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5/15/2017 ENDOVENOUS LASER THERAPY FOR VARICOSE VEINS LOWELL S. KABNICK, MD NYU LANGONE MEDICAL CENTER Disclosure Slide ANGIODYNAMICS AMSEL BARD BTG VASCULAR INSIGHTS VENITI FREE ITEMS AS ABOVE, MEDTRONIC, BSN JOBST, JANSEN, MEDI, SIGVARIS,ETC EndoVenous Laser Procedure 1 5/15/2017 Endovenous Laser Ablation Preoperative Planning Preparation of the Patient Percutaneous Insertion Supplies 2 5/15/2017 Access Methods •19 g thin walled needle with 035 system long or short sheath •18 g needle with 035 system long or short sheath system •18g wire long sheath system •18g wire short sheath system and direct fiber insertion •21g 018 micropuncture system Local Anesthesia Insertion of 21 g Needle 3 5/15/2017 Insertion of Micropuncture 018” Wire I mage courtesy of Oliv ier Pichot, MD 4 5/15/2017 Insertion of Micropuncture Sheath Laser Kit Dilator Removal 5 5/15/2017 035 Wire Insertion Removal of Microsheath 4 Fr Sheath Back-Loaded 6 5/15/2017 Sheath and Covered Fiber Fiber Position >2cm from the SFJ SFJ Tumescent Anesthesia 7 5/15/2017 Contents of the Saphenous Compartment Saphenous Eye Tumescent Anesthesia 500cc of Normal Saline Remove 55cc of fluid Add 50cc of 1% Lidocaine with epinephrine 1:100,000 Add 5cc of Sodium Bicarbonate Tumescent Halo 10mm • 10 mm diameter around vein • 10 mm between target vein & skin • 10cc/cm 10mm Purpose of Local Anesthesia •Protect against thermal skin injury •Provide local anesthesia along the treatment vein pathway 8 5/15/2017 Manual Tumescent Anesthesia Tumescent Anesthesia Tumescent Anesthesia 9 5/15/2017 Laser Pull Back •5-7 W 30-50J/cm Small Saphenous Vein Small Saphenous Vein Procedure ssv 10 5/15/2017 DUS SSV Skin Anesthesia 21 Gauge Needle Insertion 11 5/15/2017 018 wire Micropuncture sheath Upsize 035 wire 12 5/15/2017 4 Fr Sheath Placement of Sheath and Covered Fiber Fiber just before the SSV “dives” to the popliteal vein 2-3cms from the Junction Tumescent Anesthesia 13 5/15/2017 Pull Back • Watts 5-7 W •LEED 30-50 J/cm •6W ~50J/cm •8 secs/cm Laser Perforator Procedure 14 5/15/2017 15 5/15/2017 16 5/15/2017 SPOT WELD Laser set at 5W 5 sec X 2~50J/cm Weld in two places .5 cms So What Do We Know 17 5/15/2017 Hemoglobin based wavelengths produce more short term side effects than longer wavelengths Less side effects (pain, bruising) with 980nm than 810nm at the same watts Less side effects (pain, bruising) with 1320nm at 5 watts than at 8 watts Kabnick L. Outcome of different endovenous laser wavelengths for great saphenous vein ablation. J Vasc Surg. 2006 Jan;43(1):88-93. Proebstle TM, Moehler T, et al. Endovenous treatment of the great saphenous vein using a1320 nm Nd:YAG laser causes fewer side effects than using a 940 nm diode laser. Dermatol Surg. 2005 Dec;31(12):1678-83. Laser side effects •Most likely caused by laser induced vein wall perforation with extravasation of blood into the surrounding tissue •Perforations are more common with; • HSLW, higher power (watts), greater LEEDs Proebstle TM, Gul D, et al. Infrequent early recanalization of greater saphenous vein after endovenous laser treatment. J Vasc Surg 2003;38:511–516. Goldman MP, Mauricio M, et al. Intravascular 1320-nm laser closure of the great saphenous vein: a 6- to 12-month follow-up study. Dermatol Surg. 2004;30:13801385. Mundy L, Merlin TL, et al. Systematic review of endovenous laser treatment for varicose veins. Br J Surg 2005;92:1189–1194. EVLT: So What Else Do We Know? •Efficacy and Safety Profile: •Benchmark 97-99% efficacy •Randomized Control Trials: •VCSS scores improved •QOL improved • Murad et al; J Vasc Surg 2010 • Shepherd et al, Br J Surg 2010 18 5/15/2017 6 Randomized Controlled Trials •1 EVLA, RFA, sclerotherapy, surgery •1 EVLA, sclerotherapy •2 