VNUS Workshop Jordan2010

2,616 views

Published on

Workshop about VNUS ClosureFast treatment for varicose veins

Published in: Health & Medicine
0 Comments
2 Likes
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
2,616
On SlideShare
0
From Embeds
0
Number of Embeds
11
Actions
Shares
0
Downloads
86
Comments
0
Likes
2
Embeds 0
No embeds

No notes for slide
  • Dear dr Bozkurt. Ladies and Gentleman am very honored  to be with you together in this distinguished  institute  to share my experience with the VNUS ClosureFast technique for treating Venous Reflux in parients with varicose veins
  • My name is James lawson. I am vascular surgeon since 1985. I wrote a thesis about the use of umbilical vein as graft material in femoro distal bypass My current research objects are the antithrombotic therapy after vascular surgery, risk factors of atherosclerotic disease and the last couple of years I am very interested in the results of endovenous thermal ablation
  • This are the hospitals and clinics where a have my practice as a vascular surgeon. This are the numbers of venous procedures that are done at the different locations. Personally I do some 1000 endovenous procedures per year. Most of them are VNUS ablations
  • My home country is Holland . A small country with 16,6 million inhabitants 384.000 are from Turkish origin. Holland is famous because of his flowers especially the Tulips. A lot of people are thinking that they are typically Dutch. nothing is farther from the truth than that
  • The tulips are originally coming from Turkey !
  • Tourist are very fond of our wooden shoes. Actually they are still used by farmers , to keep there foot warm and dry, while working on the wet clayey soil of the farming grounds i
  • Dutch people are very proud of her Wind Mills as you can see here . They are a big tourist attraction, especially the old ones becaus e the modern ones are extremely efficient but very distractive in our original landscape. One important function especially in the past is to pump the water back to the canals into the sea
  • Our country is wet and below sea level The reason is that our country is suffering from many depressions from the Atlantic ocean so it is raining most of the year. Another problem is that most of the country is below sea level
  • The purple colour on the map is showing the area which is below sea level. If the sea level will keep rising in the coming decades a big part of holland will be swallowed up by the sea
  • That is wh at actually happened in 1953 when after a big storm a big area of the southern part of Holland was flooded.
  • After that flood there was a urgency to pay more attention to protect the country against the upcoming water. The deltaplan was necessary to close the sea arms. To protect the specific salt water nature around the sea arms Dikes were build with flood doors which were only closed during storms
  • After that flood there was a urgency to pay more attention to protect the country against the upcoming water. The deltaplan was necessary to close the sea arms. To protect the specific salt water nature around the sea arms Dikes were build with flood doors which were only closed during storms
  • O n the drawing you see the flood doors. They are very much alike the venous valves in the leg of human beings. You can compare flood with the blood volume which is coming van above because of standing up. The valves are closing.
  • In these medical situation we call these flood reflux
  • To threat this reflux of truncal veins vein stripping was the standard of care for nearly a century
  • But I n the late nineties of the last century Endovenous ablation techniques were invented and became more en more popular
  • This is my personal time line in venous surgery. As can see more than 3 decades of stripping went by before starting my endovenous career
  • Why seems the endovenous therapy to be near to an ideal treatment Non invasive and repeatable Office procedure under tumescent anesthesia Safe and less Morbidity Effective in treatment of Reflux Cosmetic acceptable Less postoperative pain No “ sick leave
  • T o compare evlt which high ligation and stripping we did a randomized trial in our clinic in Alkmaar . The results are published in the european journal of vascular surgery
  • In the varico trial there were the same clinical results between stripping and evlt procedures.
  • But we had one disappointment the recovery was actually better with stripping under local anesthesia than evlt
  • So if we choose for a thermal ablation which one is the best ?
