Future Of RF Ablation: Continuous Or Segmental?

Alan M Dietzek, MD, RVT, RPVI, FACSAlan M Dietzek, MD, RVT, RPVI, FACSClinical Associate Professor of SurgeryClinical Associate Professor of Surgery

University of Vermont College of MedicineUniversity of Vermont College of MedicineChief, Section of Vascular and Endovascular SurgeryChief, Section of Vascular and Endovascular Surgery

Linda and Stephen R Cohen Chair in Vascular SurgeryLinda and Stephen R Cohen Chair in Vascular SurgeryDanbury Hospital- Western CT Health NetworkDanbury Hospital- Western CT Health Network

12th International Varicose Vein Congress:In-Office Techniques

Lowes Hotel Miami Beach, Fla.April 24-26, 2014

Research Grant - CovidienResearch Grant - Covidien

At The StartContinuous RF Bipolar Ablation (VNUS Medical)

VNUS Medical Technologies

Closure - 1999ClosurePlus: integrated handle - 2003

Integrated handle

1995 -Restore catheter

Next Generation VNUS RF Continuous Bipolar RF Closure and ClosurePlus•Electrodes transfer RF energy (= electromagnetic energy with freq range 300kHz – 1MHz) by direct contact with vein wall

– EM waves vibrate atoms in vein wall releasing thermal energy heats vein wall to 850C (Resistive Heating)

•Continuous catheter pullback during treatment

•Two catheter sizes • 6F and 8F

Bipolar Continuous Pullback Technology

0.0250.025”” lumen lumen

Continuous RF Bipolar Technology Limitations

Operator Dependent • Treatment variability 20 to inadequate energy transfer:

• Withdraw catheter too quickly (>2-3cm/min)• speed - energy delivery

• Too little tumescence - • Poor vein wall compression -

• Poor electrode contact with wall

• Poor result with large (>12mm) veins

•

• Small Treatment Area• Only small area of vein is treated at any

given time

2–3cm/min

Rx area

Slow pullback speeds 2-3cm/min

Impedance monitoring

Multiple re-treatments often necessary

GeneratoGenerator Shut-r Shut-offoff

Clean Clean electrodelectrodeses

High High ImpedanceImpedance

Char Char buildbuildupup

Start AgainStart Again

Continuous RF Bipolar Technology Limitations – cont’d

RF Quantum LeapSegmental Ablation Technology- ClosureFAST

RF Energy heats Catheter tip (7cm heating element) to 120° C

Conductive Heat Transfer (electromagnetic radiation) from heating element to vein wall achieves temperatures of 100-110°C Vein wall heating only when catheter is stationary

Direct contact with vein wall not necessary

Segmental Ablation Tecnology- CLFAdvantages vs Bipolar

Not operator dependentNo impedance monitoring

- No generator shut-offsOne size catheter fits all vein diameters but not all lengths

Large treatment area:- 6.5cm segment of vein in 20s

45cm vein treatment ~ 2 - 45cm vein treatment ~ 2 - 5min 5min (no re-(no re-treatments)treatments)

0.5cm overlap0.5cm overlap

7cm heating element7cm heating element

Segmental AblationCurrent Flaws

Stiff catheterStiff catheterMinimum treatment length – 5cmMinimum treatment length – 5cmCannot treat perforatorsCannot treat perforatorsCostCost

7cm

3cm

What’s Next in RF?Back to the future

Olympus Celon RFiTT ProcedureOlympus Celon RFiTT ProcedureDeveloped in 2007 as alternative Developed in 2007 as alternative to VNUS bipolar RFto VNUS bipolar RFUses Bipolar technologyUses Bipolar technology

Resistive heatingResistive heating of the vein wall of the vein wall 20 J/cm vs 60-80 J/cm with CLF20 J/cm vs 60-80 J/cm with CLF

• Power is adjustable

953 patients (1172 GSV/228 SSV)953 patients (1172 GSV/228 SSV) 462 patients completed study (569 GSV and 103 SSV)462 patients completed study (569 GSV and 103 SSV) Prospective; multicenter - EuropeanProspective; multicenter - European f/u between 180 and 360 days (mean 290 f/u between 180 and 360 days (mean 290 ++ 84d) 84d) Mean vein treatment length – 50 cm Mean vein treatment length – 50 cm ++ 20cm 20cm All patients treated with bipolar Celon lab RFITT systemAll patients treated with bipolar Celon lab RFITT system Mean treatment time: 89sec Mean treatment time: 89sec ++ 66 (1.8cm/sec) 66 (1.8cm/sec)

