Systematic review, network meta-analysis and exploratory cost-effectiveness model of randomized trials of minimally invasive techniques versus surgery for varicose veins

British Journal of Surgery

Volumn 101, Issue 9, 2014, Pages 1040-1052

  Carroll, C ^a   Hummel, S ^a   Leaviss, J ^a   Ren, S ^a   Stevens, J W ^a   Cantrell, A ^a   Michaels, J ^a  

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; BIOMEDICAL TECHNOLOGY ASSESSMENT; CATHETER ABLATION; COMPARATIVE STUDY; COST BENEFIT ANALYSIS; ECONOMICS; HUMAN; LOW LEVEL LASER THERAPY; META ANALYSIS; MIDDLE AGED; PAIN; PAIN ASSESSMENT; QUALITY ADJUSTED LIFE YEAR; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENT DISEASE; REVIEW; SCLEROTHERAPY; VARICOSIS;

ADULT; CATHETER ABLATION; COST-BENEFIT ANALYSIS; HUMANS; LASER THERAPY; MIDDLE AGED; PAIN; PAIN MEASUREMENT; QUALITY-ADJUSTED LIFE YEARS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECURRENCE; SCLEROTHERAPY; TECHNOLOGY ASSESSMENT, BIOMEDICAL; VARICOSE VEINS;

EID: 84904561950     PISSN: 00071323     EISSN: 13652168     Source Type: Journal    
DOI: 10.1002/bjs.9566     Document Type: Review

References (85)

1. Kanwar A, Hansrani M, Lees T, Stansby G,. Trends in varicose vein therapy in England: radical changes in the last decade. Ann R Coll Surg Engl 2010; 92: 341-346.
2. Lim CS, Gohel MS, Shepherd AC, Davies AH,. Secondary care treatment of patients with varicose veins in National Health Service England: at least how it appeared on a National Health Service website. Phlebology 2010; 25: 184-189.
3. Department of Health. HES Statistics 2010-2011. http://www.hscic.gov.uk/ hes [accessed 13 February 2014 ].
4. Docherty JG, Morrice JJ, Bell G,. Saphenous neuritis following varicose vein surgery. Br J Surg 1994; 81: 698.
5. Morrison C, Dalsing MC,. Signs and symptoms of saphenous nerve injury after greater saphenous vein stripping: prevalence, severity, and relevance for modern practice. J Vasc Surg 2003; 38: 886-890.
6. Wood JJ, Chant H, Laugharne M, Chant T, Mitchell DC,. A prospective study of cutaneous nerve injury following long saphenous vein surgery. Eur J Vasc Endovasc Surg 2005; 30: 654-658.
7. Sam RC, Silverman SH, Bradbury AW,. Nerve injuries and varicose vein surgery. Eur J Vasc Endovasc Surg 2004; 27: 113-120.
8. Rutgers PH, Kitslaar PJ,. Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the incompetent greater saphenous vein. Am J Surg 1994; 168: 311-315.
9. Eklöf B, Rutherford RB, Bergan JJ, Carpentier PH, Gloviczki P, Kistner RL, et al.; American Venous Forum International Ad Hoc Committee for Revision of the CEAP Classification. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg 2004; 40: 1248-1252.
10. Kistner RL, Eklof B, Masuda EM,. Diagnosis of chronic venous disease of the lower extremities: the 'CEAP' classification. Mayo Clin Proc 1996; 71: 338-345.
11. Labropoulos N., CEAP in clinical practice. Vasc Surg 1997; 31: 224-225.
12. Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL,. Venous severity scoring: an adjunct to venous outcome assessment. J Vasc Surg 2000; 31: 1307-1312.
13. Kakkos SK, Rivera MA, Matsagas MI, Lazarides MK, Robless P, Belcaro G, et al. Validation of the new venous severity scoring system in varicose vein surgery. J Vasc Surg 2003; 38: 224-228.
