Abstract
Objective: The purpose of this study was to evaluate the safety and efficacy of a hemostatic puncture closure device (Angio-Seal Vascular Closure Device) in patients undergoing diagnostic and therapeutic cardiac catheterizations. Methods: All consecutive patients (n = 102) who received a hemostatic puncture closure device from January 2007 toMay 2007intheNationalChengKungUniversity Hospitalwereenrolledinthestudy.Ofthese,45(44%)patients received therapeutic cardiac catheterizations. Multivariate logistic regression analyses were used to determine the predictors of vascular complications. Results: Of 102 patients, there were 68 (67%) males, and the mean age was 67 11 years. All devices were deployed successfully, and device dysfunction occurred in only one patient (0.98%), in whom successful hemostasis was achieved later by manual and sandbag compression. There were 17 patients (16.7%) with small hematoma ( 6 cm in diameter) and three (2.9%) with large hematoma after the procedure. Compared with patients in the diagnostic group, patients in the therapeutic group had insignificantly higher complications of large hematoma (n = 3) (6.7% vs 0%, p = 0.08). However, no patients developed pseudoaneurysms, arteriovenous fistulae, and late bleeding in need of vascular repairs and blood transfusion until 7 to 14 days after discharge in both groups. Using multivariate logistic regression method, older age ( 75 years) was the only risk factor for developing large hematoma. Conclusion: Angio-Seal device offers a safe and effective hemostasis of the femoral artery in patients undergoing diagnostic and therapeutic cardiac catheterizations with acceptable morbidity rates.
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