Is there any evidence that endovenous laser therapy or ......EVRF F-Care. Munich Vascular Conference Venous Symposium, 9.12.2017. Segmental Radiofrequency Ablation. Closure. FAST Procedure

Munich Vascular Conference

Venous Symposium, 9.12.2017

Is there any evidence that endovenous laser therapy

or radiofrequency or foam sclerotherapy

is superior to each other ?

Department for Vascular Surgery

Diakonie-Klinikum, Schwäbisch Hall, Germany

C.-G. Schmedt



Disclosure

I have the following potential conflicts of interest

to report:

Receipt of grants/research support

Receipt of honoraria and travel support

Participation in a company sponsored

speakers‘ bureau

Employment in industry

Shareholder in a healthcare company

Owner of a healthcare company

I do not have any potential conflict of interest

Which is the best treatment for my patient ?

David L Sackett (1996) BMJ 312:71-72

„Evidence based medicine is

no cookbook medicine ...

... integrates the best external evidence with

individual clinical experience and

patients´ choice ... “



2013



Bountouroglou (2006)

Hamel-Desnos (2007)

Abela (2008)

Rabe (2008)

Gonzalez-Zeh (2008)

3 m

24 m

0,5 m

3 m

12 m

13 %

31 %

k.A.

31% (4%-61%)

23%

Author Follow-up

Recurrent

reflux in GSV

Randomized Controlled Trials (RCT, 1b)

Patients

n= 30

n= 74

n= 30

n=106

n= 53

Foam sclerotherapy for GSV



Painscore

Usual activity

Return to work

Reflux [12 Mo.]

LaserRFA (CLF) Foam Stripping

2.58

2 d

3.6 d

5.8 %

1.21

1 d

2.9 d

4.8%

Rasmussen LH et al. (2011)

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. Evidence level: 1b

1.60

1 d

2.9 d

16.3%

2.25

4 d

4.3 d

4.8%



Recanalisation [5 Y]

Rec. varicose veins

Re-treatment

Laser Foam Stripping

6.8%

38.6%

18.7%

5.8%

18.7%

17.0%

Lawaetz M, Serup J, Lawaetz B, Bjoern L, Blemings B, Eklof B, Rasmussen L (2017)

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; 36:281-288. Evidence level: 1b

31.5%

31.7%

37.7%

6.3%

34.6%

23.4%

RFA (CLF)



Occlusion [1Y]

Reflux below knee [1Y]

Sick leave

Haematoma [1mo]

Pigmentation [1mo]

Laser Foam Stripping

97%

16%

8d

42%

4%

51%

33%

1d

20%

67%

97%

13%

12d

62%

5%

Venermo M, Saarinen J, Eskelinen et al. (2016)

Randomized clinical trial comparing surgery, endovenous laser ablation and ultrasound-guided

foam sclerotherapy for the treatment of great saphenous varicose veins.




Venermo M, Saarinen J, Eskelinen et al. (2016)

Randomized clinical trial comparing surgery, endovenous laser ablation and ultrasound-guided

foam sclerotherapy for the treatment of great saphenous varicose veins.


Disease-specific quality of life (AVVSS)





Evidence level: 1b

Shepherd AC et al. (2010)

Randomized clinical trial of VNUS Closure FAST radiofrequency ablation versus laser for varicose veins.

Br J Surg 2010; 97: 810-818. Evidence level 1b

Pain level 3d

Pain level 10d

Analgesics 10d

26.4

22.0

20.4

36.8

34.3

35.9

0.010

0.001

0.001

ClosureFAST

n= 67

ELT (980nm, bare)

n= 64 p-value



Almeida JI, Kaufmann J, Göckeritz O, Chopra P, Evans MT, Hoheim DF, Makhoul RG, Richards T, Wenzel C,

Raines JK (2009) Radiofrequency Endovenous ClosureFAST 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. Evidence level: 1b

ClosureFAST

n= 46

ELT (980nm, bare)

n= 41

Ekchymosis

Phlebitis

Paresthesia

Erythema

Hyperpigmentation

15 (33,3%)

0

1 (2,2%)

0

1 (2,2%)

33 (81,5%)

6 (14,6)

2 (4,9%)

4 (9,8%)

0

p-value

< 0,0001

0,009

n.s.

