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VNUS ClosureFast for Treatment of Venous RefluxDr J.A.Lawson PhD ,vascular surgeon

A simple lunch break procedure

+Curriculum Dr J.A.Lawson PhD

1985 Certified in Vascular Surgery

1986 PhD Thesis: Umbilical vein as femorodistal bypass

Current Research : Antithrombotic therapy after vascular surgery, Risk Factors of Atherosclerotic Disease Endovenous Thermal Ablation

Clinical studies Analyzing exhaled breath during endovenous laser

ablation of varicose veins using an electronic nose and gas chromatography-mass spectrometry

+Venous Work Environment

1500

3000

1000

Hospital AmstellandPhlebology Centre Alkmaar

Jan van Goyen ClinicAmsterdam

Phlebologic Center Alkmaar

3000

Amsterdam

+My Home Country Holland

+Origin from TulipsTurkye !

+Wooden shoes

+Windmills

+ Our country is wet and below sea level

+Climate Change

+Big Flooding in 1953

+Jordan River, flooding near Allenby Bridge

+Famous Dike Builders

+Flood doors

Flood gates

+The floodgates are like venous valves

+Normal Valve

+Reflux Disease

Reflux disease is a result of failure of the valves in the veins to maintain drainage of blood from the legs to the heart resulting in stagnation and pooling of blood in the leg veins.

+Reflux and varicose disease

+Symptoms of Reflux

Aching leg pain

Easy leg fatigue and heaviness

Oedema

Pigmentation

Ulceration

Varicose veins

+Consensus: Treat the truncal vein first

Long ( Great) Saphenous vein

Short (Small) Saphenous vein

Giacomini

+ Vein StrippingStandard of Care for nearly a century

Significant morbidity 5-10 % wound complications 40% sensory abnormalities

Significant postoperative pain

Long sick leave

60% long term recurrence

+ Endovenous Thermal Ablation Techniques late 90’s

Radiofrequency Ablation (RFA)

Endovenous Laser Treatment ( EVLT)

Pressurized steam ablation is still in clinical trials

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Endovenous thermal ablation is an image-guided procedure that uses heat generated by radiofrequency or laser energy to seal off truncal superficial veins, diverting blood flow immediately to nearby deep veins.

+ Personal History Timeline

+The ideal treatment ( Promise or Truth) Non invasive and repeatable

Should be possible to treat truncal veins and tributaries

Office procedure under tumescent anesthesia

Safe and less Morbidity

Effective in treatment of Reflux

Cosmetic acceptable

Less postoperative pain

No “ sick leave”

+Complications Thermal Ablation

(Burns)

Phlebitis

Temporary nerve injury/ Paresthesia ( 5 %)

DVT and pulmonary embolism ( < 0,5 %)

+Relative Contraindications for ClosureFast

Pregnancy or Nursing

Liver dysfunction or Lidocain Allergy

Severe hypercoagulopathy or hypercoagulability. Use of warfarin is no contraindication

Obstructed deep venous system

Aneurysmal dilatation of the proximal GSV or SSV

Pacemaker is no contraindication

+Do we mind the skipping the crossectomy ?

Crossectomy provokes neovascularisation

Crossectomy is provoking neovascularization in 20-53%These recurrences are difficult to treat

+Crossectomy is obsolete

1,8 % recurrence rate of the junction after 24 monthsHe always ligated the anterior accessory saphenous vein

+No Crossectomy preserves physiologic flow through the tributaries

7,7 % of tributaries were refluxing. In 62 % it was theanterior accessory saphenous vein

+ Randomized trial comparing high ligation and stripping of the great saphenous vein and endovenous laser ablation (980-nm) using exclusively local tumescent anaesthesia: one year follow-up.

Pascal Pronk M.D.¹, Stefanie A Gauw BN¹, Michael C Mooij M.D.¹, Menno TW Gaastra M.D.¹, James Lawson M.D., PhD.¹, Clarissa J van Vlijmen-van Keulen M.D., PhD.¹  ¹ Flebologisch Centrum Oosterwal, Alkmaar

Submitted for EJVES

+Varico Trial : Same clinical results

HL/S 3 % recurrenceLaser 2 % recurrence( NS)

+Recovery Pain Scores HL/S and EVLT

+Long Term Results : Occlusion Rate

Foam EVLT VNUS ClosureFast

60-80% 80-95 % 95 -98%

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Endovenous Thermal Ablationgives the best long term results

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“ Simplicity is the Ultimate Sophistication”Leonardo Da Vinci

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+I am a simple doctor

So I want simple ( but effective) solutions

The disease is already complicated enough.

+How works EVLT ?

“With laser, heat is generated by the action of the laser on the chromophore (substance that absorbs the laser light). It is thought that the mechanism of damage to the vein wall is the generation of a steam bubble around the laser tip from the blood still within the vein (boiling blood). This steam then transmits its heat to the vein wall via the high temperature gradient.”

+Is Endovenous Laser a simple procedure ? Pulsed or continuous Laser

Differences in wavelength

Manual compression or not ?

Endovenous energy density (LEED)

Power settings

Bare tip or covered tip

Pullback Speed ( more power or less speed)

NO !

+ Laser Physics deserves more maintenance

+My nurses are complaining about laser

Not simple to handle

Security Measures Stiff glass fiber Need Eye protection ( potential dangerous)

+The Old VNUS Closure System

The mechanism by which RF current heats tissue is resistive (or ohmic) heating of a narrow rim of tissue that is in direct contact with the electrode. Deeper tissue planes are then slowly heated by conduction from the small region of volume heating.

