Selective Venous Thrombolysis with the Nipple-Balloon Catheter: Comparative Evaluation In Vivo

Abstract

To compare in an animal model of deep vein thrombosis, an intramural drug delivery catheter, the nipple-balloon catheter, with an occlusion balloon-infusion guide wire system. Ten juvenile pigs were used for the study. Deep vein thrombosis was induced in both hind limbs by using a previously described technique. Heparin was administered 30 minutes later (2,500 IU intravenously) and bilateral thrombolysis was attempted with use of 8 mg of alteplase as a 0.25 mg/mL solution containing heparin 50 IU/mL (n = 10) and sodium/meglumine ioxaglate 40 mgI2/mL (n = 5). In one limb, the external iliac vein was endoluminally occluded, and 0.8 mL of alteplase was administered every 3 minutes through a multisideport infusion wire placed coaxially through the balloon catheter. On the other side, a nipple-balloon catheter was used: alteplase was injected as two 0.4-mL aliquots every 3 minutes in overlapping segments of the vessel. Blood samples were taken at predetermined intervals to determine the partial thromboplastin time and plasma fibrinogen concentration. At autopsy, the thrombus mass in the iliofemoral veins was measured, and the extent of residual thrombosis in the venous tributaries was graded at four sites. The heart and the lungs were also examined for thromboemboli (n = 5). Venous specimens were then subjected to X-ray fluorescence spectrometry to determine iodine content (n = 5). Bilateral thrombolysis could be successfully completed in all animals. No procedural problem associated with the use of the nipple-balloon catheter was encountered. The mass of residual thrombus in the axial veins was significantly lower in this group (P = .005). The drug delivery system used did not appreciably influence thrombolysis in the tributaries. Signs of macroscopic damage to the veins were not observed in any animal. None of the venous specimens had detectable levels of iodine. Small thromboemboli were found in the pulmonary circulation in three of five animals. Fibrinogen levels did not decrease during the procedure. The significantly lower residual thrombus burden associated with use of the nipple-balloon catheter suggests that the device may have the potential to be an effective delivery system for selective thrombolysis in veins.