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Evaluation of the 6-F ExoSeal Vascular Closure Device in Antegrade Femoral Artery Punctures.
- Source :
- Journal of Endovascular Therapy; Dec2012, Vol. 19 Issue 6, p836-843, 8p
- Publication Year :
- 2012
-
Abstract
- Purpose: To evaluate the safety, comfort, and efficacy of an extravascularly deployed bioabsorbable plug-based vascular closure device (VCD) for sealing 6-F antegrade access sites in patients requiring peripheral endovascular intervention. Methods: A single-center, single-arm, prospective study to evaluate the 6-F ExoSeal VCD in terms of technical success, adverse events, and patient comfort enrolled 59 unselected symptomatic patients (42 men; mean age 72.1 ±9.3 years) suffering from peripheral artery disease in an 11-month period. Patients with high body mass index (BMI) or calcification at the access site were not excluded. Calcifications of the access vessel were scored as grades 1-4 from fluoroscopic images. The pain level during implantation was evaluated after the procedure using a visual rating scale. Results: Technical success rate was 98.3%; 1 primary device failure was converted to manual compression. In addition, 1 (1.7%) pseudoaneurysm, 2 (3.4%) minor hematomas, and 1 (1.7%) minor secondary bleeding were observed. There was no intravascular application of the device detected. Neither BMI, calcification of the access vessel (present in 74.6%, mean score 1.4±1.1), age, nor blood clotting had any statistically significant influence on adverse events. In total, 55 (93.2%) patients felt no pain during the VCD implantation. Conclusion: The tested VCD was safe, with an excellent technical success rate even in cases with severe access vessel calcification. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 15266028
- Volume :
- 19
- Issue :
- 6
- Database :
- Complementary Index
- Journal :
- Journal of Endovascular Therapy
- Publication Type :
- Academic Journal
- Accession number :
- 84420768
- Full Text :
- https://doi.org/10.1583/JEVT-12-3922R.1