Phlebologie 2020; 49(02): 87-97
DOI: 10.1055/a-1070-1079
Review

Treatment of varicose great saphenous veins with saphenofemoral junction insufficiency – what is the evidence? [*]

Article in several languages: English | deutsch
René Gordon Holzheimer
1   Chirurgische Tagesklinik Sauerlach/St. Anna Klinik Meran/LMU München Deutschland
,
Alfred Obermayer
2   Karl Landsteiner Institut für funktionelle Phlebologie Melk Österreich
,
Thomas Noppeney
3   Abteilung für Gefäßchirurgie KH Martha-Maria Nürnberg – Lehrbeauftragter Phlebologie, Abteilung für Gefäß- und endovaskuläre Chirurgie, Universitätsklinikum Regensburg
› Author Affiliations

Abstract

The results of studies on treatment of the great saphenous vein (GSV) with sapheno-femoral-junction (SFJ) insufficiency are unclear. Guidelines, however, recommend endovenous laser ablation (EVLA) and ultrasound-guided-foamsclerotherapy (UGFS) for symptomatic varicose large saphenous vein. There are numerous studies on GSV treatment but only a few randomized studies with a follow-up of two years and more. Meta-analyses in most instances included all studies and do not focus on studies with a follow-up of two years and longer.

Methods A literature research in Pubmed used the keyword “great saphenous vein treatment”, “large saphenous vein treatment”, “varicose therapy” in conjunction with “randomized controlled trial”, “meta-analysis” and “systematic review”. Of 128 studies only 24 randomized controlled studies investigated the effect of High Ligation and Continuous Stripping (HL + CS), Endovenous Laser Ablation (EVLA), Radiofrequency Ablation (RFA), Liquid Sclerotherapy (LS), and Ultrasound-Guided-Foam-Sclerotherapy (UGFS) and a follow-up of two and more years. Study evaluation included “reflux”, “recurrence”, “therapy technique”, numbers of patients/legs treated, length of follow-up, and primary/secondary study endpoints.

Results Most of these studies investigated surgical High Ligation and Continuous Stripping (HL + CS) with a follow-up of two years and more. This technique served a reference technique for other techniques in randomized controlled studies. However, there are major differences in techniques, mode of treatment, definitions, criteria for exclusion and inclusion, and study endpoints.

The surgery study group included 1915 legs in 19 studies, the EVLA group 1047 legs in 12 studies and 240 legs in 3 studies with combined HL + EVLA treatment. RFA was used in 299 legs in 4 studies, UGFS in 661 legs in 5 studies, combined UGFS + HL in 39 legs and LS + HL in 92 legs in one study each.

EVLA is associated with more reflux and recurrence when compared to HL + CS. RFA shows similar reflux and recurrence rates as surgery. In most studies UGFS and LS is followed by more reflux and recurrence when compared to surgery.

Conclusion Due to heterogeneity of studies comparing study results of HL + CS, EVLA, RFA, LS and UGFS is not reliable. UIP or ECOP may form a commission to establish uniform, reliable and accepted study designs for varicose vein treatment to improve comparability of further randomized studies.

* Presentation Phleb Alta 19. Januar 2018 Meran/Bozen Italien.




