| Title: |
Clinical efficacy of SoftSeal-STF hemostatic pad with short hold time compared to traditional manual compression after transfemoral catheterization |
| Authors: |
Machernis, Nolan; Mengesha, Tadele W.; Shearer, Robyn; Kostopoulos, Louie; Shalev, Yoseph; Nfor, Tonga; Khitha, Jayant; Jan, M. Fuad; Bajwa, Tanvir; Allaqaband, Suhail |
| Source: |
Aurora UW Cardiology Faculty |
| Publisher Information: |
SHARE @ Advocate Health - Midwest |
| Publication Year: |
2017 |
| Collection: |
Aurora Health Care Digital Repository |
| Subject Terms: |
Aurora Cardiology Fellows; Cardiovascular Surgery |
| Description: |
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. |
| Document Type: |
text |
| Language: |
unknown |
| Relation: |
https://institutionalrepository.aah.org/cardiologyfaculty/35 |
| DOI: |
10.1016/s0735-1097(17)34554-0 |
| Availability: |
https://institutionalrepository.aah.org/cardiologyfaculty/35; https://doi.org/10.1016/s0735-1097(17)34554-0 |
| Accession Number: |
edsbas.AFBD854F |
| Database: |
BASE |