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比较 Sofia 5Fr 导管与 Sofia 6Fr 导管之间的临床、技术和安全性结果;MaSQ-Registry 研究。

Comparison of clinical, technical, and safety outcomes between the Sofia 5Fr catheter vs. the Sofia 6Fr catheter; a MaSQ-Registry study.

机构信息

Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+ and School for Cardiovascular Diseases (CARIM), Maastricht University, Maastricht, the Netherlands.

Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, the Netherlands.

出版信息

J Stroke Cerebrovasc Dis. 2024 Nov;33(11):107967. doi: 10.1016/j.jstrokecerebrovasdis.2024.107967. Epub 2024 Aug 24.

DOI:10.1016/j.jstrokecerebrovasdis.2024.107967
PMID:39187212
Abstract

BACKGROUND

Direct aspiration during endovascular treatment (EVT) for acute ischemic stroke (AIS) patients is safe and effective. The 'Soft torqueable catheter Optimized For Intracranial Access' (Sofia) catheter is commonly used. Data on differences between 5Fr and 6Fr Sofia is limited. Hence, we aimed to compare the clinical, technical, and safety outcomes between both Sofia catheters in AIS patients.

METHODS

Patients with an intracranial anterior circulation occlusion from the 'Maastricht Stroke Quality-registry' (MaSQ-registry), who underwent EVT for AIS from September 2020 to February 2023, and treated with the Sofia catheter in the first-line technique were included. Outcomes included a shift on the modified Rankin Scale (mRS) score at 90 days, favorable functional outcome (mRS 0-2), first-attempt recanalization rate, and per procedural complications. Multivariable regression analyses were performed with adjustments.

RESULTS

Out of 511 registered patients in the MaSQ-registry, 366 patients were included. 281 patients (77 %) were treated with the Sofia 6Fr. No shift towards better outcomes on the ordinal mRS score at 90 days was observed in the Sofia 6Fr group compared to the 5Fr (adjusted common[ac] OR:1.34, 95 %CI:0.70-2.56). Favorable functional outcome (aOR:1.24, 95 %CI:0.49-3.13), and per procedural complications (aOR:1.04, 95 %CI:0.41-2.64) did not differ significantly between Sofia 6Fr and 5Fr. The Sofia 6Fr achieved higher first-attempt successful recanalization rates (53 % versus 34 %; aOR:2.28, 95 %CI:1.11-4.69), and lower total thrombectomy attempts (median:1 versus 2; aβ:-0.63, 95 %CI:-1.21 to -0.05).

CONCLUSIONS

The use of 6Fr Sofia aspiration catheter leads in this single-center registry to higher first-attempt successful recanalization rates and fewer thrombectomy attempts compared to the 5Fr Sofia catheter. However, this did not reflect in better clinical outcomes.

摘要

背景

急性缺血性脑卒中(AIS)患者血管内治疗(EVT)期间直接抽吸是安全有效的。通常使用“Soft torqueable catheter Optimized For Intracranial Access”(Sofia)导管。关于 5Fr 和 6Fr Sofia 导管之间差异的数据有限。因此,我们旨在比较 AIS 患者中两种 Sofia 导管的临床、技术和安全性结局。

方法

纳入 2020 年 9 月至 2023 年 2 月期间 Maastricht 卒中质量登记处(MaSQ-registry)中接受 EVT 治疗的颅内前循环闭塞的 AIS 患者,并采用 Sofia 导管一线技术治疗。结局包括 90 天时改良 Rankin 量表(mRS)评分的变化、良好的功能结局(mRS 0-2)、首次尝试再通率和围手术期并发症。采用多变量回归分析进行调整。

结果

在 MaSQ-registry 中登记的 511 例患者中,纳入 366 例患者。281 例(77%)患者接受 Sofia 6Fr 治疗。与 5Fr 相比,Sofia 6Fr 组 90 天时 ordinal mRS 评分的改善无统计学意义(调整后共同[ac]OR:1.34,95%CI:0.70-2.56)。良好的功能结局(aOR:1.24,95%CI:0.49-3.13)和围手术期并发症(aOR:1.04,95%CI:0.41-2.64)在 Sofia 6Fr 和 5Fr 之间无显著差异。Sofia 6Fr 首次尝试再通率更高(53%对 34%;aOR:2.28,95%CI:1.11-4.69),血栓切除术尝试次数更少(中位数:1 次对 2 次;aβ:-0.63,95%CI:-1.21 至-0.05)。

结论

在这个单中心登记处,与 5Fr Sofia 抽吸导管相比,使用 6Fr Sofia 抽吸导管可提高首次尝试再通率和减少血栓切除术尝试次数,但并未反映在更好的临床结局上。

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