CASE STUDY Geoffrey S. Ferguson, MD Evergreen Hospital Medical Center, Kirkland, WA EKOS® vs. CDT, a side-by-side comparison: Complete aortoiliac occlusion treated with bilateral lytic infusion Patient History – 82 year-old male with acute onset of numbness and weakness in both legs while in dental chair – Physical examination: cyanosis and paresis with no palpable pulse in lower extremities bilaterally – Duplex ultrasound: a doppler silent distal aorta from superior mesenteric artery (SMA) inferiorly and no flow in both left and right common iliac arteries – Angiography: complete occlusion of abdominal aorta at and distal to level of bifurcation (Fig. 1), with scant collateral flow from inferior mesenteric artery to internal iliacs (Fig. 2) Figure 1. Pre-procedural angiography Treatment Bilateral tPA infusion by EKOS® on left side and CDT on right – EKOS® device (18cm length, 106cm working length) placed in distal aorta extending into left iliac (Fig. 3) – A sidehole infusion catheter (5F, 20cm length, Uni*Fuse,™ AngioDynamics®) placed at the same level extending into right iliac (Fig. 3) – rt-PA infused at 0.5 mg/hr/catheter for 4 hrs, reduced to 0.25 mg/hr/catheter for 19 hours (total 23hr infusion) – Heparin administered with a target PTT of 40-60 seconds Initial Results Figure 2.Pre-procedural angiography EKOS EKOS CDT CDT Figure 3. Catheter placement for therapy After initial rt-PA infusion by EKOS® on left, CDT on right – Thrombus completely resolved by EKOS®, but significant occlusion remained following CDT (Fig.4) Figure 4. Complete clearance on the left (by EKOS®), but poor recanalization on the right (by CDT). Continuing Treatment and Final Results rt-PA infusion by EKOS® switched to the right side, CDT to the left – Continued overnight infusion at same dose – Complete lysis achieved on the right side with excellent flow observed proximal and distal to bifurcation bilaterally (Fig. 5) – Underlying bilateral common iliac stenoses revealed and treated with 7 x 40 mm balloon expandable stents (Fig. 6) – Patient discharged 1 day post-procedure, ambulating without difficulty, no weakness or numbness, and no evidence of distal embolization Switched to EKOS Switched to CDT Figure 5. Complete clearance achieved on right side after switching to EKOS®. Conclusion – EKOS® therapy resulted in complete thrombus resolution not achievable by CDT in patient – Discrepancy between arterial duplex and angiography was attributed to the nearly but not completely static aortic flow below SMA Figure 6. Completion angiography FDA CLEARED INDICATIONS: The EkoSonic® Endovascular System is indicated for the ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism; the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature; and the infusion of solutions into the pulmonary arteries. Instructions for Use, including warnings, precautions, potential complications, and contraindications can be found at www.ekoscorp.com. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. EKOS® and EkoSonic® are registered trademarks of EKOS Corporation, a BTG International group company. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd. © 2014 EKOS Corporation • US-EKO-2014-1529 EKOS CORPORATION 11911 N Creek Pkwy S. Bothell, WA 98011
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