007 - Novel device for catheter directed thrombolysis and concurrent hemodynamic monitoring in the pulmonary arteries
Purpose: To evaluate the safety and feasibility of delivering a novel device capable of catheter directed thrombolysis and concurrent hemodynamic monitoring in a porcine model.
Material and Methods: An IACUC approved pilot study was conducted in two Yorkshire pigs. In each animal, a novel device (Flow Medical; Chicago, IL) containing a multi-sidehole self-expanding and adjustable-length nitinol cage was placed in the right, left, and main pulmonary arteries. Functionality of proximal and distal hemodynamic monitoring ports integrated into the device were also assessed. Technical success was defined as the ability to place the device into the pulmonary artery over a .035” guidewire, expand its cage, and measure pulmonary arterial pressures. Procedure related complications including persistent cardiac arrhythmia, vessel perforation, and/or mortality were assessed.
Results: Study objectives were technically successful in both animals. No procedure related complications occurred. No radiographic evidence of vessel damage or hemorrhage was observed. In both animals, heparinized saline was successfully hand injected through the thrombolytic infusion port without resistance. A distal and proximal (i.e. 15cm proximal to the distal tip) pulmonary arterial pressure was recorded in 1 animal. In the second animal, only a distal pressure could be obtained.
Conclusions: A novel device for concurrent catheter directed thrombolysis and hemodynamic monitoring in the pulmonary arteries was technically feasible and safe in this pilot porcine study. Future studies to establish safety and efficacy in the setting of pulmonary embolism are warranted.