Sanghi Pramod, Virmani Renu, Do Dat, Erikson John, Elliott James, Cilingiroglu Mehmet, Matthews Holly, Kazi Masood, Ricker Robert, Bailey Steven R
University of Texas Health Science Center at San Antonio, Texas 78229-3900, USA.
J Interv Cardiol. 2008 Aug;21(4):329-36. doi: 10.1111/j.1540-8183.2008.00367.x. Epub 2008 Jun 28.
This study prospectively evaluated the acute and chronic arterial blood flow and vascular pathology after vessel closure using two commonly used closure devices controlled by deploying both devices in each animal.
Several vessel closure systems are approved for clinical use; however, few direct comparisons have ever been performed and no randomized case controlled study has been published using FDA-approved devices.
Nineteen Sous Scroufulae pigs underwent bilateral percutaneous arteriotomies using ultrasound-guided 6 Fr sheath insertion in both common femoral arteries. The femoral access site was then closed using either an Angio-Seal STS Plus, an absorbable collagen sponge, or StarClose, a self-closing nitinol clip. Angiograms and ultrasound of the site were performed prior to closure and immediately afterwards. At follow-up, ultrasound was performed at the site and the specimens were sent for histopathology.
Baseline femoral artery diameters (centimeters) were similar in both groups by U/S (5.2 +/- 0.3, 5.3 +/- 0.3) and quantitative angiography (4.6 +/- 0.7, 4.6 +/- 0.8). Postdeployment angiograms showed a vessel diameter stenosis of 65%+/- 24% with Angio-Seal (n = 18) and 50%+/- 22% with StarClose (n = 18), P = 0.04. 2D U/S performed immediately postdeployment showed vessel diameter stenosis of 59%+/- 33.0 with Angio-Seal (n = 19), and 35%+/- 20 with StarClose (n = 19), P = 0.01. At 7-, 30-, and 60-day follow-up, no appreciable differences in the vessel diameter were observed by U/S. At early follow-up (7 and 30 days), Angio-Seal arteriotomy closure sites were associated with higher inflammatory and hemorrhage scores, but no difference was seen at late (60-day) follow-up.
The StarClose closure device is associated with less short-term vessel injury compared to Angio-Seal STS Plus; however, this difference was not statistically significant after 60 days.
本研究通过在每只动物体内部署两种常用的闭合装置，前瞻性评估血管闭合后急性和慢性动脉血流及血管病理学情况。
几种血管闭合系统已获临床应用批准；然而，很少有直接比较，且尚无使用美国食品药品监督管理局（FDA）批准装置的随机病例对照研究发表。
19只小型猪在双侧股总动脉经超声引导插入6F鞘管后进行经皮动脉切开术。然后使用Angio-Seal STS Plus（一种可吸收胶原海绵）或StarClose（一种自闭合镍钛诺夹）闭合股动脉穿刺部位。在闭合前及闭合后立即进行该部位的血管造影和超声检查。随访时，在该部位进行超声检查，并将标本送去做组织病理学检查。
两组的基线股动脉直径（厘米）经超声检查（5.2±0.3，5.3±0.3）和定量血管造影（4.6±0.7，4.6±0.8）显示相似。部署后血管造影显示，使用Angio-Seal（n = 18）时血管直径狭窄65%±24%，使用StarClose（n = 18）时为50%±22%，P = 0.04。部署后立即进行的二维超声检查显示，使用Angio-Seal（n = 19）时血管直径狭窄59%±33.0，使用StarClose（n = 19）时为35%±20，P = 0.01。在7天、30天和60天随访时，超声检查未观察到血管直径有明显差异。在早期随访（7天和30天）时，Angio-Seal动脉切开闭合部位的炎症和出血评分较高，但在后期（60天）随访时未观察到差异。
与Angio-Seal STS Plus相比，StarClose闭合装置与较少的短期血管损伤相关；然而，60天后这种差异无统计学意义。