+Was Closure Plus a simple procedure ?

Variations in pullback speed

Measuring pullback time

Saline drip or functional tests

Tissue impedance interruptions

The procedure took to much time

NO !

+Closure Plus was too slow

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What is the secret of the ClosureFast Treatment ?

+ClosureFAST Catheter

7F, 7cm length heating element on distal end of catheter

Temperature Sensor for controlled energy delivery ( 120 C)

Conductive Heating !

ClosureFAST Catheter

+ClosureFAST: Segmental Ablation

7cm length treated all at once with conductive heating coil

No energy delivery during repositioning

Energy delivery does not vary by pullback speed

+The Generator

Modern design

Intelligent software

No maintenance

+ClosureFAST Mechanism of Action

Thermal energy transferred from heating element to vein wall through conduction, resulting in: Endothelial destruction Collagen contraction Vein lumen diameter shrinkage Inflammatory response Fibrotic sealing of vessel

+Histologic studyChristine Burgmeier

VNUS Closure EVLT

+ ClosureFAST Histology

Example of ClosureFAST animal histology Note the fibrosis of the treated veins

ClosureFAST histology at 12 weeks

+ClosureFast animation

+And it works : 2 year results

+Difference with Laser Techniques

Segmental ablation is associated with a catheter that remains stationary during energy delivery. This technique avoids pullback speed variability, which can result in variable and insufficient energy dosing and thus result in inadequate treatment.

The temperature is kept stable at 120°C during a 20-second treatment cycle, thus avoiding peak temperatures of several hundred degrees as seen with ELT ablation. This controlled heating avoids vein perforations with unintended heat damage of perivenous tissue

+VNUS ClosureFast

Stationary treatment= therapy consistency = excellent vein occlusion efficacy

Conclusion:

Very Simple and Effective

+Are patients happy with it ?

+ Recovery :Postoperative Pain with Closure Plus

+ Recovery Study EVLT vs VNUS ClosureFast Pain Score (VAS)

+Recovery study EVLT vs VNUS : Bruising

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EVLT Stripping

+Recovery EVLT vs VNUSQuality of Life

+Pain Following 980-nm Endovenous Laser Ablation and Segmental Radiofrequency Ablation for Varicose Veins: A Prospective Observational StudyShepperd Vascular and Endovascular Surgery, Vol. 44, No. 3, 212-216 (2010

+Use of pain medication vnus vs laser

+RCT comparing laser,foam,stripping and VNUS by Rasmussen ( 2010)

Procedure

Occlusion ( %) 2 years

Time to normalFunction ( days)

VNUS 93,3 1

EVLT 93,6 4

FOAM 85,0 1

Stripping

96,0 4

Low pain scores and better QOL with VNUS and Foam sclerotherapy

+Varico Trial Alkmaar : Recovery after treatment: Painscores

+VNUS is a Lunch Break Procedure

80 % of patients does not use pain killers

Back to work the same or next day

+Are there some specific disadvantages from VNUS ClosureFast ? Price: more expensive than bare tip laser but equal to radial

tip and covered tip lasers

Not suited for short length for treated vein

ASVGSV GSV GSV GSV

ASV ASV ASV

VNUS EVLT or Foam Crossectomy VNUS +Foam

Anatomic Considerations Insufficiency Both GSV and Anterolateral Thigh Vein

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+COST EFFECTIVE ?

So VNUS ClosureFast Treatment is simple and effective, there is a fast recovery after the procedure, but is it cost effective ?

+Costeffective

Depends on the reimbursement

Make it a office procedure

If you have a big workload make it as efficient as possible You need less nurses Local anesthesia ( no anesthetist) VNUS is done in half of the time of a stripping procedure No Maintenance Less recovery problems

+How are Dutch Doctor’s performVNUS ClosureFast Treatment 67 % no concomitant treatment

95 % use tumescent anesthesia

66 % < 2 day’s compression, 95% < 7 day’s

Only 29% prescribes Low-Molecular-Weight Heparin as Prophylaxis

Discussion Charing Cross Meeting 2010

Roller Coaster

Preoperative VNUS CF SSV After 1 week

+Set- Up Total Treatment

It is possible to perform 13-15 cases /day

“This is no venous surgery, this is a venous assembly line !”

Dr Vladislav Semenjuk, vascular surgeon, from Riga, Latvia

+Conclusions about VNUS ClosureFast Simple

Fast

Very Patient Friendly Fast recovery, Less Pain Excellent cosmetic result No sick leave Local anesthesia Very few complications

Cost Effective ( Office Treatment)

Long Term Results equal to Stripping and EVLT

+Take Home Message

The fundamental change that has occurred in the last decade is the move to treat varicose veins away from the operating theater under general anesthesia, towards ambulant, office-based management. This has had cost advantages, freed up expensive theater time, and has improved the convalescent phase for patients.

2004 2010 Charing cross symposium

+www.endovnus.com

+RFS Stylet for ablation of perforators

+VNUS ClosureRFS Benefits:

Minimally invasive outpatient procedure which can be performed under local anesthesia in the physician's office

Quick patient recovery time, usually returning to work same day

Minimal scarring at skin penetration points

Temperature-controlled heating at the treatment site

+RFS Stylet for ablation perforators

+Few non randomized studies about RFS

80-85 % occlusion after 12 months

Few complications Paresthesia 10% DVT < 0.5 %

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+Closure RFS for perforators

+Future developments

Vascular Therapies Global Business Unit

Trellis® Peripheral Infusion System

Shorter heating element ClosureFast

Occlusion truncal vein without anesthesia