Venous stenting for patients with outflow obstruction and leg ulcers: cost–effectiveness and budget impact analyses
Publication: Journal of Comparative Effectiveness Research
Abstract
Aim: To perform cost–effectiveness analysis (CEA) and budget impact analysis (BIA) comparing stenting to standard medical treatment (SMT) for the management of deep venous outflow obstruction and leg ulcers from the Italian Healthcare Service perspective. Materials & methods: A Markov model was developed to project costs and quality-adjusted life-years (QALYs) over 3 years, based on data from literature combined with real-world data. Moreover, a BIA was performed comparing the current scenario (100% SMT) with increasing utilization rates of stenting over SMT from 0.5 to 5%, in the next 5 years. Results: Stenting is a cost-effective (incremental cost-utility ratio €12,388/QALY) or dominant option versus SMT, according to in-patient or day-hospital settings, respectively. Increasing use of stenting over SMT, in the next 5 years, is expected to yield additional costs of 39.5 million Euros (in-patient) or savings of 5.1 million Euros (day-hospital). Conclusion: Stenting is a cost-effective option compared with SMT for patients with deep vein occlusion and ulceration in Italy.
Supplementary Material
File (suppl_file.zip)
- Download
- 327.14 KB
References
Papers of special note have been highlighted as: • of interest; •• of considerable interest
1.
Margolis DJ, Bilker W, Santanna J, Baumgarten M. Venous leg ulcer: incidence and prevalence in the elderly. J. Am. Acad. Dermatol. 46(3), 381–386 (2002).
• Provides background on epidemiology of venous leg ulcers.
2.
Wik HS, Ghanima W, Sandset PM, Kahn SR. Scoring systems for postthrombotic syndrome. Semin. Thromb. Hemost. 43(5), 500–504 (2017).
3.
Ten Cate-Hoek AJ. Prevention and treatment of the post-thrombotic syndrome. Res. Pract. Thromb. Haemost. 2(2), 209–219 (2018).
4.
Brandjes DP, Büller HR, Heijboer H et al. Randomised trial of effect of compression stockings in patients with symptomatic proximal-vein thrombosis. Lancet Lond. Engl. 349(9054), 759–762 (1997).
5.
Prandoni P, Lensing AWA, Prins MH et al. Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial. Ann. Intern. Med. 141(4), 249–256 (2004).
6.
Aschwanden M, Jeanneret C, Koller MT, Thalhammer C, Bucher HC, Jaeger KA. Effect of prolonged treatment with compression stockings to prevent post-thrombotic sequelae: a randomized controlled trial. J. Vasc. Surg. 47(5), 1015–1021 (2008).
7.
Kahn SR, Shapiro S, Wells PS et al. Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial. Lancet Lond. Engl. 383(9920), 880–888 (2014).
8.
Amsler F, Willenberg T, Blättler W. In search of optimal compression therapy for venous leg ulcers: a meta-analysis of studies comparing diverse [corrected] bandages with specifically designed stockings. J. Vasc. Surg. 50(3), 668–674 (2009).
•• Provides rationale for treatment of venous leg ulcers.
9.
Raju S, Owen S, Neglen P. The clinical impact of iliac venous stents in the management of chronic venous insufficiency. J. Vasc. Surg. 35(1), 8–15 (2002).
•• Provides rationale for the use of stenting for chronic venous insufficiency.
10.
Sang H, Li X, Qian A, Meng Q. Outcome of endovascular treatment in postthrombotic syndrome. Ann. Vasc. Surg. 28(6), 1493–1500 (2014).
11.
Tarricone R, Torbica A, Drummond M. MedtecHTA Project Group. Key recommendations from the MedtecHTA project. Health Econ. 26(Suppl. 1), 145–152 (2017).
12.
Berger ML, Sox H, Willke RJ et al. Good practices for real-world data studies of treatment and/or comparative effectiveness: recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making. Pharmacoepidemiol. Drug Saf. 26(9), 1033–1039 (2017).
13.
Adderley U, Stubbs N. Stockings or bandages for leg-ulcer compression? Nurs. Times. 110(15), 19–20 (2014).
14.
Alden PB, Lips EM, Zimmerman KP et al. Chronic venous ulcer: minimally invasive treatment of superficial axial and perforator vein reflux speeds healing and reduces recurrence. Ann. Vasc. Surg. 27(1), 75–83 (2013).
15.
Dolibog P, Franek A, Taradaj J et al. A comparative clinical study on five types of compression therapy in patients with venous leg ulcers. Int. J. Med. Sci. 11(1), 34–43 (2014).
16.
O'Hare JL, Earnshaw JJ. Randomised clinical trial of foam sclerotherapy for patients with a venous leg ulcer. Eur. J. Vasc. Endovasc. Surg. Off. J. Eur. Soc. Vasc. Surg. 39(4), 495–499 (2010).
