Propensity score analysis of vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention using thrombin hemostatic patch-facilitated manual compression.

OBJECTIVES

To evaluate the adjusted risk of vascular complications after thrombin hemostasis patch-facilitated manual compression (THP-MC) for femoral artery access site management.

BACKGROUND

Thrombin hemostatic patches shorten time to hemostasis after cardiac procedures involving femoral artery access, but whether these patches are as safe as manual compression remains uncertain.

METHODS

THP-MC (D-Stat Dry, Vascular Solutions, Minneapolis, Minnesota) was used in 3,464 consecutive patients including 2,464 diagnostic cardiac catheterizations (CATH) and 1,000 percutaneous coronary intervention procedures (PCI) performed via a femoral access at a single site (WFUBMC). A total of 4,371 procedures including 2,956 CATH and 1,415 PCI performed prior to use of THP-MC, and treated with manual compression, served as the control group. Ambulation was permitted 2 to 3 hours after THP-MC, and 3 to 8 hours after MC. Propensity to receive a THP was calculated, and adjusted in-hospital outcomes evaluated.

RESULTS

Time to hemostasis was similar for THP-MC (13.0 +/- 3.3 min) compared to MC (14.4 +/- 5.7 min), p = 0.51 for CATH, and was shorter for THP-MC (14.2 +/- 5.4 minutes) compared to MC (20.1 +/- 5.4 min), p <0.001, for PCI. Overall, the unadjusted incidence of any vascular complication (VC) was 0.6+/- for THP-MC and 1.0% for manual compression, p = 0.036. The propensity score-adjusted odds ratio for any VC comparing THP-MC to manual compression was 0.58 (0.34 to 0.99) for all procedures, 0.42 (0.20 to 0.87) for diagnostic procedures and 0.86 (0.39 to 1.88) for PCI.

CONCLUSIONS

In this large, single-center, contemporary observational study, use of THP-MC shortened manual compression time for PCI procedures, permitted early ambulation and was as safe as conventional manual compression.