IMMEDIATE SEALING OF ARTERIAL PUNCTURE SITES AFTER CARDIAC-CATHETERIZATION AND CORONARY ANGIOPLASTY USING A BIODEGRADABLE COLLAGEN PLUG - RESULTS OF AN INTERNATIONAL REGISTRY

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.