17.
Pham B, Harrison MB, Chen MH, Carley ME. Canadian Bandaging Trial Group. Cost–effectiveness of compression technologies for evidence-informed leg ulcer care: results from the Canadian Bandaging Trial. BMC Health Serv. Res. 12, 346 (2012).
18.
Szewczyk MT, Jawień A, Cierzniakowska K, Cwajda-Białasik J, Mościcka P. Comparison of the effectiveness of compression stockings and layer compression systems in venous ulceration treatment. Arch. Med. Sci. AMS. 6(5), 793–799 (2010).
19.
Taradaj J, Franek A, Brzezinska-Wcislo L, Blaszczak E, Polak A. Randomized trial of medical compression stockings versus two-layer short-stretch bandaging in the management of venous leg ulcers. Phlebologie 38(4), 157–163 (2009).
20.
Yin M, Shi H, Ye K et al. Clinical assessment of endovascular stenting compared with compression therapy alone in post-thrombotic patients with iliofemoral obstruction. Eur. J. Vasc. Endovasc. Surg. Off. J. Eur. Soc. Vasc. Surg. 50(1), 101–107 (2015).
21.
Black S, Gwozdz A, Karunanithy N et al. Two year outcome after chronic iliac vein occlusion recanalisation using the Vici Venous Stent®. Eur. J. Vasc. Endovasc. Surg. Off. J. Eur. Soc. Vasc. Surg. 56(5), 710–718 (2018).
22.
Blanch Alerany M, Izquierdo Lamoca LM, Ramirez Ortega M, Lago Rivas I, Zotta Desboeufs R, Stefanov Kiuri S. Endovascular treatment of iliofemoral chronic post-thrombotic venous flow obstruction. J. Vasc. Surg. Venous Lymphat. Disord. 2(1), 2–7 (2014).
23.
de Wolf MaF, de Graaf R, Kurstjens RLM, Penninx S, Jalaie H, Wittens CHA. Short-term clinical experience with a dedicated venous nitinol stent: initial results with the sinus-venous stent. Eur. J. Vasc. Endovasc. Surg. Off. J. Eur. Soc. Vasc. Surg. 50(4), 518–526 (2015).
24.
George R, Verma H, Ram B, Tripathi R. The effect of deep venous stenting on healing of lower limb venous ulcers. Eur. J. Vasc. Endovasc. Surg. Off. J. Eur. Soc. Vasc. Surg. 48(3), 330–336 (2014).
25.
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. Off. J. Eur. Soc. Vasc. Surg. 38(1), 118–124 (2009).
26.
Khafagy T, Regal S, Fahmy D. Iliofemoral stenting for chronic venous occlusive disease: initial and mid-term outcomes in single institution. Egypt. J. Radiol. Nucl. Med. 47(4), (2016). https://cyberleninka.org/article/n/685010
27.
Kurklinsky AK, Bjarnason H, Friese JL et al. Outcomes of venoplasty with stent placement for chronic thrombosis of the iliac and femoral veins: single-center experience. J. Vasc. Interv. Radiol. JVIR. 23(8), 1009–1015 (2012).
28.
Lichtenberg MKW, de Graaf R, Stahlhoff WF, Özkapi A, Rassaf T, Breuckmann F. Venovo venous stent in the treatment of nonthrombotic or post-thrombotic iliac vein lesions – short-term results from the Arnsberg venous registry. VASA Z. Gefasskrankheiten. 48(2), 175–180 (2019).
29.
Liu Z, Gao N, Shen L et al. Endovascular treatment for symptomatic iliac vein compression syndrome: a prospective consecutive series of 48 patients. Ann. Vasc. Surg. 28(3), 695–704 (2014).
30.
Nayak L, Hildebolt CF, Vedantham S. Postthrombotic syndrome: feasibility of a strategy of imaging-guided endovascular intervention. J. Vasc. Interv. Radiol. JVIR. 23(9), 1165–1173 (2012).
31.
Raju S, Neglén P. Percutaneous recanalization of total occlusions of the iliac vein. J. Vasc. Surg. 50(2), 360–368 (2009).
32.
Rollo JC, Farley SM, Jimenez JC, Woo K, Lawrence PF, DeRubertis BG. Contemporary outcomes of elective iliocaval and infrainguinal venous intervention for post-thrombotic chronic venous occlusive disease. J. Vasc. Surg. Venous Lymphat. Disord. 5(6), 789–799 (2017).
33.
Rosales A, Sandbaek G, Jørgensen JJ. Stenting for chronic post-thrombotic vena cava and iliofemoral venous occlusions: mid-term patency and clinical outcome. Eur. J. Vasc. Endovasc. Surg. Off. J. Eur. Soc. Vasc. Surg. 40(2), 234–240 (2010).
