A comparative evaluation of arterial blood flow and the healing response after femoral artery closure using angio-seal STS Plus and StarClose in a porcine model

Pramod Sanghi, Renu Virmani, Dat Do, John Erikson, James Elliott, Mehmet Cilingiroglu, Holly Matthews, Masood Kazi, Robert Ricker, Steven R Bailey
Journal of Interventional Cardiology 2008, 21 (4): 329-36

OBJECTIVES: 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.

BACKGROUND: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.


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