Phlebology 2013;28: 38-46

ResultsResultsOcclusion rate at mean f/u 290 days - 92%; partial Occlusion rate at mean f/u 290 days - 92%; partial occlusion 4%; failure 3%occlusion 4%; failure 3%

Occlusion rate 98.4% with Occlusion rate 98.4% with lower power 18-20 Wlower power 18-20 W Catheter withdrawal rate >1.5s/cm (no failures >2.5s/cm)Catheter withdrawal rate >1.5s/cm (no failures >2.5s/cm) Experienced (>20 cases) operatorExperienced (>20 cases) operator

Pain scores (visual analog scale)Pain scores (visual analog scale) 2/10 at day 1; 1 after 7d; 0 on all subsequent visits2/10 at day 1; 1 after 7d; 0 on all subsequent visits

Complications - Sensory disturbance 5.8%Complications - Sensory disturbance 5.8%Tumescence not used in 27% of limbsTumescence not used in 27% of limbs

Pain Score at follow-up visits1

(Scale: 0 none to 10 max)

1 RECOVERY Study: Almeida J et al. J Vasc Interv Radiol 2009

Celon RFITT

Hamel-Desnos C., Desnos P. Controversies and Updates in Vascular SurgeryJan 17-19, 2013 Paris, France

Prospective, single center study 168 Saphenous veins

126 GSV, 36 SSV, 6 ASV

Average vein diameter - 8.2 mm (3.5-15) Mean power – 19W 71% female (117); mean age 58 Mean CEAP 2 (2 - 6); mean BMI 25 (17-43)

Hamel-Desnos C., Desnos P. Controversies and Updates in Vascular SurgeryJan 17-19, 2013 Paris, France

Results:Results:•FU – 4y; Mean FU – 2.5yFU – 4y; Mean FU – 2.5y•92% of complete occlusion92% of complete occlusion

• 7.2% of partial occlusion7.2% of partial occlusion

•Mean pull back timesMean pull back times• Success: 6s/cmSuccess: 6s/cm• Failures (partial or total): 4s/cmFailures (partial or total): 4s/cm• *Paresthesias: 9s/cm*Paresthesias: 9s/cm

ComplicationsComplications• Paresthesias – 8%Paresthesias – 8%

Laser?Not!

Fcare Systems EVRF ProcedureMonopolar Technology

EVRF radio frequency generator

CR45i unipolar catheter

• Flexible catheter

• Tortuous anatomy

• 5 Fr Sheath

Fcare Systems EVRF ProcedureMonopolar Technology

One generator – 3 devicesOne generator – 3 devicesNeedle 0.150mm - for Rx of Spider veins and rosacea

Spider Veins- Veinwave technology

Catheter for Rx of VVs 1 to 4mm and Perforators

Small VVs- Not approved for use in US

Catheter CR45i for Rxof saphenous vein

GSV/SSVNot approved for use in US

EVRF Clinical Study Piñón H, MD. Presented at the XLIII Congress of Vascular Surgery November 2011 Mexico.

  Prospective, non-randomizedProspective, non-randomized 30 patients, 54 GSV30 patients, 54 GSV CEAP 3 – 6CEAP 3 – 6 1 month f/u1 month f/u

Results:Results:Occlusion rate – 92% complete, 6% - partial without reflux, 2% Occlusion rate – 92% complete, 6% - partial without reflux, 2%

partial with refluxpartial with refluxPain – 0/10 in all patients at 7 daysPain – 0/10 in all patients at 7 days

Procedure times? Complication rates? Procedure times? Complication rates?

 

EVRF Early and Midterm ResultsSzabo A and Danciu P: Vein Therapy News Feb/March 2013

150 limbs in 150 pts150 limbs in 150 pts Single center, Prospective?Single center, Prospective? Output power – 25W; 4 beeps/0.5cm?Output power – 25W; 4 beeps/0.5cm? f/u at 1d, 1wk, 1 to 2 monthsf/u at 1d, 1wk, 1 to 2 months 129 GSV, 15 SSV and 6 GSV + SSV129 GSV, 15 SSV and 6 GSV + SSV High ligation in 6 limbs with SFJ > 20mmHigh ligation in 6 limbs with SFJ > 20mm Concomitant phlebectomy in all casesConcomitant phlebectomy in all cases

ResultsResults Complete occlusion in 99% (149/150) at 1moComplete occlusion in 99% (149/150) at 1mo Postop pain score (VAS) - 2/10 (when?)Postop pain score (VAS) - 2/10 (when?)

