Catheter-directed foam sclerotherapy with tumescence of the great saphenous vein versus ultrasound-guided foam sclerotherapy: A randomized controlled trial

Abstract

Objectives

To compare the effectiveness of two foam sclerotherapy techniques of the great saphenous vein.

Methods

Fifty subjects with varicose veins, edema, and great saphenous vein incompetence (diameter 6–10 mm) were randomly categorized into two equal groups and were treated with different foam sclerotherapy techniques: A (usual ultrasound-guided) and B (catheter-directed with tumescence). Concomitant phlebectomy was performed in all patients. Patients were seen on days 7 and 28, and at six and 12 months. The primary outcomes were the full success rate of the treated great saphenous vein and the number of patients who required retreatment sessions performed at 28-day follow-up. The secondary-assisted outcomes were the full success rates of the treated great saphenous vein after the retreatment sessions at six- and 12-month follow-up. Secondary outcomes were changes in quality of life and side effects and complications of the intervention. In case of reflux, retreatment sessions were performed at 28 days and six months in both groups.

Results

Full success rate of the treated great saphenous vein was 36% in group A vs. 80% in group B (p = 0.012) and the number of patients who required retreatment sessions were n = 14 in group A vs. n = 3 in group B at 28-day follow-up (p = 0.002). Both were statistically significant. At six and 12 months, the success rates were not statistically significant between the groups. Complication rates were similar between the groups. Quality of life improved in both groups with statistical difference (p < 0.001).

Conclusions

Catheter-directed foam sclerotherapy with tumescence was better than usual ultrasound-guided foam sclerotherapy as it reached higher full success rate of the treated great saphenous vein and as a lower number of patients required retreatment sessions in the short-term. Both methods proved to be safe and improved the quality of life.

Keywords

Foam sclerotherapy ultrasound-guided foam sclerotherapy catheter-based interventions varicose veins endovenous technique

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References

Argyriou

Papasideris

Antoniou

, et al. The effectiveness of various interventions versus standard stripping in patients with varicose veins in terms of quality of life. Phlebology 2018; 33: 439–450.

Van den Bos

Proebstle

TM.

The state of the art of endothermal ablation.

Lasers Med Sci 2014; 29: 387–392.

Tessari

Cavezzi

Frullini

Preliminary experience with a new sclerosing foam in the treatment of varicose veins.

Dermatol Surg 2001; 27: 58–60.

Proebstle

Alm

Dimitri

, et al. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord 2015; 3: 2–7.

Morrison

Gibson

McEnroe

, et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg 2015; 61: 985–994.

Mueller

Raines

JK.

ClariVein mechanochemical ablation: background and procedural details

. Vasc Endovasc Surg 2013; 47: 195–206.

Boersma

van Eekeren

Werson

, et al. Mechanochemical endovenous ablation of small saphenous vein insufficiency using the ClariVein(®) device: one-year results of a prospective series. Eur J Vasc Endovasc Surg 2013; 45: 299–303.

Rasmussen

Lawaetz

Bjoern

, et al. 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.

Parsi

Catheter-directed sclerotherapy.

Phlebology 2009; 24: 98–107.

10.

Cavezzi

Frullini

Ricci

, et al. Treatment of varicose veins by foam sclerotherapy: two clinical series. Phlebology 2002; 17: 13–18.

11.

Devereux

Recke

Westermann

, et al. Catheter-directed foam sclerotherapy of great saphenous veins in combination with pre-treatment reduction of the diameter employing the principals of perivenous tumescent local anesthesia. Eur J Vasc Endovasc Surg 2014; 47: 187–195.

12.

Coleridge-Smith

Chronic venous disease treated by ultrasound guided foam sclerotherapy.

Eur J Vasc Endovasc Surg 2006; 32: 577–583.

13.

Myers

Jolley

Clough

, et al. Outcome of ultrasound-guided sclerotherapy for varicose veins: medium-term results assessed by ultrasound surveillance. Eur J Vasc Endovasc Surg 2007; 33: 116–121.

14.