34.
Sarici IS, Yanar F, Agcaoglu O et al. Our early experience with iliofemoral vein stenting in patients with post-thrombotic syndrome. Phlebology 29(5), 298–303 (2014).
35.
Stuck AK, Reich T, Engelberger RP, Sebastian T, Kucher N. Endovascular treatment of post-thrombotic and nonthrombotic iliofemoral venous outflow obstructions with self-expanding nitinol stents. VASA Z. Gefasskrankheiten. 47(4), 319–325 (2018).
36.
Tosenovsky P. One-year results of iliocaval stenting. Ann. Vasc. Surg. 59, 208–216 (2019).
37.
Ye K, Lu X, Jiang M et al. Technical details and clinical outcomes of transpopliteal venous stent placement for postthrombotic chronic total occlusion of the iliofemoral vein. J. Vasc. Interv. Radiol. JVIR. 25(6), 925–932 (2014).
38.
Bucher HC, Guyatt GH, Griffith LE, Walter SD. The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J. Clin. Epidemiol. 50(6), 683–691 (1997).
39.
Introduction to Meta-Analysis. Wiley Online Books (2009). https://onlinelibrary.wiley.com/doi/book/10.1002/9780470743386
40.
Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 327(7414), 557–560 (2003).
41.
Husereau D, Drummond M, Petrou S et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS)–explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. Value Health J. Int. Soc. Pharmacoeconomics Outcomes Res. 16(2), 231–250 (2013).
42.
PE Guidelines Around The World: Italy. https://tools.ispor.org/PEguidelines/countrydet.asp?c=13&t=4
43.
Cheng Q, Gibb M, Graves N, Finlayson K, Pacella RE. cost–effectiveness analysis of guideline-based optimal care for venous leg ulcers in Australia. BMC Health Serv. Res. 18(1), 421 (2018).
44.
Mosti G, Mattaliano V, Polignano R, Masina M. Compression therapy in the treatment of leg ulcers. Acta-Vulnologica 7(3), 113–135 (2009).
• Provides Italian costs of compression therapy.
45.
Guest JF, Fuller GW, Vowden P. Venous leg ulcer management in clinical practice in the UK: costs and outcomes. Int. Wound J. 15(1), 29–37 (2018).
46.
Clegg JP, Guest JF. Modelling the cost-utility of bio-electric stimulation therapy compared to standard care in the treatment of elderly patients with chronic non-healing wounds in the UK. Curr. Med. Res. Opin. 23(4), 871–883 (2007).
47.
Tavole di mortalità (2019). http://dati.istat.it/Index.aspx?DataSetCode=DCIS_MORTALITA1
48.
Sullivan SD, Mauskopf JA, Augustovski F et al. Budget impact analysis-principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value Health J. Int. Soc. Pharmacoeconomics Outcomes Res. 17(1), 5–14 (2014).
49.
Briggs AH, O'Brien BJ, Blackhouse G. Thinking outside the box: recent advances in the analysis and presentation of uncertainty in cost–effectiveness studies. Annu. Rev. Public Health 23, 377–401 (2002).
50.
Evans CJ, Fowkes FG, Ruckley CV, Lee AJ. Prevalence of varicose veins and chronic venous insufficiency in men and women in the general population: Edinburgh Vein Study. J. Epidemiol. Community Health. 53(3), 149–153 (1999).
51.
Hartung O, Otero A, Boufi M et al. Mid-term results of endovascular treatment for symptomatic chronic nonmalignant iliocaval venous occlusive disease. J. Vasc. Surg. 42(6), 1138–1144 (2005).
52.
Guest JF, Fuller GW, Vowden P. Clinical outcomes and cost–effectiveness of three different compression systems in newly-diagnosed venous leg ulcers in the UK. J. Wound Care. 26(5), 244–254 (2017).
53.
Ashby RL, Gabe R, Ali S et al. Clinical and cost–effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial. Lancet Lond. Engl. 383(9920), 871–879 (2014).
54.
Tangney E, O'Donnell T, Iafrati M. Cost and benefit analysis of stenting versus compression therapy for patients with chronic total venous occlusion. J. Vasc. Surg. Venous Lymphat. Disord. 4(1), 137 (2016).
•• Provides a cost–benefit analysis comparing stenting versus compression therapy.
55.
Health equipment – Hospital beds – OECD Data (2019). http://data.oecd.org/healtheqt/hospital-beds.htm
56.
Gordon L, Edwards H, Courtney M, Finlayson K, Shuter P, Lindsay E. A cost–effectiveness analysis of two community models of care for patients with venous leg ulcers. J. Wound Care. 15(8), 348–353 (2006).
57.
Blüher M, Saunders SJ, Mittard V, Torrejon Torres R, Davis JA, Saunders R. Critical Review of European Health-Economic Guidelines for the Health Technology Assessment of Medical Devices. Front. Med. 6 (2019). /
58.
