RADIOFREQUENCY ABLATION. Drs PIRET V, BERGERON P MEET CANNES 2009

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1 RADIOFREQUENCY ABLATION Drs PIRET V, BERGERON P MEET CANNES 2009

2 Superficial Venous Disease: EPIDEMIOLOGY Touch 75% of french population at different degrees ( ) 25% needs medical care ( ) Anaes (Agence nationale d accréditation et d évaluation en santé) Service Évaluation de santé publique Evaluation technologique Juin 2004

3 Why to treat them? To relieve the symptoms of the patients To avoid the appearance of ulcers esthetism Economical cost, first cause of absenteeism to the work

4 TREATMENT Surgical: stripping of great saphenous vein Endovascular: - RFA, radiofrequency ablation VNUS Closure Medical, Closure FAST - EVLA, endovenous laser ablation

5 STRIPPING OF the GSV

6 COMPLICATIONS of SURGICAL GROUP Phlebitis of calf: 4 to 5% Infections: 3 to 4% Anesthesia - paresthesia : 25% at 15 days, 8% at 6 months. Serious complications Neurological: sciatic nerve external Vasculars: - arterial stripping - stripping, ligature of femoral vein Lymphocèle, edema

7 VNUS CLOSURE-FAST, RADIOFREQUENCY ABLATION Indication The ClosureFAST catheter is intended for endovascular coagulation of blood vessels in patients with superficial venous reflux

8 ClosureFAST Mechanism of Action Thermal energy is transferred from the heating element to the vein wall through conduction, resulting in Endothelial destruction Collagen contraction Vein lumen diameter shrinkage Inflammatory response Fibrotic sealing of the vessel 7cm length treated all at once

9 Treatment Parameter Overview 7 cm length treatment in 20 seconds with a 0.5 cm overlap of treatment segments Set Temperature (device): 120 C 40 Watts max power Sterile handle button mirrors RFGPlus screen button Start treatment in sterile field Treatment stops automatically at end of 20-second cycle 2 nd press stops RF immediately when necessary Sterile catheter handle button

10 PROCEDURE STEPS Préparation patient: classique

11 VEINOUS PUNCTURE incision Direct puncture

12 7 or 8 Fr sheath Fluoroscopy at 45

13 VNUS Perivenous Tumescent Infiltration

14 Venous reflux VNUS position no reflux

15 Key Points Compression is important to assure good vein wall contact with the heating element Tumescent Infiltration Trendelenburg position to evacuate the blood

16 VNUS PROCEDURE TIME (EJVES feb 2006 Hinchliffe & al) VNUS: 25,5 min (20,5 31,3) Surgical group: 40 min (34,5 45,5) Recovery Trial 2008 Closure FAST: 12,6 +/- 10,2 LASER: 16,0 +/- 7,9

17 VNUS The activity return (JVS aug 2003 Lurie & al) Daily activities: VNUS : 80,5% at J1 Surgical: 46,9% at J1 Professional activities: VNUS : 4,7 days Surgical : 12,4 days

18 Post operative pain (Recovery Trial 2008) MAXIMUM PAIN ( 0 to 10) SCORE AT 30 DAYS (Closure Fast vs Laser) LASER Closure FAST

19 VNUS IMPROVEMENT OF THE SYMPTOMATOLOGY Improvement of the CEAP (n=330) - 82,9 % at 1 year - 83,1 % at 2 year - 86,8 % at 3 year (EJVES 2005 april, Nicolini Closure Group) Improvement of symptomes : 85 to 94 % (n=1222) with attractive success(merchant & al, JCVS feb 2006)

20 Thrombus extension Moderate to severe ecchymosis VNUS Mayo Clinic ( 2005) N=130 VNUS - COMPLICATIONS VNUS Merchant (2006) n=286 VNUS Proebstel (JVS 2008) N=252 RECOVERY TRIAL 2008 Closure Fast N=46 2,3 % NA - 0 % 2,4 % 0,7 % 5 % 6,4 % 3 % 49 % RECOVERY TRIAL 2008 Laser N=41 Hyperpigme ntation NA NA 2 % 2,2 % 0 % Phlebitis 3,6 % 2,1 % 0,8 % 0 % 14,6 % Paresthesia NA 15% 3,2 % 2,2 % 4,9 % Erythema NA NA 1,6 % 0 % 9,8 % Infection 1,4 % 0 % - 0 % 0 % Induration NA NA - 0 % 2,4 % Skin burn NA 2,1 % - 0 % 0 %

21 VNUS neovascularisation Kianifard & al (Surgeon, april 2006) Surg (n=55): 11 % at 1 year RFA (n=55): 0 % at 1 year Pichot & al ( Endovascular today nov/dec 2004) RFA (n=63): 0 % at 2 years VNUS-Closure data base: 0,5% at 2 years

22 Surgery: recurrence Fischer study: follow up 39 years, 60% neovascularisation 30% redux Gloucester randomized trial: - 8 % at 1 year - 31 % at 2 years - 41 % at 5 years - 62 % at 11 years ANAES to 25 %

23 VNUS: venous occlusion and absence of reflux Merchant & al, JCVS 2006, 34 centers, 1222 legs: At 5 years: -87,2% venous occlusion -83,8% absence of reflux Mayo Clinic, JVS 2005, n=53 Doppler between J1 and J23: 90,9% occlusion of GSV Nicolini, EJVES 2005, n=330 At 3 years: 88% absence of reflux - Dietzek Closure Fast nov 2007: 96,2 % of venous occlusion at 1 year - Proebstel (JVS 2008): 99,6 % vein occlusion at 6 month - Recovery Trial 2008: 100% vein occlusion at 1 month

24 Follow up of RFA of GSV Prospective multicenter trial N= 295 GSVs I cannot show you the result because is not yet published but this study showed a very good result at 2 years with very high succes rate and high durability of the once achieval occlusion of treated GSV together with a moderate side affect profile

25 Effect of Saphenous Vein diameter on closure rate with Closure FAST Radiofrequency catheter David Calcagno(22nd Annual Congress American College of Phlebology, november 2008) One center N= 338 GSV and SSV Group A = 242 with mean diameter at 8 +/- 2 mm Group B = 96 with mean diameter at 17 +/- 4 mm Early dupplex showed complete closure in 96% veins in group B vs 95 % in group A 6 months dupplex were completed in 43 veins in group B and showed complete closure (100%) vs 98 % in group A The conclusion of this study is the vein diameter > 12mm had no effect on closure rate with the closure FAST Catheter

26 CONCLUSIONS The RFA is an effective methode to runs and to average term It seems to be an alternate methode to the classical stripping We need to follow the evaluation in the long term of this technique

27 THANK YOU

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