Endovenous or surgical treatment of cvi

1. Endovenous or Surgical
Treatment of CVI
Professor Alun H Davies
Academic Section of Vascular Surgery,
Imperial College,
Charing Cross & St Mary’s Hospital,
London

2. Whom is best the:-
CUTTER
FRYER/FREEZER
STICKER

3. Evidence!

4. Changes in the management of varicose
veins in the US
Year Surgery RFA Laser Total
Procedures
Number of
procedures
% Number of
procedure
% Number of
procedures
%
2002 152,520 93% 9,840 6% 1,640 1% 164,000
2003 150,000 81% 12,000 6% 25,000 13% 187,000
2004 148,000 60% 42,000 16% 55,000 22% 245,000
2005 140,000 43% 60,000 18% 120,000 37% 320,000
2006 110,000 29% 80,000 21% 180,000 49% 370,000
2007 70,000 16% 95,000 22% 260,000 61% 425,000
2008 25,000 5% 130,000 26% 340,000* 69% 495,000
10% of population

5. Results

6. Systematic Review
• Ablation in 87.9-100%
• Re-treatment 1.8-3%
• DVT 1 in 1289 patients 0.08%
• Poor long-term follow up
Mundy et al, 2005
n=1289

7. Non-occlusive uncertainties
• Stripping operation requires demonstration
of sapheno-femoral junction and
disconnection
• Endovenous procedures
– Occlusion rate of 88-100% after EVLT1
– Open sapheno-femoral junction after RFO in
88%2
– Recanalisation rates of 12%3
( EVLT) to 25% at
3 years4
(RFO) 1
Proebstle et al. 2003,2006
2
Pichot et al. 2004
3
Merchant et al. 2002
4
Nicolini et al.2005

8. Surgery vs Ablation
Surgery Ablation
Bruising +++ ++ *
Paraesthesia +++ +++
DVT Same Same
Thrombophlebitis +++
Groin recurrence Same Same
Pain/work +++ + *****
Q o Life Good Good
Cost £££ ££££
Davies et al, 2007

10. 2010

11. Early benefit for EVLA
2011

12. Despite the EVLA group having
secondary visits for foam, overall
satisfaction rates were similar
2007

13. Concomitant Phlebectomy
?

15. Laser vs Radiofrequency
?

16. Laser vs Radiofrequency
• VNUS fast – no time difference
• RF– more expensive
• RF ? Less pain
• RF fixed energy delivery
• Laser varying wavelength, power etc
• Regulations on laser usage
vs

17. Pain Unilateral & Bilateral
BLARA& ULARA
Pain Scores
0
1
2
3
4
5
6
7
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Time (Days)
VASScore
EVLA (B)
RFA (B)
EVLA (U)
RFA (U)
• In unilateral group no statistical significant difference
Goode & Braithwaite, 2008

18. RECOVERY Trial – Conclusions
• 100% Vein occlusion in both RF and laser groups
• Procedure times were similar between RF and laser
• Compared to laser, RF treatment with ClosureFAST produced
significantly
– Less pain p < 0.0001
– Less tenderness p = 0.008
– Less bruising p < 0.0001
– Fewer adverse events p = 0.021

19. VALVV trial early outcomes
• RFA less painful than EVLA
• Patients took significantly more analgesia following EVLA
• Both groups experienced similar improvements in QOL and VCSS at
6 weeks
• No difference in complications

20. VALVV trial 6 month outcomes
• No difference observed between clinical and QoL
outcomes at 6 months between RFA and EVLA
• Poor correlation between duplex findings and functional
outcomes
• More treatment failure in the RFA group at 6 months
compared to EVLA (ns)

21. But Laser Changes & Steam
Steam Technique
The third technique is still
considered investigational, and
involves a very old technology —
steam. With this approach a
catheter is placed in the vein, and
the vein is "cooked" by injecting
hot steam into the catheter

23. 2010

25. 86% of patients were satisfied or very satisfied with their
treatment.
Patients undergoing treatment for primary veins were more
likely to be satisfied than those undergoing treatment for
recurrent varicose veins
(92% vs 75% respectively p=0.027 Fishers exact test)
85% of patients would be prepared to undergo the same
treatment again if necessary 2010