0,045

n.s.



He G, Zheng C, Yu MA, Zhang H (2017)

Comparison of ultrasound-guided endovenous laser ablation and radiofrequency for the varicose

veins treatment: An updated meta-analysis.

International Journal of Surgery 2017; 39: 267-275. Evidence level: 1a





He G, Zheng C, Yu MA, Zhang H (2017)

Comparison of ultrasound-guided endovenous laser ablation and radiofrequency for the varicose

veins treatment: An updated meta-analysis.

International Journal of Surgery 2017; 39: 267-275. Evidence level: 1a

• Conclusion

EVLA and RFA seem to be the same in respect to safety and efficacy

(ablated length, 3days and 10days pain scores, 1 month, 1 year quality of life,

occlusion, thrombophlebitis, haematoma and recanalisation).

Paravastu SC, Horne M, Dodd PD.

Endovenous ablation therapy (laser or

radiofrequency) or foam sclerotherapy

versus conventional surgical repair for short

saphenous varicose veins.

Cochrane Database Syst Rev. 2016 Nov

29;11:CD010878.

Nesbitt C, Bedenis R, Bhattacharya V, Stansby G.

Endovenous ablation (radiofrequency and laser)

and foam sclerotherapy versus open

surgery for great saphenous vein varices.

Cochrane Database Syst Rev. 2014 Jul

30;(7):CD005624. doi:

10.1002/14651858.CD005624.pub3.



http://www.google.de/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&ved=0ahUKEwij_5SIp_jXAhUEDOwKHaEOCMEQjRwIBw&url=http://retractionwatch.com/2010/09/20/progressive-how-the-cochrane-library-handles-updates-in-progress/&psig=AOvVaw0r17PKbERrlMg6paolG427&ust=1512749947807292



Problems of endovenous literature

• Dubiously powered

• Heterogeneous endpoints

• Potential conflict of interest

• Short follow-up

• Incomplete outcome data

• Wide selection of treatment options

• New treatment protocols

Endovenous

Thermal Ablation

Endovenous

Non-thermal Ablation

• Foam sclerotherapy

• Mechano-chemical(MOCA, Clarivein)

• Glue (Cyanoacrylate)(CAVA, VenaSeal)

Treatment options of truncal vein insufficiency

• Radiofrequency(CLF, RFITT, EVRF)

• LASER(810-1940nm, Bare, Radial)

• Steam

• Crossectomy

• Stripping

• CHIVA

• ASVAL

• Valvuloplasty

Conventional

Open



Bare Fiber



Histology (HE) Optical Coherence Tomography

(OCT)

Schmedt CG, Meissner OA, Hunger K, Babaryka G, Ruppert V, Sadeghi-Azandaryani M, Steckmeier BM, Sroka R.

Evaluation of endovenous radiofrequency ablation and laser therapy with endoluminal optical coherence tomography in

an ex vivo model. J Vasc Surg 2007; 45: 1047-1058.

ELT with Bare Fiber - Perforations of vein wall



Radial Fiber



Higher absorption in water at long wavelengths



P=15W

LEED=150J/cm

Carbonisation

Perforation

P=6W

LEED=60J/cm

Circular thermal

alteration

P=3W

LEED=30J/cm

Circular thermal

alteration

Vacuolisation

Delamination

λ = 980nm / bare fibre λ = 1470nm λ = 1940nm

Sroka R et al.

Laser-Forschungslabor, LIFE-Center, LMU München

Experimental comparison ELT 980nm vs 1470nm vs 1940nm

1-4 weeks 6 months 1 year 2 years

Paresthesia 8.5% (15/177) 5.6% (9/160) 3.8% (5/129) 3.9% (5/127)

Thrombuspropagation (EHIT) 2.3% (4/177) 0% 0% 0%

Ecchymosis 2.3% (4/177) 0% 0% 0%

Lymphocele 0.6% (1/177) 0% 0% 0%

Pigmentation 0.6% (1/177) 1.3% (2/160) 0% 0%

Phlebitis 0% 0% 0% 0%

Recanalisation 0% 0% 0.8% (1/129) 1.6% (2/127)

Epifascial reflux (AASV) 0% 0% 0.8% (1/129) 2.4% (3/127)

ELT (Tm, 1940nm) n=177 (own data)

