Effect of an NSE PTA balloon in experimental lesion models.

The effect of a scoring balloon has been reported. However, it is difficult to compare the effect of conventional vs. scoring balloons on the same lesion. Therefore, we assessed the scoring effect of the NSE with and without elements. The endpoints of this study were scoring grade in the eccentric agar model and crack incidence in the eccentric plaster model after ballooning. The scoring grade consisted of 5 levels: (1) almost none, (2) only at the surface, (3) cleavage in the depth of less than two-thirds, (4) cleavage in the depth of two-thirds or more, and (5) collapse. The scoring grade was assessed by blinded reviewers. To estimate the incidence of crack after ballooning for plaster model, balloon expansion pressure was recorded when plaster was broken. In the eccentric agar model, the overall scoring grade was significantly higher in the NSE group compared with the NSE without elements group (p = 0.002). The scoring grade at a diameter of 4.0 mm was significantly higher in the NSE group (p = 0.018). The scoring grade at nominal pressure was significantly higher in the NSE group (p = 0.016). In the eccentric plaster model, the crack incidence of the calcified region was overall significantly higher in the NSE group than that in the NSE without elements group (63 vs. 42 %, p = 0.04). A crack was found at calcification severity ≥180° in the NSE group (84 vs. 56 %, p = 0.014). Our result suggested that NSE exhibited a higher scoring effect in both models compared with conventional balloons.