EVLA, sclerotherapy, surgery •1 RFA, glue embolization •1 RFA, mechanochemical (MOCA) treatment Br J Surg. 2011 580 limbs, 500 patients Inclusion criteria • Symptomatic varicose veins with GSV reflux • C2 – C4 Exclusion criteria • Previous DVT • Axial deep venous reflux Primary Endpoint GSV Closure Patent GSV with Reflux 3 days EVLA N=144 n(%) RFA N=148 n(%) UGFS N=144 n(%) Stripping N=142 n(%) P value .053 0 (0) 0 (0) 3 (2.1) 4 (2.8) 1 month 1 (0.7) 0 (0) 2 (1.4) 3 (2.2) .20 1 year 7 (5.8) 6 (4.8) 20 (16) 4 (4.8) <.001 19 5/15/2017 30-day Complications EVLA N=144 RFA N=148 UGFS N=144 Stripping N=142 Deep vein thrombosis 0 0 1 1 Pulmonary embolism 0 0 1 0 Phlebitis* 4 12 17 5 Infection 0 1 4 1 Paraesthesia 3 6 2 5 Hyperpigmentation 3 8 8 6 Haemorrhage 1 0 1 1 Major Minor * P=.006 Disease Specific Quality of Life (AVVSS) P=NS WHICH IS MORE IMPORTANT FOR POSTOPERATIVE RECOVERY? LASER WAVELENGTH FIBERS 20 5/15/2017 Endovenous Laser Ablation H2O 1319/1320-nm 940-nm 980-nm 810-nm 1470-nm Hb What Do We Know About Fibers? Bare Covered Fiber Power density Courtesy AngioDynamics 21 5/15/2017 Presented at the Twenty-fourth Annual Meeting of the American Venous Forum, Orlando, Fla, February 8-11, 2012. Lowell S. Kabnick, MD, RPhS, FACS, Mikel Sadek, MD, FACS NYU Langone Medical Center, Division of Vascular Surgery, New York, NY 2016 The use of a JT fiber appeared to be more significant in reducing pain and bruising as compared to a longer wavelength. Moreover, the results appeared additive, and the cohort using 1470 nm with a JT fiber produced the best treatment outcomes. Additional study is required to confirm the efficacy and durability of the various iterations evaluated; however, these data should be taken into consideration when undertaking treatment with endovenous laser ablation. What is More Important? •Wavelength is Important •Fiber Type is Important •The Type of Fiber seems to be more important than the Laser Wavelength Concluding Remarks •Laser ablation is very versatile including spot welding •There is no significant difference between laser and RF in terms of •Efficacy • QOL •Safety profile •Clinical Equipoise 22 5/15/2017 Together 1470nm and covered fibers have a superior postoperative safety profile. Non-contact fibers: maybe the great equalizer in postoperative recovery between endothermal devices and wavelengths.j/cm? Is higher energy better? 23 5/15/2017 Micro-foam Therapy for Treatment of Superficial Venous Disease Paramjit “Romi” Chopra, MD Associate Professor, RUSH University, Midwest Institute for Minimally Invasive Therapies (MIMIT), Chicago, IL Disclosures SUPERFICIAL VENOUS DISEASE IS NOT UNCOMMON IS NOT BENIGN 1 5/15/2017 WHAT DO WE WANT? healthy strong, good looking legs without pain or discomfort Normal Anatomy & Physiology Venous AnatomyLower Extremity Venous Pump 2 5/15/2017 Anatomy PATHOPHYSIOLOGY • Pathologic: Valvular incompetence of the venous system. • Physiologic: Leaky valve syndrome, superficial valvular reflux Venous Hypertension Venous Reflux 3 5/15/2017 Obstruction V/S valvular Incompetence Reflux leading to Venous hypertension Foundational Principle • Regardless of the size or type of the vein Find the underlying source of the venous hypertension 4 5/15/2017 Foundational Principle Foundational principle Create a Map of venous hypertension 5 5/15/2017 Leaking perforators- Varicose veins www.themimit.com Medically Significant Venous Incompetence Disease Progression C1 : Telangiectasia C2 : Varicose veins C3 : Edema C4 : Lipodermatosclerosis or hyperpigmentation C5: Healed ulcer C6 : Active ulcer CEAP Classification1 CEAP = clinical, etiologic, anatomy, pathophysiologic classification of venous disorders 1. 2. 3. 4. Eklöf , B et al. Rev ision of the CEAP classif ication f or chronic v enous disorders: Consensus statement. Journal of Vascular Surgery . 