Pre-clinical assessment of a prototype non-invasive diagnostic device to detect aortic aneurysms.

We have developed a non-invasive diagnostic device for treating thoracic aortic aneurysm that can be applied at a peripheral artery. This study aimed to examine how configuration and size of an aneurysm as well as endoluminal pressure affect our diagnostic device's ability to detect an aneurysm, using a pulsatile mock circulation. We created three different-sized (12, 16, and 20 mm) saccular and fusiform aneurysm models using silicone and incorporated them in a pulsatile perfusion circuit to evaluate vertical vessel wall velocity wave form at a location apart from the aneurysm. We also varied the pressure condition to evaluate the changes in the detected wave forms. In both fusiform and saccular aneurysm models, biphasic wave forms indicating the presence of aneurysm within the circuit were observed. Regarding aneurysm diameter, biphasic wave forms were observed in all aneurysm models. However, in the 12-mm model, which is relevant to the minimum diameter of clinical diagnostic criteria for an aneurysm relative to normal size, no biphasic waveform was detected when the endoluminal pressure was relatively low. In the 16- and 20-mm models, biphasic waveform was detected without being affected by the configuration and endoluminal pressure. The detectability of aneurysms within a pulsatile mock circulation using our non-invasive diagnostic device was not affected by the clinically relevant configuration and size of the aneurysm under slightly hypertensive endoluminal pressure condition. Low endoluminal pressure may lower the diagnostic sensitivity for relatively small saccular aneurysm.