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新型自动压力控制桡动脉压迫装置对桡动脉压迫效果的短期前瞻性介入性初步研究。

Effect of Radial Artery Compression with a Novel Automatic Pressure-Controlled Radial Compression Device: A Short-Term Prospective Interventional Pilot Study.

机构信息

Department of Nursing, The First Hospital of Jiaxing (Affiliated Hospital of Jiaxing University), Jiaxing314000, China.

Department of Cardiology, The First Hospital of Jiaxing (Affiliated Hospital of Jiaxing University), Jiaxing314000, China.

出版信息

J Interv Cardiol. 2023 Mar 7;2023:7533702. doi: 10.1155/2023/7533702. eCollection 2023.

Abstract

This study was conducted to design a novel radial compression device with the function of automatic pressure control and evaluate the feasibility and safety of this new technique. Patients who underwent transradial access (TRA) coronary angiography and percutaneous coronary intervention (PCI) in the First Hospital of Jiaxing between August 2021and October 2021 were prospectively enrolled in this pilot interventional study. The patients were grouped in a 1 : 1 ratio to receive compression with a novel device (the experimental group) or a conventional device without pressure control (the control group). The primary endpoint was the compression time, and the main secondary endpoints were rebleeding, upper-limb swelling, radial artery occlusion (RAO), and device-related pressure injury (DPI). Eighty-four patients were enrolled in this study. No significant differences were found in the baseline clinical characteristics between the two groups. Compared with the control group, the compression time in the experimental group was significantly reduced (207.4 ± 15.5 vs. 378.1 ± 19 min,  < 0.001). Besides, the rate of upper-limb swelling was also significantly lower in the novel device group (2.4% vs. 85.7%,  < 0.001), as well as the rate of DPI (19.05% vs. 100%,  = 0.005). Furthermore, the pain score in the experimental group was significantly lower than in the control group (0.79 ± 0.42 vs. 1.83 ± 0.58,  < 0.001). There were no significant differences in the rate of rebleeding (7.1% vs. 14.3,  = 0.48) between the two groups. In addition, no RAO occurred in any of the groups. The novel automatic pressure-controlled radial compression device could reduce the hemostasis time and decrease the rate of adverse complications. It might be a promising and effective compression device in TRA coronary invasive procedures.

摘要

本研究旨在设计一种具有自动压力控制功能的新型径向压缩装置,并评估这种新技术的可行性和安全性。2021 年 8 月至 2021 年 10 月期间,嘉兴市第一医院前瞻性地招募了接受经桡动脉入路(TRA)冠状动脉造影和经皮冠状动脉介入治疗(PCI)的患者参与这项初步介入研究。患者按照 1:1 的比例分组,分别使用新型装置(实验组)或无压力控制的常规装置(对照组)进行压迫。主要终点是压迫时间,主要次要终点是再出血、上肢肿胀、桡动脉闭塞(RAO)和器械相关的压力损伤(DPI)。本研究共纳入 84 例患者。两组患者的基线临床特征无显著差异。与对照组相比,实验组的压迫时间明显缩短(207.4 ± 15.5 比 378.1 ± 19 分钟, < 0.001)。此外,新型装置组的上肢肿胀发生率也明显较低(2.4%比 85.7%, < 0.001),DPI 发生率也较低(19.05%比 100%,  = 0.005)。此外,实验组的疼痛评分明显低于对照组(0.79 ± 0.42 比 1.83 ± 0.58,  < 0.001)。两组再出血率无显著差异(7.1%比 14.3%,  = 0.48)。此外,两组均未发生 RAO。新型自动压力控制桡动脉压迫装置可缩短止血时间,降低不良并发症发生率。它可能是一种有前途且有效的 TRA 冠状动脉介入治疗压迫装置。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/145a/10014152/700a0901ff46/JITC2023-7533702.001.jpg

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