Assessment of possible thermal damage of tissue due to atherectomy by means of a mechanical debulking device

In vitro and cadaver experiments, coupled with numerical simulations, were performed to assess the possibility mat orbital atherectomy might cause thermal damage of tissue. The experiments involved debulking operations on a surrogate artery and on the plaque-lined posterior tibial artery of a cadaver. Temperatures and coolant flow rates measured during these experiments enabled a numerical simulation of the debulking of a plaque-lined artery in a living human. The temperature variations from the numerical simulations were used to evaluate a thermal injury index. The resulting values of the index were found to be several orders of magnitude below the threshold value for thermal injury. It is concluded that it is extremely unlikely that the use of an orbital debulking device, the Diamondback 360°™ (Cardiovascular Systems, Inc.), can lead to thermal injury of the artery wall.