ENDOVASCULAR TREATMENT OF CHRONIC VENOUS OCCLUSIVE DISEASE — SPECIFICATIONS OF ENDOPROSTHESES AND COMPARISON OF RESULTS
DOI:
https://doi.org/10.48750/acv.271Keywords:
Venous insufficiency, Venous thrombosis, Self-Expandable Metal Stents, Endovascular proceduresAbstract
Introduction: Chronic occlusive venous disease manifests mainly at the level of the iliofemoral vein, and its treatment has been revolutionized by the emergence of endovascular techniques. Venous system stenting has evolved from the existing treatments of arterial occlusive disease. Some arterial stents were used in the venous system with good results, however, the need to improve the characteristics of these devices led to the development of stents dedicated exclusively to venous pathology. In recent years several dedicated endoprostheses have been approved, however, there are few studies comparing their characteristics and results.
Objectives: Update on the venous stents available and comparison of their characteristics and results.
Methodology: The bibliographic research was performed in database "Natural Library of Medicine PubMed - Medline". Articles from the last 20 years with language in Portuguese and English were included. Greater relevance was given to research articles, but books and review articles relevant to the topic were also included
Results/Discussion There are currently 7 devices used in iliofemoral occlusive disease Wallstent™ Endoprosthesis, Zilver® Vena ™, Sinus-Venous®, Sinus Obliquus®, Vici® Venous Stent, Venovo® Venous Stent, Sinus Obliquus®and Abre™ Venous. The short-term outcomes show high rates of technical success, primary and secondary patency, null mortality and low rates of periprocedural complications.
Conclusion: Existing stents for venous use appear to be effective and safe in the treatment of iliofemoral occlusive venous disease. None of the devices stand out in terms of effectiveness, however, dedicated stents appear to have lower complication rates. Long-term studies are needed to confirm these results.
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References
1. Rabe E, Guex JJ, Puskas A, Scuderi A, Fernandez Quesada F. Epidemiology of chronic venous disorders in geographically diverse populations: results from the Vein Consult Program. Int Angiol. 2012;31(2):105-115.
2. Rabe E, Pannier F. Societal costs of chronic venous disease in CEAP C4, C5, C6 disease. Phlebology. 2010;25 Suppl 1:64-67.
3. Fernandes J, Natário A, Matos A, et al. Rede de Referenciação Hospitalar Angiologia e Cirurgia Vascular. In: SNS, ed: Republica Portuguesa; 2017:34-39.
4. Youn YJ, Lee J. Chronic venous insufficiency and varicose veins of the lower extremities Korean J Intern Med. 2019;34(2):269-283.
5. Wen-da W, Yu Z, Yue-Xin C. Stenting for chronic obstructive venous disease: A current comprehensive meta-analysis and systematic review. Phlebology. 2016;31(6):376-389.
6. Eklof B, Rutherford RB, Bergan JJ, et al. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg. 2004;40(6):1248-1252.
7. Attaran RR. Latest Innovations in the Treatment of Venous Disease. J Clin Med. 2018;7(4):1-16.
8. Pannier F, Rabe E. The relevance of the natural history of varicose veins and refunded care. Phlebology. 2012;27 Suppl 1:23-26.
9. Razavi MK, Jaff MR, Miller LE. Safety and Effectiveness of Stent Placement for Iliofemoral Venous Outflow Obstruction: Systematic Review and Meta-Analysis. Circ Cardiovasc Interv. 2015;8(10):e002772.
10. Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2014;130(4):333-346.
11. Santler B, Goerge T. Chronic venous insufficiency - a review of pathophysiology, diagnosis, and treatment. JDDG: Journal der Deutschen Dermatologischen Gesellschaft. 2017;15(5):538-556.
12. Shamimi-Noori SM, Clark TWI. Venous Stents: Current Status and Future Directions. Techniques in Vascular and Interventional Radiology. 2018;21(2):113-116.
13. Alhalbouni S, Hingorani A, Shiferson A, et al. Iliac-femoral venous stenting for lower extremity venous stasis symptoms. Ann Vasc Surg. 2012;26(2):185-189.
