Background: Progressive atherosclerosis of the coronary arteries is associated with angina pectoris, recurrent hospitalization, low quality of life, and early death. Current therapeutic approaches include coronary stenting, and bypass surgeries. These approaches cannot be implicated in a subset of the patients who are not considered to be candidates for invasive surgeries, and in whom PCI attempts cannot be performed or have failed.
The unrevascularizable patients represent up to 20% of all patients with coronary disease. Our aim was to propose an alternative approach to the treatment of this common medical condition. We hypothesized that implantation of a specialized apparatus to the ascending aorta, with coiling properties will be capable of enhancing diastolic coronary flow and thereby, improve angina pectoris symptoms and associated complications.
Methods: An intra-vascular-device, composed of an expendable stent backbone and membrane-covered coil was developed (Figure 1). The hemodynamic effects of the device was tested using an in vitro digitally-controlled fluid pump capable of simulating the cardiac pulsatile flow, which in turn was connected to a simulated 3-dimentional model of the humanized vascular tree. Coronary and aortic outputs were measured and averaged. The influences of the proposed device following intra-aortic implantation were evaluated using appropriate statistical methods.
Results: The apparatus was found to increase the flow to the simulated coronary artery by 7.38% (p<0.001) compared to control. The flow to the ascending aorta distally to the implanted device was not significantly compromise.
Conclusions: In this in-vitro study we presented a novel approach toward the treatment of unrevascularizable coronary vascular disease using an implantable intra-aortic medical apparatus. To this end, we demonstrated that simulated coronary blood flow could be significantly increased by amplification of coronary diastolic blood flow. We suggest that this approach may be superior to conservative therapy alone in a subset of the cardiac patients.
