Fixed low-dose ultrasound-assisted catheter-directed thrombolysis followed by routine stenting of residual stenosis for acute ilio-femoral deep-vein thrombosis

Rolf P. Engelberger; Jennifer Fahrni; Torsten Willenberg; Frederic Baumann; David Spirk; Nicolas Diehm; Dai-Do Do; Iris Baumgartner; Nils Kucher

doi:10.1160/TH13-11-0932

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2014; 111(06): 1153-1160
DOI: 10.1160/TH13-11-0932

New Technologies, Diagnostic Tools and Drugs

Schattauer GmbH

Fixed low-dose ultrasound-assisted catheter-directed thrombolysis followed by routine stenting of residual stenosis for acute ilio-femoral deep-vein thrombosis

Rolf P. Engelberger

¹Clinic for Angiology, Swiss Cardiovascular Center, Inselspital, University Hospital and University of Bern, Switzerland

,

Jennifer Fahrni

¹Clinic for Angiology, Swiss Cardiovascular Center, Inselspital, University Hospital and University of Bern, Switzerland

,

Torsten Willenberg

¹Clinic for Angiology, Swiss Cardiovascular Center, Inselspital, University Hospital and University of Bern, Switzerland

,

Frederic Baumann

¹Clinic for Angiology, Swiss Cardiovascular Center, Inselspital, University Hospital and University of Bern, Switzerland

,

David Spirk

²Institute of Pharmacology, University of Bern, Switzerland

,

Nicolas Diehm

¹Clinic for Angiology, Swiss Cardiovascular Center, Inselspital, University Hospital and University of Bern, Switzerland

,

Dai-Do Do

¹Clinic for Angiology, Swiss Cardiovascular Center, Inselspital, University Hospital and University of Bern, Switzerland

,

Iris Baumgartner

¹Clinic for Angiology, Swiss Cardiovascular Center, Inselspital, University Hospital and University of Bern, Switzerland

,

Nils Kucher

¹Clinic for Angiology, Swiss Cardiovascular Center, Inselspital, University Hospital and University of Bern, Switzerland

› Author Affiliations

Abstract

Summary

Patients with ilio-femoral deep-vein thrombosis (DVT) are at high risk of developing the postthrombotic syndrome (PTS). In comparison to anticoagulation therapy alone, extended venography-guided catheter-directed thrombolysis without routine stenting of venous stenosis in patients with ilio-femoral DVT is associated with an increased risk of bleeding and a moderate reduction of PTS. We performed a prospective single-centre study to investigate safety, patency and incidence of PTS in patients with acute iliofemoral DVT treated with fixed-dose ultrasound-assisted catheter-directed thrombolysis (USAT; 20 mg rt-PA during 15 hours) followed by routing stenting of venous stenosis, defined as residual luminal narrowing >50%, absent antegrade flow, or presence of collateral flow at the site of suspected stenosis. A total of 87 patients (age 46 ± 21 years, 60% women) were included. At 15 hours, thrombolysis success ≥50% was achieved in 67 (77%) patients. Venous stenting (mean 1.9 ± 1.3 stents) was performed in 70 (80%) patients, with the common iliac vein as the most frequent stenting site (83%). One major (1%; 95% CI, 0–6%) and 6 minor bleedings (7%; 95%CI, 3–14%) occurred. Primary and secondary patency rates at 1 year were 87% (95% CI, 74–94%) and 96% (95% CI, 88–99%), respectively. At three months, 88% (95% CI, 78–94%) of patients were free from PTS according to the Villalta scale, with a similar rate at one year (94%, 95% CI, 81–99%). In conclusion, a fixed-dose USAT regimen followed by routine stenting of underlying venous stenosis in patients with iliofemoral DVT was associated with a low bleeding rate, high patency rates, and a low incidence of PTS.

