LEVEL 2 Trial - Endovenous Laser Therapy (EVLT) with long ...€¦ · Laser 1940nm. Laser 1470nm. RFA ClosureFAST. Study period: 23. June 2017 – 22. June 2018. Laser 1940nm. 8th

LEVEL 2 Trial - Endovenous Laser Therapy (EVLT)with long wavelength (1940nm) and reduced energy density

1 Department for Vascular Surgery, Diakonie-Klinikum, Schwäbisch Hall2 Laser Research Laboratory, LIFE Center, Ludwig-Maximilians-University, Munich3 Department for Vascular and Endovascular Surgery, Goethe University, Frankfurt am Main

C.-G. Schmedt1, S. Dikic1, A. Beisswenger1, A. Setia1, F. Comsa1

R. Sroka2, T. Schmitz-Rixen3

8th Munich Vascular Conference 201806-08 December 2018, Klinikum rechts der Isar, Munich

Disclosures

I have the following potential conflicts of interest to report: Receipt of grants/research support (StarMedTec) Receipt of honoraria and travel support

(Biolitec, Medtronic, Covidien, VNUS Technologies) Participation in a company sponsored speakers‘ bureau Employment in industry Shareholder in a healthcare company (iMS) Owner of a healthcare company

I do not have any potential conflict of interest


Longer wavelength Increased absorption in waterReduced optical penetration



Laser wavelength /nm

Abso

rptio

n (b

lue)

/ %

Fibe

r-Tr

ansm

issi

on (r

ed) /

%

4-times

P=15WLEED=150J/cmCarbonisation

Perforation

P=6WLEED=60J/cm

Circularthermal

alteration

P=3WLEED=30J/cm

Circularthermal

alterationDelaminationVacuolisation

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

Sroka R et al. (2013)Laser Research Laboratory, LIFE-Center, Ludwig-Maximilians-University Munich

Experimental Comparison 980nm vs 1470nm vs 1940nm


Wavelength:

Fiber type:

Power:

Pullback:

LEED:

1940nm

Radial Fiber

4-9 Watt

Continous 1mm/s

40-90 Joule/cm

Schmedt CG, Esipova A, Dikic S, Demhasaj S, Comsa F, Sroka R (2015)First clinical results of endovenous laser therapy (ELT) for the occlusion of incompetent saphenous veins usingTm-laser (1940nm) and radial light application. (Oral presentation).Charing Cross International Symposium 2015, London, Abstract Book p114

Long Wave Endvenous Laser AblationLEVEL 1 Trial

Schmedt CG, Esipova A, Dikic S, Setia A, Demhasaj S, Dieckmann T, Tipi MM, Sroka R (2016)Endovenous laser therapy (ELT) of saphenous vein reflux using thulium laser (Tm, 1940nm) with radial fiber –One year results.Eur J Vasc Endovasc Surg 2016: 52:413-414.


Wavelength:

Fiber type:

Power:

Pullback:

LEED:

Recruitment:

Procedures:

LEVEL 1

1940 nm

Radial

4-9 Watt

Continuous 1mm/s

40-90 Joule/cm

6/2013 – 1/2015

n=177

LEVEL 2

1940 nm

Radial

2-4 Watt

Continuous 1mm/s

20-40 Joule/cm

6/2017 – 6/2018

n=125

LEVEL 2 Trial with reduced LEED


LEVEL 2 – Treatment protocol

Radial fiber 600μm / 400μm

Thulium Laser 1940nm Power 2-4 Watt

Central position of fiber tip


Continuous pullback 1mm/s

Postoperative evaluation


Follow-up protocol

D3 M6 Y1 Y2 Yx

3 days 6 months 1 year 2 years long term


• Thrombus propagation (EHIT)

• Dysesthesia

• Ecchymosis

• Analgesic doses [n]

• Pain score (NAS 0-10)

• Return to work [d]

Safety / Pain

• Stump length

• Vein diameter

• rVCSS

• CEAP

• REVAS

Effectiveness


LEVEL 2 Trial (1940nm, Radial, LEED 20-40 J/cm)