2004 40(6): 1248-1252.. Labropoulos N, Leon L, Kwon S, et al. Study of the v enous ref lux progression. J Vasc Surg. 2005;41(2):291-295 Kaplan RM, et al. Quality of lif e in patients with chronic v enous disease: San Diego population study . J Vasc Surgery . 2003; 37:1047-53 Callam MJ et al., Chronic ulcer of the leg: clinical history . British Medical Journal. 1987; 294:1389-1391. Create a Map of venous hypertension C2 6 5/15/2017 Treatment Options • Relief of the hypertension • Conservative • Thermal Tumescent PLANNING AND COUNSELING • Planning the therapy – Detailed discussion – What’s the baseline – Establish the Goals of treatment • Healing a wound • Relief of symptoms • Counseling – – – – Timeline of therapy Realistic expectations Cost issues Long term follow-up – Pain, swelling etc • Cosmetic – Conservative therapy first Graduated Compression Therapy • is the cornerstone of the modern treatment of venous insufficiency • Properly fitted gradient compression stockings provide 30-40 or 40-50 mm Hg of compression at the ankle • sufficient to restore normal venous flow patterns in many or most patients with superficial venous reflux and to improve venous flow, even in patients with severe deep venous incompetence. 7 5/15/2017 Graduated Compression • Graduated compression of superficial veins • Allows blood to drain upwards • Decrease venous hypertension in legs www.mimit.org Interventions • Move to interventions if compression therapy not meeting the goals of therapy • Important to establish goals of therapy and timeline of expected improvement • The patient reached this degree of problem over a prolonged period – Important to emphasize that this will not all magically disappear www.mimit.org MICROFOAM THERAPY 8 5/15/2017 Polidocanol injectable foam is a Comprehensive Above and Below the Knee Intervention1 www.themimit.com Above Knee2 (Proximal GSV) • Endovenous thermal ablation • Stripping and ligation • (polidocanol injectable foam) Visible Varicosities 2 (GSV tributaries) • Ambulatory phlebectomy • PCF/Liquid sclerotherapy • (polidocanol injectable foam) Primary cause of symptoms PCF = physician-compounded foam 1. Todd et al,. Phlebology. 2013;1-11. Below Knee2 (Distal GSV) • PCF sclerotherapy • Some endovenous thermal ablation • Varithena® 2. Glov iczki P, et al. J Vasc Surg. 2011;539(suppl 5):2S-48S. CEAP 2 Medial thigh and leg Before After Before Lower leg After 9 5/15/2017 CEAP 6 CASE STUDY MICRO-FOAM THERAPY Polidocanol injectable foam Endovenous Microfoam Ablation Procedure www.themimit.com Catheter based endovascular procedure performed under ultrasound guidance • FDA approved as first line treatment for GSV Incompetence • Not adjunctive or subsequent to surgical ligation or thermal ablation • Does not require tumescent anesthesia • Physician performed18 step procedure • Procedure requires ≥ 2 professionals FDA agreed upon physician training Risk Management Plan (RMP) • Physician prerequisite of ≥ 100 vein cases within past two years & attestation of experience • Must complete four online training modules • Documented proficiency (exam) • Must successfully complete training program to gain access to product • BTG clinical specialist support is required for each physician’s initial cases 10 5/15/2017 Addressing a History of Decreased Efficacy with Physician Compounded Foam (PCF) • Historically, physician compounded foam has yielded poor performance in large diameter vessels such as the Great Saphenous Vein (GSV)1 • Why? – Variability in foam (differing compositions) – Low stability of foam 1. 