Keywords

Haemorrhage - mechanical thrombolysis - postthrombotic syndrome - vascular patency - venous thrombosis

Full Text

References

References
1 Kahn SR, Shrier I, Julian JA. et al. Determinants and time course of the postthrombotic syndrome after acute deep venous thrombosis. Ann Intern Med 2008; 149: 698-707.
2 Enden T, Klow NE, Sandvik L. et al. Catheter-directed thrombolysis vs Anticoagulant therapy alone in deep vein thrombosis: Results of an open randomized, controlled trial reporting on short-term patency. J Thromb Haemost 2009; 07: 1268-1275.
3 Bergan JJ, Schmid-Schonbein GW, Smith PD. et al. Chronic venous disease. N Engl J Med 2006; 355: 488-498.
4 Johnson BF, Manzo RA, Bergelin RO. et al. Relationship between changes in the deep venous system and the development of the postthrombotic syndrome after an acute episode of lower limb deep vein thrombosis: A one- to six-year follow-up. J Vasc Surg 1995; 21: 307-313.
5 Meissner MH, Gloviczki P, Comerota AJ. et al. Early thrombus removal strategies for acute deep venous thrombosis: Clinical practice guidelines of the society for vascular surgery and the american venous forum. J Vasc Surg 2012; 55: 1449-1462.
6 Jaff MR, McMurtry MS, Archer SL. et al. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension: A scientific statement from the american heart association. Circulation 2011; 123: 1788-1830.
7 Kearon C, Akl EA, Comerota AJ. et al. Antithrombotic therapy for vte disease: Antithrombotic therapy and prevention of thrombosis, 9th ed. American college of chest physicians evidence-based clinical practice guidelines Chest. 2012; 141: e419S-e494S.
8 Fahrni J, Engelberger RP, Kucher N. et al. Catheter-based treatment of iliofemoral deep vein thrombosis – an update on current evidence. Vasa 2013; 42: 161-167.
9 Engelberger RP, Kucher N. Catheter-based reperfusion treatment of pulmonary embolism. Circulation 2011; 124: 2139-2144.
10 Braaten JV, Goss RA, Francis CW. Ultrasound reversibly disaggregates fibrin fibers. Thromb Haemost 1997; 78: 1063-1068.
11 Siddiqi F, Odrljin TM, Fay PJ. et al. Binding of tissue-plasminogen activator to fibrin: Effect of ultrasound. Blood 1998; 91: 2019-2025.
12 Enden T, Haig Y, Klow NE. et al. Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the cavent study): A randomised controlled trial. Lancet 2012; 379: 31-38.
13 Ruiz-Bailen M, Brea-Salvago JF, de Hoyos EA. et al. Post-thrombolysis intracerebral haemorrhage: Data from the spanish register ariam. Crit Care Med 2005; 33: 1829-1838.
14 Strijkers R, Grommes J, Arnoldussen C. et al. Ultrasound-accelerated catheter-directed thrombolysis in acute iliofemoral deep venous thrombosis. J Vasc Surg: Venous and Lym Dis 2013; 01: 225-230.
15 Gao B, Zhang J, Wu X. et al. Catheter-directed thrombolysis with a continuous infusion of low-dose urokinase for non-acute deep venous thrombosis of the lower extremity. Korean J Radiol 2011; 12: 97-106.
16 Manninen H, Juutilainen A, Kaukanen E. et al. Catheter-directed thrombolysis of proximal lower extremity deep vein thrombosis: A prospective trial with venographic and clinical follow-up. Eur J Radiol 2012; 81: 1197-1202.
17 Chung JW, Yoon CJ, Jung SI. et al. Acute iliofemoral deep vein thrombosis: Evaluation of underlying anatomic abnormalities by spiral ct venography. J Vasc Interv Radiol 2004; 15: 249-256.
18 Arnoldussen CW, Wittens CH. An imaging approach to deep vein thrombosis and the lower extremity thrombosis classification. Phlebology 2012; 27 (Suppl. 01) 143-148.
19 Vedantham S, Grassi CJ, Ferral H. et al. Reporting standards for endovascular treatment of lower extremity deep vein thrombosis. J Vasc Interv Radiol 2006; 17: 417-434.
20 Goldhaber SZ, Bounameaux H. Pulmonary embolism and deep vein thrombosis. Lancet 2012; 379: 1835-1846.
21 Engelberger RP, Moschovitis A, Fahrni J. et al. Fixed low-dose ultrasound-assisted catheter-directed thrombolysis for intermediate and high-risk pulmonary embolism. Eur Heart J. 2013 Epub ahead of print.
