Abstract

We aimed to develop a hemostatic device with physiological evidence that allows ambulation soon after atrial fibrillation (AF) ablation. We measured right femoral vein pressure in 57 participants to clarify why groin post-venipuncture rebleeding often occurs during the transition from supine to sitting under compression bandage application and found that it increased more than threefold when raising the upper body (8.6 ± 4.1 to 27.6 ± 6.9 mmHg; P < 0.001). Based on that data, we created a novel hemostatic belt. Its capability test including 25 participants demonstrated that the belt gave much higher compression pressures on the right groin while sitting than the compression bandage (59.5 ± 14.9 vs. 8.1 ± 4 mmHg; P < 0.001), achieving pressures above the maximum femoral vein pressure in 92% of participants. A randomized trial comparing the belt with compression bandage in 74 AF patients demonstrated that the belt reduced time to ambulation without any rebleeding (340 [92.5-360] vs. 360 [360-360] min; P < 0.001) and satisfied more patients. The novel hemostatic belt provided a much higher compression pressure on the right groin during the sitting position than the conventional compression bandage, achieving a pressure above the maximum femoral vein pressure in 92% of the participants.

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