Publication History

Article published online:
20 February 2020

© Georg Thieme Verlag KG
Stuttgart · New York

 
  • References

  • 1 Nicolaides A, Kakkos S, Eklof B. et al Management of chronic venous disorders of the lower limbs – guidelines according to scientific evidence. Int Angiol 2014; 33: 87-208
  • 2 O’Flynn N, Vaughan M, Kelley K. Diagnosis and management of varicose veins in the legs: NICE guideline. Br J Gen Pract 2014; 64: 314-315 . doi: 10.3399/bjgp14X680329
  • 3 Wittens C, Davies AH, Baekgaard N. et al Editor’s choice – Management of chronic venous disease. Eur J Vasc Endovasc Surg 2015; 49: 678-737 . doi: 10.1016/j.ejvs.2015.02.007. Epub 2015 Apr 25
  • 4 Gianesini S, Occhionorelli S, Menegatti E. et al Femoral vein valve incompetence as a risk factor for junctional recurrence. Phlebology 2018; 33 (03) 206-212 . doi: 10.1177/0268355517690056. Epub 2017 Jan 29.
  • 5 Stücker M, Moritz R, Altmeyer P. et al New concept: different types of insufficiency of the saphenofemoral junction identified by duplex as a chance for a more differentiated therapy of the great saphenous vein. Phlebology 2013; 28 (05) 268-274 . doi: 10.1177/0268355513476215. Epub 2013 May 6.
  • 6 Bayer A, Kahle B, Horn M. et al Modern treatment of varicose veins. Dtsch Med Wochenschr 2019; 144 (09) 606-623 . doi: 10.1055/a-0855-2401. Epub 2019 Apr 26.
  • 7 Carandina S, Mari C, De Palma M. et al Varicose vein stripping vs haemodynamic correction (CHIVA). A long term randomized trial. Eur J Vasc Endovasc Surg 2008; 35 (02) 230-237 . Epub 2007 Oct 26.
  • 8 Christenson JT, Gueddi S, Gemayel G. et al 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 (05) 1234-1241 . doi: 10.1016/j.jvs.2010.06.104.
  • 9 Disselhoff BC, der Kinderen DJ, Kelder JC. et al Five-year results of a randomized clinical trial comparing endovenous laser ablation with cryostripping for great saphenous varicose veins. Br J Surg 2011; 98 (08) 1107-1111 . doi: 10.1002/bjs.7542. Epub 2011 Jun 1.
  • 10 Disselhoff BC, der Kinderen DJ, Kelder JC. et al Five-year results of a randomised clinical trial of endovenous laser ablation of the great saphenous vein with and without ligation of the saphenofemoral junction. Eur J Vasc Endovasc Surg 2011; 41 (05) 685-690 . doi: 10.1016/j.ejvs.2010.12.014. Epub 2011 Feb 18.
  • 11 El-Sheikha J, Nandhra S, Carradice D. et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant or sequential phlebectomy following endovenous laser ablation for varicose veins. Br J Surg 2014; 101 (09) 1093-1097 . doi: 10.1002/bjs.9565. Epub 2014 Jun 11.
  • 12 Flessenkämper IH, Stenger D, Hartmann M. et al Two-year results of a prospective randomised controlledmulticenter trial to compare open operative therapy vs. endoluminal venous laser therapy with and without high ligation for the therapy of varicose greater saphenous veins. Zentralbl Chir 2015; 140 (01) 27-34 . doi: 10.1055/s-0033-1360347. Epub 2014 May 8.
  • 13 Gauw SA, Lawson JA, van Vlijmen-van Keulen CJ. et al Five-year follow-up of a randomized, controlled trial comparing saphenofemoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anesthesia. J Vasc Surg 2016; 63 (02) 420-428 . doi: 10.1016/j.jvs.2015.08.084. Epub 2015 Oct 23.
  • 14 Morrison N, Kolluri R, Vasquez M. et al Comparison of cyanoacrylate closure and radiofrequency ablation for the treatment of incompetent great saphenous veins: 36-Month outcomes of the VeClose randomized controlled trial. Phlebology. 2019; 34 (06) 380-390 . doi: 0.1177/0268355518810259. Epub 2018 Nov 7.
