Key result
Undersized cutting balloons (0.25-0.5 mm less than reference) with two blades facing a 180° calcification generated higher stresses for fracturing calcium while reducing stress in the adjacent artery.
Why the study?
Calcifications with maximum calcium angles ≤ 180° are rarely fractured during conventional balloon angioplasty, and cutting balloons carry risks of vessel dissection and perforation.
Does the number of blades facing a calcified lesion and the balloon-to-diameter ratio affect the potential for calcification fracturing and vessel injury in a 180° calcified artery model?
Does the number of blades facing a calcified lesion and the balloon-to-diameter ratio affect the potential for calcification fracturing and vessel injury in a 180° calcified artery model?
Finite element analysis suggests that using undersized cutting balloons with two blades facing a 180° calcified lesion may effectively fracture calcium while reducing the risk of arterial dissection.
Optimizing blade orientation with undersized cutting balloons may enhance calcium fracture while limiting vessel stress; hypothesis-generating pending clinical validation.
Calcified artery lesions cause stent under-expansion and increase the risk of in-stent restenosis and stent thrombosis. Cutting balloons facilitate the fracturing of calcification prior to stent implantation, although vessel dissection and perforation are potential issues. In clinical practice, calcifications having maximum calcium angles ≤ 180° are rarely fractured during conventional balloon angioplasty. We hypothesize that the lesion/device diameter ratio and the number of blades facing a non-circular calcified lesion may be crucial for fracturing the calcification while avoiding vessel injury. The geometries of the cutting balloons were constructed and their finite-element models were generated by folding and wrapping the balloon model. Numerical simulations were performed for balloons with five different diameters and two types of blade directions in a 180° calcification model. The calcification expansion ability was distinctly higher when two blades faced the calcification than when one blade did. Moreover, when two blades faced the calcification model, larger maximum principal stresses were generated in the calcification even when using undersized balloons with diameters reduced by 0.25 or 0.5 mm from the reference diameter, when compared with the case where one blade faced the calcified model and a balloon of diameter equal to the reference diameter was used. When two blades faced the calcification, smaller stresses were generated in the artery adjacent to the calcification; further, the maximum stress generated in the artery model adjacent to the calcification under the rated pressure of 12 atm when employing undersized balloons was smaller than that when only one blade faced the calcification and when lesion-identical balloon diameters were used under a nominal pressure of 6 atm. Our study suggested that undersized balloons of diameters 0.25 or 0.5 mm less than the reference diameter might be effective in not only expanding the calcified lesion but also reducing the risk of dissection.
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Zhu et al. (2021) studied Coronary artery calcification. Cutting balloon expansion (undersized, 2 blades facing calcification) vs. Reference diameter balloon with 1 blade facing calcification was evaluated on Maximum principal tensile stress in calcification and adjacent artery. Undersized cutting balloons (0.25-0.5 mm less than reference) with two blades facing a 180° calcification generated higher stresses for fracturing calcium while reducing stress in the adjacent artery.
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