Background: Bleeding and vascular access site complications are an important cause of morbidity after percutaneous femoral procedures. Together with collagen-based and suture-based vascular closure devices, new hemostatic dressings have been developed to control heavy bleeding.
Aim of study: To evaluate safety and efficacy results of the first clinical QuikClot Interventional Hemostatic Bandage use for femoral artery closure after diagnostic or interventional procedures.
Methods: The first European safety study was performed at the Centro Cardiologico Monzino in Milan, Italy, on January 2010. Forty consecutive patients (75% male, mean age 68 ± 11years) undergoing diagnostic angiography (62%) or PCI (38%) by femoral approach with a 6- (90%) or 7-Fr (10%) size introducer, received arterial sheath removal with the QuikClot Interventional gauze use. The mean ACT value at hemostasis time was 138 ± 24s (range 95-186s). Hemostasis was achieved in a mean time of 4.9 ± 0.5 min. Only one hemostasis failure occurred requiring prolonged mechanical compression. Neither major bleeding, re-bleeding nor hematoma occurred after early (4h after procedure) ambulation.
Conclusions: QuikClot Interventional Bandage obtained prompt hemostasis and allowed for an early ambulation without clinical complications.
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