Key result
The FemoSeal vascular closure device achieved hemostasis in 100% of 50 patients with 7F femoral arterial puncture sites, with a mean time to hemostasis of 57.8 seconds.
Why the study?
Does the FemoSeal vascular closure device safely and effectively seal 7F femoral arterial puncture sites in patients undergoing cardiac catheterization?
Observational (n=50)
Does the FemoSeal vascular closure device safely and effectively seal 7F femoral arterial puncture sites in patients undergoing cardiac catheterization?
The FemoSeal vascular closure device, originally approved for 6F sheaths, appears safe and effective for achieving hemostasis in larger 7F femoral arterial puncture sites.
Answers are grounded in this paper and cite their sources.
Supports evaluation of FemoSeal for 7F access; leaves open need for prospective trials before clinical adoption.
Post-cardiac catheterization femoral artery hemostasis can be accomplished with several mechanisms, including the FemoSeal® hemostasis device which has been designed and approved for closure of 6 French (F) arterial puncture sites. The aim of this study was to investigate whether the FemoSeal® vascular closure device can effectively and safely seal 7F arterial puncture sites after diagnostic and interventional cardiac catheterizations. Femoral artery puncture sites of 50 consecutive patients undergoing cardiac catheterization were closed with the FemoSeal® vascular closure device, according to the manufacturer's instructions. Efficacy endpoints were time to hemostasis and successful ambulation. Safety endpoints included bleeding complications, vessel occlusion and pseudoaneurysms. Mean time to hemostasis was 57.8±26.3 seconds (0-125 seconds). Hemostasis was achieved in 100 percent of the 50 patients. One patient suffered minor bleeding the next day, i.e. local hematoma. This clinical study demonstrates that the FemoSeal® vascular closure device, initially approved for closure of 6F arterial puncture sites, shows promising efficacy and safety to seal a larger (7F) femoral arterial puncture sites after diagnostic and interventional cardiac catheterizations.
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Wanitschek et al. (2011) conducted an observational in Diagnostic and interventional cardiac catheterizations (n=50). FemoSeal vascular closure device was evaluated on Time to hemostasis and successful ambulation. The FemoSeal vascular closure device achieved hemostasis in 100% of 50 patients with 7F femoral arterial puncture sites, with a mean time to hemostasis of 57.8 seconds.
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