2. Rasmussen et al, British Journal of Surgery 2011; 98: 1079-1087. Carugo et al, Phlebology , June 2015. www.themimit.com Chemical Ablative Properties Polidocanol injectable foam FDA approved • Manufactured drug/device under Good Manufacturing Practice (GMP) standards • Endovenous Microfoam Chemical Ablation Agent • Stable, low density, sterile, cohesive microfoam provides a two-step mechanism of action o o • o o • 65% O2 / 35% CO2 1:7 Liquid to gas ratio by volume Small consistent narrow bubble size o o o Displace blood from vein to be treated Chemically ablates endothelial layer Nitrogen Content <0.8% Median bubble size <100 μm No bubble >500 μm Little to no remaining surfactant after bubbles take their effect Polidocanol Liquid • • • • 1. FDA approved Manufactured via GMP Liquid Sclerosing Agent Indicated for uncomplicated spider and reticular veins (< 3 mm in diameter) 1 Polidocanol injectable foam PCF ® Physician compounded foam (PCF) • • • • Not FDA approved Non-GMP Extemporaneously compounded in the physician office setting using a variety of techniques, gases, active agents, and concentrations Final product is highly variable and operator dependent Asclera Full Perscribing Information , p. 1 Adverse Events Associated with PCF Significant Adverse Events have been reported with physician compounded foam 1,2,3 Why? • Large bubbles migrate in vasculature and block vessels downstream to treatment area • Large bubble migration is associated with Nitrogen content of the gas mixture used4 1. 2. 3. 4. Ceulen et al, New England Journal of Medicine, 2008: 358;14 Murad et al. J Vasc Surg. 2011;53 (suppl):49S; 2. Sarvananthan et al. J Vasc Surg. 2012;55:243; Bush et al. Phlebology. 2008;23:189 Eckmann, Dermatol Surgery, 2005: 31;636-343 11 5/15/2017 Polidocanol injectable foam Safety Profile • 60 high risk patients with confirmed right to left shunt treated with Polidocanol injectable foam • No evidence of lesion on diffusion weighted MRI sequence • No neurological symptoms • No elevation in cardiac troponin levels 1. Regan et al, Journal of Vascular Surgery 2011; 53: 131-138 Summary • Newer Non-thermal Non tumescent treatment options available • FDA approved • Safe • Effective • Faster and Better • Reimbursed by Insurance • Cost-effective 12 5/15/2017 VenaSealSapheonClosureSystemvs RadiofrequencyAblationforIncompetent GreatSaphenousVeins (VeClose) 36MonthResults andupdate 30 April 10:20-10:35 Now 5 min at moderate pace w/o video Antelope Canyon, AZ, USA Nick Morrison, MD, FACPh, FACS, RPhS President, International Union of Phlebology Morrison Vein Institute Phoenix, AZ, USA Disclosures Medtronic Research Grant Speakers Bureau/Consultant Pierre Fabre Speakers Bureau Medi Educational Grant Speakers Bureau Sedona, AZ, USA Morrison Training Institute Medical Director The procedure 1 5/15/2017 VENASEAL™ CLOSURE SYSTEM: PROCEDURE VenaSeal™ closure system Access GSV using catheter technique Compress cephalad to catheter Position catheter 5 cm from SFJ 4 VENASEAL™ CLOSURE SYSTEM: PROCEDURE Inject 0.10 cc adhesive into the vein, pull back 1 cm, inject 0.10 cc pull back 3 cm Compress 3 minutes Inject 0.10 cc, pull back 3 cm, compress for 30 seconds Repeat process throughout vein 5 ULTRASOUND VIEW OF VENASEAL™ CATHETER VenaSeal™ catheter image VenaSeal™ catheter during administration of adhesive Images courtesy of Dr. R. Raabe 6 2 5/15/2017 ULTRASOUND IMAGES 8 WEEKS POST TREATMENT VenaSeal™ Procedure Closure RFA Procedure Closure Images courtesy of Dr. R. Raabe 7 FEATURES OF THE VENASEAL™ PROCEDURE Eliminates need for tumescent anesthesia No risk of thermal injury No post treatment compression stockings needed1,2* Rapid return to normal activities No capital equipment 1. Almeida JI, et al. Two-year follow-up of first human use of cyanoacrylateadhesive for treatment of saphenousvein incompetence. Phlebology / Venous Forum of the Royal Society of Medicine 2014. 2. Proebstle TM, et al. