6/1/2017. Mechanico-Chemical Ablation MOCA? Disclaimer

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1 Cox Health Venous Symposium June 2-3, 207 Mechanico-Chemical Ablation Non-thermal, Non-tumescent Venous Ablation Therapy ROBERT W. VORHIES, M.D., F.A.C.S. VASCULAR AND ENDOVASCULAR SURGERY ENDOVENOUS THERAPY AND VEIN AESTHETICS FERRELL-DUNCAN CLINIC, COX HEALTH SYSTEMS MOCA? Disclaimer Descriptions of brand name devices will be used during this presentation but do not imply endorsement of any particular device. Descriptions of billing codes are intended for reference only and should not be used for actual clinical use. Please refer to your own billing and collections departments for details. You are to be commended if you have stayed through the entire conference and still have the motivation to read this disclaimer all the way to the finish.

2 What is the problem? Varicose veins are the result of poorly selecting one s grandparents. -Sir William Osler, MD What is the problem? CEAP Classification for Chronic Venous Disorders C: Telangiectasia or Reticular Veins C2: Varicose Veins C3: Edema Images courtesy of Jennifer Heller, M.D. 6 2

3 CEAP Classification for Chronic Venous Disorders C4b: C4a: Pigmentation Lipodermatoscleros or Eczema is or Atrophie Blanche C5: Healed Venous Ulcer C6: Active Venous Ulcer Images courtesy of Gordon Gibbs, M.D. and Jennifer Heller, M.D 7 What are the solutions? Conservative Therapies Exercise Leg elevation Compression stockings Unna boot Thermal Ablation Radiofrequency Ablation Laser Ablation 9 Surgical Stripping Phlebectomy Current Treatment Disadvantages Surgery Manually removes the vein segment from the leg General anesthesia required Long incision scar Extended post procedure discomfort and wound care 2-3 weeks recovery Compression stockings Thermal Therapies Hyperpigmentation Scarring Endothermal heat-induced thrombus (EHIT) Hematoma Thrombophlebitis Nerve injury Compression stockings Zahn H. & Bush R. A review of the current management and treatment options for superficial venous insufficiency. World J Surg (204) 38: p

4 Complications of Thermal Ablation Complications Week (N=395) 3 Months (N=37) Year (N=350) 5 Years (N=279) Ecchymosis 5.8% 0.0% 0.0% 0.0% Erythema.3% 0.0% 0.0% 0.0% Hematoma.0% 0.3% 0.0% 0.0% Infection 0.0% 0.0% 0.0% 0.0% Pain.8% 0.0% 0.6% 0.0% Paresthesia.5% 2.4% 0.3% 0.7% Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (Veith Symposium) New York City; November 9, 203 More Recent Treatment Options Non-thermal, Non-tumescent Non-thermal, Non-tumescent, Non-sclerosant Mechanochemical Foam Sclerotherapy Cyanoacrylate adhesive 2 Chemical Ablation: Ultrasound Guided Foam Sclerotherapy (UGFS) 4

5 Polidocanol Endovenous Microfoam: VANISH 2 Study Randomized, multi-center Primary Endpoints Patients injected with polidocanol endovenous microfoam (PEM) 232 patients were randomized to: Patient-reported improvement in symptoms, as measured by the change from baseline to week 8 in the 7-day average VVSymQ TM * score. Placebo PEM 0.5% Secondary Endpoints Included the improvement in appearance of varicosities from 58 baseline to week 8, as measured by patients (using PA-V) and by a 25 PEM.0% physician review panel (IPR-V). PEM 0.25% Improvement in VCSS, VEINES-QOL and occlusion/reflux were also assessed at week 8 as tertiary endpoints. Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and.0% compared with placebo for the treatment of incompetence. Phlebology; 203 Jul 7 4 VANISH 2 Study Results Duplex ultrasound response at 8 weeks: Placebo PEM 0.25% PEM 0.5% PEM.0% Duplex responders.8% 59.6% 83.3% 86.2% 2 The most commonly reported adverse events in %: Placebo PEM 0.25% PEM 0.5% PEM.0% 0.5% 2.3% 5.0% Pain in extremity 5.5% 0 0.5%.7% Retained coagulum 27.6% Thrombophlebitis superficial.8% 7.0% 3.3% 3.4% Deep vein thrombosis 8.6% 0 3.5% 3.3% CFVTE 3 6.9% 0 0.7% Tenderness 6.9% P < P < 0.00 compared to PEM 0.25% 3 CFVTE Common Femoral Vein Thrombus Extension. This is non-occlusive thrombi starting in the superficial vein and extending into the common femoral vein (similar to EHIT). Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and.0% compared with placebo for the treatment of incompetence. Phlebology; 203 Jul 7 VANISH 2 Study Summary Percentage of patients treated with the.0% polidocanol solution experienced the following mild to moderate adverse events: Closure Rate Reported pain Experienced retained coagulum (blood trapped in varicosities) 5.5% 27.6% 86.20% Experienced a DVT 8.6% Duration 8 Weeks CFVTE 6.9% Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and.0% compared with placebo for the treatment of incompetence. Phlebology; 203 Jul 7 6 5