  • I am are going to be more serious . Steve Jobs was a great admirer of Leonardo da Vinci. He is one of the most famous scientists He recited many times one of his best quotes
  • Simplicity is the beste sophistication Take that in your mind
  • 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
  • No it is not . If we study the literature about clinical results , we must always find how they did it
  • N ot very simple machines who needs regular maintenance
  • 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. This real radiofrequency technique we still find this in the RFS catheter for treating perforators. We talk about this later
  • Then they found out the closurefast catheter. . Radiofrequency was just used to heat a electric coil at the end of the catheter. Heat was transferred directly to the the waal of the vain by conduction. That is simple as that . Because of the conductions it is important to empty the treated vein with abundant tumescent and trendelenburg position
  • 7cm length treated all at once with conductive heating coil No energy delivery during repositioning Energy delivery does not vary by pullback speed Stationary treatment= therapy consistency = excellent vein occlusion efficacy Conclusion: very simple !
  • The software is guiding you through the process
  • This is a slide demonstrating the animal histology of ClosureFAST catheter after ablation of goat saphenous veins. Note the complete fibrotic occlusion of the vein. Note also that these slides were taken at different time intervals. Twelve weeks was chosen for ClosureFAST testing because it is a much better indicator of long-term results,
  • Painscores Closure Plus vs Laser and Stripping
  • P ainscores shepperd study
  • Shepperds study: pain medication after treatment
  • Recovery after treatment: Painscores
  • In 2009 we did a survey under Dutch customers which perform the VNUS ClosureFast treatment. This are the results
  • To define a specific set-up in your varicose vein clinic, with dedicated staff and employees, you can reach a high grade of efficacy which makes the procedures cost effective
  • T h is what a visiting surgeon from Riga Letland thought and said from our Phelebology center in Alkmaar. He is performing 4 cases/ day
  • 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
  • he ClosureRFS Stylet is the only intravascular ablation device specifically cleared by the FDA for the treatment of incompetent perforator veins. This minimally invasive outpatient treatment can be either the primary procedure or an adjunct to saphenous vein ablation with the VNUS ClosureFAST™ catheter
  • 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
  • There are only a few publications describing results from the RFS treatment
  • Finally something about future developments Covidien developed a strategy of becoming a leading partner with interventional radiologists and vascular surgeons. Thats why they building new Vascular Therapies global business unit.” Besides acquisition of several innovative products They want to do more Research and Development of vascular therapies In the pipeline is a shorter coil for the ClosureFast Procedure Thank you very much for your attention
  • VNUS Workshop Jordan2010

    1. 1. VNUS ClosureFast for Treatment of Venous Reflux Dr J.A.Lawson PhD ,vascular surgeon A simple lunch break procedure
    2. 2. Curriculum Dr J.A.Lawson PhD <ul><li>1985 Certified in Vascular Surgery </li></ul><ul><li>1986 PhD Thesis: Umbilical vein as femorodistal bypass </li></ul><ul><li>Current Research : </li></ul><ul><ul><li>Antithrombotic therapy after vascular surgery, </li></ul></ul><ul><ul><li>Risk Factors of Atherosclerotic Disease </li></ul></ul><ul><ul><li>Endovenous Thermal Ablation </li></ul></ul><ul><ul><ul><li>Clinical studies </li></ul></ul></ul><ul><ul><ul><li>Analyzing exhaled breath during endovenous laser ablation of varicose veins using an electronic nose and gas chromatography-mass spectrometry </li></ul></ul></ul>
    3. 3. Venous Work Environment 1500 3000 1000 H ospital Amstelland Ph lebology Centre Alkmaar Jan van Goyen Clinic Amsterdam Phlebologic Center Alkmaar 3000 Amsterdam
    4. 4. My Home Country Holland
    5. 5. Origin from Tulips Turkye !
    6. 6. W ooden shoes
    7. 8. Windmills
    8. 9. Our country is wet and below sea level
    9. 10. Climate Change
    10. 11. Big Flooding in 1953
    11. 12. Jordan River, flooding near Allenby Bridge
    12. 13. Famous Dike Builders
    13. 14. Flood doors F lood gates
    14. 15. T he floodgates are like venous valves
    15. 16. Normal Valve
    16. 17. Reflux Disease <ul><li>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. </li></ul>
    17. 18. Reflux and varicose disease
    18. 19. Symptoms of Reflux <ul><li>Aching leg pain </li></ul><ul><li>Easy leg fatigue and heaviness </li></ul><ul><li>O edema </li></ul><ul><li>Pigmentation </li></ul><ul><li>Ulceration </li></ul><ul><li>Varicose veins </li></ul>
    19. 20. Consensus: Treat the truncal vein first <ul><li>Long ( Great) Saphenous vein </li></ul><ul><li>Short (Small) Saphenous vein </li></ul><ul><li>Giacomini </li></ul>
    20. 21. Which patients you must treat ?
