Leclercq Florence, Delseny Delphine, Gervasoni Richard, Lattuca Benoit, Roubille François, Cayla Guillaume, Macia Jean Christophe
Department of Cardiology, University of Montpellier, Montpellier, France.
Department of Cardiology, University of Montpellier, Montpellier, France.
Arch Cardiovasc Dis. 2015 Apr;108(4):250-7. doi: 10.1016/j.acvd.2014.11.005. Epub 2015 Mar 6.
The benefits of vascular closure devices (VCDs) in the prevention of vascular complications after femoral intervention remain controversial.
To evaluate the efficiency of collagen plug-based VCDs in the prevention of femoral access complications after balloon aortic valvuloplasty.
We conducted a prospective analysis of consecutive patients who underwent balloon aortic valvuloplasty by femoral retrograde technique in our centre between 2009 and 2012. Group 1 included 75 patients in whom femoral puncture haemostasis was obtained with the use of an 8F collagen plug-based VCD (Angio-Seal™; Saint-Jude Medical, Inc.); group 2 included 105 patients who had manual or mechanical groin compression (FemoStop™; RADI Medical Systems, Inc.). We did not use heparin during the procedure. We collected data on major in-hospital adverse events, major bleeding (Bleeding Academic Research Consortium classification≥3) and vascular access complications.
We included 180 patients with severe and symptomatic aortic stenosis. Indications for valvuloplasty were mainly bridge to transcatheter aortic valve implantation or palliative therapy (72%). The groups were similar in terms of median age, lower limb artery disease and body mass index. Vascular and bleeding complications occurred in 11.1% of patients and were not decreased with the use of VCDs (relative risk 2.60, 95% confidence interval 1.10-3.09; P=0.05). These findings were consistent across all prespecified subgroups. Duration of hospital stay was not reduced by VCDs.
Based on the results of this study, performed with small-size sheaths and without heparin, collagen plug-based VCDs increase femoral access complications following aortic valvuloplasty. Systematic use of VCDs in elderly patients, with probable advanced limb atherosclerosis, is questionable.
血管闭合装置（VCDs）在预防股动脉介入术后血管并发症方面的益处仍存在争议。
评估基于胶原蛋白封堵器的VCDs在预防球囊主动脉瓣成形术后股动脉穿刺并发症中的有效性。
我们对2009年至2012年在本中心采用股动脉逆行技术行球囊主动脉瓣成形术的连续患者进行了前瞻性分析。第1组包括75例使用基于8F胶原蛋白封堵器的VCD（Angio-Seal™；圣犹达医疗公司）实现股动脉穿刺止血的患者；第2组包括105例采用人工或机械腹股沟压迫（FemoStop™；RADI医疗系统公司）的患者。术中未使用肝素。我们收集了院内主要不良事件、严重出血（出血学术研究联盟分类≥3级）和血管穿刺并发症的数据。
我们纳入了180例重度有症状主动脉瓣狭窄患者。瓣膜成形术的适应证主要是作为经导管主动脉瓣植入术的桥梁或姑息治疗（72%）。两组在年龄中位数、下肢动脉疾病和体重指数方面相似。11.1%的患者发生了血管和出血并发症，使用VCDs并未降低并发症发生率（相对风险2.60，95%置信区间1.10 - 3.09；P = 0.05）。在所有预先设定的亚组中，这些结果都是一致的。VCDs并未缩短住院时间。
基于本研究的结果，在使用小尺寸鞘管且未使用肝素的情况下，基于胶原蛋白封堵器的VCDs增加了主动脉瓣成形术后股动脉穿刺并发症。在可能存在晚期肢体动脉粥样硬化的老年患者中系统性使用VCDs是值得怀疑的。