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. Journal of Vascular Surgery: Venous and Lymphatic Disorders2015;3:2-7. *Some patients may benefit from compression stockings post procedure. 8 VeClose Study Overview Title VenaSeal Closure System vs. Radiofrequency Ablation for Incompetent Great Saphenous Veins Purpose Demonstrate the safety and effectiveness of the VenaSeal Closure System for the treatment of lower extremity truncal reflux compared to RFA (ClosureFAST system) Study Design US multi-center, randomized controlled IDE study. The study takes a non-inferiority approach to effectiveness for anatomical closure at 3 months. 36 months effectiveness assessed and compared across groups. Enrollment / Sites 242 (20 roll-in and 222 randomized) subjects enrolled at 10 study sites (Sept 2013) Follow-up Follow-up visits at 3 days post-procedure, 1, 3, 6, 12, 24 36 , and 60 months. Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94. 3 5/15/2017 VeClose Primary Endpoint Primary Endpoint Complete closure of the target vein at 3 months after index procedure as judged by the core laboratory. Complete closure is defined as Doppler ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5 cm. Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94. Intraoperative Pain evaluation : Following procedure, self rated pain experienced during 2 phases of the treatment procedure on a 0-10 NRS • Phase 1: From initial local anesthesia injection at the access site to venous access with the micro-access catheter • Phase 2: From introduction of the RFA or CAC catheter to completion of vein treatment and device removal Secondary Endpoints Ecchymosis at Day 3: Investigator assessment of ecchymosis along the treated area using a 0-5 point grading scale 0 - none 1 - involving <25% of the treatment area 2 - 25%-50% 3 - 50%-75% 4 - 75%-100% 5 - extension above or below the treatment segment CAC, cyanoacrylate closure; NRS, numeric rating scale; RFA, radiofrequency ablation Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94. Additional Endpoints Assessments related to venous disease severity: Change in VCSS scores Change in CEAP scores Assessments related to QoL: Change in AVVQ scores Change in EQ-5D TTO scores Comparison of adverse event rates related to target GSV AVVQ, aberdeen varicose vein questionnaire; CEAP, clinical-etiology-anatomy-pathophysiology classification; GSV, great saphenous vein; EQ-5D, euro quality of life-5D; QoL, quality of life; TTO, time trade-off; VCSS, vein clinical severity score. Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94. 4 5/15/2017 VeClose - Sites & Enrollments Site # Site Name PI # Enrolled Location Roll-in Randomized 11 Morrison Vein Institute Morrison Scottsdale, AZ 2 14 12 Vein Clinics of America King, Hlavcek Oakbrook Terrace, IL 2 19 13 Inovia Vein Specialty Center Jones Bend, OR 2 44 14 Lake Washington Vascular Gibson 2 58 16 Radiology Imaging Associates Spencer 17 GBK Cosmetic Laser Dermatology Goldman Bellevue, WA Greenwood Village, CO San Diego, CA 18 Prairie Education & Research Cooperative Kolluri, Matos Springfield, IL 2 9 19 Maryland Laser Skin & Vein Institute Weiss Hunt Valley, MD 2 17 McEnroe Virginia Beach, VA 2 24 Vasquez Amherst, NY 2 20 22 Vein Center of Virginia/Sentara Vascular Specialists Venous Institute of Buffalo 2 4 2 24 9 20 222 242 Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94. VeClose Study Design Enrolled (N=242) CAC Roll-In group Randomized (1:1) and Treated Subjects (N=20) Subjects (N=222) CAC (n=108) RFA (n=114) Evaluation of perioperative parameters Baseline Assessments Intraoperative pain Ecchymosis Follow up at Day 3; and at 1,3,6, 12, 24, 36, 60 months Reevaluation of clinical assessments and adverse events CAC – Cyanoacylate Closure; RFA, radiofrequency ablation Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94. Demographics and Baseline Characteristics Baseline Characteristics CAC (N=108) Age (years) 49.0 Body Mass Index 27.0 Mean GSV diameter (mm) Proximal 6.3 Mid-thigh 4.9 Mean Treatment Length 32.8 (108) (cm) Mean VCSS 5.5 ± 2.6 Mean AVVQ 18.9 ± 9.0 Mean EQ-5D TTO 0.935 ± 0.113 RFA (N=114) 50.5 27.0 6.6 5.1 P-value 0.34 0.95 0.15 0.28 35.1 (114) 0.17 5.6 ± 2.6 19.4 ± 9.9 0.918± 0.116 0.99 0.72 0.29 Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94. 