Evaluation of a coronary lysing system: results of a preclinical safety and efficacy study

The purpose of this study was to evaluate the efficacy and safety of a recently developed transluminal lysing system in the removal of coronary stenotic lesions from a human cadaver heart and in the cannulation of coronaries in the anesthetized dog. The left coronary arteries of three dogs were cannulated on separate occasions, with coronary arteriography and translation of the transluminal lysing system cutter to the distal segments of the coronary vessels performed each time. Proximal and distal coronary pressures were recorded from the guiding catheter and the transluminal lysing system cutter, demonstrating no significant pressure differential and minimal damping. Pathological examination of the dog coronaries after sacrifice demonstrated minor intimal irregularities with no significant thrombosis or vessel perforation. A significant portion of the occlusive stenotic lesions were removed from coronary vessels of a human cadaver heart with subsequent reestablishment of angiographic dye flow to the distal coronary vessels without evidence of debris loss from the transluminal lysing system cutter or the appearance of occlusions in the distal vessels. We conclude that the transluminal lysing system can be introduced into the coronary artery of a living dog on repeated occasions without causing significant coronary damage, coronary occlusive thrombosis, myocardial destruction, morbidity, or mortality; furthermore, occlusive stenotic lesions can be removed from cadaver coronary vessels by the transluminal lysing system with the establishment of angiography patency.