Post on 02-Feb-2021
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
Munich Vascular Conference
Venous Symposium, 9.12.2017
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 ... “
Munich Vascular Conference
Venous Symposium, 9.12.2017
2013
Munich Vascular Conference
Venous Symposium, 9.12.2017
Munich Vascular Conference
Venous Symposium, 9.12.2017
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
Munich Vascular Conference
Venous Symposium, 9.12.2017
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%
Munich Vascular Conference
Venous Symposium, 9.12.2017
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)
Munich Vascular Conference
Venous Symposium, 9.12.2017
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.
Br J Surg 2016; 103:1438-1444. Evidence level: 1b
Munich Vascular Conference
Venous Symposium, 9.12.2017
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.
Br J Surg 2016; 103:1438-1444. Evidence level: 1b
Disease-specific quality of life (AVVSS)
Munich Vascular Conference
Venous Symposium, 9.12.2017
Munich Vascular Conference
Venous Symposium, 9.12.2017
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
Munich Vascular Conference
Venous Symposium, 9.12.2017
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.
Munich Vascular Conference
Venous Symposium, 9.12.2017
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
Munich Vascular Conference
Venous Symposium, 9.12.2017
Munich Vascular Conference
Venous Symposium, 9.12.2017
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.
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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
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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
Munich Vascular Conference
Venous Symposium, 9.12.2017
Bare Fiber
Munich Vascular Conference
Venous Symposium, 9.12.2017
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
Munich Vascular Conference
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Radial Fiber
Munich Vascular Conference
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Higher absorption in water at long wavelengths
Munich Vascular Conference
Venous Symposium, 9.12.2017
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)
Munich Vascular Conference
Venous Symposium, 9.12.2017
Evidence level: 1b
Doganci S, Demirkiliz U (2010)
Eur J Vasc Endovasc Surg 40: 254-259 Evidence level: 1b
Munich Vascular Conference
Venous Symposium, 9.12.2017
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.
Munich Vascular Conference
Venous Symposium, 9.12.2017
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
Munich Vascular Conference
Venous Symposium, 9.12.2017
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
Munich Vascular Conference
Venous Symposium, 9.12.2017
Evidence based Evaluation
• Safety
• Effectiveness
• Patients comfort
• Costs
FoamRFA
+
-
++
+
+
(+)
+
-
Laser
+
(+)
+
-
Stripping
+
+
-
(+)
Munich Vascular Conference
Venous Symposium, 9.12.2017
Munich Vascular Conference
Venous Symposium, 9.12.2017
• 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
Munich Vascular Conference
Venous Symposium, 9.12.2017
Bipolar Radiofrequency Ablation
VNUS Closure PLUS Olympus Celon RFITT
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Endovenous Radiofrequency Ablation
EVRF F-Care
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Segmental Radiofrequency Ablation
Closure FAST Procedure
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Venous Symposium, 9.12.2017
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
Munich Vascular Conference
Venous Symposium, 9.12.2017
Transversal „Donut“
after ELT (1940nm)
Longitudinal „Cookie“
after ELT (1940nm)
No stump after ELT (1940nm)
Sapheno-femorale junction longitudinal
Munich Vascular Conference
Venous Symposium, 9.12.2017
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)