VNUS Closure Plus – bipolar technology Vein Occlusion Rates – single center results

Weiss & WeissWeiss & Weiss11: : 140 limbs / 120 patients140 limbs / 120 patients

98% complete vein occlusion at 1 wk98% complete vein occlusion at 1 wk

90%90% (19/21) complete vein disappearance under ultrasound at 2 years (19/21) complete vein disappearance under ultrasound at 2 years

KistnerKistner22 300 cases300 cases

Vein occlusion Vein occlusion 97% 97% @ 1 year@ 1 year

WhiteleyWhiteley33

1022 limbs1022 limbs Vein Occlusion RatesVein Occlusion Rates Limbs Limbs PercentagePercentage

1 year1 year 216/217216/217 99%99%

2 year2 year 106/106106/106 100% 100%

3 year3 year 26/2626/26 100% 100%

1. Weiss RA, Weiss MA. Controlled radiofrequency endovenous occlusion using a unique radiofrequency catheter under duplex guidance to eliminate saphenous varicose vein reflux: a 2-year follow-up. Dermatol Surg. 2002;28:38-42.

2. Kistner RL. Endovascular obliteration of the greater saphenous vein: The Closure procedure. Jpn J Phlebol 2002;13: 325-33.

3. Whiteley MS, Holdstock J, Price B, Gallagher T, Scott M. Radiofrequency ablation of refluxing superficial and perforating veins using VNUS Closure and TRLOP technique. Abstract presented at the XVII Annual meeting of the European Society for Vascular Surgery, Dublin, Ireland, Sept. 6-8, 2003.

Segmental Ablation 3year Occlusion Rate - 92.9%Kaplan Meier Analysis

3

0 5 10 15 20 25

100

99

98

97

96

95

94

93

92

Time (months)

Occlusion Rate (%)

1 month99.7%n=337 6 Months

98.5%n=317

1 Year 96.4%n=286

2 Year 94.7%n=286

30 35 40

3 Year 92.9%n=255

ClosurePlus (continuous RF) 3 year Occlusion Rate - 84% 1 1. Merchant RF, et al. J Vasc Surg 2005; 42: 502-509

Future Of RFA: Continuous Or Segmental? Summary New Continuous RF caths are smaller and more New Continuous RF caths are smaller and more

flexible than present Segmental cathsflexible than present Segmental caths Continuous RF still operator dependent, but with Continuous RF still operator dependent, but with

faster pullback times – may lead to less variable faster pullback times – may lead to less variable resultsresults

Published data for alternative RF devices is sparse, Published data for alternative RF devices is sparse, short term and of poor quality short term and of poor quality

Segmental ablation is still the Segmental ablation is still the Gold StandardGold Standard for for endovenous ablation but new Continous RF endovenous ablation but new Continous RF technologies show promisetechnologies show promise

Catheter cost may dictate the future Catheter cost may dictate the future

Go Knicks!

2013

Thank You

2014

Go Brooklyn

First Generation RFA Device Results: How Good Was It?

Substantial Body of Clinical Evidence Over 60 publications

Mechanism of action and pathophysiological

outcomes well understood

4 randomized trials comparing RFA with vein stripping

surgery demonstrated superiority of RFA

Multicenter registry involving 30+ centers worldwide

with 1222 limbs/1005 pts treated proven the durability

of the treatment with 5-year follow-up data

Multiple independent reports validated the results of

major trials

First Generation RFA DeviceAll Randomized Trials: RFA vs. Stripping

1. Rautio T, Ohinmaa A, Perala J, Ohtonen P, Heikkinen T, Wiik H, Karjalainen P, Haukipuro K, Juvonen T. Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs. J Vasc Surg. 2002; 35: 958-65.

2. Lurie F, Creton D, Eklof B, Kabnick LS, Kistner RL, Pichot O, Schuller-Petrovic S, Sessa C. Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study). J Vasc Surg. 2003; 38: 207-14.

3. Lurie F, Creton D, Eklof B, Kabnick LS, Kistner RL, Pichot O, Sessa C, Schuller-Petrovic S. Prospective Randomised Study of Endovenous Radiofrequency Obliteration (Closure) Versus Ligation and Vein Stripping (EVOLVeS): Two-year Follow-up. Eur J Vasc Endovasc Surg. 2005;29:67-73.