- Endpoints -


70

125

33

47

Treatment of truncal vein insufficiencyin our Department

Crossectomy /StrippingLaser 1940nm

Laser 1470nm

RFAClosureFAST

Study period: 23. June 2017 – 22. June 2018

Laser 1940nm


• Procedures• Patients• Age• CEAP C2• CEAP C3• CEAP C4• CEAP C5• CEAP C6• Diameter GSV• Diameter SSV

n=125n=10556 years (24-82)14 %60 %21 %3 %1 %7.2mm (3.7-12.9)5.7mm (2.4-10.8)


- Patients -


Day 1.-3. D3

6 monthsM6

1 yearY1

2 yearsY2

Follow-up

100%(125/125)

69,5%(57/82)

LEVEL 2 Trial (1940nm, Radial, LEED 20-40J/cm)

- Follow up -


Level 2 Trial(LEED 20-40J/cm)

Level 1 Trial(LEED 40-90J/cm)

T3 M6 T3 M6

Non-occlusion

6.4mm(0-28mm)

11.1mm(0-50mm)

5.0 mm(0-34 mm)

7.0mm(0-20mm)

DVTD(Deep vein thrombus distance)

4.1mm(0-17mm)

6.6mm(0-23mm)

4.1mm(0-27mm)

4.0mm(0-20mm)

DVTD

Non-Occlusion

Effectiveness – Stump length

P2

P1

GSV and SSV


Preop. D3 M6

D2 6.9mm 6.0mm 4.9mm

D3 5.6mm 4.7mm 3.3mm

Effectiveness – Vein diameterGSV and SSV


D3 M6

Occlusion 100% 98,2% (56/57)

Recanalisation with reflux 0% 1,8% (1/57)

Reflux in AASV 0% 0%


- Effectiveness -


Effectiveness – CEAP (C-Clinical)

0,0

10,0

20,0

30,0

40,0

50,0

60,0

70,0

Preop. 6 months

C1C2C3C4C5C6

%


Effectiveness – rVCSS Score

Preop. 6 months 1 year 2 years

Level 2 6(3-12)

2(0-14)

Level 1 6(2-21)

1(0-6)

2(0-10)

1(0-10)


Day 1-3D3

6 monthsM6

Dysesthesia 1.6% (2/125) 1.8% (1/57)

Thrombus propagation (EHIT) 1.6% (2/125) 0%

Ecchymosis 3.2% (4/125) 0%

Lymphocele 0% 0%

Pigmentation 0% 0%

Phlebitis 0% 0%


- Safety -


• Pain (NAS >0)

• Pain score (NAS 1-10)

• Taking analgesics

• Analgesic doses [n]

• Return to work [d]

Level 1 Trial

34.1% (60/176)

1 (1-4)

64.2% (113/176)

1 (1-10)

8 (0-28)

Results – Pain

Level 2 Trial

12,8% (16/125)

1 (1-4)

52.8% (66/125)

1 (1-3)

2 (1-30)


Author

Schmedt

Mendes-Pinto

Schmedt

Viarengo

de Araujo

Park

Schreiner

Schmedt

Wavelength

1940nm

1920nm

1940nm

1940nm

1940nm

1940nm

1940nm

1940nm

EVLT with long wavelength (1940nm) - Review

Year

2015

2016

2016

2017

2018

2018

2018

2018

Procedures

n= 72

n= 48

n=177

n= 41

n= 20

n=160

n=100

n=302

Level of evidence

III

IIa

III

III

IV

III

III

IIb

Fiber type

Radial

Radial

Radial

Radial

Radial

Bare

Radial

Radial


EVLT with 1940nm, Radial, LEED 20-40 J/cm

• Effective

• Safe

• High patient comfort

• Reduced Laser power

• Further follow up

• More clinical trials


• Long wavelength (1940nm)

• Reduced Power/LEED

• Reduced amount of tumescent fluid

• Radial fibers, Diffuser fibers

• Standardisation of treatment protocol

• Slow continuous pullback (1mm/s)

• Short stumps („Laser Crossectomy“)

The future of Endovenous Laser Therapy (EVLT)


Documents

LEVEL 2 Trial - Endovenous Laser Therapy (EVLT) with long ...€¦ · Laser 1940nm. Laser 1470nm. RFA ClosureFAST. Study period: 23. June 2017 – 22. June 2018. Laser 1940nm. 8th