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用于慢性完全冠状动脉闭塞再血管化的专用导丝和微导管技术的安全性和有效性:旭化成慢性完全闭塞研究的主要结果。

Safety and efficacy of dedicated guidewire and microcatheter technology for chronic total coronary occlusion revascularization: principal results of the Asahi Intecc Chronic Total Occlusion Study.

作者信息

Kandzari David E, Grantham J Aaron, Karmpaliotis Dimitrios, Lombardi William, Moses Jeffrey W, Nicholson William, Cook Stephen, Pershad Ashish, Popma Jeffrey J

机构信息

Piedmont Heart Institute, Atlanta, Georgia.

St Luke's Mid-America Heart Institute and the University of Missouri Kansas City, Kansas City, Missouri.

出版信息

Coron Artery Dis. 2018 Dec;29(8):618-623. doi: 10.1097/MCA.0000000000000668.

Abstract

BACKGROUND

Limited study has detailed the procedural outcomes and utilization of contemporary coronary guidewires and microcatheters designed for chronic total occlusion (CTO) percutaneous revascularization and with application of modern techniques.

PATIENTS AND METHODS

A prospective, multicenter, single-arm trial was conducted to evaluate procedural and in-hospital outcomes among 163 patients undergoing attempted CTO revascularization with specialized guidewires and microcatheters. The primary endpoint was defined as successful guidewire recanalization and absence of in-hospital cardiac death, myocardial infarction, or repeat target vessel revascularization (major adverse cardiac events).

RESULTS

The prevalence of diabetes was 42.9%; prior myocardial infarction, 41.1%; and previous bypass surgery, 36.8%. Average (mean±SD) CTO length was 41±29 mm, and mean Japanese CTO score was 2.6±1.3. A guidewire support catheter was used in 91.7% of cases, and the mean number of CTO-specific guidewires per procedure was 3.1±2.9. Overall, procedural success was observed in 73.0% of patients. The rate of successful guidewire recanalization was 89.0%, and absence of in-hospital major adverse cardiac event was 81.0%. Methods included antegrade (45.4%), retrograde (5.5%) and combined antegrade/retrograde techniques (49.1%). Total mean procedure time was 119±68 min; mean radiation dose, 2613±1881 mGy; and contrast utilization, 287±142 ml. Clinically significant perforation resulting in hemodynamic instability and/or requiring intervention occurred in 13 (8.0%) patients.

CONCLUSION

In this multicenter, prospective registration trial representing contemporary technique, favorable procedural success and early clinical outcomes inform technique and strategy using dedicated CTO guidewires and microcatheters in a high lesion complexity patient population.

摘要

背景

关于当代用于慢性完全闭塞(CTO)经皮血管重建术的冠状动脉导丝和微导管的操作结果及应用情况,且应用现代技术的相关研究较少。

患者与方法

开展了一项前瞻性、多中心、单臂试验,以评估163例使用专门导丝和微导管尝试进行CTO血管重建术患者的操作及院内结局。主要终点定义为导丝成功再通且无院内心源性死亡、心肌梗死或再次进行靶血管血运重建(主要不良心脏事件)。

结果

糖尿病患病率为42.9%;既往心肌梗死患病率为41.1%;既往搭桥手术患病率为36.8%。CTO平均(均值±标准差)长度为41±29 mm,平均日本CTO评分2.6±1.3。91.7%的病例使用了导丝支撑导管,每次操作CTO专用导丝的平均数量为3.1±2.9。总体而言,73.0%的患者操作成功。导丝成功再通率为89.0%,无院内主要不良心脏事件发生率为81.0%。方法包括正向(45.4%)、逆向(5.5%)和联合正向/逆向技术(49.1%)。总平均操作时间为119±68分钟;平均辐射剂量为2613±1881 mGy;造影剂用量为287±142 ml。13例(8.0%)患者发生导致血流动力学不稳定和/或需要干预的具有临床意义的穿孔。

结论

在这项代表当代技术的多中心前瞻性注册试验中,良好的操作成功率和早期临床结局为在高病变复杂性患者群体中使用专用CTO导丝和微导管的技术及策略提供了依据。

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