4. Stoetter L, Schaaf I, Bockelbrink A. Invaginating stripping, kryostripping or endoluminal radiofrequency obliteration to treat GSV insufficiency: duplex ultrasound findings and clinical outcome postoperatively and at 1-year follow up. 17th annual meeting of American Venous Forum. San Diego, Feb, 2005

5. Hinchliffe RJ, Ubhi J, Beech A, Ellison J, Braithwaite BD. A Prospective Randomised Controlled Trial of VNUS Closure versus Surgery for the Treatment of Recurrent Long Saphenous Varicose Veins. Eur J Vasc Endovasc Surg. 2005 Aug 30; [Epub ahead of print]

Summary Summary RFA patients - significantly less pain and RFA patients - significantly less pain and post-op morbidity, faster recovery and better post-op morbidity, faster recovery and better quality of life than stripping patientsquality of life than stripping patients

First Generation RFA DeviceVNUS Clinical Registry – ResultsMulticenter (>30 centers);1006 patients and 1222 limbs treated

1. Merchant RF, et al. Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for superficial venous insufficiency. J Vasc Surg 2005, 42(3): 502-509

1 Yr 2 Yrs 3 Yrs 4 Yrs 5 Yrs

Absence of reflux417/473

88%

232/263

88%

117/133

88%

103/119

87%

98/117

84%

First Generation RFA DeviceVNUS Clinical Registry - Results

1. Merchant RF, et al. Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for superficial venous insufficiency. J Vasc Surg 2005, 42(3): 502-509

1 Yr 2 Yrs 3 Yrs 4 Yrs 5 Yrs

Absence of reflux417/473

88%

232/263

88%

117/133

88%

103/119

87%

98/117

84%

First Generation RFA DeviceVNUS Clinical Registry - Results

1. Merchant RF, et al. Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for superficial venous insufficiency. J Vasc Surg 2005, 42(3): 502-509

1 Yr 2 Yrs 3 Yrs 4 Yrs 5 Yrs

Absence of reflux417/473

88%

232/263

88%

117/133

88%

103/119

87%

98/117

84%

Vein occlusion( 3 cm patent stump)

412/473412/473

87%87%

232/263

88%

111/133

84%

101/119

85%

102/117102/117

87%87%

New Generation RFA Device ClosureFAST Study

Multicenter (13 Study Centers in Europe and the US) 326 patients; 396 limbs treated Percent Female = 73.3% Average Age = 47.2 ± 12.4 years Average Height = 170.0 cm ± 8.4 cm Average Weight = 74.2 kg ± 16.9 kg All veins treated were GSV from groin to knee Average vein diameter at 3 cm from SFJ 5.5 ± 2.1 mm (2.0 - 18.0mm ) Average length of veins treated: 36.9 ± 10.6 cm Average energy delivery time: 2.2 ± 0.6 min Average procedure time (cath in to cath out): 15.2 ± 7.5m

CLF Occlusion Rate at 3 Years - 92.9%Kaplan Meier Analysis

•0 •5 •10 •15 •20 •25

•100

•99

•98

•97

•96

•95

•94

•93

•92

Time (months)

Occlusion Rate (%)

1 month

99.7%

n=337 6 Months

98.5%

n=317

1 Year

96.4%

n=286 2 Year

94.7%

n=286

•30 •35 •40

3 Year

92.9%

n=255

ClosurePlus 3 year Occlusion Rate - 84% 1 1. Merchant RF, et al. J Vasc Surg 2005; 42: 502-509

CLF Reflux Free Rate at 3 Years– 96.0%Kaplan Meier Analysis

•0 •5 •10 •15 •20 •25

•100.0

•99.5

•99.0

•98.5

•98.0

•97.5

•97.0

•96.5

•96.0

Time (months)

Reflux Free Rate (%)

1 month

99.7%

n=337 6 Months

99.4%

n=320

1 Year

99.1%

n=292

2 Year

97.5%

n=292

•30 •35 •40

3 Year

96.0%

n=258

ClosurePlus 3 year Reflux Free Rate – 88%1

1. Merchant RF, et al. J Vasc Surg 2005; 42: 502-509

CEAP Clinical Class CEAP Clinical Class DistributionDistribution

Pre-treatment Pre-treatment

CEAP Clinical Class CEAP Clinical Class DistributionDistribution

At 36 MonthsAt 36 Months

ComplicationsFollow-up Time PointFollow-up Time Point All TimeAll Time 2 Year2 Year 3 Year3 Year

