Interventional Radiology Unit, Norfolk and Norwich University Hospitals, Norwich, UK.
Vasc Endovascular Surg. 2024 Nov;58(8):847-853. doi: 10.1177/15385744241276688. Epub 2024 Aug 22.
Our retrospective study aimed at assessing safety of vascular closure devices (VCDs) used in a large single-centre Interventional Radiology (IR) department. Complication and deployment failure rates using collagen-based (Angio-seal) and suture-based (ProGlide) devices for common femoral artery haemostasis were compared.
Data from VCDs deployed over a 6-year period were retrospectively analysed for patient age, procedure indication, puncture mode (antegrade/retrograde), sheath size, deployment failure and complications (haematoma, pseudoaneurysm formation, limb occlusion). Numerical and statistical analysis was undertaken.
Overall, 1321 common femoral artery punctures in 1217 patients were closed using VCDs. Failure rate using ProGlide was significantly higher when compared with Angio-seal (=<0.001) in sheath sizes ≤8 Fr. Heparin was not administered in embolisation procedures compared with angioplasty with or without stenting. Therefore, haematoma tended to occur more frequently following angioplasty without stenting ( = 0.003) and angioplasty with stenting ( = 0.001), when compared with embolisation. Deployment failure occurred more frequently when heparin was used during the procedure ( = 0.005).
Although complications relating to sheath size are well established in the literature, there remains a paucity of data assessing the impact of procedure specific factors when comparing VCDs. Our study challenges that size is the sole determinant of VCD success and invites a more holistic view of VCD deployment strategies. This study advocates continued research into the nuances of other potential confounding variables to optimise patient outcomes.
本回顾性研究旨在评估大型介入放射学(IR)中心使用血管闭合装置(VCD)的安全性。比较了胶原蛋白基(Angio-seal)和缝合线基(ProGlide)装置在常见股动脉止血中的并发症和部署失败率。
对 6 年内使用 VCD 的患者数据进行回顾性分析,包括患者年龄、手术指征、穿刺模式(顺行/逆行)、鞘管大小、部署失败和并发症(血肿、假性动脉瘤形成、肢体闭塞)。进行了数值和统计分析。
共有 1217 例患者 1321 次股动脉穿刺采用 VCD 闭合。在鞘管尺寸≤8 Fr 时,ProGlide 的失败率明显高于 Angio-seal(= <0.001)。与血管成形术加或不加支架置入相比,在栓塞术中未给予肝素。因此,与栓塞相比,血管成形术无支架置入(= 0.003)和血管成形术加支架置入(= 0.001)时,血肿更常发生。当术中使用肝素时,部署失败更常发生(= 0.005)。
尽管与鞘管大小相关的并发症在文献中已有充分记载,但在比较 VCD 时,评估特定手术因素的影响的数据仍然很少。我们的研究表明,大小并不是 VCD 成功的唯一决定因素,并邀请对 VCD 部署策略进行更全面的研究。本研究提倡继续研究其他潜在混杂变量的细微差别,以优化患者结局。