26. Patient preference for local or general
anaesthesia during laser ablation
• Single centre study, 290 patients undergoing EVLA of saphenous veins with
concomitant avulsion of varicosities
• Following informed consent patients chose either general (GA) or local anaesthesia
(LA) with tumescence
• 56% chose LA, 44% chose GA
• Patients undergoing unilateral treatment were more likely to prefer LA than those
undergoing bilateral intervention (63% vs 36%, p<0.01)
• 24% of those who chose LA said they would prefer GA if they required a second
treatment, mostly due to anxiety and pain. ie 57% prefer GA
• Sridar P et al. International Angiology, August 2009. 28; 4, suppl 1 pp 6.

29. Sclerotherapy and foam sclerotherapy for
varicose veins.
• RCTs limited
• Foam better than liquid
• 3% polidocanol foam is no more effective than 1%
• optimum ratio of gas to liquid is 4:1
• carbon dioxide foam reduces the systemic
complications
• The relative advantages or disadvantages of this
treatment in the longer term have yet to be
published.
Coleridge Smith 2009

30. • Filtering
• Occluding junction
• CO2
• Leg elevation before
• Leg elevation after
• Immobilization after the procedure
2011BUT – volume / time interval

31. Darvall et al, 2009
Changes in health-related quality of life
after ultrasound-guided foam sclerotherapy
for great and small saphenous varicose veins
Medium-term results of ultrasound-guided
foam sclerotherapy for small saphenous
varicose
Darvall et al, 2010
Recovery after ultrasound-guided foam
sclerotherapy compared with conventional
surgery for varicose veins
Darvall et al, 2009

32. Surgery vs UGFS: an RCT
• 29 surgery and 27 by UGFS
• 180 days after treatment, ocllusion in 78%
of the surgery group, compared with 90% in
the foam sclerotherapy group
• UGFS effective
Figueiredo et al, 2009

33. Is foam safe?
• 9 case reports (11 patients)
6 CVAs 1 TIA
• 17 series (8888 patients)
1 CVA 1 TIA
Sarvananthan, et al 2011

34. 2011

35. OUTCOMES

37. Clarivein

41. Time and cost issues
• Cost of endovenous procedures higher
than stripping
– Equipment cost (RF ablator, LASER
probe)
– Ultrasound (equipment and expertise)
– Follow up outpatient appointment for
ultrasound and sclerotherapy1
• Endovenous procedures take more time
even in experienced hands2
1
Mundy et al. 2005
2
Rautio et al. 2002
But depends on what and how you do it with adjuvant procedures
Davies 2007

42. 2010

43. 2010

44. Excluded
Not meeting inclusion criteria
Fulfil exclusion criteria
Refusal to participate
Assessed for eligibility
reflux >1 second on ultrasound
Consented; Baseline assessment; Randomised
Stratum 1 - Conventional surgery vs Foam sclerotherapy vs EVLA
Stratum 2 - Conventional surgery vs Foam sclerotherapy
Foam
sclerotherapy
Adults age 18+ with symptomatic primary varicose veins with long or short saphenous main
stem incompetence. Referred to the surgical out-patient department.
EVLA with
foam sclerotherapy
Conventional
surgery
6 week
assessment
Foam sclerotherapy to
residual varicosities
Foam sclerotherapy
to residual varicosities
6 week
assessment
6 week assessment
6 month
assessment
6 month
assessment
6 month assessment
CLASS
TRIAL
BUT !

45. Quality of life
• Major improvement following
truncal intervention.
Smith et al, 1999,2002
Mackenzie et al,2002
Rasmussen et al 2007,2010
Shepherd et al, 2010

46. Treatment options
Surgery
Sclerotherapy
Laser
Radiofrequency

48. http://www.rsm.ac.uk/academ/downloads/venous_referral_guidelines_jan11.pdf
The Care of Patients with Varicose Veins
and Associated Chronic Venous Diseases

49. The Department of Health has asked NICE:
To produce a clinical guideline on
‘the management of varicose veins’
Publication date 2013

50. Twenty nine RCT’s (32 articles) on radiofrequency
ablation(RFA), endovenous laser ablation (EVLA) and
chemical ablation (CA) have been identified
Conventional open Surgery (OS) vs RFA (n = 7)
Conventional open Surgery (OS) vs EVLA (n = 10)
Conventional open Surgery (OS) vs CA (n = 6)
EVLA vs. RFA (n = 5)
OS vs. Thermal vs. Chemical ablation (n =1)
Summation Data from M Perrin and Bo Eklof

51. Summary results on OS versus
RFA
- Almost all RCT’s conclude that after radiofrequency
ablation there was less postoperative pain, faster
recovery and earlier return to work and normal activities,
as well as higher patient satisfaction.
- The longest follow-up is 3 years and there is no
difference in terms of clinical result between classical
surgery and radiofrequency ablation.

