Comparison of the FemoSeal Vascular Closure Device With Manual Compression After Femoral Artery Puncture - Post-hoc Analysis of a Large-Scale, Randomized Clinical Trial.

OBJECTIVES

To assess the safety and efficacy of arteriotomy closure with the intravascular FemoSeal vascular closure device (VCD; St. Jude Medical) compared to manual compression in patients undergoing diagnostic cardiac catheterization via the common femoral artery.

BACKGROUND

There is limited evidence on the performance of individual contemporary VCDs compared to manual compression.

METHODS

This is a subanalysis of 3018 patients who underwent transfemoral diagnostic coronary angiography and were randomly assigned to arteriotomy closure with either the intravascular FemoSeal VCD or manual compression within the investigator-initiated, large-scale, randomized, multicenter, open-label ISAR-CLOSURE trial. Primary endpoint was the composite of access-site related vascular complications at 30 days. Secondary endpoints were time to hemostasis and repeat manual compression.

RESULTS

Vascular access-site complications were lower in patients assigned to the FemoSeal VCD compared to manual compression (6.0% vs 7.9%; P=.04), driven by a lower incidence of hematomas in the FemoSeal group (4.3% vs 6.8%; P<.01). Pseudoaneurysm rates were comparable in both groups (1.5% vs 1.5%; P=.88). Time to hemostasis was significantly shortened with the FemoSeal VCD compared to manual compression (0.5 min [IQR, 0.2-1.0 min] vs 10 min [IQR, 10-15 min]; P<.001). However, repeat manual compression was increased with the FemoSeal VCD (1.5% vs 0.7%; P=.03).

CONCLUSION

In patients undergoing transfemoral diagnostic coronary angiography, the use of the FemoSeal VCD is associated with shortened time to hemostasis and a reduction in vascular access-site complications driven by fewer hematomas when compared to manual compression.