Davidson Laura J, Luna Jorge, Virmani Renu, Asscher Jacqueline A, Davidson Charles J
Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Catheter Cardiovasc Interv. 2014 Jul 1;84(1):30-6. doi: 10.1002/ccd.25152. Epub 2013 Sep 10.
This study was designed to evaluate the efficacy and safety of the CardioDex arterial closure device, which is a novel femoral artery closure device used following percutaneous cardiac catheterization.
Current devices utilized to achieve hemostasis of the femoral artery following percutaneous cardiac catheterization include collagen plug and suture mediated devices, but are associated with significant vascular complications. The CardioDex closure device utilizes thermal energy to cause collagen shrinking and swelling and thereby, achieve hemostasis.
The device was evaluated in a prospective nonrandomized single-center trial with patients undergoing 6F invasive cardiac procedures. Femoral artery puncture closure was performed immediately at completion of the procedure, followed by 3-4 minutes of manual compression. Time to hemostasis (TTH), time to ambulation (TTA), and short-term clinical follow-up data were collected.
A total of 34 patients including 21 diagnostic and 13 interventional cases were evaluated. The median TTH was 3 min in diagnostic and 4 min in interventional cases. TTH was independent of activated clotting time (ACT). The median TTA was 2.75 hr and 3.37 hr in diagnostic and interventional groups, respectively. There were no major adverse events identified at 1 week and 30 day follow up.
This first in human clinical experience with the CardioDex closure device demonstrates that in the small cohort studied, it is safe and effective in diagnostic cardiac catheterization and also in interventional cases on mild anticoagulation (mean ACT = 188 sec). It has the advantage of leaving no foreign material in the body following use.
本研究旨在评估CardioDex动脉闭合装置的有效性和安全性，该装置是一种用于经皮心脏导管插入术后的新型股动脉闭合装置。
目前用于经皮心脏导管插入术后实现股动脉止血的装置包括胶原塞和缝线介导装置，但会伴有严重的血管并发症。CardioDex闭合装置利用热能使胶原收缩和膨胀，从而实现止血。
在一项前瞻性非随机单中心试验中对该装置进行评估，试验对象为接受6F侵入性心脏手术的患者。手术结束后立即进行股动脉穿刺闭合，随后进行3 - 4分钟的手动压迫。收集止血时间（TTH）、下床活动时间（TTA）以及短期临床随访数据。
共评估了34例患者，包括21例诊断性病例和13例介入性病例。诊断性病例的中位TTH为3分钟，介入性病例为4分钟。TTH与活化凝血时间（ACT）无关。诊断组和介入组的中位TTA分别为2.75小时和3.37小时。在1周和30天随访时未发现重大不良事件。
CardioDex闭合装置的首次人体临床经验表明，在所研究的小队列中，它在诊断性心脏导管插入术以及轻度抗凝（平均ACT = 188秒）的介入性病例中是安全有效的。其优点是使用后体内不留任何异物。