    21. 22. Vein Stripping Standard of Care for nearly a century <ul><li>Significant morbidity </li></ul><ul><ul><li>5-10 % wound complications </li></ul></ul><ul><ul><li>40% sensory abnormalities </li></ul></ul><ul><li>Significant postoperative pain </li></ul><ul><li>Long sick leave </li></ul><ul><li>60% long term recurrence </li></ul>
    22. 23. Endovenous Thermal Ablation Techniques late 90’s <ul><li>Radiofrequency Ablation (RFA) </li></ul><ul><li>Endovenous Laser Treatment ( EVLT) </li></ul><ul><li>Pressurized steam ablation is still in clinical trials </li></ul>
    23. 24. 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 .
    24. 25. Personal History Timeline
    25. 26. The ideal treatment ( Promise or Truth) <ul><li>Non invasive and repeatable </li></ul><ul><li>S hould be possible to treat truncal veins and tributaries </li></ul><ul><li>Office procedure under tumescent anesthesia </li></ul><ul><li>Safe and less Morbidity </li></ul><ul><li>Effective in treatment of Reflux </li></ul><ul><li>Cosmetic acceptable </li></ul><ul><li>Less postoperative pain </li></ul><ul><li>No “ sick leave” </li></ul>
    26. 27. Complications Thermal Ablation <ul><li>(Burns) </li></ul><ul><li>Phlebitis </li></ul><ul><li>Temporary nerve injury/ Paresthesia ( 5 %) </li></ul><ul><li>DVT and pulmonary embolism ( < 0,5 %) </li></ul>
    27. 28. Relative Contraindications for ClosureFast <ul><li>Pregnancy or Nursing </li></ul><ul><li>Liver dysfunction or Lidocain Allergy </li></ul><ul><li>Severe hypercoagulopathy or hypercoagulability. </li></ul><ul><ul><li>Use of warfarin is no contraindication </li></ul></ul><ul><li>Obstructed deep venous system </li></ul><ul><li>Aneurysmal dilatation of the proximal GSV or SSV </li></ul><ul><li>Pacemaker is no contraindication </li></ul>
    28. 29. Do we mind the skipping the crossectomy ? <ul><li>Crossectomy provokes neovascularisation </li></ul>Crossectomy is provoking neovascularization in 20-53% These recurrences are difficult to treat
    29. 30. Crossectomy is obsolete 1,8 % recurrence rate of the junction after 24 months H e always ligated the anterior accessory saphenous vein
    30. 31. No Crossectomy preserves physiologic flow through the tributaries 7,7 % of tributaries were refluxing. I n 62 % it was the a nterior accessory saphenous vein
    31. 32. 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 S ubmitted for EJVES
    32. 33. Varico Trial : Same clinical results HL/S 3 % recurrence Laser 2 % recurrence ( NS)
    33. 34. Recovery Pain Scores HL/S and EVLT
    34. 35. Long Term Results : Occlusion Rate F oam EVLT VNUS ClosureFast 60-80% 80-95 % 95 -98%
    35. 36. Endovenous Thermal Ablation gives the best long term results
    36. 38. <ul><li>“ </li></ul>
    37. 39. “ Simplicity is the Ultimate Sophistication” Leonardo Da Vinci
    38. 41. I am a simple doctor <ul><li>So I want simple ( but effective) solutions </li></ul><ul><li>The disease is already complicated enough. </li></ul>
    39. 42. How works EVLT ? <ul><li>“ 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.” </li></ul>
    40. 43. Is E ndovenous Laser a simple procedure ? <ul><li>P ulsed or continuous Laser </li></ul><ul><li>Differences in wavelength </li></ul><ul><li>Manual compression or not ? </li></ul><ul><li>Endovenous energy density (LEED) </li></ul><ul><li>Power settings </li></ul><ul><li>Bare tip or covered tip </li></ul><ul><li>Pullback Speed ( more power or less speed) </li></ul><ul><li>NO ! </li></ul>
    41. 44. Laser Physics deserves more maintenance
    42. 45. My nurses are complaining about laser <ul><li>Not simple to handle </li></ul><ul><ul><li>Security Measures </li></ul></ul><ul><ul><li>S tiff glass fiber </li></ul></ul><ul><ul><li>Need Eye protection ( potential dangerous) </li></ul></ul>
    43. 46. The Old VNUS Closure System <ul><li>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. </li></ul>
    44. 47. Was Closure Plus a simple procedure ? <ul><li>Variations in pullback speed </li></ul><ul><li>Measuring pullback time </li></ul><ul><li>Saline drip or functional tests </li></ul><ul><li>Tissue impedance interruptions </li></ul><ul><li>The procedure took to much time </li></ul><ul><li>NO ! </li></ul>
    45. 48. Closure Plus was too slow
    46. 49. What is the secret of the ClosureFast Treatment ?
