Non-surgical treatment of severe varicose veins

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1 Non-surgical treatment of severe varicose veins Yasu Harasaki UCHSC Department of Surgery General Surgery Grand Rounds March 19, 2007

2 Definition Dilated, palpable, subcutaneous veins generally >3mm in diameter Manifestation of chronic venous disease

3 Epidemiology Prevalence of varicose veins 5-30% in adult population 3:1 female predominance Framingham study : annual incidence 2.6% in women, 1.9% in men Evans CJ et al. J Epidemiol Community Health, Eberhardt RT and Raffetto JD. Circulation, 2005

4 Risk factors Gender Age Family history Both parents -> 90% One parent -> 62% for women, 25% for men Obesity Pregnancy h/o leg injury Rutherford Vascular Surgery 6 th Ed, Pp Cornu-Thenard A, et al, J Derm Surg Oncol.

5 Pathophysiology Primary varicose veins Structural changes in vein wall Secondary disease: Valve incompetence Venous hypertension Chronic inflammation Obstruction (thrombosis), valve incompetence (trauma)

6 Anatomy Superficial veins Great Saphenous, Small saphenous, nonsaphenous Superficial compartment -> not supported by muscular fascia Perforator veins Deep veins

7 Anatomy Great saphenous Small saphenous

8 Treatment algorithm

9 Treatment: Conservative

10 Compression Therapy Effective for symptom reduction Requires indefinite use Studied in venous ulcer healing Series of 113 pts, 93% ulcer healing in mean 5.3 months High recurrence rate with non-compliance (60-100%) Poor compliance difficulty of application in elderly, aesthetic concerns

11 Treatment: interventional

12 Treatment: Interventional Objectives Treat saphenous vein hypertension hydrostatic forces of saphenous vein reflux hydrodynamic forces of perforator vein reflux Remove varicose clusters

13 Treatment: Interventional Objectives Treat saphenous vein hypertension hydrostatic forces of saphenous vein reflux hydrodynamic forces of perforator vein reflux Remove varicose clusters

14 Treatment of saphenous HTN Surgical Ligation of saphenous vein Does not address perforator incompetence Ligation and stripping of saphenous vein Non-surgical Endovascular ablation

15 Treatment: Stripping and Ligation

16 Treatment: Saphenous hypertension Endovascular ablation Radiofrequency ablation Laser ablation

17 Treatment: RFA

18 Treatment: RFA

19 RFA vs S&L: EVOLVES Stripping & ligation (S&L) vs RFA: EVOLVES study Multi-center prospective RCT 79 patients (80 limbs) Follow-up at 72 hrs, 1 week, 3 weeks, 4 months, 1 year, and 2 years Lurie F et al. J Vasc Surg, Lurie F et al. Eur J Vasc Endovasc Surg, 2005

20 RFA vs S&L: EVOLVES Endpoints QOL score at each timepoint(civiq2 questionnaire) Time to return to work Time to return to regular activity Adverse sequelae

21 RFA vs S&L: EVOLVES Time to return to work RFA: 4.7 days (95% CI ) S&L: 12.4 days (95% CI ) Time to return to normal activity RFA: <1 day in 80.5% S&L: <1 day in 46.9% p<0.01

22 CIVIQ2 RFA vs S&L: EVOLVES

23 RFA vs S&L: EVOLVES QOL scores (higher score -> decreased QoL) Lurie F et al. J Vasc Surg, Lurie F et al. Eur J Vasc Endovasc Surg, 2005

24 RFA vs S&L: EVOLVES Prevalence of recurrence (p>0.05) Lurie F et al. J Vasc Surg, Lurie F et al. Eur J Vasc Endovasc Surg, 2005

25 Treatment: Saphenous Adverse sequelae hypertension Lurie F et al. J Vasc Surg, Lurie F et al. Eur J Vasc Endovasc Surg, 2005

26 Treatment: Saphenous hypertension Cost analysis: Rautio, 2002 S&L RFA Fixed cost (RFA generator) $0.00 $18.90 Variable cost (OR costs) $ $ Indirect cost (lost working days) $1, $ Total $1, $1, Rautio T, et al. J Vasc Surg, 2002.