14. Khilnani NM, Grassi CJ, Kundu S, D'Agostino HR, Khan AA, McGraw JK, et al.; Cardiovascular Interventional Radiological Society of Europe, American College of Phlebology; Society of Interventional Radiology Standards of Practice Committees. Multi-society consensus quality improvement guidelines for the treatment of lower-extremity superficial venous insufficiency with endovenous thermal ablation from the Society of Interventional Radiology, Cardiovascular Interventional Radiological Society of Europe, American College of Phlebology, and Canadian Interventional Radiology Association. J Vasc Interv Radiol 2010; 21: 14-31.
15. Fischer R, Chandler JG, Stenger D, Puhan MA, De Maeseneer MG, Schimmelpfennig L,. Patient characteristics and physician-determined variables affecting saphenofemoral reflux recurrence after ligation and stripping of the great saphenous vein. J Vasc Surg 2006; 31: 81-87.
16. Winterborn RJ, Foy C, Heather BP, Earnshaw JJ,. Randomised trial of flush saphenofemoral ligation for primary great saphenous varicose veins. Eur J Vasc Endovasc Surg 2008; 36: 477-484.
17. Winterborn RJ, Foy C, Earnshaw JJ,. Causes of varicose vein recurrence: late results of a randomized controlled trial of stripping the long saphenous vein. J Vasc Surg 2004; 40: 634-639.
18. Campbell WB, Vijay Kumar A, Collin TW, Allington KL, Michaels JA,; Randomised and Economic Analysis of Conservative and Therapeutic Interventions for Varicose veins Study. The outcome of varicose vein surgery at 10 years: clinical findings, symptoms and patient satisfaction. Ann R Coll Surg Engl 2003; 85: 52-57.
19. National Institute for Clinical Excellence (NICE). Endovenous Laser Treatment of the Long Saphenous Vein. NICE: London, 2004.
20. National Institute for Clinical Excellence (NICE). Radiofrequency Ablation of Varicose Veins. NICE: London, 2003.
21. National Institute for Health and Clinical Excellence (NICE). Ultrasound-Guided Foam Sclerotherapy for Varicose Veins. Interventional procedure guidance 217. NICE: London, 2007.
22. National Institute for Health and Care Excellence (NICE). Varicose Veins in the Legs: the Diagnosis and Management of Varicose Veins. Clinical guideline CG168. NICE: London, 2013.
23. Carroll C, Hummel S, Leaviss J, Ren S, Stevens JW, Everson-Hock E, et al. Clinical effectiveness and cost-effectiveness of minimally invasive techniques to manage varicose veins: a systematic review and economic evaluation. Health Technol Assess 2013; 17: i-xvi, 1-141.
24. Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA Statement. Ann Intern Med 2009; 151: 264-269.
25. Spiegelhalter D, Thomas A, Best N, Lunn D,. OpenBUGS User Manual, Version 3·2.1. MRC Biostatistics Unit: Cambridge, 2011.
26. Lunn DJ, Thomas A, Best N, Spiegelhalter D,. WinBUGS-a Bayesian modelling framework: concepts, structure, and extensibility. Statistics and Computing 2000; 10: 325-337.
27. Brooks SP, Gelman A,. Alternative methods for monitoring convergence of iterative simulations. Journal of Computational and Graphical Statistics 1998; 7: 434-445.
28. National Institute for Health and Clinical Excellence (NICE). Guide to the Methods of Technology Appraisal. NICE: London, 2008.
29. Shepherd AC, Gohel MS, Lim CS, Davies AH,. A study to compare disease-specific quality of life with clinical anatomical and hemodynamic assessments in patients with varicose veins. J Vasc Surg 2011; 53: 374-382.
30. Merchant RF, Pichot O,; Closure Study Group. Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for superficial venous insufficiency. J Vasc Surg 2005; 42: 502-509.
31. Darvall KA, Sam RC, Bate GR, Silverman SH, Adam DJ, Bradbury AW,. Changes in health-related quality of life after ultrasound-guided foam sclerotherapy for great and small saphenous varicose veins. J Vasc Surg 2010; 51: 913-920.
32. Bountouroglou DG, Azzam M, Kakkos SK, Pathmarajah M, Young P, Geroulakos G,. Ultrasound-guided foam sclerotherapy combined with sapheno-femoral ligation compared to surgical treatment of varicose veins: early results of a randomised controlled trial. Eur J Vasc Endovasc Surg 2006; 31: 93-100.
