USE of IMplanting the Biotronik PassEo-18 Lux drug coated balloon to treat failing haemodialysis arteRiovenous FIstulas and grafts (SEMPER FI Study).

IF 1.6 3区医学 Q3 PERIPHERAL VASCULAR DISEASE Journal of Vascular Access Pub Date : 2025-01-01 Epub Date: 2023-11-17 DOI:10.1177/11297298231209070

Tze Gek Ho, Tjun Yip Tang, Charyl Jia Qi Yap, Hao Yun Yap, Shaun Wen Yang Chan, Chuo Ren Leong, Dexter Yak Seng Chan

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引用次数: 0

Abstract

Background: Plain old balloon angioplasty has been the mainstay of treatment for arteriovenous fistula (AVF) stenoses. Recent studies suggest that drug coated balloons (DCB) may significantly reduce re-intervention rates on native and recurrent lesions. The Passeo-18 Lux DCB (Biotronik AG, Buelach, Switzerland) is packaged with a 3.0 µg/mm² dose of paclitaxel. The hypothesis is that its use provides better target lesion primary patency (TLPP), primary assisted patency (PP), secondary patency (SP) rates and reduces the number of visits for re-intervention in a cohort of patients with stenotic AVF and arteriovenous grafts (AVGs).

Methods: The USE of IMplanting the Biotronik PassEo-18 Lux DCB to treat failing haemodialysis arteRiovenous FIstulas and grafts trial (SEMPER FI) was a prospective double-centre, multi-investigator, non-consecutive, non-blinded single-arm study investigating the efficacy and safety of the Passeo-18 Lux DCB in patients with stenotic AVF/AVG lesions between January 2021 and January 2022. Patient demographics, clinical characteristics, vascular access history, operative indications, details and outcomes were collected prospectively. TLPP, circuit access primary patency (CAP), PP, SP and deaths 6- and 12-months post-intervention were studied.

Results: Ninety-one patients with 110 lesions were recruited across the two centres. 62.6% (n = 57) were male with a median age of 63.5 years (SD = 10.5). 62.6% (n = 57) were taking anti-platelets. Eighty-five AVFs and six AVGs were treated. 60% (n = 54) of AVFs intervened were radiocephalic. 52.7% (n = 58) of targeted lesions were juxta-anastomotic stenosis (JAS) and one-third (n = 33) at the AVF/AVG outflow. 70.9% (n = 78) of lesions were recurrent. Median time from last intervention was 219 days. 78% of target lesions (n = 85) and circuits (n = 70) were patent at 6-months, of which 96.7% (n = 87) of those requiring assisted intervention were patent.

Conclusion: This study shows that the Passeo-18 Lux DCB can be an effective and safe tool in the treatment of failing haemodialysis AVFs/AVGs.

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使用植入Biotronik paseo -18 Lux药物包被球囊治疗失败的血液透析动静脉瘘和移植物(SEMPER FI研究)。

背景:普通旧球囊血管成形术一直是治疗动静脉瘘(AVF)狭窄的主要方法。最近的研究表明，药物包被球囊(DCB)可以显著降低原发和复发病变的再干预率。paseo -18 Lux DCB (Biotronik AG, Buelach, Switzerland)包装有3.0µg/mm2剂量的紫杉醇。假设它的使用提供了更好的靶病变原发性通畅(TLPP)、原发性辅助通畅(PP)、继发性通畅(SP)率，并减少了狭窄性AVF和动静脉移植物(AVGs)患者队列的再干预次数。方法:使用植入Biotronik paseo -18 Lux DCB治疗失败的血液透析动静脉瘘和移植物试验(SEMPER FI)是一项前瞻性双中心、多研究者、非连续、非盲单臂研究，研究paseo -18 Lux DCB在2021年1月至2022年1月期间治疗狭窄性AVF/AVG病变患者的有效性和安全性。前瞻性收集患者人口统计学、临床特征、血管通路史、手术指征、细节和结果。研究TLPP、通路初级通畅(CAP)、PP、SP和干预后6个月和12个月的死亡率。结果:在两个中心招募了91名患者，共110个病变。62.6% (n = 57)为男性，中位年龄63.5岁(SD = 10.5)。62.6% (n = 57)患者服用抗血小板药物。avf 85例，avg 6例。60% (n = 54)的介入avf为放射性脑损伤。52.7% (n = 58)的病灶位于吻合口旁狭窄(JAS)，三分之一(n = 33)位于AVF/AVG流出口。70.9% (n = 78)病变复发。从上次干预开始的中位时间为219天。78%的目标病变(n = 85)和回路(n = 70)在6个月时是专利的，其中需要辅助干预的96.7% (n = 87)是专利的。结论:paseo -18 Lux DCB可作为治疗血液透析衰竭avf / avg的有效、安全的工具。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Vascular Access 医学-外周血管病

CiteScore

3.40

自引率

31.60%

发文量

181

审稿时长

6-12 weeks

期刊介绍： The Journal of Vascular Access (JVA) is issued six times per year; it considers the publication of original manuscripts dealing with clinical and laboratory investigations in the fast growing field of vascular access. In addition reviews, case reports and clinical trials are welcome, as well as papers dedicated to more practical aspects covering new devices and techniques. All contributions, coming from all over the world, undergo the peer-review process. The Journal of Vascular Access is divided into independent sections, each led by Editors of the highest scientific level: • Dialysis • Oncology • Interventional radiology • Nutrition • Nursing • Intensive care Correspondence related to published papers is also welcome.