Background: We evaluated the long term clinical outcomes of femoral vascular closure devices following its deployment in coronary angiography and percutaneous coronary intervention (PCI) procedures.
Methods: From June 2000 to September 2004, 265 patients who received femoral vascular closure devices after coronary angiography and PCIs were enrolled into the study. Patients' medical records were reviewed and vascular complications within 1 year of follow-up period were recorded. Rutherford's categories of claudication were used to quantify different degrees of claudication and leg ischaemia. Duplex ultrasonography of both femoral arteries (using the nonaccessed site as control) was performed at 1 year after deployment of vascular closure devices. Vessel diameter and flow velocities for both common femoral arteries were obtained.
Results: There was no occurrence of late vascular complications like arteriovenous fistula, pseudoaneurysm, surgical repair of access site complications, late groin bleeding and infection. By Rutherford categories of claudication, 99.2% of patients had grade 0 claudication while the remaining 0.8% was in grade 1. By arterial Duplex ultrasonography, the peak systolic velocity of the accessed femoral artery (predominantly right side) was nonsignificantly higher, 94.9 + or - 26.0 cm/s when compared to 91.5 + or - 24.8 cm/s in the control site (P = 0.12). As for vessel diameter, no significant difference was found in the mean end-diastolic vessel diameter 8.8 + or - 1.3 mm (puncture site) versus 8.7 + or - 4.4 mm (control site) (P = 0.72).
Conclusion: We found that the use of femoral closure devices was safe and it was not associated with any adverse long term vascular complications.