33. Subramonia S, Lees T,. Radiofrequency ablation vs conventional surgery for varicose veins-a comparison of treatment costs in a randomised trial. Eur J Vasc Endovasc Surg 2010; 39: 104-111.
34. Michaels JA, Campbell WB, Brazier JE, Macintyre JB, Palfreyman SJ, Ratcliffe J, et al. Randomised clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial). Health Technol Assess 2006; 10: 1-196, iii-iv.
35. Department of Health. 2010-11 Reference Costs Publication. https://www.gov.uk/government/publications/2010-11-reference-costs-publication [accessed 13 February 2014 ].
36. Curtis L., Unit Costs of Health and Social Care 2011. Personal Social Services Research Unit, University of Kent: Canterbury, 2011.
37. Browne J, Jamieson L, Lewsey J, van der Meulen J, Copley L, Black N,. Case-mix & patients' reports of outcome in Independent Sector Treatment Centres: comparison with NHS providers. BMC Health Serv Res 2008; 8: 78.
38. Carradice D, Mazari FA, Mekako A, Hatfield J, Allgar V, Chetter IC,. Energy delivery during 810 nm endovenous laser ablation of varicose veins and post-procedural morbidity. Eur J Vasc Endovasc Surg 2010; 40: 393-398.
39. Carradice D, Mazari FA, Samuel N, Allgar V, Hatfield J, Chetter IC,. Modelling the effect of venous disease on quality of life. Br J Surg 2011; 98: 1089-1098.
40. Durkin MT, Turton EP, Wijesinghe LD, Scott DJ, Berridge DC,. Long saphenous vein stripping and quality of life-a randomised trial. Eur J Vasc Endovasc Surg 2001; 21: 545-549.
41. Nordon IM, Hinchliffe RJ, Brar R, Moxey P, Black SA, Thompson MM, et al. A prospective double-blind randomized controlled trial of radiofrequency versus laser treatment of the great saphenous vein in patients with varicose veins. Ann Surg 2011; 254: 876-881.
42. Ara R, Brazier JE,. Populating an economic model with health state utility values: moving toward better practice. Value Health 2010; 13: 509-518.
43. Carradice D, Mekako AI, Mazari FA, Samuel N, Hatfield J, Chetter IC,. Randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. Br J Surg 2011; 98: 501-510.
44. Carradice D, Mekako AI, Mazari FA, Samuel N, Hatfield J, Chetter IC,. Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. Br J Surg 2011; 98: 1117-1123.
45. Christenson JT, Gueddi S, Gemayel G, Bounameaux H,. Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up. J Vasc Surg 2010; 52: 1234-1241.
46. Darwood RJ, Theivacumar N, Dellagrammaticas D, Mavor AI, Gough MJ,. Randomized clinical trial comparing endovenous laser ablation with surgery for the treatment of primary great saphenous varicose veins. Br J Surg 2008; 95: 294-301.
47. de Medeiros CA, Luccas GC,. Comparison of endovenous treatment with an 810 nm laser versus conventional stripping of the great saphenous vein in patients with primary varicose veins. Dermatol Surg 2005; 31: 1685-1694.
48. Kalteis M, Berger I, Messie-Werndl S, Pistrich R, Schimetta W, Pölz W, et al. High ligation combined with stripping and endovenous laser ablation of the great saphenous vein: early results of a randomized controlled study. J Vasc Surg 2008; 47: 822-829.
49. Rasmussen LH, Bjoern L, Lawaetz M, Lawaetz B, Blemings A, Eklöf B,. Randomised clinical trial comparing endovenous laser ablation with stripping of the great saphenous vein: clinical outcome and recurrence after 2 years. Eur J Vasc Endovasc Surg 2010; 39: 630-635.
50. Pronk P, Gauw SA, Mooij MC, Gaastra MT, Lawson JA, van Goethem AR, et al. Randomised controlled trial comparing sapheno-femoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anaesthesia: one year results. Eur J Vasc Endovasc Surg 2010; 40: 649-656.
