Preclinical evaluation of a Rheolytic (TM) catheter for percutaneous coronary artery/saphenous vein graft thrombectomy

The presence of thrombus increases the rate of acute complications and rest enosis in percutaneous revascularization of native coronary arteries and sa phenous vein grafts. Rheolytic thrombectomy uses high velocity saline jets to create a Bernoulli effect for thrombus entrainment, dissociation, and ev acuation of debris, providing a novel approach to the treatment of thrombot ic lesions. The study objective was to determine the preclinical safety and effectiveness of a 5 French rheolytic thrombectomy catheter designed for u se in coronary arteries and saphenous vein grafts. In vitro testing was per formed to evaluate catheter effectiveness (clot removal rate) and safety (p article generation and hemolysis), This was followed by acute (n = 6) and c hronic (n = 6) canine studies to determine hemodynamic, angiographic, and h istopathologic effects of the catheter, The results showed effective clot r emoval with minimal embolization: 99.4% of the total clot volume was remove d,vith only 0.1% proximal embolization and 0.5% distal embolization, 98.4% of the embolic particles were less than 10 mu m. Canine studies revealed no significant angiographic, hemodynamic, histopathologic, or electrocardiogr aphic abnormalities with the exception of transient heart block in one anim al. There was transient hemolysis which normalized within 24 hours with no adverse effects. These results demonstrate the effectiveness and safety of coronary rheolytic thrombectomy and provided the basis for clinical trials to further evaluate this promising new approach for coronary thrombectomy.