EkoSonic Thrombolysis as a Therapeutic Adjunct in Venous Occlusive Disease

Abstract

Objective The use of ultrasound waves in conjunction with local thrombolysis may accelerate clot resolution and serve as an important therapeutic adjunct in the treatment of venous occlusive disease. Our goal was to provide a larger sample population over a 5-year period to evaluate our experience with the EkoSonic endovascular system (EKOS, EKOS Corporation, Bothell, WA). We suspected that ultrasound-accelerated thrombolysis (UAT) using EKOS would provide excellent thrombolysis and midterm patency rates with minimal thrombolytic complications.

Methods A retrospective study was conducted to provide a case series with UAT using EKOS. Data were collected over a 5-year period. Primary end points included degree of thrombolysis. Secondarily, we analyzed thrombolytic usage, complication rates, and midterm patency, over a 1-year period.

Results A total of 48 limbs were treated with UAT. Forty cases were diagnosed as acute, whereas the remaining 8 were chronic. Complete thrombolysis was successful in 38/48 (79%) of patients, and partial thrombolysis was accomplished in 10/48 (21%) of patients. Overall mean infusion time was 22.4 hours ±3.6. There were a total of three complications (6%), all of which were minor bleeding. One-year patency was shown to be 87% with no signs of valvular reflux.

Conclusion UAT using EKOS demonstrated effective rates of thrombolysis with very few complications. In addition, our 1-year patency rates were comparable to published data using conventional catheter-directed thrombolysis. UAT provides lytic therapy by utilizing the benefits of ultrasonic waves to help augment the fibrinolytic process. Our institution currently favors the use of EKOS as the treatment of choice in patients that are appropriate thrombolytic candidates.

Keywords

catheter-directed thrombolysis - deep vein thrombosis - DVT - endovascular procedure - iliofemoral occlusive disease - percutaneous - thrombolytic