14. Raju S. Treatment of iliac-caval outflow obstruction. Semin Vasc Surg. 2015;28(1):47-53.
15. Schwein A, Georg Y, Lejay A, et al. Endovascular Treatment for Venous Diseases: Where are the Venous Stents? Methodist DeBakey cardiovascular journal. 2018;14(3):208-213.
16. Dabir D, Feisst A, Thomas D, et al. Physical Properties of Venous Stents: An Experimental Comparison. Cardiovasc Intervent Radiol. 2018;41(6):942-950.
17. Saraf AR, Yadav SP. 2 - Fundamentals of bare-metal stents. In: Wall JG, Podbielska H, Wawrzyńska M, eds. Functionalised Cardiovascular Stents: Woodhead Publishing; 2018:27-44.
18. Duda SH, Wiskirchen J, Tepe G, et al. Physical Properties of Endovascular Stents: An Experimental Comparison. Journal of Vascular and Interventional Radiology. 2000;11(5):645-654.
19. Stoeckel D, Bonsignore C, Duda S. A survey of stent designs. Minimally Invasive Therapy & Allied Technologies. 2002;11(4):137-147.
20. Kang CH, Yang SB, Lee WH, et al. Comparison of Open-Cell Stent and Closed-Cell Stent for Treatment of Central Vein Stenosis or Occlusion in Hemodialysis Patients. Iran J Radiol. 2016;13(4):e37994.
21. Marston W. The Critical Need for an Iliofemoral Venous Obstruction Classification System. Endovascular Today. 2017;16(7):48-54.
22. FDA US. Summary of Safety and Effectiveness Data WALLSTENT Venous Endoprosthesis with Unistep Plus Delivery System. Silver Spring- Washington D.C.: U.S. Food and Drug Administration (FDA);2001. P980033.
23. Gagne PJ, Gagne N, Kucher T, Thompson M, Bentley D. Long-term clinical outcomes and technical factors with the Wallstent for treatment of chronic iliofemoral venous obstruction. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2019;7(1):45-55.
24. Gutzeit A, Zollikofer Ch L, Dettling-Pizzolato M, Graf N, Largiader J, Binkert CA. Endovascular stent treatment for symptomatic benign iliofemoral venous occlusive disease: long-term results 1987-2009. Cardiovasc Intervent Radiol. 2011;34(3):542-549.
25. O'Sullivan GJ, McCann-Brown JA. Results from VIVO-EU, a Prospective Study of the Zilver Vena Venous Stent in the Treatment of Symptomatic Iliofemoral Outflow Obstruction. Paper presented at: CIRSE 2016; 10 Setembro, 2016; Barcelona.
26. O'Sullivan GJ, Sheehan J Fau - Lohan D, Lohan D Fau - McCann-Brown JA, McCann-Brown JA. Iliofemoral venous stenting extending into the femoral region: initial clinical experience with the purpose-designed Zilver Vena stent. The Journal of Cardiovascular Surgery. 2013;54(2):255-261.
27. de Wolf MA, de Graaf R, Kurstjens RL, Penninx S, Jalaie H, Wittens CH. Short-Term Clinical Experience with a Dedicated Venous Nitinol Stent: Initial Results with the Sinus-Venous Stent. Eur J Vasc Endovasc Surg. 2015;50(4):518-526.
28. van Vuuren T, Doganci S, Wittens CHA. Patency rates and clinical outcomes in a cohort of 200 patients treated with a dedicated venous stent. J Vasc Surg Venous Lymphat Disord. 2018;6(3):321-329.
29. Kabnick L. Does Lumen Shape Matter. Paper presented at: American Venous Forum Meeting2018; Tucson,US.
30. Lichtenberg M, Breuckmann F, Stahlhoff WF, Neglen P, Rick G. Placement of closed-cell designed venous stents in a mixed cohort of patients with chronic venous outflow obstructions - short-term safety, patency, and clinical outcomes. Vasa. 2018;47(6):475-481.
