Illuminati Giulio, Pacilè Maria Antonietta, Ceccanei Gianluca, Ruggeri Massimo, La Torre Giuseppe, Ricco Jean-Baptiste
Department of Surgical Sciences, University of Rome "La Sapienza", Rome, Italy.
Department of Surgical Sciences, University of Rome "La Sapienza", Rome, Italy.
Ann Vasc Surg. 2020 Apr;64:54-61. doi: 10.1016/j.avsg.2019.11.013. Epub 2019 Nov 11.
The aim of this study was to compare intravascular ultrasound (IVUS) assistance for endovascular aortic aneurysm repair (EVAR) to standard assistance by angiography.
From June 2015 to June 2017, 173 consecutive patients underwent EVAR. In this group, 69 procedures were IVUS-assisted with X-ray exposure limited to completion angiography for safety purposes because an IVUS probe does not yet incorporate a duplex probe (group A), and 104 were angiography-assisted procedures (group B). All IVUS-assisted procedures were performed by vascular surgeons with basic duplex ultrasound (DUS) training. The primary study endpoints were mean radiation dose, duration of fluoroscopy, amount of contrast media administered, procedure-related outcomes, and renal clearance expressed as the glomerular filtration rate (GFR) before and after the procedure. Secondary endpoints were operative mortality, morbidity, and arterial access complications.
Mean duration of fluoroscopy time was significantly lower for IVUS-assisted procedures (24 ± 15 min vs. 40 ± 30 min for angiography-assisted procedures, P < 0.01). Moreover, mean radiation dose (Air KERMA) was significantly lower in IVUS-assisted procedures (76m Gy [44-102] vs. 131 mGy [58-494]), P < 0.01. IVUS-assisted procedures required fewer contrast media than standard angiography-assisted procedures (60 ± 20 mL vs. 120 ± 40 mL, P < 0.01). The mean duration of the procedure was comparable in the two groups (120 ± 30 min vs. 140 ± 30 min, P = 0.07). No difference in renal clearance before and after the procedure was observed in either of the two groups (99.0 ± 4/97.8 ± 2 mL/min in group A and 98.0 ± 3/97.6 ± 5 mL/min in group B) (P = 0.28). The mean length of follow-up was nine months (6-30 months). No postoperative mortality, morbidity, or arterial access complications occurred. No type 1 endoleak was observed. Early type II endoleaks were observed in 21 patients (11%), 12 in the angiography-assisted group (11%) and nine in the IVUS-assisted group (12%). They were not associated with sac enlargement ≥5 mm diameter and therefore did not require any additional treatment.
Compared with standard angiography-assisted EVAR, IVUS significantly reduces renal load with contrast media, fluoroscopy time, and radiation dose while preserving endograft deployment efficiency. Confirmation from a large prospective study with improved IVUS probes will be required before IVUS-assisted EVAR alone can become standard practice.
本研究旨在比较血管内超声（IVUS）辅助腹主动脉瘤腔内修复术（EVAR）与标准血管造影辅助的效果。
2015年6月至2017年6月，173例连续患者接受了EVAR治疗。在该组中，69例手术采用IVUS辅助，出于安全目的，X线暴露仅限于完成血管造影，因为IVUS探头尚未集成双功能探头（A组），104例为血管造影辅助手术（B组）。所有IVUS辅助手术均由接受过基本双功能超声（DUS）培训的血管外科医生进行。主要研究终点为平均辐射剂量、透视时间、造影剂用量、手术相关结局以及手术前后以肾小球滤过率（GFR）表示的肾清除率。次要终点为手术死亡率、发病率和动脉入路并发症。
IVUS辅助手术的平均透视时间显著缩短（24±15分钟，血管造影辅助手术为40±30分钟，P<0.01）。此外，IVUS辅助手术的平均辐射剂量（空气比释动能）显著降低（76mGy[44-102]，血管造影辅助手术为131mGy[58-494]），P<0.01。IVUS辅助手术所需的造影剂比标准血管造影辅助手术少（60±20mL比120±40mL，P<0.01）。两组手术的平均持续时间相当（120±30分钟比140±30分钟，P=0.07）。两组手术前后的肾清除率均无差异（A组为99.0±4/97.8±2mL/min，B组为98.0±3/97.6±5mL/min）（P=0.28）。平均随访时间为9个月（6-30个月）。未发生术后死亡、发病或动脉入路并发症。未观察到I型内漏。21例患者（11%）观察到早期II型内漏，血管造影辅助组12例（11%），IVUS辅助组9例（12%）。它们与瘤腔直径增大≥5mm无关，因此无需任何额外治疗。
与标准血管造影辅助的EVAR相比，IVUS在保留腔内移植物植入效率的同时，显著降低了造影剂、透视时间和辐射剂量对肾脏的负荷。在IVUS辅助的EVAR单独成为标准治疗方法之前，需要通过改进IVUS探头的大型前瞻性研究加以证实。