6 How do the VANISH 2 Study Results Compare to RFA?* Proebstle Study,2 vs VANISH 2 Study 3 Multi-center Multi-center 326 patients 232 patients 99.6% occlusion at 6 months 90.0% occlusion at 5 years 87.9% occlusion at 8 weeks No data at 5 years Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (Veith Symposium) New York City; November 9, Proebstle et al. Three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great saphenous vein with or without treatement of calf varicosities. Journal of Vascular Surgery; 20 3 Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and.0% compared with placebo for the treatment of incompetence. Phlebology; 203 Jul 7 *ClosureFast long-term data is shown for perspective only and not meant to imply that the data can be used in a head-to-head comparison with the data from the Vanish 2 study. 7 Summary: UGFS Non tumescent Non thermal Less effective More side effects Mechanico- Chemical Ablation (MOCA): Non-thermal Non-tumescent MOCA combines mechanical damage to the endothelium of the vein wall with the infusion of a sclerosant. (). van Eekeren, Doeke Boersma, Vincent Konijn, Jean Paul P. M. de Vries, and Michel M. J. P. Reijnen, Arnhem and Nieuwegein, The Netherlands. Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg 203; 57:

7 MOCA Mechanical damage: Promotes coagulation activation by minimal mechanical damage to the endothelium Induces vasospasm that reduces the diameter of the vein, Increases the action of sclerosant by an increase in surface. Ensures an even distribution of the sclerosant at the endothelium. Chemical Ablation Liquid sclerosant produces irreversible damage to the venous endothelium. Cellular membranes of the endothelium are damaged, creating endofibrosis. This causes venous obliteration and thrombus development. Damage of the endothelium depends on the concentration of sclerosant. How does ClariVein TM work? ClariVein TM 7

8 How well does it work? Mechanochemical Tumescentless Endovenous Ablation (MOCA): Elias Study Prospective, singlecenter 30 GSVs in 29 patients Treated with ClariVein TM * catheter Avg. diameter was 8.mm Avg. length of treated segment was 37.5cm Avg. total procedure time was 4 minutes Follow-ups were week, month, 3 months, and 6 months post-procedure Primary Endpoints Safety (measured through adverse events). Closure rate at 6 months. Secondary Endpoints Procedural pain, post procedural pain, pain medication use, and degree of ecchymosis. Elias and Raines Mechanochemical Tumescentless Endovenous Ablation: Final Results of the Initial Clinical Trial. Phlebology 202;27:67-72 *Trademark of its respective owner. 2 5 Elias Study Results Closure Rate 96.70% Duration 260 days Elias and Raines Mechanochemical Tumescentless Endovenous Ablation: Final Results of the Initial Clinical Trial. Phlebology 202;27:

9 Summary of Clinical Efficacy 05.0% CLF Percent Occlusion 97.5% 90.0% % 87.9% 87.3% 0.9 EVLA MOCA UGFS 82.5% 2-8 Weeks 3-6 Months Year 5 Years Rasmussen et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. BJS 20;98: Elias and Raines Mechanochemical Tumescentless Endovenous Ablation: Final Results of the Initial Clinical Trial. Phlebology 202;27:67-72 Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (Veith Symposium) New York City; November 9, 203 Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to ev aluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and.0% compared with placebo for the treatment of incompetence. Phlebology; 203 Jul What is the code for MOCA? Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, mechanochemical; first vein treated subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure) (Use in conjunction with 36473) (Do not report more than once per extremity) (Do not report 36473, in conjunction with 2958, 29582, 36000, 36002, 36005, 3640, 36425, 36475, 36476, 36478, 36479, 3724, 75894, 76000, 7600, 76937, 76942, 76998, 77022, 93970, 9397 in the same surgical field) (For catheter injection of sclerosant without concomitant endovascular mechanical disruption of the vein intima, use 37799) (For catheter injection of an adhesive, use 37799) Summary- MOCA Non Thermal Non Tumescent Very few adverse side effects Safe and efficacious Reimbursement is available 9