31. Razavi M, Marston W, Black S, Bentley D, Neglen P. The initial report on 1-year outcomes of the feasibility study of the VENITI VICI VENOUS STENT in symptomatic iliofemoral venous obstruction. J Vasc Surg Venous Lymphat Disord. 2018;6(2):192-200.
32. Razavi MK. Virtus Clinical Trail. Paper presented at: LINC 2019; Leipiz.
33. Dake M. The BARD® VENOVO™ Venous Stent Study - A Prospective, Non-Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease - an Assessment for Effectiveness and Safety (VERNACULAR). U.S. National Library Of Medicine2019.
34. Lichtenberg MKW, de Graaf R, Stahlhoff WF, Ozkapi A, Rassaf T, Breuckmann F. Venovo venous stent in the treatment of non-thrombotic or post-thrombotic iliac vein lesions - short-term results from the Arnsberg venous registry. Vasa. 2019;48(2):175-180.
35. FDA US. Summary of safety and effectiveness data Venovo Venous stent System. Silver Spring- Washington D.C.: U.S. Food and Drug Administration (FDA);2019. P180037.
36. Stuck AK, Kunz S, Baumgartner I, Kucher N. Patency and Clinical Outcomes of a Dedicated, Self-Expanding, Hybrid Oblique Stent Used in the Treatment of Common Iliac Vein Compression. J Endovasc Ther. 2017;24(1):159-166.
37. Medtronic. Abre Venous Self-Expanding Stent System. Endovascular Today Europe. 2018;6(5):101.
38. Rutherford RB, Baker JD, Ernst C, et al. Recommended standards for reports dealing with lower extremity ischemia: Revised version. Journal of Vascular Surgery. 1997;26(3):517-538.
39. Hartung O, Loundou AD, Barthelemy P, Arnoux D, Boufi M, Alimi YS. Endovascular management of chronic disabling ilio-caval obstructive lesions: long-term results. Eur J Vasc Endovasc Surg. 2009;38(1):118-124.
40. te Riele WW, Overtoom TTC, van den Berg JC, van de Pavoordt EDWM, de Vries J-PPM. Endovascular Recanalization of Chronic Long-Segment Occlusions of the Inferior Vena Cava: Midterm Results. Journal of Endovascular Therapy. 2006;13(2):249-253.
41. Raju S, Hollis K, Neglen P. Obstructive lesions of the inferior vena cava: Clinical features and endovenous treatment. Journal of Vascular Surgery. 2006;44(4):820-827.
42. Blattler W, Blattler IK. Relief of obstructive pelvic venous symptoms with endoluminal stenting. Journal of Vascular Surgery. 1999;29(3):484-488.
43. Neglén P, Hollis KC, Olivier J, Raju S. Stenting of the venous outflow in chronic venous disease: Long-term stent-related outcome, clinical, and hemodynamic result. Journal of Vascular Surgery. 2007;46(5):979-990.e971.
44. Oguzkurt L, Tercan F, Ozkan U, Gulcan O. Iliac vein compression syndrome: Outcome of endovascular treatment with long-term follow-up. European Journal of Radiology. 2008;68(3):487-492.
45. Black S, Gwozdz A, Karunanithy N, et al. Two Year Outcome After Chronic Iliac Vein Occlusion Recanalisation Using the Vici Venous Stent<sup>®</sup>. European Journal of Vascular and Endovascular Surgery. 2018;56(5):710-718.
46. Lichtenberg M, de Graaf R, Stahlhoff WF, Özkapi A, Simon M, Breuckmann F. Patency rates, safety and clinical results of the sinus-Obliquus venous stent in the treatment of chronic ilio-femoral venous outflow obstruction – data from the Arnsberg venous registry. Vasa. 2018;48(3):270-275.
47. Guillen K, Falvo N, Nakai M, et al. Endovascular stenting for chronic femoro-iliac venous obstructive disease: Clinical efficacy and short-term outcomes. Diagnostic and Interventional Imaging. 2019.
