Author + information
- Nolan Machernis,
- Tadele Mengesha,
- Robyn Shearer,
- Louie Kostopoulos,
- Yoseph Shalev,
- Tonga Nfor,
- Jayant Khitha,
- M. Fuad Jan,
- Tanvir Bajwa and
- Suhail Allaqaband
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<0.0001) using a 5% margin.
Conclusions: Clinical efficacy of the SS with significantly shorter hold times is equivalent to TMC.
Poster Hall, Hall C
Saturday, March 18, 2017, 9:45 a.m.-10:30 a.m.
Session Title: Vascular Access and Hemostasis Issues
Abstract Category: 26. Interventional Cardiology: Vascular Access and Complications
Presentation Number: 1192-126
- 2017 American College of Cardiology Foundation