51. Gale SS, Lee JN, Walsh ME, Wojnarowski DL, Comerota AJ,. A randomized, controlled trial of endovenous thermal ablation using the 810-nm wavelength laser and the ClosurePLUS radiofrequency ablation methods for superficial venous insufficiency of the great saphenous vein. J Vasc Surg 2010; 52: 645-650.
52. Goode SD, Chowdhury A, Crockett M, Beech A, Simpson R, Richards T, et al. Laser and radiofrequency ablation study (LARA study): a randomised study comparing radiofrequency ablation and endovenous laser ablation (810 nm). Eur J Vasc Endovasc Surg 2010; 40: 246-253.
53. Morrison N., Saphenous ablation: what are the choices, laser or RF energy. Semin Vasc Surg 2005; 18: 15-18.
54. Shepherd AC, Gohel MS, Brown LC, Metcalfe MJ, Hamish M, Davies AH,. Randomized clinical trial of VNUS ClosureFAST radiofrequency ablation versus laser for varicose veins. Br J Surg 2010; 97: 810-818.
55. Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B,. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg 2011; 98: 1079-1087.
56. Disselhoff BC, der Kinderen DJ, Kelder JC, Moll FL,. Randomized clinical trial comparing endovenous laser with cryostripping for great saphenous varicose veins. Br J Surg 2008; 95: 1232-1238.
57. Disselhoff BC, der Kinderen DJ, Kelder JC, Moll FL,. Five-year results of a randomized clinical trial comparing endovenous laser ablation with cryostripping for great saphenous varicose veins. Br J Surg 2011; 98: 1107-1111.
58. Helmy ElKaffas K, ElKashef O, ElBaz W,. Great saphenous vein radiofrequency ablation versus standard stripping in the management of primary varicose veins-a randomized clinical trial. Angiology 2011; 62: 49-54.
59. Hinchliffe RJ, Ubhi J, Beech A, Ellison J, Braithwaite BD,. A prospective randomised controlled trial of VNUS closure versus surgery for the treatment of recurrent long saphenous varicose veins. Eur J Vasc Endovasc Surg 2006; 31: 212-218.
60. Lin SM, Zhang ZH, Yao YD, Xiao JB,. [ Experience of endovenous radiofrequency combined with TriVex in treatment of chronic venous insufficiency in lower extremity.] Zhonghua Wai Ke Za Zhi 2009; 47: 271-274.
61. Lurie F, Creton D, Eklof B, Kabnick LS, Kistner RL, Pichot O, et al. Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study). J Vasc Surg 2003; 38: 207-214.
62. Rautio T, Ohinmaa A, Perälä J, Ohtonen P, Heikkinen T, Wiik H, et al. Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs. J Vasc Surg 2002; 35: 958-965.
63. Perälä J, Rautio T, Biancari F, Ohtonen P, Wiik H, Heikkinen T, et al. Radiofrequency endovenous obliteration versus stripping of the long saphenous vein in the management of primary varicose veins: 3-year outcome of a randomized study. Ann Vasc Surg 2005; 19: 669-672.
64. Subramonia S, Lees T,. Randomized clinical trial of radiofrequency ablation or conventional high ligation and stripping for great saphenous varicose veins. Br J Surg 2010; 97: 328-336.
65. Abela R, Liamis A, Prionidis I, Mathai J, Gorton L, Browne T, et al. Reverse foam sclerotherapy of the great saphenous vein with sapheno-femoral ligation compared to standard and invagination stripping: a prospective clinical series. Eur J Vasc Endovasc Surg 2008; 36: 485-490.
66. Figueiredo M, Araujo S, Barros N Jr, Miranda F Jr., Results of surgical treatment compared with ultrasound-guided foam sclerotherapy in patients with varicose veins: a prospective randomised study. Eur J Vasc Endovasc Surg 2009; 38: 758-763.
67. Jia X, Liu XP, Xiong J, Zhang HP, Liu M, Du X, et al,. [ Foam sclerotherapy of the great saphenous vein with sapheno-femoral ligation compared to standard stripping: a prospective randomized controlled trial.] Zhonghua Wai Ke Za Zhi 2010; 48: 1731-1734.
