Endovenous Radiofrequency Ablation Of Varicose Veins in an Asian Centre Zhiwen Joseph LO, Pravin LINGAM, Ryan Jun-Yi TAN, Glenn Wei Leong TAN Thank you chairman and big thank you to ____ and the scientific committee for accepting my study. 1

No potential conflict of interest 2

Ligation/stripping >> sclerotherapy >> EVLT >> RFA Varicose veins are as old as Hippocrates. Venefit: segmental RFA RFITT: bipolar RFA Ligation/stripping >> sclerotherapy >> EVLT >> RFA Van den Bremer. Historical overview of varicose vein surgery. Ann Vasc Surg. 2010. 24 (3):426-32 3

4

Segmental (Venefit) vs bipolar (RFITT) vs monopolar (EVRF) A Double Blind Randomised Controlled Trial of Radiofrequency Thermo-ablation Treatments of Great Saphenous Varicose Veins: Venefit (Closurefast) vs. Radiofrequency Induced Thermal Therapy (RFITT) vs. Endovenous Radiofrequency (EVRF) - NCT02441881 By Worchestershire NHS Primary Outcome Measures: Percentage of participants with 100% ablation of the previously treated vein segment [ Time Frame: 6 months ] [ Designated as safety issue: No ]Duplex confirmed absence of recanalisation of the ablated
 Secondary Outcome Measures: Pain score on the visual scale [ Time Frame: 7 days ] [ Designated as safety issue: No ]Percentage of patients scoring pain in each category for the three treatments Quality of life measured by SF36, Euroqual 5D and Aberdeen varicose veins questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ] A double blind RCT of RFA treatments of great saphenous varicose veins: Segmental (Venefit) vs bipolar (RFITT) vs monopolar (EVRF) Assessments by visual pain scores, duplex ablation and quality of life questionaires 5

EVRF CR45i As compared to VNUS segmental radiofrequency ablation The EVRF system (F-Care, Belgium), which utilizes monopolar radio frequency energy, was introduced in 2009. The central unit works with CR45i and CR30i catheters The maximum heating power of the probe is 15W. It can be preset individually according to vessel lumen diameter and its location relative to skin surface. The 120cm long CR45i catheter of 1.5 mm diameter, is inserted into the vein through the 6F needle. Thermoablation is performed using the 1-25W continuous impulse. The exposure time for each 5mm segment is approx. 5 seconds. The 5mm working electrode generates the temperature of 80-120oC within the vein. It effectively denatures vascular endothelial cells and vascular wall collagen, so that the vein shrinks and becomes fibrotic. ### Variable energy 20 – 25 W >> 25 W above knee & 22 W at level of knee and below ### Less expensive 6

Ultrasound EVRF console Tumescence A Double Blind Randomised Controlled Trial of Radiofrequency Thermo-ablation Treatments of Great Saphenous Varicose Veins: Venefit (Closurefast) vs. Radiofrequency Induced Thermal Therapy (RFITT) vs. Endovenous Radiofrequency (EVRF) - NCT02441881 By Worchestershire NHS Primary Outcome Measures: Percentage of participants with 100% ablation of the previously treated vein segment [ Time Frame: 6 months ] [ Designated as safety issue: No ]Duplex confirmed absence of recanalisation of the ablated
 Secondary Outcome Measures: Pain score on the visual scale [ Time Frame: 7 days ] [ Designated as safety issue: No ]Percentage of patients scoring pain in each category for the three treatments Quality of life measured by SF36, Euroqual 5D and Aberdeen varicose veins questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ] 7

SFJ EVRF tip EVRF tip (pre-tumescence) EVRF tip (post-tumescence) Variable energy: 20-25W 25W above knee 22W below knee

1st long black mark Withdraw sheath 2nd long black mark Stop ablation Able to burn very short segments of vein with the same catheter as burning tip only 5 mm Useful for treating short saphenous vein and anterior thigh vein 9

Buddy-wire Long sheath LSV & ATV cannulated Very rarely unable to pass CR45 catheter up to SFJ as catheter is flexible and lower profile Techniques to overcome tortuous vein Terumo glidewire as “buddy wire” to straighten vein Use of long 35 cm sheath 10

Study Design Retrospective 2013 – 2014 1,400-bed tertiary hospital Single surgeon Pilot 50 patients, 80 limbs Factors investigated Demographics BMI Co-morbidities Previous venous interventions CEAP classification Venous duplex RFA treatment energy and time Post-op complications 6-month clinical surveillance - First Asian centre report for EVRF monopolar RFA BMI: Body Mass Index ; CEAP: clinical, etiology, anatomical, pathophysiology ; RFA: radio-frequency ablation 11

Results Demographics Study population Study period Male : Female Chinese : Malay : Indian : Others Mean age (range) Mean BMI (range) Right : Left : 50 patients, 80 limbs 2013 – 2014 51% : 49% 79% : 5% : 11% : 5% 59 (27-75) years old 28 (20-39) kg/m2 Co-morbidities Type 2 DM Peripheral arterial disease Previous venous surgery 10 (20%) 3 (1%) CEAP classification C1 C2 C3 C4 C5 C6 0 (0%) 30 (38%) 16 (20%) 21 (26%) 13 (16%) DM: diabetes mellitus 12

Results Venous duplex SFJ incompetence LSV reflux SPJ incompetence SSV reflux Deep veins reflux ATV present 61 (76%) 80 (100%) 12 (15%) 1 (1%) 15 (19%) Post-op complications Saphenous neuralgia Phlebitis DVT Recurrence 5 (6%) 7 (9%) 0 (0%) ATV: anterior thigh vein ; DVT: deep vein thrombosis ; LSV: long saphenous vein ; SFJ: sapheno-femoral junction ; SPJ: sapheno-popliteal junction ; SSV: short saphenous vein 13

Conclusions EVRF is a feasible endovenous modality for varicose veins with low complication rates Benefits include: Lower profile with need for only 6Fr sheath Variable energy level hence allowing for below knee cannulation Shorter active tip hence allowing for treatment of shorter vein segments (e.g. anterior thigh veins or short saphenous veins) Less expensive catheters Further analysis of 1174 varicose veins treatment from 2008-2014, with comparison between monopolar RFA versus segmental RFA will be undertaken 14

Thank you 15

Disadvantages of Venefit Less flexible, large profile (7 Fr) 3 or 7 cm ablation tips Working port usually occludes after first ablation rendering it unusable If unable to cross the tortuous vein, then need 018 wire (costly at $180 with risk of vein wall perforation) Unable to adjust the temperature according to level of ablation (option to reduce the temperature for SSV and below knee LSV ablation reducing risk of neuralgia) - First Asian centre report for EVRF monopolar RFA 17

Disadvantages of Clarivein Risk of ulceration on contrast extravasation Will need double puncture as clarivein catheter shorter and unable to reach SFJ from ankle Skin staining and pigmentation Pain when spinning tip of clarivein catches on side-branch DVT risk increased - First Asian centre report for EVRF monopolar RFA 18