Post TreatmentPost Treatment n = 396n = 396 n = 267n = 267

EcchymosisEcchymosis 21 (5.3%)21 (5.3%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)

ErythemaErythema 9 (2.3%)9 (2.3%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)

HematomaHematoma 4 (1.0%)4 (1.0%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)

ParesthesiaParesthesia 16 (4.0%)16 (4.0%) 1 (0.3%)1 (0.3%) 1 (0.3%)1 (0.3%)

PhlebitisPhlebitis 6 (1.5%)6 (1.5%) 0 (0.0%)0 (0.0%) 1 (0.3%)1 (0.3%) 1

Skin PigmentationSkin Pigmentation 12 (3.0%)12 (3.0%) 1 (0.3%)1 (0.3%) 0 (0.0%)0 (0.0%)

Thermal Skin InjuryThermal Skin Injury 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)

Thrombus Extension / DVTThrombus Extension / DVT2 6 (1.5%)6 (1.5%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)

ComplicationsFollow-up Time PointFollow-up Time Point All TimeAll Time 2 Year2 Year 3 Year3 Year

Post TreatmentPost Treatment n = 396n = 396 n = 267n = 267

EcchymosisEcchymosis 21 (5.3%)21 (5.3%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)

ErythemaErythema 9 (2.3%)9 (2.3%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)

HematomaHematoma 4 (1.0%)4 (1.0%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)

ParesthesiaParesthesia 16 (4.0%)16 (4.0%) 1 (0.3%)1 (0.3%) 1 (0.3%)1 (0.3%)

PhlebitisPhlebitis1 6 (1.5%)6 (1.5%) 0 (0.0%)0 (0.0%) 1 (0.3%)1 (0.3%)

Skin PigmentationSkin Pigmentation 12 (3.0%)12 (3.0%) 1 (0.3%)1 (0.3%) 0 (0.0%)0 (0.0%)

Thermal Skin InjuryThermal Skin Injury 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)

Thrombus Extension / DVTThrombus Extension / DVT2 6 (1.5%)6 (1.5%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)

1. Patient had foam sclerotherapy and phlebectomy between years 2 and 3

2. Before recommendation to place catheter ≥ 2 cm from the SFJ

Evolution of RF Endovenous AblationSummary

ClosureFAST ClosureFAST More efficient design and reliable mode of action than More efficient design and reliable mode of action than

older RF devicesolder RF devicesMore User FriendlyMore User FriendlyBetter Vein Occlusion and Reflux Free ratesBetter Vein Occlusion and Reflux Free ratesSimilar mild recovery and long term symptom relief Similar mild recovery and long term symptom relief

profileprofileEquivalent or lower complication ratesEquivalent or lower complication rates

Evolution of Endovenous Ablation: Closure and ClosurePlus (CLP) – 1st Generation

Design and Mode of Action• Electrodes for transfer of RF energy to vein wall (bipolar technology)– Heats vein wall to 850C

• Continuous catheter pullback during treatment

• Thermocouple monitors vein wall temperature and impedance with feedback loop to generator

• Saline drip required

• Two catheter sizes • 6F and 8F

Bipolar Continuous Pullback Technology

RF Ablation How the Device has Evolved

VNUS MedicalTechnologies is founded - 1995

RF energy: Restore catheter

0.0250.025”” lumen lumen

Closure Catheter - 2001

ClosurePlus – 2003Integrated handle

First Generation RF DeviceLimitations

Operator Dependent treatment variability Inadequate Transfer of Energy• Pullback too fast (>2-3cm/min)

• speed – decrease energy delivery

• Inadequate tumescent compression

•Poor Electrode Contact with vein wall

• Especially vein diameters >12mm (supine)

• Only small area of vein is treated at any given time

2–3cm/min

First Generation Device - CLPEase of Use

Slow pullback speeds 2-3cm/min

Impedance monitoring

Generator Shut-off

Clean electrodes

High Impedance

Char buildup

Start Again!!!