52. Summary results on OS versus
EVLA
- All RCT’s except two used 980 nm bare tipped fibers.
Observation time was < 1 year in 7 studies and >1 year in 4
studies.
Quality of safety and early efficacy was high with no real
difference between the groups.
- After two years no significant difference was found in
clinical or DUS recurrence, clinical severity or QOL.

53. No Difference!!
Surgery
Sclerotherapy
Laser
Radiofrequency
=

55. Other studies
n=404 80% Primary success with EVLT
Myers et al,2006
n=145 31% Recurrent/residual vein
Sharif et al,2006
n=150 82% vein occlusion with RF
Welch et al,2006
n=145 22% re-canalization after RFA plus SFJ ligation
Salles-Cunha et al,2006

56. Systematic Review:- Complications
• Ecchymosis 23-100%
• Paraesthesia 1-36.5%
• Induration 55-100%
• Phlebitis 1.6-12%
Mundy et al, 2005
n=1289

57. Medium-term results of ultrasound-guided foam
sclerotherapy for small saphenous varicose veins
UGFS was an effective treatment for
SSV, in 92 legs with abolition of reflux
in 91% and 93% of visible varicose
veins, and improvement in HRQL for at
least 12 months.
Darvall et al, 2009

58. Changes in health-related quality of life after
ultrasound-guided foam sclerotherapy for great
and small saphenous varicose veins.
• n= 296 66% C2-3
• Improvement in SF12 and AVVQ
Darvall et al, 2010

59. Recovery after ultrasound-guided foam
sclerotherapy compared with conventional
surgery for varicose veins.
UGFS 332 (84.9 per cent) of 391
Surgery 53 (56 per cent) of 94
UGFS was associated with less pain and
analgesia requirement, time off work and
quicker return to driving
Darvall et al, 2009

60. • Short-term closure rate for foam (3 months) was 87% (26/30 patients)
Traditional
surgery group
Sclerotherapy
group
P
No of patients 30 30 -
Median time of returning to normal
activities
8 days 2 days <0.001
Aberdeen Vein Questionnaire (AVQ) score
at 3 months
↓40% ↓46% <0.001
Median Venous Clinical Severity Score
(VCSS) at 3 months
From 7 to 3 From 5 to 1 <0.001
Cost of procedure £1120.64 £672.97 -
Foam sclerotherapy and
crosectomy
Eur J Vasc Endovasc Surg 2006;31:93-100

61. Conventional open Surgery (OS) versus Endovenous laser
ablation EVLA # RCT’s 10, articles 11
Theivacumar NS. Neovascularization and recurrence 2 years after treatment for sapheno-femoral and
great saphenous reflux : a comparison of surgery and endovenous laser. Eur J Vasc Endovasc Surg
2009;38:203-207
Christenson JT. 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;52:1234-41
Rassmussen LH. Randomized 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;39:630-5
Pronk P. 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
Rass K. Comparable Effectiveness of Endovenous Laser Ablation and High Ligation With Stripping of
the Great Saphenous Vein Arch Dermatol online september19,.2011 doi:10.1001/archdermatol.2011.27

