Téllez A, Cheng Y, Wallace-Bradley D, Alviar C, Gallego C, Conditt GB, McGregor JC, Kaluza G, Granada JF

Language: Spanish
References: 13
Page: 23-28
PDF size: 207.26 Kb.

ABSTRACT

Background: Device-based arterial closure is a widely available method to achieve arterial hemostasis following percutaneous coronary intervention. However, little is known about the in-vivo vascular compatibility and resorption patterns of these devices. In this study we aimed to characterize the in vivo absorption of the Angio-Seal vascular closure device with serial intravascular ultrasound (IVUS) imaging and histology. Methods: Femoral access was gained under fluoroscopy guidance using a typical percutaneous (Seldinger) technique and a 6F vascular sheath in 12 femoral arteries of 6 pigs. Right after removal, a total of 12 Angio-Seal closure devices were implanted. Using carotid access, angiograms and IVUS were performed at baseline, 3, 5, 7, 14, 31 and 42 days. Arteries were harvested and processed for histologic evaluation of the device absorption at 14 days (4 devices), 31 days (4 devices) and 42 days (4 devices). Results: The maximum cross-sectional area of the intravascular component (anchor) remained stable up to 14 days by IVUS (18.7 ± 2.5 mm²) and decreased by 50% at 30 days (9.46 ± 2.8 mm²) and by 78% by 42 days (4.2 ± 2.9 mm²). By histology, there was a progressive decline in the area of the intravascular component which started around 14 days (area=19.7 ± 3.3 mm²) and continued to decrease at 30 (14 ± 2.6 mm²) and 42 days (4.6 ± 3.6 mm²). Histological evaluation demonstrated almost complete absorption of the intravascular component and no signs of residual inflammation by 42 days. Conclusion: Serial imaging using IVUS demonstrated almost complete absorption of the intravascular component of the Angio-Seal closure device by 42 days in normal porcine femoral arteries. At the same time-point, there was no evidence of residual vascular inflammation demonstrated by histology.

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