  • 15 Hammarsten J, Pedersen P, Cederlund CG. et al Long saphenous vein saving surgery for varicose veins. A longterm follow-up. Eur J Vasc Surg 1990; 4 (04) 361-364
  • 16 Hamel-Desnos C, Ouvry P, Benigni JP. et al Comparison of 1% and 3% polidocanol foam in ultrasound guided sclerotherapy of the great saphenous vein: a randomised, doubleblind trial with 2 year-follow-up. “The 3/1 Study”. Eur J Vasc Endovasc Surg 2007; 34 (06) 723-729 . Epub 2007 Sep 20.
  • 17 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 (01) 49-54 doi: 10.1177/0003319710380680. Epub 2010 Aug 18.
  • 18 Kalodiki E, Lattimer CR, Azzam M. et al Long-term results of a randomized controlled trial on ultrasoundguided foam sclerotherapy combined with saphenofemoral ligation vs standard surgery for varicose veins. J Vasc Surg 2012; 55 (02) 451-457 . doi: 10.1016/j.jvs.2011.08.040. Epub 2011 Nov 21
  • 19 Kalteis M, Adelsgruber P, Messie-Werndl S. et al Five-year results of a randomized controlled trial comparing high ligation combined with endovenous laser ablation and stripping of the great saphenous vein. Dermatol Surg 2015; 41 (05) 579-586 . doi: 10.1097/DSS.0000000000000369.
  • 20 Lam YL, Lawson JA, Toonder IM. et al Eight-year follow-up of a randomized clinical trial comparing ultrasound-guided foam sclerotherapy with surgical stripping of the great saphenous vein. Br J Surg 2018; 105 (06) 692-698 . doi: 10.1002/bjs.10762.
  • 21 Lawaetz M, Serup J, Lawaetz B. et al Comparison of endovenous ablation techniques, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Extended 5-year follow-up of a RCT. Int Angiol 2017; 36 (03) 281-288 . doi: 10.23736/S0392-9590.17.03827-5. Epub 2017 Feb 17.
  • 22 Lurie F, Creton D, Eklof B. et al Prospective randomised study of endovenous radiofrequency obliteration (closure) versus ligation and vein stripping (EVOLVeS): two-year follow-up. Eur J Vasc Endovasc Surg 2005; 29 (01) 67-73
  • 23 Perälä J, Rautio T, Biancari F. 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 (05) 669-672
  • 24 Rasmussen L, Lawaetz M, Bjoern L. et al Randomized clinical trial comparing endovenous laser ablation and stripping of the great saphenous vein with clinical and duplex outcome after 5 years. J Vasc Surg 2013; 58 (02) 421-426 . doi: 10.1016/j.jvs.2012.12.048. Epub 2013 Jun 12.
  • 25 Rass K, Frings N, Glowacki P. et al Same Site Recurrence is More Frequent After Endovenous Laser Ablation Compared with High Ligation and Stripping of the Great Saphenous Vein: 5 year Results of a Randomized Clinical Trial (RELACS Study). Eur J Vasc Endovasc Surg 2015; 50 (05) 648-656 . doi: 10.1016/j.ejvs.2015.07.020. Epub 2015 Aug 28.
  • 26 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 (04) 311-315
  • 27 Samuel N, Wallace T, Carradice D. et al Comparison of 12-w versus 14-w endovenous laser ablation in the treatment of great saphenous varicose veins: 5-year outcomes from a randomized controlled trial. Vasc Endovascular Surg 2013; 47 (05) 346-352 . doi: 10.1177/1538574413487265. Epub 2013 May 3.
  • 28 Vähäaho S, Halmesmäki K, Albäck A. et al Five-year follow-up of a randomized clinical trial comparing open surgery, foam sclerotherapy and endovenous laser ablation for great saphenous varicose veins. Br J Surg 2018; 105 (06) 686-691 . doi: 10.1002/bjs.10757
  • 29 van der Velden SK, Biemans AA, De Maeseneer MG. et al Five-year results of a randomized clinical trial of conventional surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins. Br J Surg 2015; 102 (10) 1184-1194 . doi: 10.1002/bjs.9867. Epub 2015 Jul 1.
  • 30 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 (04) 634-639
