- 期刊
The Efficacy and Safety of Anglo-Seal Percutaneous Femoral Artery Closure Device after Diagnostic and Therapeutic Cardiac Catheterizations-A Single Center's Experience
在診斷和治療性心導管後使用Angio-Seal動脈黏合器之有效度及安全性
摘要
目的 本研究目的在評估做完診斷和治療性心導管後使用Angio-Seal動脈黏合器的有效度和安全性的比較。 方法 從2007年一月至2007年五月，共有102位病人在國立成功大學附設醫院接受完診斷或治療性心導管後使用Angio-Seal動脈黏合器。其中，有45(44%)位病人同時接受診斷和治療性心導管，利用多變數回歸分析方法找出使用Angio-Seal動脈黏合器後會發生血管併發症的危險因子。 結果 102位病人的平均年齡為67±11歲而有68(67%)位男性。所有Angio-Seal動脈黏合器都被成功植入，但是有一個(0.98%)病人在放完動脈黏合器後並無法立即止血，必須以手壓止血及後續使用沙袋加壓後才成功獲得止血。在之後出院前追蹤中，共有17(16.7%)位病人出現小血腫（直徑≦6公分）及3(2.9%)位病人出現大血腫（直徑＞6公分）。與接受診斷性心導管的病人比較起來，接受治療性心導管的病人似乎有較高比例會出肥大血腫（3位）(6.7% vs 0%, p=0.08)，不過並無統計學的意義。但是，在後續出院後7至14天的追蹤中並沒有任何病人發生重大血管併發症需要手術治療或輸血，包括假血管瘤、動靜脈瘻管、延遲傷口出血。利用多變數回歸分析方法找出年老（年紀≧75歲）是唯一在使用Angio-Seal動脈黏合器後會出現大血腫的危險因子。 結論 接受完診斷或治療性心導管後使用Angio-Seal動脈黏合器都可以安全並有效的讓股動脈止血，而它所造成的血管併發症是可以接受的。
並列摘要
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 to May 2007 in the National Cheng Kung University Hospital were enrolled in the study. Of these, 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%) mates, 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 vita achieved later by manual and sandbag compression. There were 17 patients (16.7%) with small hemosatoma (≦6cm 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.