Verification of the differences of scoring effect in current scoring balloons

The characteristics of each scoring balloon seem to be different because material or configuration of scoring element in each device is unique. The aim of this study is to clarify the difference of scoring effect among 3 different scoring devices. We prepared 3 different scoring devices [Wolverine™ Cutting Balloon™ (CB), ScoreFlex™ NC (SF), NSE Alpha™ (NSE), n = 5 respectively. Balloon diameter is 3 mm and 2 types of silicone tubes with different elasticity [140 kPa (tube S) and 576 kPa (tube H), respectively. Inner diameter is 3 mm]. We dilated each balloon in each silicone tube with nominal pressure (NP) and 20 atmosphere (HP) and took a picture using a micro CT. We measured penetration depth of all scoring elements into silicone tube wall and calculated their percentage using the following formula; penetration depth/original scoring element height × 100. We also observed the deformation of scoring element during balloon inflation in each device. Scoring element of CB cut deeper into both tubes significantly than SF and NSE at both pressure (40.5% vs 25.1% and 16.8% at NP and 86.1% vs 33.5% and 29.1% at HP in tube S, p < 0.01, respectively, 62.6% vs 33.5% and 17.0% at NP and 93.3% vs 45.1% and 36.5% at HP in tube H, p < 0.01, respectively). Although no deformation of scoring element was recognized in CB, some deformations were observed in 50% of NSE and 40% of SF (p = 0.0377). Scoring balloon with sharp and firmly fixed scoring elements like CB may show definite scoring effect.