62. Conventional open Surgery (OS) versus
Radiofrequency ablation (RFA) # 7 RCT’s, 9 articles
Rautio T. Endovenous obliteration versus conventional stripping operating in the treatment of primary
varicose veins : a randomized controlled trial with comparison of the costs. J Vasc Surg 2002;35:958-65
Lurie F. Prospective randomized study of endovenous radiofrequency Obliteration (Closure procedure)
vs ligation and stripping in a selected patient population (EVOLVES Study) J Vasc Surg 2003;38:207-14
Lurie F. Prospective randomized study of endovenous radiofrequency obliteration (Closure) versus
ligation and vein stripping (EVOLVeS) Two-year follow-up. Eur J Vasc Endovasc Surg 2005;29:67-73
Perala J. Radiofrequency endovenous obliteration vs stripping of the long saphenous vein in the
management of primary varicose veins:3-year outcome of a randomized study. Ann Vasc Surg
2005;19:1-4
Hinchliffe RJ. A prospective randomized controlled trial of VNUS Closure versus surgery for the
treatment of recurrent long saphenous varicose veins. Eur J Vasc Endovasc Surg 2006;31:212-8
Kianifard B. Radiofrequency ablation (VNUS Closure) does not cause neo-vascularisation at the groin
at one year : results of a case controlled study.Surgeon 2006;4:71-74
Stötter L. Comparative outcomes of radiofrequency endoluminal ablation, invagination
stripping and cryostripping in the treatment of great saphenous vein. Phlebology 2006;21:60-4
Subramonia S. Radiofrequency ablation versus conventional surgery for varicose veins-a comparison of
treatment costs in a randomized trials. Eur J Vasc Endovasc Surg 2009;39:104-11
Elkaffas KH. Great saphenous vein radiofrequency ablation versus standard stripping in the management
of primary varicose veins- a randomized clinical trial. Angiology 2010;62:49-54

63. Conventional open Surgery (OS) versus Endovenous laser
ablation EVLA # RCT’s 10, articles 11
de Medeiros CAF. 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;31:1685-94
Vuylstecke M. Endovenous laser obliteration for the treatment of primary varicose veins.
Phlebology 2006;21:80-87
Ying L. A random, comparative study on endovenous laser therapy and saphenous veins stripping for
the treatment of great saphenous vein incompetence. Zhonghua-Yi-Xue-Za-Zhi 2007;87(43):3043-3046.
Rassmussen LH. Randomized trial comparing endovenous laser ablation of the great saphenous vein
with ligation and stripping in patients with varicose veins : short-term results J Vasc Surg 2007;46:308
15
Darwood RJ. Randomized Clinical trial comparing endovenous laser ablation with surgery for the
treatment of primary great saphenous veins. Br J Sug 2008;95:294-301
Kalteis M. 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;47:822-9

64. Conventional Open Surgery (OS) versus
Chemical Ablation (CA) # 6
Bountouroglou DG. 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
Wright D. 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;21:180-90.
Abela R. Reverse foam sclerotherapy of the great saphenous vein with sapheno-femoral ligation
compared to standardand invagination stripping: a prospective clinical series.
Eur J Vasc Endovasc Surg. 2008;36:485-90
Figueiredo M. Results of surgical treatment compared with ultrasound guided foam sclerotherapy
inpatients with varicose veins: a prospective randomised study.
Eur J Vasc Endovasc Surg 2009;38:758-63
Liu X. Ultrasound-guided foam sclerotherayof the great saphenous vein with-saphenofemoral
junction ligation compared to standard stripping: a prospective clinical study. International
Angiology 2011;30:321
Kalodiki E. Long Term Results of a Randomized Controlled Trial on Ultrasound Guided Foam
Sclerotherapy Combined with sapheno-femoral Ligation versus standard Surgery for Varicose
Veins. JVS 2011;accepted for publication

65. EVLA versus RFA # 5
Almeida JI. Radiofrequency Endovenous Closure FAST® versus Laser Ablation for the Treatment of
Great Saphenous Reflux : A Multicenter, Single-blinded, Randomized Study (RECOVERY Study).
J Vasc Interv Radiol 2009;20:752-759
Shepherd AC. Randomized clinical trial of VNUS Closure FAST radiofrequency ablation versus laser
for varicose veins. Br J Surg 2010;97;810-8
Gale SS. 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;52:645-50
Goode SD. Laser and Radiofrequency ablation Sudy : a randomized Study comparing
Radiofrequency Ablation and Endovenous Laser Ablation ( 810 nm). Eur J Vasc Endovasc Surg
2010;40:246-53
Nordon IM. EVVERT comparing laser and radiofrequency: An update on endovenous treatment
options. In Greenhalgh R, editor. BIBA publishing, UK. 2011:381-388