68. Kalodiki E, Azzam M, Kakkos SK, Zambas N, Bountouroglou D, Geroulakos G,. Ultrasound-guided foam sclerotherapy combined with saphenofemoral ligation versus surgical treatment of varicose veins: intermediate results of a randomized controlled trial. Phlebology 2008; 23: 242-243.
69. Liamis A, Prionidis I, Mathai J, Gorton L, Browne T, Panayiotopoulos YP,. Long saphenous vein reverse foam sclerotherapy with saphenofemoral junction ligation compared with head and invagination stripping: a prospective randomized trial. Phlebology 2005; 20: 149.
70. Shadid N, Nelemans P, Sommer A,. Duplex-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein: a randomized controlled trial. 11th Meeting of the European Venous Forum, Antwerp, 2010.
71. Wright D, Gobin JP, Bradbury AW, Coleridge-Smith P, Spoelstra H, Berridge D, et al.; Varisolve European Phase III Investigators Group. Varisolve polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomized controlled trial. Phlebology 2006; 21: 180-190.
72. Alòs J, Carreño P, Lõpez JA, Estadella B, Serra-Prat M, Marinel-Lo J,. Efficacy and safety of sclerotherapy using polidocanol foam: a controlled clinical trial. Eur J Vasc Endovasc Surg 2006; 31: 101-107.
73. Hamel-Desnos C, Desnos P, Wollmann JC, Ouvry P, Mako S, Allaert FA,. Evaluation of the efficacy of polidocanol in the form of foam compared with liquid form in sclerotherapy of the greater saphenous vein: initial results. Dermatol Surg 2003; 29: 1170-1175.
74. Ouvry P, Allaert FA, Desnos P, Hamel-Desnos C,. Efficacy of polidocanol foam versus liquid in sclerotherapy of the great saphenous vein: a multicentre randomised controlled trial with a 2-year follow-up. Eur J Vasc Endovasc Surg 2008; 36: 366-370.
75. Rabe E, Otto J, Schliephake D, Pannier F,. Efficacy and safety of great saphenous vein sclerotherapy using standardised polidocanol foam (ESAF): a randomised controlled multicentre clinical trial. Eur J Vasc Endovasc Surg 2008; 35: 238-245.
76. Rasmussen LH, Lawaetz M, Serup J, Bjoern L, Vennits B, Blemings A, et al,. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy, and surgical stripping for great saphenous varicose veins with 3-year follow-up. J Vasc Surg Venous Lymphat Disord 2013; 1: 349-356.
77. Gohel MS, Epstein DM, Davies AH,. Cost-effectiveness of traditional and endovenous treatments for varicose veins. Br J Surg 2010; 97: 1815-1823.
78. Disselhoff BC, Buskens E, Kelder JC, der Kinderen DJ, Moll FL,. Randomised comparison of costs and cost-effectiveness of cryostripping and endovenous laser ablation for varicose veins: 2-year results. Eur J Vasc Endovasc Surg 2009; 37: 357-363.
79. Jia X, Mowatt G, Burr JM, Cassar K, Cook J, Fraser C,. Systematic review of foam sclerotherapy for varicose veins. Br J Surg 2007; 94: 925-936.
80. Luebke T, Brunkwall J,. Systematic review and meta-analysis of endovenous radiofrequency obliteration, endovenous laser therapy, and foam sclerotherapy for primary varicosis. J Cardiovasc Surg (Torino) 2008; 49: 213-233.
81. Luebke T, Gawenda M, Heckenkamp J, Brunkwall J,. Meta-analysis of endovenous radiofrequency obliteration of the great saphenous vein in primary varicosis. J Endovasc Ther 2008; 15: 213-223.
82. Murad MH, Coto-Yglesias F, Zumaeta-Garcia M, Elamin MB, Duggirala MK, Erwin PJ, et al. A systematic review and meta-analysis of the treatments of varicose veins. J Vasc Surg 2011; 53 (Suppl): 49S-65S.
83. Nesbitt C, Eifell R, Coyne P, Badri H, Bhattacharya V, Stansby G,. Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional surgery for varicose veins. Cochrane Database Syst Rev 2011; (10)CD005624.
84. van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T,. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg 2009; 49: 230-239.
85. Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2011; 53 (Suppl): 2S-48S.