• References

• 1 Comerota AJ, Gravett MH. Iliofemoral venous thrombosis. J VascSurg 2007; 46 (5) 1065-1076
• 2 Comerota AJ. Quality-of-life improvement using thrombolytic therapy for iliofemoral deep venous thrombosis. Rev Cardiovasc Med 2002; 3 (Suppl. 02) S61-S67
• 3 Semba CP, Razavi MK, Kee ST, Sze DY, Dake MD. Thrombolysis for lower extremity deep venous thrombosis. Tech Vasc IntervRadiol 2004; 7 (2) 68-78
• 4 Deatrick KB, Eliason JL, Lynch EM , et al. Vein wall remodeling after deep vein thrombosis involves matrix metalloproteinases and late fibrosis in a mouse model. J VascSurg 2005; 42 (1) 140-148
• 5 Nicolaides AN, Hussein MK, Szendro G, Christopoulos D, Vasdekis S, Clarke H. The relation of venous ulceration with ambulatory venous pressure measurements. J VascSurg 1993; 17 (2) 414-419
• 6 Comerota AJ, Aldridge SC. Thrombolytic therapy for deep venous thrombosis: a clinical review. Can J Surg 1993; 36 (4) 359-364
• 7 McLafferty RB. Endovascular management of deep venous thrombosis. Perspect Vasc Surg EndovascTher 2008; 20 (1) 87-91
• 8 Atar S, Rosenschein U. Perspectives on the role of ultrasonic devices in thrombolysis. J Thromb Thrombolysis 2004; 17 (2) 107-114
• 9 Braaten JV, Goss RA, Francis CW. Ultrasound reversibly disaggregates fibrin fibers. ThrombHaemost 1997; 78 (3) 1063-1068
• 10 Tachibana K, Tachibana S. Prototype therapeutic ultrasound emitting catheter for accelerating thrombolysis. J Ultrasound Med 1997; 16 (8) 529-535
• 11 Lauer CG, Burge R, Tang DB, Bass BG, Gomez ER, Alving BM. Effect of ultrasound on tissue-type plasminogen activator-induced thrombolysis. Circulation 1992; 86 (4) 1257-1264
• 12 Nedelmann M, Eicke BM, Lierke EG, Heimann A, Kempski O, Hopf HC. Low-frequency ultrasound induces nonenzymatic thrombolysis in vitro. J Ultrasound Med 2002; 21 (6) 649-656
• 13 Francis CW, Onundarson PT, Carstensen EL , et al. Enhancement of fibrinolysis in vitro by ultrasound. J Clin Invest 1992; 90 (5) 2063-2068
• 14 Olsson SB, Johansson B, Nilsson AM, Olsson C, Roijer A. Enhancement of thrombolysis by ultrasound. Ultrasound Med Biol 1994; 20 (4) 375-382
• 15 Sehgal CM, Leveen RF, Shlansky-Goldberg RD. Ultrasound-assisted thrombolysis. Invest Radiol 1993; 28 (10) 939-943
• 16 Shlansky-Goldberg RD, Cines DB, Sehgal CM. Catheter-delivered ultrasound potentiates in vitro thrombolysis. J Vasc IntervRadiol 1996; 7 (3) 313-320
• 17 Francis CW, Blinc A, Lee S, Cox C. Ultrasound accelerates transport of recombinant tissue plasminogen activator into clots. Ultrasound Med Biol 1995; 21 (3) 419-424
• 18 Siddiqi F, Odrljin TM, Fay PJ, Cox C, Francis CW. Binding of tissue-plasminogen activator to fibrin: effect of ultrasound. Blood 1998; 91 (6) 2019-2025
• 19 Tachibana K. Enhancement of fibrinolysis with ultrasound energy. J Vasc IntervRadiol 1992; 3 (2) 299-303
• 20 Vedantham S, Grassi CJ, Ferral H , et al; Technology Assessment Committee of the Society of Interventional Radiology. Reporting standards for endovascular treatment of lower extremity deep vein thrombosis. J Vasc Interv Radiol 2009; 20 (7, Suppl) S391-S408
• 21 Porter JM, Moneta GL ; International Consensus Committee on Chronic Venous Disease. Reporting standards in venous disease: an update. J VascSurg 1995; 21 (4) 635-645
• 22 Mewissen MW, Seabrook GR, Meissner MH, Cynamon J, Labropoulos N, Haughton SH. Catheter-directed thrombolysis for lower extremity deep venous thrombosis: report of a national multicenter registry. Radiology 1999; 211 (1) 39-49
• 23 AbuRahma AF, Perkins SE, Wulu JT, Ng HK. Iliofemoral deep vein thrombosis: conventional therapy versus lysis and percutaneous transluminal angioplasty and stenting. Ann Surg 2001; 233 (6) 752-760
• 24 Bjarnason H, Kruse JR, Asinger DA , et al. Iliofemoral deep venous thrombosis: safety and efficacy outcome during 5 years of catheter-directed thrombolytic therapy. J Vasc IntervRadiol 1997; 8 (3) 405-418
• 25 Castaneda F, Li R, Young K, Swischuk JL, Smouse B, Brady T. Catheter-directed thrombolysis in deep venous thrombosis with use of reteplase: immediate results and complications from a pilot study. J Vasc IntervRadiol 2002; 13 (6) 577-580
• 26 Comerota AJ, Kagan SA. Catheter-directed thrombolysis for the treatment of acute iliofemoral deep venous thrombosis. Phlebology 2001; 15: 149-155
• 27 Elsharawy M, Elzayat E. Early results of thrombolysis vs anticoagulation in iliofemoral venous thrombosis.A randomised clinical trial. Eur J Vasc EndovascSurg 2002; 24 (3) 209-214
• 28 Grunwald MR, Hofmann LV. Comparison of urokinase, alteplase, and reteplase for catheter-directed thrombolysis of deep venous thrombosis. J Vasc IntervRadiol 2004; 15 (4) 347-352
• 29 Jackson LS, Wang XJ, Dudrick SJ, Gersten GD. Catheter-directed thrombolysis and/or thrombectomy with selective endovascular stenting as alternatives to systemic anticoagulation for treatment of acute deep vein thrombosis. Am J Surg 2005; 190 (6) 864-868
• 30 Kim HS, Patra A, Paxton BE, Khan J, Streiff MB. Adjunctive percutaneous mechanical thrombectomy for lower-extremity deep vein thrombosis: clinical and economic outcomes. J Vasc IntervRadiol 2006; 17 (7) 1099-1104
• 31 Laiho MK, Oinonen A, Sugano N , et al. Preservation of venous valve function after catheter-directed and systemic thrombolysis for deep venous thrombosis. Eur J Vasc EndovascSurg 2004; 28 (4) 391-396
• 32 Ogawa T, Hoshino S, Midorikawa H, Sato K. Intermittent pneumatic compression of the foot and calf improves the outcome of catheter-directed thrombolysis using low-dose urokinase in patients with acute proximal venous thrombosis of the leg. J VascSurg 2005; 42 (5) 940-944
• 33 Semba CP, Dake MD. Catheter-directed thrombolysis for iliofemoral venous thrombosis. Semin VascSurg 1996; 9 (1) 26-33
• 34 Sillesen H, Just S, Jørgensen M, Baekgaard N. Catheter directed thrombolysis for treatment of ilio-femoral deep venous thrombosis is durable, preserves venous valve function and may prevent chronic venous insufficiency. Eur J Vasc EndovascSurg 2005; 30 (5) 556-562
• 35 Verhaeghe R, Stockx L, Lacroix H, Vermylen J, Baert AL. Catheter-directed lysis of iliofemoral vein thrombosis with use of rt-PA. EurRadiol 1997; 7 (7) 996-1001
• 36 Raabe A. Ultrasound-facilitated thrombolysis in treating DVT. Endovasc Today 2006; 5: 75-79
• 37 Motarjeme A. Ultrasound-enhanced Thrombolysis. J EndovascTher 2007; 14 (2) 251-256
• 38 Dumantepe M, Tarhan A, Yurdakul I, Özler A. US-accelerated catheter-directed thrombolysis for the treatment of deep venous thrombosis. Diagn IntervRadiol 2013; 19 (3) 251-258
• 39 Grommes J, Strijkers R, Greiner A, Mahnken AH, Wittens CH. Safety and feasibility of ultrasound-accelerated catheter-directed thrombolysis in deep vein thrombosis. Eur J Vasc EndovascSurg 2011; 41 (4) 526-532
• 40 Parikh S, Motarjeme A, McNamara T , et al. Ultrasound-accelerated thrombolysis for the treatment of deep vein thrombosis: initial clinical experience. J Vasc IntervRadiol 2008; 19 (4) 521-528
• 41 Owens CA. Ultrasound-Enhanced Thrombolysis: EKOS EndoWave Infusion Catheter System. Semin InterventRadiol 2008; 25 (1) 37-41
• 42 Engelberger RP, Spirk D, Willenberg T , et al. Ultrasound-assisted versus conventional catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis. Circ CardiovascInterv 2015; 8 (1) e002027