vnus workshop jordan2010
DESCRIPTION
Workshop about VNUS ClosureFast treatment for varicose veinsTRANSCRIPT
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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