Department of Diagnostic and Interventional Radiology, University Hospital Wuerzburg, Wuerzburg, Germany.
Protestant Amalie Sieveking Hospital, Internal Medicine, Hamburg, Germany.
J Vasc Access. 2022 Sep;23(5):778-787. doi: 10.1177/11297298211012829. Epub 2021 Apr 28.
This retrospective study investigates the efficacy and safety of the novel Celt ACD vascular closure device (VCD) following antegrade and retrograde common femoral artery (CFA) punctures for the treatment of peripheral artery disease in a challenging patient collective (e.g. calcifications, obesity, and anticoagulation).
A total of 208 VCDs (i.e. 100 antegrade and 108 retrograde) were deployed between October 2019 and December 2020 in a tertiary referral interventional radiology department. Fifty-two devices were undersized in relation to the introducer sheath (up to 2 Fr). Technical success and VCD related complications were evaluated in the immediate post procedure period and the following 24 h clinically. In 68% of cases, additional duplex ultrasound was performed prior to discharge.
The overall technical success rate was 97%. Technical failures following antegrade approach were due to a too acute access angle (⩾60°), rendering it impossible to pass the applicator tip through the sheath lumen. A subgroup analysis of technical success pinpoints severe calcification as another key limiting factor in VCD use ( = 0.004). Comparing equally sized with undersized device selection ( = 0.196), direction of approach ( = 0.265), and body mass index ( = 0.184) proved to be insignificant. Five (2%, 5/208) major complications occurred: Four antegrade (i.e. one false aneurysm, one vessel laceration with retroperitoneal hemorrhage, two device migrations; 4%, 4/100) and one following retrograde access (i.e. >6 cm hematoma, 1%, 1/108)). Complications were successfully managed with manual compression or interventional procedures.
The novel clip-based VCD proved to be effective with a low VCD related complication rate.
本回顾性研究调查了新型 Celt ACD 血管闭合装置（VCD）在前瞻性和逆行股总动脉（CFA）穿刺治疗外周动脉疾病（如钙化、肥胖和抗凝）的挑战性患者群体中的疗效和安全性。
在 2019 年 10 月至 2020 年 12 月期间，在一家三级转诊介入放射科共部署了 208 个 VCD（即 100 个前瞻性和 108 个逆行性）。52 个装置与导入鞘（最多 2Fr）相比尺寸过小。在术后即刻和随后的 24 小时内，临床评估了技术成功率和 VCD 相关并发症。在 68%的病例中，在出院前进行了额外的双功超声检查。
总体技术成功率为 97%。经前瞻性方法出现的技术失败是由于进入角度太陡（≥60°），使得无法将施夹器尖端穿过鞘管内腔。技术成功的亚组分析指出，严重钙化是 VCD 使用的另一个关键限制因素（ = 0.004）。比较同等尺寸和尺寸过小的装置选择（ = 0.196）、方法方向（ = 0.265）和体重指数（ = 0.184）证明无统计学意义。发生了 5 例（2%，5/208）主要并发症：4 例经前瞻性（即 1 例假性动脉瘤、1 例血管裂伤伴腹膜后出血、2 例装置移位；4%，4/100），1 例经逆行性入路（即 >6cm 血肿；1%，1/108））。并发症通过手动压迫或介入程序成功处理。
新型基于夹的 VCD 具有有效的效果，且与 VCD 相关的并发症发生率较低。
