BACKGROUND: Hemostasis at the femoral venous access site after atrial fibrillation (AF) ablation is often prolonged because of aggressive anticoagulation and the use of several large-sized sheaths. A newly developed hemostatic pad containing a natural mineral called kaolin causes blood to clot quickly. We evaluated the efficacy of this pad for hemostasis at the venous access site after AF ablation. METHODS:Patients who were scheduled to undergo AF ablation were randomized to be treated with manual compression with (n = 59) or without kaolin-impregnated pads (n = 59) as hemostatic approaches at the femoral venous access site following sheath removal. Hemostasis time, rebleeding frequency, massive hematoma, device-related complications, and deep venous thrombosis (DVT) were compared between the two groups. RESULTS:Hemostasis time in the patients treated with kaolin-impregnated pads was significantly shorter than in those treated without (6.1 ± 2.3 vs. 14.5 ± 4.0 min; p < 0.0001). Multiple linear regression analysis revealed that the use of kaolin-impregnated pads was the only independent variable reducing hemostasis time (β = -0.78; p < 0.0001). However, rebleeding rates of the two groups were similar (37% with vs. 46% without kaolin-impregnated pads; p = 0.35). Only one patient had a massive groin hematoma, and no patient had device-related complications or DVT. CONCLUSIONS:Kaolin-impregnated hemostatic pads safely and effectively decreased hemostasis time for the femoral venous access site in patients undergoing AF ablation. However, whether its use allows earlier postprocedural ambulation is difficult to predict.
RCT Entities:
BACKGROUND: Hemostasis at the femoral venous access site after atrial fibrillation (AF) ablation is often prolonged because of aggressive anticoagulation and the use of several large-sized sheaths. A newly developed hemostatic pad containing a natural mineral called kaolin causes blood to clot quickly. We evaluated the efficacy of this pad for hemostasis at the venous access site after AF ablation. METHODS:Patients who were scheduled to undergo AF ablation were randomized to be treated with manual compression with (n = 59) or without kaolin-impregnated pads (n = 59) as hemostatic approaches at the femoral venous access site following sheath removal. Hemostasis time, rebleeding frequency, massive hematoma, device-related complications, and deep venous thrombosis (DVT) were compared between the two groups. RESULTS: Hemostasis time in the patients treated with kaolin-impregnated pads was significantly shorter than in those treated without (6.1 ± 2.3 vs. 14.5 ± 4.0 min; p < 0.0001). Multiple linear regression analysis revealed that the use of kaolin-impregnated pads was the only independent variable reducing hemostasis time (β = -0.78; p < 0.0001). However, rebleeding rates of the two groups were similar (37% with vs. 46% without kaolin-impregnated pads; p = 0.35). Only one patient had a massive groin hematoma, and no patient had device-related complications or DVT. CONCLUSIONS:Kaolin-impregnated hemostatic pads safely and effectively decreased hemostasis time for the femoral venous access site in patients undergoing AF ablation. However, whether its use allows earlier postprocedural ambulation is difficult to predict.
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