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新型基于支架的机械血栓切除术装置治疗伴有大血栓负荷的急性心肌梗死病例的初步经验。

Initial experience with a novel stent-based mechanical thrombectomy device for management of acute myocardial infarction cases with large thrombus burden.

机构信息

Cardiology Division, Heart Center, Luzerner Kantonsspital, 6000, Lucerne 16, Switzerland.

Faculty of Medicine, University of Basel, Basel, Switzerland.

出版信息

Cardiovasc Interv Ther. 2024 Jul;39(3):262-272. doi: 10.1007/s12928-024-00998-3. Epub 2024 Apr 20.

Abstract

BACKGROUND

Patients with acute myocardial infarction (AMI) and large thrombus burden (LTB) still represent a challenge. Afflicted patients have a high morbidity and mortality. Aspiration thrombectomy is often ineffective in those cases. Mechanical thrombectomy devices (MTDs), which are effective for management of ischemic strokes, were recently CE-approved for treatment of thrombotic coronary lesions. Real-world data about their performance in AMI cases with LTB are scarce. This study sought to summarize our early experience with a novel MTD device in this context.

METHODS

We analyzed consecutive patients from the prospective OPTIMISER registry (NCT04988672), who have been managed with the NeVa™ MTD (Vesalio, USA) for AMI with LTB at a tertiary cardiology facility. Outcomes of interest included, among others, periprocedural complications, target lesion failure (TLF), target lesion revascularization (TLR) and target vessel myocardial infarction (TV-MI).

RESULTS

Overall, 15 patients underwent thrombectomy with the NeVa™ device. Thrombectomy was successfully performed in 14 (93%) patients. Final TIMI 3 flow was achieved in 13 (87%) patients, while 2 (13%) patients had TIMI 2 flow. We encountered no relevant periprocedural complications, especially no stroke, stent thrombosis or vessel closure. After a mean follow-up time of 26 ± 2.9 months, 1 (7%) patient presented with TLR due to stent thrombosis (10 months after treatment with the MTD and stenting).

CONCLUSIONS

In AMI patients with LTB, the deployment of the novel NeVa™ MTD seems efficient and safe. Further randomized trials are warranted to assess whether the use of the NeVa™ device in cases with LTB improves procedural and clinical outcomes.

摘要

背景

急性心肌梗死(AMI)合并大血栓负荷(LTB)的患者仍然是一个挑战。此类患者发病率和死亡率较高。对于这些病例,抽吸血栓切除术往往效果不佳。机械血栓切除术装置(MTD)对于缺血性脑卒中的治疗非常有效,最近已获得 CE 批准用于治疗血栓性冠状动脉病变。关于其在 LTB 的 AMI 病例中的应用的真实世界数据非常有限。本研究旨在总结我们在这方面使用新型 MTD 装置的早期经验。

方法

我们分析了前瞻性 OPTIMISER 注册研究(NCT04988672)中的连续患者,这些患者在一家三级心脏病学中心因 AMI 合并 LTB 接受了 NeVa™ MTD(Vesalio,美国)治疗。感兴趣的结果包括围手术期并发症、靶病变失败(TLF)、靶病变血运重建(TLR)和靶血管心肌梗死(TV-MI)等。

结果

总体而言,有 15 名患者接受了 NeVa™ 装置的血栓切除术。14 名(93%)患者成功完成了血栓切除术。13 名(87%)患者最终实现 TIMI 3 级血流,而 2 名(13%)患者为 TIMI 2 级血流。我们未发现任何相关的围手术期并发症,尤其是无卒中、支架血栓形成或血管闭塞。在平均 26±2.9 个月的随访后,1 名(7%)患者因支架血栓形成(MTD 治疗和支架置入后 10 个月)出现 TLR。

结论

在 LTB 的 AMI 患者中,新型 NeVa™ MTD 的应用似乎既有效又安全。需要进一步的随机试验来评估在 LTB 病例中使用 NeVa™ 装置是否能改善手术和临床结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c30f/11164735/53f4805b29db/12928_2024_998_Fig1_HTML.jpg

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