Endovenous thermal ablation for varicose vein

Joint Hospital Surgical Grand Round16-4-2011

Wong Kwok Kei, Kwong Wah Hospital

Endovenous great saphaneous vein thermal ablation

• Laser• Radiofrequency

Potential advantages of Endovenous thermal treatment

• “Minimally invasive”• LA, day case• Earlier return to normal activities

Limitation of Endovenous thermal treatment

• Not for vein >12mm diameter (?result inferior to surgery)

• Too tortuous• Patient not ambulatory• pacemaker, internal defibrillator, active

implanted device for RFA• EVLT & RFA mainly for GSV

– ? Perforator

Endovenous thermal Treatment

Endovenous thermal therapy

Thrombosis

Organization of thrombus

Recanalization Fibrous cord

Endovenous laser therapy (EVLT)

• A laser is a device that emits light (electromagnetic radiation) through a process called stimulated emission

Endovenous Laser Therapy: mechanism

Direct thermal: → carbonization of vein wall

on direct contact → vein wall destruction → thrombosis → fibrosis

Indirect thermal:→ absorbed by Hb / water in blood (chromophore) → steam bubbles

→ vein wall destruction → thrombosis → fibrosis

Radiofrequency Ablation(RFA)

• Bipolar radiofrequency current

• Resistive heating – transmural death → thrombosis → fibrosis

Endovenous thermal ablation Procedure

Bola Pratt P&S MS 4

GSV entered at the knee under USG guidanceLongitudinal US visualization of sheath 1-2 cm distally to the SFJ

Tumescent anesthesia Pull back of laser/ RFA fibreNeed phlebectomy/ sclerotherapy for

thigh and calf varicosities

Early technical successEVLT- duplex findings < 6 months

Study end point

Early technical successRFA - duplex findings < 6 months

Study end point

GSV thermal ablationlong term results

Study end point

Endovenous therapies of lower extremity varicosities: A meta-analysisRenate van den Bos, MD,a Lidia Arends, PhD,b,c Michael Kockaert, MD,a

Martino Neumann, MD, PhD,a and Tamar Nijsten, MD, PhD,a Rotterdam, The Netherlands(J Vasc Surg 2009;49:230-9.)

RCT RFA vs surgeryPerälä J, Rautio T, Biancari F et al

Lurie F, Creton D, Eklöf B, et al

Stötter L, Schaaf I, Bockelbrink A, et al

Hinchcliff RJ, Ubhi J, Beech A, et al

Number of patient

28 85 20 16 (bil recurrent VV after HL)

Follow up 3 years 2 years 1 year 1 year

Less pain RFA RFA RFA RFA

Less minor complication eg. Bruise, edema

RFA RFA RFA

Better QOL RFA

Faster recovery RFA 6.5 days; HL/S 15.6 days

RFA RFA

Total societal costs

RFA $1401; HL/S $1926

Operative time RFA 25mins, HL/S 40mins

RCT EVLT vs surgeryDe Medeiros CAF, Luccas GC

Vuysteke M, Bussche DVd, Audenaert EA et al.

Rasmussen LH, Bjoern L, Lawaetz M, et al

Ogawa T, Hoshino S, Makimura S, et al

Kalteis M, Berger I, Messie-Werndl S, et al

Darwood RJ, Theivacumar N, Dellagrammaticas D, et al

Number of patient 20 164 121 92 100 103

Laser 810nm 810nm 980nm 980nm 810nm 810nm

Follow up 2 years 9 months 2 years 6 months 4 months 1 year

Less pain similar similar similar EVLT

Less minor complication

EVLT similar EVLT similar

Return to routine activities

EVLT 8.6, HL/S 22.4

HL/S 14, EVLT 20

EVLT

QOL at FU similar similar similar

Hospital stay EVLT 1.5 HL/S 2.7

RCT RF vs EVLTMorrison N Almeida J,

Kaufman J, Makhoul R, et al

Goode S, Crockett M, Richards T, et al

Gale SS, Lee JN, Walsh WE et al.

A. C. Shepherd,M. S. Gohel, L. C. Brown et al.

Patient 50, bil VV

87 22, bil VV 119 131

EVL 980nm 810nm 600nm 980nm

RF Closure-Fast Celon RFiTT Closure Plus ClosureFAST

Follow up 1 year 30 days 14 days 1 year 6 weeks

Less pain Similar RFA RFA RFA RFA

Less minor Cx similar RFA RFA RFA RFA

Procedure time similar EVLT 19mins, RFA 13 mins

QOL at FU similar similar

Is laser really inferior to RF in terms of post operative pain and minor complication?

• Comparison of 980 nm Laser and Bare-tip Fibre with 1470 nm Laser and Radial Fibre in the Treatment of Great Saphenous Vein Varicosities: A Prospective Randomised Clinical Trial

S. Doganci*, U. DemirkilicEur J Vasc Endovasc Surg (2010) 40

Advancement in EVLT: wavelength

Wavelengths; 810, 940, 980, 1319,1320,1470nm.Type of laser;• Diode; 810, 940, 980,1470.• Nd:YAG; 1319, 1320.Dominant chromophore;• Hemoglobin; 810, 940, 980• Water (collagen in vein wall) ; 1319,

1320,1470

Advancement in EVLT: fibre

• jacket-tip fibers• Glass• Ceramic• Radial• Tulip-tip

Advancement in RFA

• 1999: Use of Radiofrequency to heat up long saphenous vein

• 2003: 2nd G RFA Cath (VNUS ClosurePlus) commercially a/v in HK

• 2006: FDA Approval of 3rd G RFA VV(VNUS ClosureFAST)

• 10/2007: first 3rd G RFA VV cath(VNUS ClosureFAST) in HK

Advancement in RFA• 2nd generation VNUS ClosurePlus• 85 degree Celsius• Pull back 1cm per min for 5 min

then 2-3 cm per min for remainder• Impendence: 8Fr >100 OM• 6Fr >150 OM• Power 3-4 Watt

• VNUS ClosureFAST:• 120 degree Celsius• Automatic impedance and power• 5-40watt• 7cm treatment site

The ClosureFAST catheter and the RFGPlus™ generator.

2nd generation RFA catheter

Conclusion

• Endovenous thermal ablation:1.Occlusion rate comparable with surgery2.Perform under local anesthesia;3.same - day procedure;4. less pain, discomfort and complications;5.earlier return to normal activities

Conclusion

• RFA was associated with less postprocedural pain, minor complication (eg. Bruising, phlebitis) than EVLT.

Conclusion: Ideal RCT• RCT comparing ablation of the incompetent GSV

using surgery vs RF (Closure-Fast) vs laser (Jacket-tipped?1470 nm?) vs foamsclerotherapy.

• Participants stratified by the severity of symptoms and signs eg, CEAP classification

• Long follow-up, at least 5 years;• Assess patient - important outcomes:

– Varicose vein recurrence– Patient satisfaction

Disability and QOL– Use standardized disease-specific scales for these

outcomes (VCSS, AVVSSS)– Cost-effectiveness data.

The Comparison of LAaser, Surgery andfoam Sclerotherapy (CLASS) trial

• HTA funded – started Summer 2008• UK multi centre RCT – 5 centres• Outcomes; 6 wks, 6 mths & 5 yrs• Primary: disease specific and general QoL

changes• Secondary: technical success, clinical success,

cost effectiveness• Sample size = 1015 pts (203 / centre)

Thank you!