Although debulking devices and intravascular lithotripsy have been prevalent for severely calcified lesions in recent years, scoring and cutting balloons are also often used for plaque modification in calcified lesions. A novel scoring balloon was launched by Kaneka Corp. This retrospective, observational, multicenter study was conducted in three collaborating hospitals in Japan. It was designed as an exploratory analysis of early cases to evaluate crossability and effectiveness in severely calcified lesions, as assessed by optical coherence tomography (OCT). Seven patients treated with the novel scoring balloon were evaluated, and all patients underwent an OCT-guided procedure. We analyzed OCT findings, including calcium arc, calcium thickness, calcium fracture, minimum stent area, and expansion index. All lesions were located in the left anterior descending artery and had a calcium score of 4. Six patients underwent lesion debulking before balloon dilation. The novel scoring balloon was successfully delivered after pre-balloon OCT observation in all patients. Post-ballooning OCT revealed calcium fractures in 5 patients. The median calcium fracture thickness was 565 μm and the median calcium thickness at the fracture was 765 μm. In the receiver operating characteristic curve analysis, the optimal calcium arc and minimum calcium thickness cutoff values for predicting calcium fracture were 218° and 655 μm, respectively. In almost all the patients, an adequate expansion index was achieved after stenting. The novel scoring balloon demonstrated sufficient crossability and dilation in severely calcified lesions. Further studies with a larger number of cases, including comparisons with other scoring systems or cutting balloons, are warranted.
Yoshijima et al. (Tue,) studied this question.