    47. 50. Closure FAST Catheter <ul><li>7F, 7cm length heating element on distal end of catheter </li></ul><ul><li>Temperature Sensor for controlled energy delivery ( 120 C) </li></ul><ul><li>Conductive Heating ! </li></ul>Closure FAST Catheter
    48. 51. <ul><li>7cm length treated all at once with conductive heating coil </li></ul><ul><li>No energy delivery during repositioning </li></ul><ul><li>Energy delivery does not vary by pullback speed </li></ul>Closure FAST: Segmental Ablation
    49. 52. The Generator <ul><li>M odern design </li></ul><ul><li>Intelligent software </li></ul><ul><li>No maintenance </li></ul>
    50. 53. Closure FAST Mechanism of Action <ul><li>Thermal energy transferred from heating element to vein wall through conduction, resulting in: </li></ul><ul><ul><li>Endothelial destruction </li></ul></ul><ul><ul><li>Collagen contraction </li></ul></ul><ul><ul><li>Vein lumen diameter shrinkage </li></ul></ul><ul><ul><li>Inflammatory response </li></ul></ul><ul><ul><li>Fibrotic sealing of vessel </li></ul></ul>
    51. 54. Histologic study Christine Burgmeier VNUS Closure EVLT
    52. 55. Closure FAST Histology <ul><li>Example of Closure FAST animal histology </li></ul><ul><ul><li>Note the fibrosis of the treated veins </li></ul></ul>Closure FAST histology at 12 weeks
    53. 56. ClosureFast animation
    54. 57. And it works : 2 year results
    55. 58. Difference with Laser Techniques <ul><li>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. </li></ul><ul><li>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 </li></ul>
    56. 59. VNUS ClosureFast <ul><li>Stationary treatment= therapy consistency = excellent vein occlusion efficacy </li></ul><ul><li>Conclusion: </li></ul>Very Simple and Effective
    57. 60. Are patients happy with it ?