First Generation RFA Devices – Closure and

ClosurePlusDesign and Mode of ActionElectrodes for transfer of

RF energy to vein wall (bipolar technology)– Heats vein wall to 850C

Continuous catheter pullback during treatment

Thermocouple monitors vein wall temperature and impedance with feedback loop to generator

Saline drip requiredTwo catheter sizes

6F and 8F

New Generation RF - ClosureFAST Design and Mode of Action

RF Energy heats Catheter tip (7cm heating element) to 120° C

Conductive Heat Transfer from heating element to vein wall achieves temperatures of 100-110°C Vein wall heating only when catheter is stationary (energy dosage not physician-dependant)

No impedance monitoring No saline drip

Small saphenous

Intersaphenous

Anterior accessory saphenous

Posterior accessory saphenous

Source: Laredo, J, et al. Endovenous Thermal Ablation of the Anterior Accessory Great Saphenous Vein

18%

10%

Great saphenous

70%

Various Sources of Superficial Venous Reflux

What’s Next in RF?Back to the futureOlympus Celon RFiTT ProceduOlympus Celon RFiTT ProcedurereDeveloped in 2007 as alternative to VNUSDeveloped in 2007 as alternative to VNUSUses Bipolar technologyUses Bipolar technology

Resistive heating of the vein wallResistive heating of the vein wall 20 J/cm vs 60-80 J/cm with CLF20 J/cm vs 60-80 J/cm with CLF

Celon RFiTT CatheterBipolar Technology - Resistive Heating

RF Ablation In the Beginning

VNUS MedicalTechnologies is founded - 1995

RF energy: Restore catheter

0.0250.025”” lumen lumen

Closure Catheter - 2001

ClosurePlus – 2003Integrated handle

RF Data – Baseline for RF Data – Baseline for Comparison Comparison Recovery StudyRecovery Study

Almeida J et al. J Vasc Interv Radiol Almeida J et al. J Vasc Interv Radiol 20092009

- Multicenter, single-blinded, randomized Multicenter, single-blinded, randomized studystudy

- 69 patients; 87 limbs (46 CLF; 41 EVLA – 69 patients; 87 limbs (46 CLF; 41 EVLA – 980nm)980nm)

- Patient followup at 2,7,14 & 30d post EVLA Patient followup at 2,7,14 & 30d post EVLA

- Primary endpointsPrimary endpoints- Post-op painPost-op pain- Severity of bruisingSeverity of bruising- Adverse eventsAdverse events

- Secondary endpointsSecondary endpointsOcclusion status, VCSS, Reflux, Tenderness, Occlusion status, VCSS, Reflux, Tenderness, QOL (CIVIQ2)QOL (CIVIQ2)

Pain Score at follow-up visits1

(Scale: 0 none to 10 max)

0

0.5

1

1.5

2

2 Days 7 Days 14 Days 30 Days

ClosureFAST™ catheter 980 nm Laser

p < 0.0001 p < 0.0001 p < 0.0001 NS

CLF catheter

1. RECOVERY Study: Almeida J et al. J Vasc Interv Radiol 2009

0.7

Venous Clinical Severity Score (VCSS)

22.5

33.5

44.5

55.5

66.5

7

Screening 2 Days 7 Days 14 Days 30 Days

ClosureFAST™ catheter 980 nm Laser

NS

p = 0.0009p = 0.0002

p = 0.0035

NS

Note: Lower score reflects a better QOL

CLF catheter

What’s Next in RF?Back to the future

Olympus Celon RFiTT ProcedureOlympus Celon RFiTT ProcedureDeveloped in 2007 as alternative Developed in 2007 as alternative to VNUSto VNUSUses Bipolar technologyUses Bipolar technology

Resistive heatingResistive heating of the vein wall of the vein wall 20 J/cm vs 60-80 J/cm with CLF20 J/cm vs 60-80 J/cm with CLF

llskjljl

Continuous Bipolar RF Technology Limitations

2–3cm/min

Rx area

• Based on the same technology as the ClosureFast™ catheter with a 4cm shorter heating element

• Shorter segmental ablation with the versatility to treat various sources of superficial venous reflux

7cm

3cm

ClosureFAST 3cm

Segmental RF AblationMost Recent Improvement

Rx 3 - 5cm vein segments

Continuous Monopolar RF

AdvantagesAdvantagesCatheters are thin (5Fr sheath) and pliableCatheters are thin (5Fr sheath) and pliable

Better for tortuous veins?Better for tortuous veins?

Significantly cheaper catheters than Significantly cheaper catheters than Segmental cathetersSegmental catheters

DisadvantagesDisadvantagesMay take longer than Segmental RFMay take longer than Segmental RFPull back technology – may lead to Pull back technology – may lead to

inconsistent resultsinconsistent results

Pain Score at follow-up visits1

(Scale: 0 none to 10 max)p < 0.0001 p < 0.0001 p < 0.0001 NS

CLF catheter

1 RECOVERY Study: Almeida J et al. J Vasc Interv Radiol 2009

0.7

0.2