27 Treatment: Saphenous hypertension Nerve injuries Great saphenous vein: saphenous nerve Decreased injury with groin-to-knee treatment No evidence for difference between S&L and endoablation techniques: 0-8.5% in RFA, 6-13% in PIN Small saphenous vein: sural nerve Sam RC et al. Eur J Vasc Endovasc Surg

28 Treatment: Saphenous hypertension What about laser ablation? Min, 2002 Prospective consecutive-enrollment series at single center 499 GSVs in 423 patients, followed for 2 years 3 months: 99.3% (444/447) 1 year: 97.5% (310/318) 2 years: 93.4% (113/121)

29 Treatment: Saphenous hypertension Laser ablation vs RFA? Almeda et al, Almeda JI and Raines JK, Ann Vasc Surg, 2006

30 Treatment: Interventional Objectives Treat saphenous vein hypertension hydrostatic forces of saphenous vein reflux hydrodynamic forces of perforator vein reflux Remove varicose clusters

31 Treatment: Varicose clusters Surgical Ambulatory phlebectomy Powered phlebectomy (Trivex) Non-surgical sclerotherapy

32 Treatment: Varicose clusters Ambulatory phlebectomy

33 Treatment: Varicose clusters Powered phlebectomy

34 Treatment: Varicose clusters Treatment: Varicose clusters Non-surgical: sclerotherapy

35 Treatment: phlebectomy vs sclerotherapy De Roos KP, et al Prospective RCT Sclerotherapy with polidocanol (N=49 legs) vs ambulatory phlebectomy (N=49 legs) End points: recurrence at 1 and 2 yrs, complications

36 Treatment: phlebectomy vs sclerotherapy phlebectomy sclero p value recurrence 2.10% 37.50% <0.001 blister 31% 0% <0.001 bandage 19% 4% 0.02 phlebitis 12% 27% 0.07 scar 17% 0% <0.001

37 Treatment: sclerotherapy Myers et al Prospective series with previously untreated varicose veins: 677 legs, 489 pts Primary and secondary success rates at 3 years Meyers KA, et al. Eur J Vasc Endovasc Surg, 2007.

38 Treatment: sclerotherapy Primary success: 52.4% (95%CI 46-58%) Secondary success: 76.8% (95%CI 71-82%) Meyers KA, et al. Eur J Vasc Endovasc Surg, 2007.

39 Treatment: sclerotherapy Primary success rates by vein type: 83.4% in tributaries (95%CI 69-91%) Meyers KA, et al. Eur J Vasc Endovasc Surg, 2007.

40 Summary Endovascular ablation vs S&L RFA superior to S&L in return to work, return to normal activity, QoL, complications, and overall cost Laser ablation may be superior to RFA in primary closure rates

41 Summary Sclerotherapy vs ambulatory phlebectomy Higher primary recurrence rates with sclerotherapy BUT good long-term success with repeat therapy, less invasive, fewer complications, easily performed as outpatient procedure

42 References Rautio T 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. 35: Lurie F 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. 38: Lurie F et al. Prospective randomized study of endovenous radiofrequency obliteration (Closure) versus ligation and vein stripping (EVOLVeS): Two year followup Eur J Vasc Endovasc Surg. 29:67-73 Aleida JI and Raines JK. Radiofrequency ablation and laser ablation in the treatment of varicose veins Ann Vasc Surg 20: De Roos KP et al. Ambulatory phlebectomy versus compression sclerotherapy: Results of a randomized controlled trial Derm Surg. 293): Meyers KA et al. Outcome of ultrasound-guided sclerotherapy for varicose veins: medium-term results assessed by ultrasound surveillance Eur J Endovasc Vasc Surg. 33: Sam RC et al. Nerve injuries and varicose vein surgery Eur J Vasc Endovasc Surg 27: Min RJ et al. Endovenous laser treatment of saphenous vein reflux: long-term results J Vasc Interv Radiol 14:

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