    58. 61. Recovery :Postoperative Pain with Closure Plus
    59. 62. Recovery Study EVLT vs VNUS ClosureFast Pain Score (VAS)
    60. 63. Recovery study EVLT vs VNUS : Bruising
    61. 64. EVLT Stripping
    62. 65. Recovery EVLT vs VNUS Quality of Life
    63. 66. Pain Following 980-nm Endovenous Laser Ablation and Segmental Radiofrequency Ablation for Varicose Veins: A Prospective Observational Study Shepperd Vascular and Endovascular Surgery, Vol. 44, No. 3, 212-216 (2010
    64. 67. U se of pain medication vnus vs laser
    65. 68. RCT comparing laser,foam,stripping and VNUS by Rasmussen ( 2010) L ow pain scores and better QOL with VNUS and Foam sclerotherapy Procedure O cclusion ( %) 2 years T ime to normal F unction ( days) VNUS 93,3 1 EVLT 93,6 4 FOAM 85,0 1 Stripping 96,0 4
    66. 69. Varico Trial Alkmaar : Recovery after treatment: Painscores
    67. 70. VNUS is a Lunch Break Procedure <ul><li>80 % of patients does not use pain killers </li></ul><ul><li>Back to work the same or next day </li></ul>
    68. 71. Are there some specific disadvantages from VNUS ClosureFast ? <ul><li>Price: more expensive than bare tip laser but equal to radial tip and covered tip lasers </li></ul><ul><li>Not suited for short length for treated vein </li></ul>
    69. 72. Anatomic Considerations Insufficiency Both GSV and Anterolateral Thigh Vein ASV GSV GSV GSV GSV ASV ASV ASV VNUS EVLT or Foam Crossectomy VNUS +Foam 7
    70. 73. COST EFFECTIVE ? <ul><li>So VNUS ClosureFast Treatment is simple and effective, there is a fast recovery after the procedure, but is it cost effective ? </li></ul>
    71. 74. Costeffective <ul><li>Depends on the reimbursement </li></ul><ul><li>Make it a office procedure </li></ul><ul><li>If you have a big workload make it as efficient as possible </li></ul><ul><ul><li>You need less nurses </li></ul></ul><ul><ul><li>L ocal anesthesia ( no anesthetist) </li></ul></ul><ul><ul><li>VNUS is done in half of the time of a stripping procedure </li></ul></ul><ul><ul><li>N o Maintenance </li></ul></ul><ul><ul><li>L ess recovery problems </li></ul></ul>
    72. 75. How are Dutch Doctor’s perform VNUS ClosureFast Treatment <ul><li>67 % no concomitant treatment </li></ul><ul><li>95 % use tumescent anesthesia </li></ul><ul><li>66 % < 2 day’s compression, 95% < 7 day’s </li></ul><ul><li>Only 29% prescribes Low-Molecular-Weight Heparin as Prophylaxis </li></ul>D iscussion Charing Cross Meeting 2010
    73. 76. Roller Coaster Preoperative VNUS CF SSV A fter 1 week
    74. 77. Set- Up Total Treatment It is possible to perform 13-15 cases /day
    75. 78. “ This is no venous surgery, this is a venous assembly line !” Dr Vladislav Semenjuk, vascular surgeon, from Riga, Latvia
    76. 79. Conclusions about VNUS ClosureFast <ul><li>Simple </li></ul><ul><li>Fast </li></ul><ul><li>Very Patient Friendly </li></ul><ul><ul><li>Fast recovery, Less Pain </li></ul></ul><ul><ul><li>Excellent cosmetic result </li></ul></ul><ul><ul><li>No sick leave </li></ul></ul><ul><ul><li>L ocal anesthesia </li></ul></ul><ul><ul><li>V ery few complications </li></ul></ul><ul><li>Cost Effective ( Office Treatment) </li></ul><ul><li>Long Term R esults equal to Stripping and EVLT </li></ul>
    77. 80. Take Home Message <ul><li>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. </li></ul>2004 2010 C haring cross symposium
    78. 81. www.endovnus.com
    79. 82. RFS Stylet for ablation of perforators
    80. 83. VNUS ClosureRFS Benefits: <ul><li>Minimally invasive outpatient procedure which can be performed under local anesthesia in the physician's office </li></ul><ul><li>Quick patient recovery time, usually returning to work same day </li></ul><ul><li>Minimal scarring at skin penetration points </li></ul><ul><li>Temperature-controlled heating at the treatment site </li></ul>
    81. 84. RFS Stylet for ablation perforators
    82. 85. F ew non randomized studies about RFS <ul><li>80-85 % occlusion after 12 months </li></ul><ul><li>F ew complications </li></ul><ul><ul><li>Paresthesia 10% </li></ul></ul><ul><ul><li>DVT < 0.5 % </li></ul></ul>
    83. 87. Closure RFS for perforators
    84. 88. Link for Windows PC’s !
    85. 89. Future developments <ul><li>Vascular Therapies Global Business Unit </li></ul><ul><li>Trellis® Peripheral Infusion System </li></ul><ul><li>S horter heating element ClosureFast </li></ul><ul><li>Occlusion truncal vein without anesthesia </li></ul>

    ×