Background: Cutting balloons are commonly used for the preparation of calcified lesions, but problems with crossability occasionally limit the use of these balloons. A novel cutting balloon was recently developed and reported to have improved crossability in clinical settings. However, the predictors of its unsuccessful crossing have been unclear. The aims of this study were to examine the delivery success rate and to identify the predictors of unsuccessful crossing with the novel cutting balloon.

Methods and Results: We prospectively enrolled 502 calcified lesions treated with the novel Wolverine cutting balloon under the guidance of either intravascular ultrasound (IVUS) or optical coherence tomography (OCT). The primary study outcome was the balloon delivery success, which we defined as successful crossing to the target lesion immediately after the IVUS or OCT evaluation. A multivariate analysis evaluated the independent predictors for unsuccessful crossing. The balloon delivery success rate was 92.4%. The multivariate analysis showed that non-left anterior descending (non-LAD) lesions (odd ratio [OR] 2.27, 95% confidence interval [CI]: 1.09–4.71, p = 0.028) and previous history of percutaneous coronary intervention (PCI) (OR 2.46, 95% CI: 1.09–5.53, p = 0.029) were the independent predictors for unsuccessful crossing.

Conclusion: The Wolverine cutting balloon demonstrated high crossability. However, we should device its usage for non-LAD lesions and patients with a previous history of PCI.

This article briefly reviews the history of the early and middle-term development of cardiovascular angioscopic techniques and devices prior to the end of the 20th century in Japan, in particular with regard to the more advanced stages of laser angioplasty of the peripheral arteries. Relevant findings abroad are also cited. In the early days of angioscopy, techniques to see inside the heart or vessels required stiff angioscopes, surgically opened hearts, or arterial or venous cutdowns.

As the technology advanced, percutaneous techniques to see the inside of the arteries or heart were developed. For the purpose of treating arteriosclerotic stenosis or occlusion of the peripheral arteries, new angioscopes enabling laser angioplasty under angioscopy were developed in collaboration with Olympus Optical Co., Ltd., Clinical Supply Co., Ltd., and other companies and research facilities in Japan.

The techniques of cardiovascular angioscopy, especially coronary angioscopy, were much improved and several important findings regarding arteriosclerotic changes in the coronary artery were reported by cardiologists in Japan.