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RAVI 注册研究:栓塞手术中桡动脉入路的前瞻性多中心研究——30 天随访

The RAVI registry: prospective, multicenter study of radial access in embolization procedures - 30 days follow up.

作者信息

Guimaraes Marcelo, Fischman Aaron, Yu Hyeon, Tasse Jordan, Stewart Jessica, Pereira Keith

机构信息

Department of Radiology and Radiological Science, Medical University of South Carolina, 25 Courtenay Drive MSC 226, Room 3304, Charleston, SC, 29425, USA.

Department of Diagnostic, Molecular and Interventional Radiology, Urology and Surgery, Icahn School of Medicine, Mt. Sinai Hospital, New York City, NY, USA.

出版信息

CVIR Endovasc. 2024 Jan 30;7(1):15. doi: 10.1186/s42155-023-00415-5.

Abstract

BACKGROUND

There is a lack of registry studies about transradial access (TRA) outcomes. This prospective registry evaluated the TRA and procedure outcomes of visceral embolizations performed via TRA with 30-day follow-up.

MATERIAL & METHODS: Prospective, multicenter registry included uterine fibroids (UFE), prostate artery (PAE), liver tumors (LT), and other hypervascular tumors (OHT) embolization performed in six US hospitals. Between February 2020 and January 2022, 99 patients underwent one radial artery visceral intervention (RAVI); 70 had UFE (70.7%), 16 PAE (16.2%), 7 LT (7.1%), and 6 OHT (6.1%). The mean age was 50.1 (±11.1) years, and 74/99 (74.7%) were females. The primary safety endpoints included hand ischemia, stroke, and death. Procedural success was defined as completing the intended procedure via radial artery (RA) access. Technical success was defined as the successful delivery of HydroPearl™ microspheres and complete embolization of the target vessel.

RESULTS

Procedural and technical successes were 100% and 97%, respectively. There was no stroke, hand ischemia, radial-to-femoral conversion, access-related serious adverse events, or clinically evident radial artery occlusion at 30 days. There were two deaths: one respiratory failure and one progression of liver disease. Minor RA-related adverse event included arterial spasm, hematoma, and post-procedure discomfort.

CONCLUSION

This prospective, multicenter, open-label registry confirmed the high safety profile and effectiveness of radial access in UFE, PAE, LT, and OHT embolization procedures without stroke, hand ischemia, or access-related serious adverse events at 30-day follow-up.

摘要

背景

目前缺乏关于经桡动脉入路(TRA)结局的注册研究。这项前瞻性注册研究评估了经TRA进行内脏栓塞术的TRA及手术结局,并进行了30天的随访。

材料与方法

前瞻性、多中心注册研究纳入了在美国六家医院进行的子宫肌瘤(UFE)、前列腺动脉(PAE)、肝肿瘤(LT)及其他富血管肿瘤(OHT)栓塞术。在2020年2月至2022年1月期间,99例患者接受了一次桡动脉内脏介入治疗(RAVI);其中70例为UFE(70.7%),16例为PAE(16.2%),7例为LT(7.1%),6例为OHT(6.1%)。平均年龄为50.1(±11.1)岁,74/99(74.7%)为女性。主要安全终点包括手部缺血、中风和死亡。手术成功定义为通过桡动脉(RA)入路完成预定手术。技术成功定义为成功输送HydroPearl™微球并实现靶血管的完全栓塞。

结果

手术成功率和技术成功率分别为100%和97%。30天时未发生中风、手部缺血、桡动脉转股动脉转换、与入路相关的严重不良事件或临床上明显的桡动脉闭塞。有两例死亡:一例呼吸衰竭,一例肝病进展。与RA相关的轻微不良事件包括动脉痉挛、血肿和术后不适。

结论

这项前瞻性、多中心、开放标签的注册研究证实了桡动脉入路在UFE、PAE、LT和OHT栓塞术中具有较高的安全性和有效性,在30天随访时未发生中风、手部缺血或与入路相关的严重不良事件。

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