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.