BACKGROUND: The aim of our study was to evaluate the practicability and the complication rates of two different forms of the post-angiographic closure of the femoral artery. METHODS: We randomized 239 patients over a time period of 4 months to either amechanical compression system (FemoStop, 111 patients) or to conventional manual compression (128 patients). A Doppler-sonographic examination was performed if the patient reported pain of the puncture site, or if auscultation or palpation suspected a complication on the day after compression. RESULTS: After manual compression, Doppler-sonography had to be performed in 21 patients (16.4%). In the FemoStop-group only 14 patients (12.6%, p = ns) had to be referred for ultrasound examination. A complication was detected in 13 patients (10.1%) after manual compression and in 5 patients (4.5%, p = ns) after closure with the mechanical device. The incidence of a pseudo-aneurysma or of an arterio-venous fistula did not show any difference between the two groups. In 6 patients of the manual compression group a hematoma was found (p < 0.05), whereas no hematoma occurred in the FemoStop-group. None of the hematomas required the infusion of blood concentrates or surgical correction. In one patient with extreme overweight the mechanical compression device could not be applied. The mechanical compression device was used successfully in patients who had received heparin, acetyl-salicyl-acid or a glycoprotein IIb/IIIa receptor antagonist and in whom a significantly longer compression time and higher complication rate could have been expected. In addition, post-angiographic closure with the was less time consuming for the staff involved. In contrast, the higher cost of the mechanical compression device presents a disadvantage. CONCLUSION: A mechanical compression device (FemoStop) can be used successfully in routine post-angiographic management and shows a trend to lower complication rates than manual compression and increased acceptance by patients and physicians. However, the overall costs are higher for the mechanical compression device.
RCT Entities:
BACKGROUND: The aim of our study was to evaluate the practicability and the complication rates of two different forms of the post-angiographic closure of the femoral artery. METHODS: We randomized 239 patients over a time period of 4 months to either a mechanical compression system (FemoStop, 111 patients) or to conventional manual compression (128 patients). A Doppler-sonographic examination was performed if the patient reported pain of the puncture site, or if auscultation or palpation suspected a complication on the day after compression. RESULTS: After manual compression, Doppler-sonography had to be performed in 21 patients (16.4%). In the FemoStop-group only 14 patients (12.6%, p = ns) had to be referred for ultrasound examination. A complication was detected in 13 patients (10.1%) after manual compression and in 5 patients (4.5%, p = ns) after closure with the mechanical device. The incidence of a pseudo-aneurysma or of an arterio-venous fistula did not show any difference between the two groups. In 6 patients of the manual compression group a hematoma was found (p < 0.05), whereas no hematoma occurred in the FemoStop-group. None of the hematomas required the infusion of blood concentrates or surgical correction. In one patient with extreme overweight the mechanical compression device could not be applied. The mechanical compression device was used successfully in patients who had received heparin, acetyl-salicyl-acid or a glycoprotein IIb/IIIa receptor antagonist and in whom a significantly longer compression time and higher complication rate could have been expected. In addition, post-angiographic closure with the was less time consuming for the staff involved. In contrast, the higher cost of the mechanical compression device presents a disadvantage. CONCLUSION: A mechanical compression device (FemoStop) can be used successfully in routine post-angiographic management and shows a trend to lower complication rates than manual compression and increased acceptance by patients and physicians. However, the overall costs are higher for the mechanical compression device.