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专用导丝、微导管和引导导管延长技术在慢性完全闭塞冠状动脉血运重建中的安全性和有效性:Teleflex 慢性完全闭塞研究的主要结果。

Safety and efficacy of dedicated guidewire, microcatheter, and guide catheter extension technologies for chronic total coronary occlusion revascularization: Primary results of the Teleflex Chronic Total Occlusion Study.

机构信息

Piedmont Heart Institute, Atlanta, Georgia, USA.

Division of Cardiology, Henry Ford Health System, Detroit, Michigan, USA.

出版信息

Catheter Cardiovasc Interv. 2022 Feb;99(2):263-270. doi: 10.1002/ccd.29962. Epub 2021 Sep 28.

DOI:10.1002/ccd.29962
PMID:34582080
Abstract

BACKGROUND

Description of procedural outcomes using contemporary techniques that apply specialized coronary guidewires, microcatheters, and guide catheter extensions designed for chronic total occlusion (CTO) percutaneous revascularization is limited.

METHODS

A prospective, multicenter, single-arm study was conducted to evaluate procedural and in-hospital outcomes among 150 patients undergoing attempted CTO revascularization utilizing specialized guidewires, microcatheters and guide extensions. The primary endpoint was defined as successful guidewire recanalization and absence of in-hospital cardiac death, myocardial infarction (MI), or repeat target lesion revascularization (major adverse cardiac events, MACE).

RESULTS

The prevalence of diabetes was 32.7%; prior MI, 48.0%; and previous bypass surgery, 32.7%. Average (mean ± standard deviation) CTO length was 46.9 ± 20.5 mm, and mean J-CTO score was 1.9 ± 0.9. Combined radial and femoral arterial access was performed in 50.0% of cases. Device utilization included: support microcatheter, 100%; guide catheter extension, 64.0%; and mean number of study guidewires/procedure was 4.8 ± 2.6. Overall, procedural success was achieved in 75.3% of patients. The rate of successful guidewire recanalization was 94.7%, and in-hospital MACE was 19.3%. Achievement of TIMI grade 2 or 3 flow was observed in 93.3% of patients. Crossing strategies included antegrade (54.0%), retrograde (1.3%) and combined antegrade/retrograde techniques (44.7%). Clinically significant perforation resulting in hemodynamic instability and/or requiring intervention occurred in 16 (10.7%) patients.

CONCLUSIONS

In a multicenter, prospective registration study, favorable procedural success was achieved despite high lesion complexity using antegrade and retrograde guidewire maneuvers and with acceptable safety, yet with comparably higher risk than conventional non-CTO PCI.

摘要

背景

应用专门设计用于慢性完全闭塞(CTO)经皮血运重建的冠状动脉导丝、微导管和引导导管延长段的现代技术,对手术结果的描述有限。

方法

一项前瞻性、多中心、单臂研究评估了 150 名接受 CTO 血运重建的患者的手术和住院期间结果,使用了专门的导丝、微导管和引导导管延长段。主要终点定义为导丝再通成功且无住院期间心源性死亡、心肌梗死(MI)或再次靶病变血运重建(主要不良心脏事件,MACE)。

结果

糖尿病患病率为 32.7%;既往心肌梗死为 48.0%;既往旁路手术为 32.7%。平均(均数±标准差)CTO 长度为 46.9±20.5mm,平均 J-CTO 评分为 1.9±0.9。50.0%的病例采用桡动脉和股动脉联合入路。器械使用率包括:支持微导管 100%;导引导管延长段 64.0%;平均使用研究导丝/手术 4.8±2.6 根。总体而言,75.3%的患者手术成功。导丝再通成功率为 94.7%,住院期间 MACE 发生率为 19.3%。93.3%的患者达到 TIMI 血流 2 级或 3 级。穿通策略包括正向(54.0%)、逆行(1.3%)和正向/逆行联合技术(44.7%)。16 例(10.7%)患者出现有临床意义的穿孔导致血流动力学不稳定和/或需要介入治疗。

结论

在一项多中心前瞻性注册研究中,尽管病变复杂程度高,但通过正向和逆行导丝操作实现了有利的手术成功率,且安全性可接受,但与常规非 CTO PCI 相比风险相当高。

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