02;剂量面积乘积,147±75Gy·cm 比 208±102Gy·cm;P=.006)相关。1 例患者(1%)在 30 天内死亡。使用肾下主动脉和髂动脉密封区的患者主要不良事件发生率无差异(22%比 18%;P=.63),包括任何脊髓损伤(13%比 9%;P=.54)和 3 级脊髓损伤(7%比 7%;P=1.0)。平均临床随访时间为 24±18 个月。两组各有 1 例患者发生 TIbE(P=1.0)。肾下主动脉密封组的 3 年 TIbE 无复发率和无二次干预率分别为 98%±2%和 67%±8%,髂动脉密封组分别为 97%±3%和 67%±8%(P=NS)。在使用肾下主动脉密封区的患者中,3 年后肾下主动脉直径平均增大 5±3.2mm。肾下主动脉无因疾病进展而导致的迟发性 TIbE。
在 FB-EVAR 中,肾下主动脉和髂动脉密封区是安全有效的,只要患者有合适的节段。使用肾下主动脉密封区具有较短的腔内和透视时间以及较低的辐射暴露等适度的手术优势。临床结局或 TIbE 的发展无差异。