48. Qiu P, Zha B, Xu A, et al. Systematic Review and Meta-Analysis of Iliofemoral Stenting for Post-thrombotic Syndrome. European Journal of Vascular and Endovascular Surgery. 2019;57(3):407-416.
49. Seager MJ, Busuttil A, Dharmarajah B, Davies AH. A Systematic Review of Endovenous Stenting in Chronic Venous Disease Secondary to Iliac Vein Obstruction. European Journal of Vascular and Endovascular Surgery. 2016;51(1):100-120.
50. van Vuuren TM, van Laanen JHH, de Geus M, Nelemans PJ, de Graaf R, Wittens CHA. A randomised controlled trial comparing venous stenting with conservative treatment in patients with deep venous obstruction: research protocol. BMJ Open. 2017;7(9):e017233-e017233.
2. Rabe E, Pannier F. Societal costs of chronic venous disease in CEAP C4, C5, C6 disease. Phlebology. 2010;25 Suppl 1:64-67.
3. Fernandes J, Natário A, Matos A, et al. Rede de Referenciação Hospitalar Angiologia e Cirurgia Vascular. In: SNS, ed: Republica Portuguesa; 2017:34-39.
4. Youn YJ, Lee J. Chronic venous insufficiency and varicose veins of the lower extremities Korean J Intern Med. 2019;34(2):269-283.
5. Wen-da W, Yu Z, Yue-Xin C. Stenting for chronic obstructive venous disease: A current comprehensive meta-analysis and systematic review. Phlebology. 2016;31(6):376-389.
6. Eklof B, Rutherford RB, Bergan JJ, et al. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg. 2004;40(6):1248-1252.
7. Attaran RR. Latest Innovations in the Treatment of Venous Disease. J Clin Med. 2018;7(4):1-16.
8. Pannier F, Rabe E. The relevance of the natural history of varicose veins and refunded care. Phlebology. 2012;27 Suppl 1:23-26.
9. Razavi MK, Jaff MR, Miller LE. Safety and Effectiveness of Stent Placement for Iliofemoral Venous Outflow Obstruction: Systematic Review and Meta-Analysis. Circ Cardiovasc Interv. 2015;8(10):e002772.
10. Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2014;130(4):333-346.
11. Santler B, Goerge T. Chronic venous insufficiency - a review of pathophysiology, diagnosis, and treatment. JDDG: Journal der Deutschen Dermatologischen Gesellschaft. 2017;15(5):538-556.
12. Shamimi-Noori SM, Clark TWI. Venous Stents: Current Status and Future Directions. Techniques in Vascular and Interventional Radiology. 2018;21(2):113-116.
13. Alhalbouni S, Hingorani A, Shiferson A, et al. Iliac-femoral venous stenting for lower extremity venous stasis symptoms. Ann Vasc Surg. 2012;26(2):185-189.
14. Raju S. Treatment of iliac-caval outflow obstruction. Semin Vasc Surg. 2015;28(1):47-53.
15. Schwein A, Georg Y, Lejay A, et al. Endovascular Treatment for Venous Diseases: Where are the Venous Stents? Methodist DeBakey cardiovascular journal. 2018;14(3):208-213.
16. Dabir D, Feisst A, Thomas D, et al. Physical Properties of Venous Stents: An Experimental Comparison. Cardiovasc Intervent Radiol. 2018;41(6):942-950.
17. Saraf AR, Yadav SP. 2 - Fundamentals of bare-metal stents. In: Wall JG, Podbielska H, Wawrzyńska M, eds. Functionalised Cardiovascular Stents: Woodhead Publishing; 2018:27-44.
18. Duda SH, Wiskirchen J, Tepe G, et al. Physical Properties of Endovascular Stents: An Experimental Comparison. Journal of Vascular and Interventional Radiology. 2000;11(5):645-654.
19. Stoeckel D, Bonsignore C, Duda S. A survey of stent designs. Minimally Invasive Therapy & Allied Technologies. 2002;11(4):137-147.