Gianesini S, Obi A, Onida S et al. Global guidelines trends and controversies in lower limb venous and lymphatic disease: narrative literature revision and experts’ opinions following the vWINter international meeting in Phlebology, Lymphology & Aesthetics, 23–25 January 2019. Phlebology 34(Suppl. 1), 4–66 (2019).
59.
Franks PJ, Barker J, Collier M et al. Management of patients with venous leg ulcers: challenges and current best practice. J. Wound Care. 25(Suppl. 6), S1–S67 (2016).
Information & Authors
Information
Published In
Pages: 705 - 720
PubMed: 32686480
Copyright
© 2020 Carla Rognoni. This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License
History
Received: 13 February 2020
Accepted: 19 May 2020
Published online: 20 July 2020
Keywords:
Topics
Authors
Metrics & Citations
Metrics
Article Usage
Article usage data only available from February 2023. Historical article usage data, showing the number of article downloads, is available upon request.
Citations
How to Cite
Venous stenting for patients with outflow obstruction and leg ulcers: cost–effectiveness and budget impact analyses. (2020) Journal of Comparative Effectiveness Research. DOI: 10.2217/cer-2020-0030
Export citation
Select the citation format you wish to export for this article or chapter.
Citing Literature
- S.G. Gavrilov, A.V. Vasilyev, S.V. Chubchenko, Economic Aspects of Endovascular Treatment of Pelvic Venous Disorders, Journal of Venous Disorders, 10.17116/flebo20262001116, 20, 1, (16), (2026).
- Marzia Lugli, Oscar Maleti, Endovascular Treatment for Venous Obstructions, VAS European Book on Angiology/Vascular Medicine, 10.1007/978-3-031-82232-2_75, (905-912), (2026).
- Oscar Maleti, Marzia Lugli, Deep Venous Valve Reconstruction Indications and Results, VAS European Book on Angiology/Vascular Medicine, 10.1007/978-3-031-82232-2_64, (757-765), (2026).
- Anthony Teta, Jay Mohan, Vincent Varghese, Jon C. George, Jacqueline Powers, Ehrin J. Armstrong, Yulanka Castro-Dominguez, Iliofemoral Acute Deep Venous Thrombosis, Chronic Deep Venous Thrombosis, and May-Thurner Syndrome, Interventional Cardiology Clinics, 10.1016/j.iccl.2024.11.014, 14, 2, (297-310), (2025).
- Dwayne Boyers, Moira Cruickshank, Lorna Aucott, Charlotte Kennedy, Paul Manson, Paul Bachoo, Miriam Brazzelli, Automated devices for identifying peripheral arterial disease in people with leg ulceration: an evidence synthesis and cost-effectiveness analysis, Health Technology Assessment, 10.3310/TWCG3912, (1-158), (2024).
- Kush R. Desai, Saher S. Sabri, Steve Elias, Paul J. Gagne, Mark J. Garcia, Kathleen Gibson, Misaki M. Kiguchi, Santhosh J. Mathews, Erin H. Murphy, Eric A. Secemsky, Windsor Ting, Raghu Kolluri, Consensus Statement on the Management of Nonthrombotic Iliac Vein Lesions From the VIVA Foundation, the American Venous Forum, and the American Vein and Lymphatic Society, Circulation: Cardiovascular Interventions, 10.1161/CIRCINTERVENTIONS.124.014160, 17, 8, (2024).
- Oscar Maleti, Massimiliano Orso, Marzia Lugli, Michel Perrin, Systematic review and meta-analysis of deep venous reflux correction in chronic venous insufficiency, Journal of Vascular Surgery: Venous and Lymphatic Disorders, 10.1016/j.jvsv.2023.07.003, 11, 6, (1265-1275.e5), (2023).
- Tina Moon, Thomas F O’Donnell, Derek Weycker, Mark Iafrati, Impact of lymphedema in the management of venous leg ulcers, Phlebology: The Journal of Venous Disease, 10.1177/02683555231197597, 38, 9, (613-621), (2023).
- Carla Rognoni, Alessandro Furnari, Marzia Lugli, Oscar Maleti, Alessandro Greco, Rosanna Tarricone, Time-Driven Activity-Based Costing for Capturing the Complexity of Healthcare Processes: The Case of Deep Vein Thrombosis and Leg Ulcers, International Journal of Environmental Research and Public Health, 10.3390/ijerph20105817, 20, 10, (5817), (2023).
- S.G. Gavrilov, I.S. Lebedev, A.V. Vasiliev, N.Yu. Mishakina, Medical and Economic Rationale of Venous Stenting for Chronic Obstruction, Journal of Venous Disorders, 10.17116/flebo20231702192, 17, 2, (92), (2023).