Barrett

Allen

Ockelford

, et al. Microfoam ultrasound-guided sclerotherapy treatment for varicose veins in a subgroup with diameters at the junction of 10 mm or greater compared with a subgroup of less than 10 mm. Dermatol Surg 2004; 30: 1386–1390.

15.

Thibault

Internal compression (peri-venous) following ultrasound guided sclerotherapy to the great and small saphenous veins. Aust NZ J Phleb 2005; 9: 29–32.

16.

Parsi

Exner

Connor

, et al. In vitro effects of detergent sclerosants on coagulation, platelets and microparticles. Eur J Vasc Endovasc Surg 2007; 34: 731–740.

17.

Watkins

MR.

Deactivation of sodium tetradecyl sulphate injection by blood proteins.

Eur J Vasc Endovasc Surg 2011; 41: 521–525.

18.

Cavezzi

Izzo

Sclerosant agents. In: Bergan

Paquette

NB (

eds) The vein book. 2nd ed. New York, NY: Oxford University Press, 2014, pp.100–108.

19.

Cavezzi

Mosti

Di Paolo

, et al. Ultrasound-guided peri-saphenous tumescence infiltration improves the outcomes of long catheter foam sclerotherapy combined with phlebectomy of the varicose tributaries. Veins Lymphatics 2015; 4: 18–23.

20.

Cavezzi

Mosti

Campana

, et al. Catheter foam sclerotherapy of the great saphenous vein, with perisaphenous tumescence infiltration and saphenous irrigation. Eur J Vasc Endovasc Surg 2017; 54: 629–635.

21.

Mendoza

Blättler

Amsler

Great saphenous vein diameter at the saphenofemoral junction and proximal thigh as parameters of venous disease class.

Eur J Vasc Endovasc Surg 2013; 45: 76–83.

22.

Rabe

Pannier

Sclerotherapy of varicose veins with polidocanol based on the guidelines of the German Society of Phlebology.

Dermatol Surg. 2010; 36: 968–975.

23.

Kölbel

Hinchliffe

Lindblad

Catheter-directed foam sclerotherapy of axial saphenous reflux: early results.

Phlebology 2007; 22: 219–222.

24.

Coleridge-Smith

Labropoulos

Partsch

, et al. Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs – UIP consensus document. Part I. Basic principles. Eur J Vasc Endovasc Surg 2006; 31: 83–92.

25.

De Maeseneer

Pichot

Cavezzi

, 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.

26.

Rabe

Breu

Cavezzi

, et al. European guidelines for sclerotherapy in chronic venous disorders. Phlebology 2014; 29: 338–354.

27.

Cavezzi

Tessari

Foam sclerotherapy techniques: different gases and methods of preparation, catheter versus direct injection.

Phlebology 2009; 24: 247–251.

28.

Parsi

Extended long line echosclerotherapy. Sclerother Soc Aust Newsbull 1997; 1: 10–12.

29.

Thibault

Parsi

Empty vein technique: can perivenous tumescent compression help?

Eur J Vasc Endovasc Surg 2017; 54: 369.

30.

Ali

Elbadawy

Saleh

, et al. Mid-term results of catheter directed foam sclerotherapy combined with tumescent local anaesthesia for treatment of great saphenous vein incompetence. Eur J Vasc Endovasc Surg 2017; 54: 363–368.

31.

McAree

Ikponmwosa

Brockbank

, et al. Comparative stability of sodium tetradecyl sulphate (STD) and polidocanol foam: impact on vein damage in an in-vitro model. Eur J Vasc Endovasc Surg 2012; 43: 721–725.

32.

Pittaluga

Chastanet

Rea

, et al. Midterm results of the surgical treatment of varices by phlebectomy with conservation of a refluxing saphenous vein. J Vasc Surg 2009; 50: 107–118.

33.

Cavezzi

Parsi

Complications of foam sclerotherapy. Phlebology 2012; 00: 1–6.

34.

Brittenden

Cotton

Elders

, et al. A randomized trial comparing treatments for varicose veins. N Engl J Med 2014; 371: 1218–1227.

35.

Rasmussen

Lawaetz

Serup