  • 31 Winterborn RJ, Foy C, Heather BP. et al Randomised trial of flush saphenofemoral ligation for primary great saphenous varicose veins. Eur J Vasc Endovasc Surg 2008; 36 (04) 477-484 . doi: 10.1016/j.ejvs.2008.06.022. Epub 2008 Aug 20.
  • 32 Begg C, Cho M, Eastwood S. et al Improving the quality of reporting of randomized controlled trials. The consort statement. JAMA 1996; 278 (08) 637-639
  • 33 De Maesener M, Pichot O, Carezzi A. et al Duplex ultrasound investigation of the veins of the lower limbs after treatment for varicose veins – UIP consensus document. Eur J Vasc Endovasc Surg 2011; 42: 89-102 . doi: 10.1016/j.ejvs.2011.03.013. Epub 2011 May 6.
  • 34 Turton EPL, Scott DJA, Richards SP. et al Duplex-derived evidence of reflux after varicose vein surgery: neo reflux or neovasculatrization?. Eur J Vasc Endovasc Surg 1999; 17: 230-233
  • 35 Perrin MR, Guex JJ, Ruckley CV. et al Recurrent varices after surgery (REVAS). A consensus document. REVAS group. Cardiovasc Surg 2000; 8 (04) 233-245
  • 36 Stonebridge PA, Chalmers N, Beggs I. et al Recurrent varicose veins: a varicographic analysis leading to a new practical classification. Br J Surg 1995; 82: 60-62
  • 37 Glass GM. Neovascularisation in recurrence of the varicose great saphenous vein following transaction. Phlebology 1987; 2: 81-91
  • 38 Van Rij AM, Jones GF, Hill GB. et al Neovascularization and recurrent varicose veins: more histological and ultrasound evidence. J Vasc Surg 2004; 40: 296-302
  • 39 Flessenkemper I, Hartmann M, Hartmann K. et al Endovenous laser ablation with and without highligation compared to high ligation and stripping for treatment of great saphenous varicose veins: results of a multicentre randomized controlled trial with up to 6 years follow-up. Phlebology 2016; 31 (01) 23-33 . doi: 10.1177/0268355514555547. Epub 2014 Oct 22.
  • 40 Hamann SAS, Giang J, de Maeseneer MGR. et al Editor’s choice – Five year results of great saphenous vein treatment: A Meta-analysis. Eur J Vasc Endvasc Surg 2017; 54: 760-770 . doi: 10.1016/j.ejvs.2017.08.034. Epub 2017 Oct 14.
  • 41 Van den Bos R, Arenfds L, Kokaert M. et al Endovenous therapies of lower extremity varicosities: A meta-analysis. J Vasc Surg 2009; 49: 230-239
  • 42 Cavezzi A, Labropoulos N, Partsch H. et al Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs – UIP consensus document. Part II. Anatomy. Eur J Vasc Endovasc Surg 2006; 31: 288-299
  • 43 Cappelli M, Molino-Lova R, Giangrandi I. et al Ligation of the saphenofemoral junction tributaries as a risk factor for groin recurrence. J Vasc Surg Venous Lymphat Disord 2018; 6 (02) 224-229 . doi: 10.1016/j.jvsv.2017.09.005. Epub 2017 Dec 28.
  • 44 Zollmann P, Zollmann C, Zollmann P. et al Determining the origin of superficial venous reflux in the groin with duplex ultrasound and implications for varicose vein surgery. J Vasc Surg Venous Lymphat Disord 2017; 5 (01) 82-86 . doi: 10.1016/j.jvsv.2016.10.001.
  • 45 De Maeseneer MGR, Biemans AAM, Pichot O. New concepts on recurrence of varicose veins according to the different treatment techniques. Phlebologie 2013; 66: 54-60
  • 46 Fischer R, Chandler JG, Stenger D. et al Patient characteristics and physician-determined variables affecting saphenofemoral reflux recurrence after ligation and strippingof the great saphenous vein. J Vasc Surg 2006; 43: 81-87
  • 47 Krysa J, Jones GT, van Rij AM. Evidence for a genetic role in varicose veins and chronic venous insufficiency. Phlebology 2012; 27: 329-35 . doi: 10.1258/phleb.2011.011030. Epub 2012 Feb 3
