OBJECTIVES: The aim of this study was to evaluate the safety and efficacy of a biodegradable collagen plug that has been developed to reduce the arterial compression time required to achieve hemostasis at the arterial puncture site after diagnostic and interventional coronary procedures. BACKGROUND: After diagnostic and interventional coronary catheterization procedures, local arterial compression is required to achieve hemostasis and complications may ensue, especially in patients on full anticoagulation. METHODS: Between March 1991 and July 1991, 252 patients admitted for routine coronary angiography or angioplasty to four large hospitals received such a hemostatic device immediately after the procedure. Hemostasis was achieved with collagen in 87% of patients after a mean compression time of 4.8 min. Time to hemostasis was independent of the heparin load. A total of 54 hematomas (21%) was reported; all but 2 resolved without additional treatment. Two patients had a severe hematoma, requiring blood transfusion, and two patients required surgery to repair a pseudoaneurysm. During a follow-up period of 4 weeks no severe late complications were reported. CONCLUSIONS: We conclude that the collagen plug appears to be a safe device to achieve hemostasis at the arterial puncture site, independent of anticoagulation.
OBJECTIVES: The aim of this study was to evaluate the safety and efficacy of a biodegradable collagen plug that has been developed to reduce the arterial compression time required to achieve hemostasis at the arterial puncture site after diagnostic and interventional coronary procedures. BACKGROUND: After diagnostic and interventional coronary catheterization procedures, local arterial compression is required to achieve hemostasis and complications may ensue, especially in patients on full anticoagulation. METHODS: Between March 1991 and July 1991, 252 patients admitted for routine coronary angiography or angioplasty to four large hospitals received such a hemostatic device immediately after the procedure. Hemostasis was achieved with collagen in 87% of patients after a mean compression time of 4.8 min. Time to hemostasis was independent of the heparin load. A total of 54 hematomas (21%) was reported; all but 2 resolved without additional treatment. Two patients had a severe hematoma, requiring blood transfusion, and two patients required surgery to repair a pseudoaneurysm. During a follow-up period of 4 weeks no severe late complications were reported. CONCLUSIONS: We conclude that the collagen plug appears to be a safe device to achieve hemostasis at the arterial puncture site, independent of anticoagulation.
Authors: H Eggebrecht; M Haude; D Baumgart; O Oldenburg; J Herrmann; C Bruch; P Hunold; C Neurohr; C von Birgelen; D Welge; M A Katz; R Erbel Journal: Herz Date: 1999-12 Impact factor: 1.443