Tsitsiou Yvonne, Ekpe Jadesola, Harris Laura, Kashef Elika, Hamady Mohamad
Department of Interventional Radiology, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.
Department of Surgery and Cancer, Imperial College, London, UK.
CVIR Endovasc. 2021 Dec 2;4(1):81. doi: 10.1186/s42155-021-00268-w.
During subintimal angioplasty (SIA), it is not always possible to re-enter the vessel lumen due to a variety of factors. Recanalization using hydrophilic wires and catheters alone, apart from its potential technical failure, is also limited by minimal control over the re-entry point. This is frequently well beyond the point of occlusion, thus often compromising important collaterals. In order to bypass the obstruction and attain controlled re-entry into the lumen of the diseased vessel, a re-entry device (RED) may be required. This paper assesses our centre's experience with the safety and efficacy of the Pioneer re-entry system and systematically reviews the pertinent literature.
A single centre retrospective study of subintimal angioplasty involving the use of the Pioneer Plus intravascular guided reentry catheter was performed. Patient demographics including age, gender, risk factors, comorbidities clinical indication and complications were recorded. Lesion characteristics, including location and severity of calcification were also assessed. A systematic literature review of all reported studies where the Pioneer RED was used for iliac and lower limb revascularization was conducted by 2 of the authors using the PubMed (MEDLINE) and EMBASE databases.
The study comprised 30 cases. Technical success was 97%. A small, quickly resolved extravasation was the only device related complication. These results are in line with the systematic review which identified 16 studies using the Pioneer RED, reporting a technical success rate of 87.4-100% (median = 100%) and complication rate of 0-25.8% (median = 0%). However, due to heterogeneity in definitions of technical success, data was not pooled.
在血管内膜下血管成形术（SIA）过程中，由于多种因素，并非总能重新进入血管腔。仅使用亲水导丝和导管进行再通，除了可能存在技术失败外，对再入点的控制也很有限。这通常远远超出闭塞点，因此常常会影响重要的侧支循环。为了绕过阻塞并实现对病变血管腔的可控再入，可能需要一种再入装置（RED）。本文评估了我们中心使用先锋再入系统的安全性和有效性，并系统地回顾了相关文献。
对使用先锋增强型血管内引导再入导管的血管内膜下血管成形术进行单中心回顾性研究。记录患者的人口统计学数据，包括年龄、性别、危险因素、合并症、临床指征和并发症。还评估了病变特征，包括钙化的位置和严重程度。两位作者使用PubMed（MEDLINE）和EMBASE数据库，对所有报道使用先锋RED进行髂动脉和下肢血管重建的研究进行了系统的文献综述。
该研究包括30例病例。技术成功率为97%。唯一与装置相关的并发症是少量且迅速消退的血管外渗。这些结果与系统综述一致，该综述确定了16项使用先锋RED的研究，报告的技术成功率为87.4%-100%（中位数=100%），并发症发生率为0%-25.8%（中位数=0%）。然而，由于技术成功定义的异质性，数据未进行汇总。