  • 48 Brar R, Nordon JM, Hinchliffe R. et al Surgical management of varicose veins. Meta-analysis Vascular 2010; 18 (04) 205-220
  • 49 Nesbitt C, Eifell RK, Coyne P. et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional surgery for great saphenous vein varices. Cochrane Database Syst Rev 2011; 5 (10) CD005624 . doi: 10.1002/14651858.CD005624.pub2.
  • 50 Siribumrungwong B, Noorit P, Wilasrusmee C. et al A systematic review and meta-analysis of randomised controlled trials comparing endovenous ablation and surgical intervention in patients with varicose vein. Eur J Vasc Endovasc Surg 2012; 44 (02) 214-223 . doi: 10.1016/j.ejvs.2012.05.017. Epub 2012 Jun 15.
  • 51 Pan Y, Zhao J, Mei J. et al Comparison of endovenous laser ablation and high ligation and stripping for varicose vein treatment: a meta-analysis. Phlebology 2014; 29 (02) 109-119 . doi: 10.1177/0268355512473911. Epub 2013 May 6.
  • 52 Quarto G, Amato B, Giani U. et al Comparison of traditional surgery and laser treatment of incontinent great saphenous vein. Results of a meta-Analysis. Ann Ital Chir 2016; 87: 61-67
  • 53 Nesbitt C, Bedenis R, Bhattacharya V. et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus open surgery for great saphenous vein varices. Cochrane Database Syst Rev 2014; 30 (07) CD005624 . doi: 10.1002/14651858.CD005624.pub3.
  • 54 Lynch NP, Clarke M, Fulton GJ. Surgical management of great saphenous vein varicose veins: A meta-analysis. Vascular 2015; 23 (03) 285-296 . doi: 10.1177/1708538114542633. Epub 2014 Jul 15
  • 55 He G, Zheng C, Yu MA. et al Comparison of ultrasound-guided endovenous laser ablation and radiofrequency for the varicose veins treatment: An updated metaanalysis. Int J Surg 2017; 39: 267-275 . doi: 10.1016/j.ijsu.2017.01.080. Epub 2017 Jan 21.
  • 56 Rathbun S, Norris A, Stoner J. Efficacy and safety of endovenous foam sclerotherapy: meta-analysis for treatment of venous disorders. Phlebology 2012; 27 (03) 105-117 . doi: 10.1258/phleb.2011.011111. Epub 2012 Feb 20
  • 57 Murad MH, Coto-Yglesias F, Zumaeta-Garcia M. et al A systematic review and meta-analysis of the treatments of varicose veins. Vasc Surg 2011; 53 (Suppl. 05) 49S-65S . doi: 10.1016/j.jvs.2011.02.031.
  • 58 Balint R, Farics A, Parti K. et al Which endovenous ablation method does offer a better long-term technical success in the treatment of the incompetent great saphenous vein?. Review Vascular 2016; 24 (06) 649-657 . Epub 2016 Apr 28.
  • 59 Bellmunt-Montoya S, Escribano JM, Dilme J. et al CHIVA: method for the treatment of chronic venous insufficiency. Cochrane Database Syst Rev 2015; 29 (06) CD009648 . doi: 10.1002/14651858.CD009648.pub3.
  • 60 Marsden G, Perry M, Bradbury A. et al Cost-effectiveness Analysis of Surgery, Endothermal Ablation, Ultrasound-guided Foam Sclerotherapy and Compression Stockings for Symptomatic Varicose Veins. Eur J Vasc Endovasc Surg 2015; 50 (06) 794-801 . doi: 10.1016/j.ejvs.2015.07.034. Epub 2015 Oct 2.
  • 61 Coughlin PA, Berridge DC. Is there a continuing role for traditional surgery?. Phlebology 2015; 30 (02) 29-35 . doi: 10.1177/0268355515589248
  • 62 Malskat WS, Poluektova AA, van der Geld CW. et al Endovenous laser ablation (EVLA): a review of mechanisms, modeling outcomes, and issues for debate. Lasers Med Sci 2014; 29 (02) 393-403 . doi: 10.1007/s10103-013-1480-5. Epub 2013 Dec 24.
  • 63 Thakur B, Shalhoub J, Hill AM. et al Heterogeneity of reporting standards in randomised clinical trials of endovenous interventions for varicose veins. Eur J Vasc Endovasc Surg 2010; 40 (04) 528-533 . doi: 10.1016/j.ejvs.2010.06.018. Epub 2010 Jul 23.