T3 W4 M6 J1 J2

Non-

occlusi

on

0.5 cm(0-3.4 cm)

0.6 cm(0-3.8 cm)

0.7 cm(0-2.0 cm)

0.7 cm(0-3.2 cm)

0.7 cm(0-4.0 cm)

DVTD(Deep

vein

thrombus

distance)

0.4 cm(0-2.7 cm)

0.4 cm(0-3.3 cm)

0.4 cm(0-2.0 cm)

0.5 cm(0-2.5 cm)

0.5 cm(0-3.5 cm)

DVTD

Non-

Occlusion

ELT (Tm, 1940nm) n=177 (own data)



Evidence level: 1b

Doganci S, Demirkiliz U (2010)

Eur J Vasc Endovasc Surg 40: 254-259 Evidence level: 1b



ELT (1470nm) Bare Fibern= 168

Radial Fiber

n= 144

Occlusion rate (3 Mo.)

Phlebitis

Paresthesia

Ecchymosis / Hematoma

No analgesics

Analgesics (Doses)

100%

1,8%

0%

83,9%

21,4%

103 mg

100%

2,1%

0%

63,9%

35,4%

82 mg

0,0001

0,04

p-Wert

Schwarz T, von Hodenberg E, Furtwängler C, Rastan A, Zeller T, Neumann FJ

Endovenous laser ablation of varicose veins with the 1470nm diode laser.

J Vasc Surg 2010 51:1474-1478. Evidence level: 2b.



Hirokawa M, Kurihara N (2014)

Comparison of Bare Tip and Radial Fiber in Endovenous Laser Ablation with 1470nm Diode Laser.

Ann Vasc Dis 2014; 239-245. Evidence level: 3b



Bozoglan O, Mese B, Eroglu E, Ekerbicer, Yasim A (2017)

Comparison of Endovenous Laser and Radiofrequency Ablation in treating varices in the same

patient.

Journal of Lasers in Medical Sciences 2017; 8:13-16. Evidence level: 2b



Evidence based Evaluation

• Safety

• Effectiveness

• Patients comfort

• Costs

FoamRFA

+

-

++

+

+

(+)

+

-

Laser

+

(+)

+

-

Stripping

+

+

-

(+)





• Reduced effectiveness of foam sclerotherapy

• No significant difference between RFA and Laser

• Heterogeneity of study designs

• Evidence level moderate-low

• Continuous technical development

• Laser: Long wave length and radial fiber

• More trials with well defined endpoints needed

Summary

Foam Sclerotherapy



Bipolar Radiofrequency Ablation

VNUS Closure PLUS Olympus Celon RFITT



Endovenous Radiofrequency Ablation

EVRF F-Care



Segmental Radiofrequency Ablation

Closure FAST Procedure



Bare Fibre980nm 20W 1mm/s

ELVeS Radial1470nm 6W 1mm/s

rigid – shrinkage

charring from blood

rigid – shrinkage

white coagulated tissue

Exp. approach clinical gain: comparable in rigidnes

Sroka R, Pongratz T, Siegrist K, Burgmeier C, Barth H.-D., Schmedt CG (2013)

Endoveous Laser Application: Stategies to improve energy application

Phlebologie 2013; 42: 117-176



Transversal „Donut“

after ELT (1940nm)

Longitudinal „Cookie“

after ELT (1940nm)

No stump after ELT (1940nm)

Sapheno-femorale junction longitudinal



Level Therapy / Prevention, Aetiology / Harm

1a Systematic Review of RCTs

1b Individual RCT

1c All or none

2a Systematic Review of cohort studies

2b Individual cohort study (including low quality RCT)

2c “Outcomes” Research; Ecological studies

3a Systematic Review of case-control studies

3b Individual Case-Control Study

4 Case-series

5 Expert opinion

Produced by Bob Phillips, Chris Ball, Dave Sackett, Doug Badenoch, Sharon Straus, Brian Haynes, Martin Dawes since November 1998. Updated by Jeremy Howick March 2009

Levels of Evidence (CEBM Oxford)

Documents

Is there any evidence that endovenous laser therapy or ......EVRF F-Care. Munich Vascular Conference Venous Symposium, 9.12.2017. Segmental Radiofrequency Ablation. Closure. FAST Procedure