Compression Performance of a Novel Leaf-Spring Pocket Compression Device: A Randomized Crossover Evaluation

Pocket compression is routinely applied after cardiac implantable electronic device procedures to reduce hematoma formation, but conventional compression bandaging has important limitations, including positional instability of pressure and patient discomfort. We developed a novel leaf-spring pocket compression device designed to provide stable, localized compression. This study was conducted as a preparatory performance evaluation prior to a planned multicenter randomized controlled trial (jRCTs042250188). In this randomized crossover study, 33 healthy male volunteers underwent pressure assessment with both the leaf-spring device and conventional compression bandaging across six clinically relevant body positions. The target compression pressure range was predefined as 8–32 mmHg on physiological grounds. The number of body positions in which compression pressure fell within the target range was higher with the leaf-spring device than with conventional compression bandaging (5 [4–6] vs. 4 [3–5] per participant, P=0.005). Pressure variability across body positions was smaller with the leaf-spring device (P<0.001), and comfort scores were higher (5 [4–5] vs. 3 [2–4], P<0.001). No clinically significant skin complications were observed. These findings demonstrate that the leaf-spring device provided more stable and physiologically appropriate compression than conventional compression bandaging while improving comfort, supporting further clinical evaluation in patients undergoing cardiac device implantation.