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新型上肢预加载输送系统在胸主动脉瘤腔内修复中的应用效果。

Outcomes of a novel upper extremity preloaded delivery system for fenestrated-branched endovascular repair of thoracoabdominal aneurysms.

机构信息

Advanced Endovascular Aortic Program, Aortic Center Mayo Clinic, Rochester, Minn.

Cook Medical Aortic Division, Bloomington, Ind.

出版信息

J Vasc Surg. 2020 Aug;72(2):470-479. doi: 10.1016/j.jvs.2019.09.058. Epub 2020 Jan 25.

Abstract

OBJECTIVE

The aim of this study was to evaluate the feasibility and outcomes of endovascular repair of thoracoabdominal aortic aneurysms (TAAAs) using a novel low profile (LP) device with upper extremity preloaded guidewire system (PGS) and compare procedural metrics and outcomes with a standard multibranch stent graft (t-Branch; Cook Medical, Bloomington, Ind).

METHODS

We reviewed the clinical data of 232 consecutive patients treated by fenestrated-branched endovascular aortic repair for TAAA and enrolled in a prospective nonrandomized trial between 2014 and 2017. Patients who had repair using t-Branch or patient-specific TAAA devices using upper extremity LP-PGS were included. End points were technical success, operative and fluoroscopic time, patient radiation exposure, time from arterial access to complete device deployment, total contrast volume, and 30-day rates of major adverse events (MAEs) and mortality.

RESULTS

There were 54 patients, including 33 males (67%) and 21 females (33%), with a mean age of 73 ± 9 years old. Forty-nine patients (91%) had extent I-III and five patients (9%) had extent IV TAAAs. Device design was t-Branch in 24 patients (44%) and LP-PGS in 30 patients (56%). A total of 206 renal-mesenteric arteries were incorporated with no difference between groups (mean, 3.8 ± 0.6 target vessels/patient; P = .92). Patients treated by t-Branch device had larger mean aneurysm diameter (79 ± 16 vs 66 ± 10 mm; P = .0006). All patients had transbrachial approach. Technical success was achieved in all patients in both groups. Patients treated by LP-PGS devices had lower radiation dose (1250 ± 849 vs 3154 ± 2421 mGy; P = .003) and shorter operating time for complete device deployment (105 ± 42 vs 123 ± 34 minutes; P = .043). There was no difference in mean operative time (252 ± 69 vs 273 ± 56 minutes; P = .23), fluoroscopy time (82 ± 29 vs 96 ± 35 minutes; P = .08) or contrast volume (163 ± 59 vs 197 ± 75 mL; P = .07) comparing LP-PGS and t-Branch respectively. There was no 30-day or in-hospital mortality. There were no differences in MAEs, which occurred in 18 patients (33%) in both groups (P > .05).

CONCLUSIONS

Endovascular TAAA repair using the standard or LP-PGS multibranch stent graft was associated with high technical success, no mortality, and a low rate of MAEs in this study. Patients treated by upper extremity LP-PGS had shorter time to complete device deployment, suggesting decreased technical demand with preloaded systems.

摘要

目的

本研究旨在评估使用新型低轮廓(LP)装置联合上肢预加载导丝系统(PGS)进行胸主动脉瘤(TAAA)血管内修复的可行性和结果,并与标准多分支支架移植物(t-Branch;库克医疗公司,印第安纳州布卢明顿)的手术指标和结果进行比较。

方法

我们回顾了 2014 年至 2017 年间接受开窗/分支型主动脉腔内修复术治疗 TAAA 的 232 例连续患者的临床数据,并纳入了一项前瞻性非随机试验。包括使用 t-Branch 或使用上肢 LP-PGS 的患者特异性 TAAA 装置进行修复的患者。终点为技术成功率、手术和透视时间、患者辐射暴露、从动脉入路到完全装置部署的时间、总造影剂体积以及 30 天主要不良事件(MAE)和死亡率。

结果

共有 54 例患者,包括 33 例男性(67%)和 21 例女性(33%),平均年龄 73±9 岁。49 例(91%)患者为 I-III 型 TAAA,5 例(9%)患者为 IV 型 TAAA。装置设计为 t-Branch 24 例(44%),LP-PGS 30 例(56%)。共纳入 206 支肾-肠系膜动脉,两组之间无差异(平均每个患者 3.8±0.6 个目标血管;P=0.92)。接受 t-Branch 装置治疗的患者平均动脉瘤直径更大(79±16 与 66±10mm;P=0.0006)。所有患者均采用经肱动脉入路。两组患者均达到了技术上的成功。使用 LP-PGS 装置的患者辐射剂量较低(1250±849 与 3154±2421mGy;P=0.003),完全装置部署的手术时间更短(105±42 与 123±34 分钟;P=0.043)。两组间平均手术时间(252±69 与 273±56 分钟;P=0.23)、透视时间(82±29 与 96±35 分钟;P=0.08)或造影剂体积(163±59 与 197±75 毫升;P=0.07)无差异。两组均无 30 天或住院期间死亡。两组均发生 18 例(33%)MAE(P>0.05),无差异。

结论

本研究中,使用标准或 LP-PGS 多分支支架移植物进行 TAAA 血管内修复术与高技术成功率、无死亡率和低 MAE 发生率相关。使用上肢 LP-PGS 的患者完全装置部署时间更短,表明预加载系统的技术需求较低。

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