22 Kucher N, Boekstegers P, Muller O. et al. Randomized controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism. Circulation 2014; 129: 479-486.
23 Kahn SR, Partsch H, Vedantham S. et al. Definition of postthrombotic syndrome of the leg for use in clinical investigations: A recommendation for standardisation. J Thromb Haemost 2009; 07: 879-883.
24 Villalta S, Bagatella P, Piccioli A. et al. Assessment of validity and reproducibility of a clinical scale for the postthrombotic syndrome. Haemostasis 1994; 24: 158a.
25 Eklof B, Rutherford RB, Bergan JJ. et al. Revision of the ceap classification for chronic venous disorders: Consensus statement. J Vasc Surg 2004; 40: 1248-1252.
26 Vasquez MA, Rabe E, McLafferty RB. et al. Revision of the venous clinical severity score: Venous outcomes consensus statement: Special communication of the american venous forum ad hoc outcomes working group. J Vasc Surg 2010; 52: 1387-1396.
27 Mewissen MW, Seabrook GR, Meissner MH. et al. Catheter-directed thrombolysis for lower extremity deep venous thrombosis: Report of a national multi-centre registry. Radiology 1999; 211: 39-49.
28 Diehm N, Pattynama PM, Jaff MR. et al. Clinical endpoints in peripheral endovascular revascularisation trials: A case for standardized definitions. Eur J Vasc Endovasc Surg 2008; 36: 409-419.
29 Schulman S, Kearon C. Definition of major bleeding in clinical investigations of antihaemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 03: 692-694.
30 Grewal NK, Martinez JT, Andrews L. et al. Quantity of clot lysed after catheter-directed thrombolysis for iliofemoral deep venous thrombosis correlates with postthrombotic morbidity. J Vasc Surg 2010; 51: 1209-1214.
31 Ghanima W, Kleven IW, Enden T. et al. Recurrent venous thrombosis, postthrombotic syndrome and quality of life after catheter-directed thrombolysis in severe proximal deep vein thrombosis. J Thromb Haemost 2011; 09: 1261-1263.
32 Grommes J, Strijkers R, Greiner A. et al. Safety and feasibility of ultrasound-accelerated catheter-directed thrombolysis in deep vein thrombosis. Eur J Vasc Endovasc Surg 2011; 41: 526-532.
33 Baker R, Samuels S, Benenati JF. et al. Ultrasound-accelerated vs standard catheter-directed thrombolysis-a comparative study in patients with iliofemoral deep vein thrombosis. J Vasc Interv Radiol 2012; 23: 1460-1466.
34 Baekgaard N, Broholm R, Just S. et al. Long-term results using catheter-directed thrombolysis in 103 lower limbs with acute iliofemoral venous thrombosis. Eur J Vasc Endovasc Surg 2010; 39: 112-117.
35 Broholm R, Sillesen H, Damsgaard MT. et al. Postthrombotic syndrome and quality of life in patients with iliofemoral venous thrombosis treated with catheter-directed thrombolysis. J Vasc Surg 2011; 54: 18S-25S.
36 Parikh S, Motarjeme A, McNamara T. et al. Ultrasound-accelerated thrombolysis for the treatment of deep vein thrombosis: Initial clinical experience. J Vasc Interv Radiol 2008; 19: 521-528.
37 Motarjeme A. Ultrasound-enhanced thrombolysis. J Endovasc Ther 2007; 14: 251-256.
38 Bjorgell O, Robertson F. Scoring systems for grading deep leg vein thrombosis. Acta Radiol 2002; 43: 299-305.
39 O’Sullivan GJ, Lohan DG, Gough N. et al. Pharmacomechanical thrombectomy of acute deep vein thrombosis with the trellis-8 isolated thrombolysis catheter. J Vasc Interv Radiol 2007; 18: 715-724.
40 Bush RL, Lin PH, Bates JT. et al. Pharmacomechanical thrombectomy for treatment of symptomatic lower extremity deep venous thrombosis: Safety and feasibility study. J Vasc Surg 2004; 40: 965-970.
41 Lin PH, Zhou W, Dardik A. et al. Catheter-direct thrombolysis versus pharmacomechanical thrombectomy for treatment of symptomatic lower extremity deep venous thrombosis. Am J Surg 2006; 192: 782-788.
42 Lichtenberg M, Stahlhoff FW, Boese D. Endovascular treatment of acute limb ischemia and proximal deep vein thrombosis using rotational thrombectomy: A review of published literature. Cardiovasc Revasc Med 2013; 14: 343-348.
43 Neglen P, Tackett Jr TP, Raju S. Venous stenting across the inguinal ligament. J Vasc Surg 2008; 48: 1255-1261.