OBJECTIVE: The aim of this study was to evaluate the safety and efficacy of the closure device Angioseal. MATERIAL AND METHODS: All consecutive patients, who underwent a therapeutic radiological intervention using the femoral artery approach from January 2001 to January 2005 in the Service of Vascular Surgery, Henri Mondor Hospital, Creteil, France, were prospectively included in the study. The efficacy of Angioseal was defined by the ability of the device to cover the puncture site and stop bleeding. The safety was defined by the rate of complications. RESULTS: A total of 79 Angioseal devices were employed on 77 patients. There were 62 (78.5%) males and 17 (21.5%) females. The mean age of the patients was 65.2+/-11.6 years (mean+/-SD). All Angioseal devices were deployed successfully. There were 62 (78.4%) 6F and 17 (21.6%) 8F sheaths employed during the procedures. There were two minor (2.5%) hematomas, one (1.2%) major hematoma and one (1.2%) pseudoaneurysm after the procedure. The mean time of discharge from the hospital was 2.1+/-1.8 (mean+/-SD) days. The patients were followed up for a mean of 9.0+/-9.3 (1-60 months) months. CONCLUSIONS: Angioseal provides a safe and effective way of closing the femoral artery puncture site with acceptable morbidity rates.
OBJECTIVE: The aim of this study was to evaluate the safety and efficacy of the closure device Angioseal. MATERIAL AND METHODS: All consecutive patients, who underwent a therapeutic radiological intervention using the femoral artery approach from January 2001 to January 2005 in the Service of Vascular Surgery, Henri Mondor Hospital, Creteil, France, were prospectively included in the study. The efficacy of Angioseal was defined by the ability of the device to cover the puncture site and stop bleeding. The safety was defined by the rate of complications. RESULTS: A total of 79 Angioseal devices were employed on 77 patients. There were 62 (78.5%) males and 17 (21.5%) females. The mean age of the patients was 65.2+/-11.6 years (mean+/-SD). All Angioseal devices were deployed successfully. There were 62 (78.4%) 6F and 17 (21.6%) 8F sheaths employed during the procedures. There were two minor (2.5%) hematomas, one (1.2%) major hematoma and one (1.2%) pseudoaneurysm after the procedure. The mean time of discharge from the hospital was 2.1+/-1.8 (mean+/-SD) days. The patients were followed up for a mean of 9.0+/-9.3 (1-60 months) months. CONCLUSIONS: Angioseal provides a safe and effective way of closing the femoral artery puncture site with acceptable morbidity rates.