10 What else is coming out? Current Treatment Disadvantages Surgery Manually removes the vein segment from the leg General anesthesia required Long incision scar Extended post procedure discomfort and wound care 2-3 weeks recovery Compression stockings Thermal Therapies Hyperpigmentation Scarring Endothermal heat-induced thrombus (EHIT) Hematoma Thrombophlebitis Nerve injury Compression stockings Zahn H. & Bush R. A review of the current management and treatment options for superficial venous insufficiency. World J Surg (204) 38: p Opportunities for Improvement Elimination of: Tumescent anesthesia Post-procedure compression stockings Post-procedure pain and bruising 3 4 0

11 Cyanoacrylate: Venaseal Non-tumescent Non-thermal Non-sclerosant Safety of Cyanoacrylate Adhesives Widely used medical tissue adhesive. Antimicrobial effect against grampositive organisms. 2 Used safely on millions of patients with no reported carcinogenicity in humans (986 study). 2 Lawson et al. Sapheon: the solution? Phlebology 203, 28 Suppl :2-9, p3 2 Quinn J., Tissue Adhesives in Clinical Medicine, 2nd ed.(2005) p Properties of Ideal Cyanoacrylate for Venous Closure Ideal viscosity Polymerize quickly Soft and elastic Maintains a strong bond Eliminate need for compression stockings* *Some patients may benefit from compression stockings post procedure. 3 9

12 How does it work? When cyanoacrylate (CA) comes in contact with blood or plasma, it begins to polymerize. The body encapsulates the polymer as a foreign body. CA triggers inflammatory reaction in the vessel wall resulting in occlusion. Almeida J. et.al. Cyanoacrylate adhesive for the closure of truncal veins: 60 day swine model results. Vasc and Endovasc Surg (20) 000(00) -5. DOI 0.77/ p. 4 Features of the VenaSeal Procedure Procedure Features Eliminates need for tumescent anesthesia. No risk of thermal injury. No post treatment compression stockings needed.,2 * Rapid return to normal activities. 2 Almeida, J et al., Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology / Venous Forum of the Royal Society of Medicine Gibson, K. A Randomized, controlled study comparing cyanoacrylate adhesive embolization with radiofrequency ablation for treatment of incompetent great saphenous veins VeClose study. German Society of Phlebology, 204. *Some patients may benefit from compression stockings post procedure. 4 2 VeClose (U.S. pivotal trial) Study Design Prospective, randomized : comparing the VenaSeal system (VSCS) to RFA (ClosureFast catheter). Purpose Demonstrate safety and effectiveness of the VenaSeal closure system (VSCS) for the treatment of lower extremity truncal reflux by showing non-inferiority at three months to RFA using the ClosureFast system. Closure Rates 3-Months: RFA: 94.3% VSCS: 98.9% 6-Months: RFA: 94.3% VSCS: 98.9% No adjunctive treatments for 3 months Gibson, K. A Randomized, Controlled Study Comparing Cyanoacrylate Adhesive Embolization With Radiofrequency Ablation For Treatment Of Incompetent Great Saphenous Veins VeClose Study. German Society of Phlebology,

