Clinical efficacy of SoftSeal-STF hemostatic pad with short hold time compared to traditional manual compression after transfemoral catheterization


Aurora Cardiovascular Services

Aurora Sinai/Aurora St. Luke’s Medical Centers


BACKGROUND: Access site complications after angiography and percutaneous coronary intervention (PCI) affect mortality, morbidity, length of stay and overall cost. The SoftSeal-STF Hemostatic Pad (SS) is a novel product to achieve hemostasis. We hypothesized SS with a short hold time was equivalent to traditional manual compression (TMC) after femoral catheterization.

METHODS: Retrospective analysis of consecutive patients undergoing femoral cardiac catheterization with and without PCI was conducted. Patients were divided into 2 groups: those with SS and short hold time and those with TMC. Groups underwent 1:1 propensity matching for bleeding risk score and type of anticoagulant used.

RESULTS: Between April 2015 and June 2016, a total of 1,348 patients were included in the propensity match analysis. After matching, SS group included 218 patients and TMC 1,130. SS group [65.6% male (n=143), mean age 67 years, 85.3% PCI] had an average hold time of 7.79 minutes while TMC group [58.8% male (n=664), mean age 67.3 years, 60.2% PCI] had an average hold time of 20 minutes. Mean SS hold time 7.79 minutes (SD+/- 3.38) with 95% CI (7.79, 8.25) is statistically significant (P< 0.001) compared to TMC. Primary endpoint of hemostasis without complication occurred in 97.2% of SS group and 96.9% of TMC group, proportion difference with 95% CI is 0.35% (-2.14%, 2.83), significant for equivalence (p

CONCLUSIONS: Clinical efficacy of the SS with significantly shorter hold times is equivalent to TMC.

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