20. Kang CH, Yang SB, Lee WH, et al. Comparison of Open-Cell Stent and Closed-Cell Stent for Treatment of Central Vein Stenosis or Occlusion in Hemodialysis Patients. Iran J Radiol. 2016;13(4):e37994.
21. Marston W. The Critical Need for an Iliofemoral Venous Obstruction Classification System. Endovascular Today. 2017;16(7):48-54.
22. FDA US. Summary of Safety and Effectiveness Data WALLSTENT Venous Endoprosthesis with Unistep Plus Delivery System. Silver Spring- Washington D.C.: U.S. Food and Drug Administration (FDA);2001. P980033.
23. Gagne PJ, Gagne N, Kucher T, Thompson M, Bentley D. Long-term clinical outcomes and technical factors with the Wallstent for treatment of chronic iliofemoral venous obstruction. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2019;7(1):45-55.
24. Gutzeit A, Zollikofer Ch L, Dettling-Pizzolato M, Graf N, Largiader J, Binkert CA. Endovascular stent treatment for symptomatic benign iliofemoral venous occlusive disease: long-term results 1987-2009. Cardiovasc Intervent Radiol. 2011;34(3):542-549.
25. O'Sullivan GJ, McCann-Brown JA. Results from VIVO-EU, a Prospective Study of the Zilver Vena Venous Stent in the Treatment of Symptomatic Iliofemoral Outflow Obstruction. Paper presented at: CIRSE 2016; 10 Setembro, 2016; Barcelona.
26. O'Sullivan GJ, Sheehan J Fau - Lohan D, Lohan D Fau - McCann-Brown JA, McCann-Brown JA. Iliofemoral venous stenting extending into the femoral region: initial clinical experience with the purpose-designed Zilver Vena stent. The Journal of Cardiovascular Surgery. 2013;54(2):255-261.
27. de Wolf MA, de Graaf R, Kurstjens RL, Penninx S, Jalaie H, Wittens CH. Short-Term Clinical Experience with a Dedicated Venous Nitinol Stent: Initial Results with the Sinus-Venous Stent. Eur J Vasc Endovasc Surg. 2015;50(4):518-526.
28. van Vuuren T, Doganci S, Wittens CHA. Patency rates and clinical outcomes in a cohort of 200 patients treated with a dedicated venous stent. J Vasc Surg Venous Lymphat Disord. 2018;6(3):321-329.
29. Kabnick L. Does Lumen Shape Matter. Paper presented at: American Venous Forum Meeting2018; Tucson,US.
30. Lichtenberg M, Breuckmann F, Stahlhoff WF, Neglen P, Rick G. Placement of closed-cell designed venous stents in a mixed cohort of patients with chronic venous outflow obstructions - short-term safety, patency, and clinical outcomes. Vasa. 2018;47(6):475-481.
31. Razavi M, Marston W, Black S, Bentley D, Neglen P. The initial report on 1-year outcomes of the feasibility study of the VENITI VICI VENOUS STENT in symptomatic iliofemoral venous obstruction. J Vasc Surg Venous Lymphat Disord. 2018;6(2):192-200.
32. Razavi MK. Virtus Clinical Trail. Paper presented at: LINC 2019; Leipiz.
33. Dake M. The BARD® VENOVO™ Venous Stent Study - A Prospective, Non-Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease - an Assessment for Effectiveness and Safety (VERNACULAR). U.S. National Library Of Medicine2019.
34. Lichtenberg MKW, de Graaf R, Stahlhoff WF, Ozkapi A, Rassaf T, Breuckmann F. Venovo venous stent in the treatment of non-thrombotic or post-thrombotic iliac vein lesions - short-term results from the Arnsberg venous registry. Vasa. 2019;48(2):175-180.
35. FDA US. Summary of safety and effectiveness data Venovo Venous stent System. Silver Spring- Washington D.C.: U.S. Food and Drug Administration (FDA);2019. P180037.
36. Stuck AK, Kunz S, Baumgartner I, Kucher N. Patency and Clinical Outcomes of a Dedicated, Self-Expanding, Hybrid Oblique Stent Used in the Treatment of Common Iliac Vein Compression. J Endovasc Ther. 2017;24(1):159-166.