13 van Eekeren, Doeke Boersma, Vincent Konijn, Jean Paul P. M. de Vries, and Michel M. J. P. Reijnen, Arnhem and Nieuwegein, The Netherlands. Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical 6//207 Summary: VenaSeal Non Thermal Non Tumescent Non Sclerosant Non compression stockings Safe and effective Very few adverse effects No distinct coding reimbursement at this time. Conclusions: Thermal ablation is effective but has shortcomings that interfere with complete patient satisfaction. Safety and efficacy of ClariVein and VenaSeal is well supported, ultrasound guided foam sclerotherapy is not. Reimbursements are evolving to include these new techniques. Eliminating heat and the need for tumescent anesthesia and reducing or eliminating the need for compression stockings without compromising procedural success is another promising advance in the treatment of chronic venous diease. References: Beebe-Dimmer Jl, Pfeifer JR, Engle, JS, et al. The Epidemiology of Chronic Venous Insufficiency and Varicose Veins. Ann Epidemiol. 2005;5(3): Zahn H. & Bush R. A rev iew of the current management and treatment options for superficial v enous insufficiency. World J Surg (204) 38: p.2584 Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endov ascular Issues, Techniques, Horizons (Veith Symposium) New York City; November 9, 203 Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to ev aluate the efficacy and safety of polidocanol endov enous microfoam 0.5% and.0% compared with placebo for the treatment of incompetence. Phlebology; 203 Jul 7 Proebstle et al. Three-year European follow-up of endov enous radiofrequency-powered segmental thermal ablation of the great saphenous v ein with or without treatement of calf v aricosities. Journal of Vascular Surgery; 20 endovenous ablation of incompetent great saphenous veins. J Vasc Surg 203; 57: Elias and Raines Mechanochemical Tumescentless Endov enous Ablation: Final Results of the Initial Clinical Trial. Phlebology 202;27:67-72 Rasmussen et al. Randomized clinical trial comparing endov enous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous v aricose v eins. BJS 20;98: Elias and Raines Mechanochemical Tumescentless Endov enous Ablation: Final Results of the Initial Clinical Trial. Phlebology 202;27:67-72 Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endov ascular Issues, Techniques, Horizons (Veith Symposium) New York City; November 9, 203 Zahn H. & Bush R. A rev iew of the current management and treatment options for superficial v enous insufficiency. World J Surg (204) 38: p.2584 Quinn J., Tissue Adhesiv es in Clinical Medicine, 2nd ed.(2005) p Lawson et al. Sapheon: the solution? Phlebology 203, 28 Suppl :2-9, p3 Almeida J. et.al. Cyanoacrylate adhesiv e for the closure of truncal v eins: 60 day swine model results. Vasc and Endov asc Surg (20) 000(00) -5. DOI 0.77/ p. Almeida, J et al., Two-year follow-up of first human use of cyanoacrylate adhesiv e for treatment of saphenous v ein incompetence. Phlebology / Venous Forum of the Royal Society of Medicine 204. Gibson, K. A Randomized, controlled study comparing cyanoacrylate adhesiv e embolization with radiofrequency ablation for treatment of incompetent great saphenous veins VeClose study. German Society of Phlebology,

14 Venous Symposium Wrap Up 5 Chronic Venous Insufficiency and Varicose Veins are extremely common and remarkably under treated. Evaluation of lymphedema, varicose veins, and venous disease in general, relies on listening carefully to the history, examining the extremities, and obtaining a thorough venous duplex ultrasound with reflux testing. A multi-specialty approach, including conservative therapy, wound care, and procedures, is essential for the successful treatment of chronic venous disease and it s complications. Deep vein interventions and central venous pathology continue to be challenging, and Venous stasis ulcers require a lifelong commitment to maintenance compression therapy. Overall, treatment modalities for venous disease have evolved tremendously and continue to improve the patient s outcomes with less risk and less morbidity. Summary-Venous Symposium Overview Robert Vorhies, MD Anatomy and Physiology John Waites, MD Ultrasound Evaluations Brent Wilkinson, RDMS Conservative therapies Julie Highfill, PA-C Laura Ross, PA-C Lymphedema Jan Weiss, PT, DHS, CLT-LANA Deep vein interventions Randy Mullins, MD Venous stasis and ulcers John Waites, MD Pelvic congestion Randy Mullins, MD Varicose vein procedures Zak Schmittling, MD Mechanico-Chemical Ablation Robert Vorhies, MD Thank you Planning Committee Lisa Boyer Triesa Massey Kristen Richner Bryan Wiliams Becky Watts Leah Cook Steve Shoemaker Cathy Adams Julie Highfill Laura Ross Vascular Ultrasonographers Brent Wilkinson Lauren Tennison Maddie Manes Javona Killion Steve Shoemaker Vein Center Nursing staff Sam Williams Nina Mann Kelley Everett Brad Hampton Kathryn Pallister Tina Johnson Kayla Scantlin Vein Center Office staff Sarah Myers Lauren Chumbley Marsha Maggi Brittney Cook Vein Center Office Nurses Crystal Price Cindy White Glenda Bostic Cassie Lawrence Lori Davis 4

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