Long-term clinical outcomes after deployment of femoral vascular closure devices in coronary angiography and percutaneous coronary intervention: an observational single-centre registry follow-up.

Objectives: There are few data evaluating the long-term effect of femoral vascular closure devices (FCDs) on patients' clinical outcome. We aim to evaluate the incidence of peripheral vascular disease (PVD) in patients who received FCD following its deployment in coronary angiography and percutaneous coronary intervention (PCI) procedures.

Design And Setting: Observational study of a single-centre registry.

Participants: From June 2000 to September 2004, 265 patients who received FCD after coronary angiography and PCIs were enrolled on the study.

Outcome Measures: Clinical follow-up (using Rutherford's categories of claudication), ankle brachial index (ABI) and duplex ultrasound of femoral arteries (using the non-accessed side as control) were performed to evaluate the presence of PVD.

Results: The mean follow-up interval was 3320±628 days. 1 patient (0.4%) suffered from grade 2 claudication and another (0.4%) suffered from grade 1 claudication. The mean ABIs of the accessed side and non-accessed side were 1.06±0.13 and 1.08±0.11, respectively (p=0.17). For duplex ultrasound, the mean common femoral artery peak systolic velocities of the accessed side and non-accessed side were 87.4±22.3 and 87.7±22.1 cm/s, respectively (p=0.73); the mean superficial femoral artery peak systolic velocities of the accessed side and non-accessed side were 81.4±20.1 and 81.31±17.8 cm/s, respectively (p=0.19).

Conclusions: The use of FCD after a coronary angiogram and PCI is safe and does not increase the long-term risk of PVD.