37. Medtronic. Abre Venous Self-Expanding Stent System. Endovascular Today Europe. 2018;6(5):101.
38. Rutherford RB, Baker JD, Ernst C, et al. Recommended standards for reports dealing with lower extremity ischemia: Revised version. Journal of Vascular Surgery. 1997;26(3):517-538.
39. Hartung O, Loundou AD, Barthelemy P, Arnoux D, Boufi M, Alimi YS. Endovascular management of chronic disabling ilio-caval obstructive lesions: long-term results. Eur J Vasc Endovasc Surg. 2009;38(1):118-124.
40. te Riele WW, Overtoom TTC, van den Berg JC, van de Pavoordt EDWM, de Vries J-PPM. Endovascular Recanalization of Chronic Long-Segment Occlusions of the Inferior Vena Cava: Midterm Results. Journal of Endovascular Therapy. 2006;13(2):249-253.
41. Raju S, Hollis K, Neglen P. Obstructive lesions of the inferior vena cava: Clinical features and endovenous treatment. Journal of Vascular Surgery. 2006;44(4):820-827.
42. Blattler W, Blattler IK. Relief of obstructive pelvic venous symptoms with endoluminal stenting. Journal of Vascular Surgery. 1999;29(3):484-488.
43. Neglén P, Hollis KC, Olivier J, Raju S. Stenting of the venous outflow in chronic venous disease: Long-term stent-related outcome, clinical, and hemodynamic result. Journal of Vascular Surgery. 2007;46(5):979-990.e971.
44. Oguzkurt L, Tercan F, Ozkan U, Gulcan O. Iliac vein compression syndrome: Outcome of endovascular treatment with long-term follow-up. European Journal of Radiology. 2008;68(3):487-492.
45. Black S, Gwozdz A, Karunanithy N, et al. Two Year Outcome After Chronic Iliac Vein Occlusion Recanalisation Using the Vici Venous Stent<sup>®</sup>. European Journal of Vascular and Endovascular Surgery. 2018;56(5):710-718.
46. Lichtenberg M, de Graaf R, Stahlhoff WF, Özkapi A, Simon M, Breuckmann F. Patency rates, safety and clinical results of the sinus-Obliquus venous stent in the treatment of chronic ilio-femoral venous outflow obstruction – data from the Arnsberg venous registry. Vasa. 2018;48(3):270-275.
47. Guillen K, Falvo N, Nakai M, et al. Endovascular stenting for chronic femoro-iliac venous obstructive disease: Clinical efficacy and short-term outcomes. Diagnostic and Interventional Imaging. 2019.
48. Qiu P, Zha B, Xu A, et al. Systematic Review and Meta-Analysis of Iliofemoral Stenting for Post-thrombotic Syndrome. European Journal of Vascular and Endovascular Surgery. 2019;57(3):407-416.
49. Seager MJ, Busuttil A, Dharmarajah B, Davies AH. A Systematic Review of Endovenous Stenting in Chronic Venous Disease Secondary to Iliac Vein Obstruction. European Journal of Vascular and Endovascular Surgery. 2016;51(1):100-120.
50. van Vuuren TM, van Laanen JHH, de Geus M, Nelemans PJ, de Graaf R, Wittens CHA. A randomised controlled trial comparing venous stenting with conservative treatment in patients with deep venous obstruction: research protocol. BMJ Open. 2017;7(9):e017233-e017233.
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Published
2019-10-16
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1.
Bento D, Machado R, Mendes D, de Almeida R. ENDOVASCULAR TREATMENT OF CHRONIC VENOUS OCCLUSIVE DISEASE — SPECIFICATIONS OF ENDOPROSTHESES AND COMPARISON OF RESULTS. Angiol Cir Vasc [Internet]. 2019 Oct. 16 [cited 2024 Dec. 26];15(2):76-85. Available from: https://acvjournal.com/index.php/acv/article/view/271
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