15 5 5/15/2017 VeClose Pain Scores CAC (N=108) RFA (N=114) P-value Not applicable 272 - 1.6 2.7 0.1 1.2 N/A - During Vein Access 1.6 2.0 0.13 During Treatment 2.2 2.4 0.11 Tumescent Anesthesia Volume (mL) Lidocaine Use During Procedure (mL) Cyanoacrylate delivered, (mL) Intraoperative pain Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94. Total Dose of NSAIDs and Narcotic Use in First 24 Hrs Assessed at Day 3 Medication Use VenaSeal N (%) RFA N (%) P-Value No medication 86 (79.6%) 90 (78.9%) 1.00 0 1 (0.9%) Narcotic NSAIDs Hydrocodone Ibuprofen Aspirin Naproxen Other 17 (15.7%) 22 (19.3%) 1 (0.9%) 0 1 (0.9%) 1 (0.9%) 3 (2.8%) 1 (0.9%) 1.00 0.60 0.49 1.00 0.36 Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94. Secondary Endpoint : Ecchymosis at Day 3 100 90 Assessed by investigators with a 5-point scale on Day 3 80 70 67.6 60 50 48.2 VenaSeal 40 33.3 ClosureFast 26.9 30 20 14.0 10 2.8 1.9 3.5 0.9 0.9 25-50% 50-75% 75-100% 0 None <25% Subjects treated with VenaSeal™ system had significantly less ecchymosis at Day 3 compared to RFA (p< 0.01). Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94. 6 5/15/2017 Primary Endpoint: Rate of GSV closure at Month 3 Proportion of closure Complete occlusion, n (%) CAC (N=104) RFA (N=108) Roll-in (N=19) 103 (99.0) 103 (95.4) 19 (100) Incomplete occlusion, n (%) 1 (1) 5 (4.6) 0 (0) No. of patients lost during follow up, n (total) 4 (108) 6 (114) 1 (20) Complete closure defined as Doppler ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5 cm. This includes compressible segments with and without flow. Ultrasound exams used 2D imaging, color Doppler and pulsed Doppler. Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94. VeClose Primary Endpoint – Complete Closure VenaSeal RFA Day 3 Timepoint 100% (108) 99.1% (114) Month 1 100% (105) 87.3% (110) Month 3* 99% (104) 95.4% (108) Month 6 99% (101) 96.2% (105) Month 12 96.8% (95) 95.9% (97) Month 24 95.3% (86) Month 36 94% 94.4% (72) (84) 91.9% (74) 94.4% closure rates, demonstrating long term durability at 36 months; and continued, non-inferiority results to RFA (P=0.005) through 36 months. * Complete closure based on clinical site assessment. The month 3 core lab assessment with LOCF rates are 99.1% for VSCS and 95.6% for RFA with non-inferiority p-value of <.0001. 36 Month - Venous Clinical Severity Score (VCSS) VCSS demonstrated statistically significant improvement out to 6 months and sustained through 12, 24, and 36 month time points. 8 VCSS, Mean (SE) 6 RFA 1.69 ± 2.42 VS 1.25 ± 1.60 p-value = 0.5643* 4 Treatment VenaSeal RFA 2 108 108 105 104 114 114 110 108 101 105 0 6 1 3 95 97 12 87 84 72 74 24 36 Follow-up Months VCSS : an evaluative instrument that is responsive to changes in disease severity over time and in response to treatment p-value comparing change scores between VSCS and RFA was based on repeated measures analysis of variance. 7 5/15/2017 36 Month - Aberdeen Varicose Vein Questionnaire Subjects experienced statistically significant improvement from baseline and 25 improvement (decreasing total AVVQ score) over time through 36 months. AWQ, Mean (SE) 20 RFA 8.21 ± 7.76 VS 7.33 ± 6.19 p-value = 0.6778* 15 Treatment VenaSeal RFA 10 5 0 107 102 104 111 109 108 100 105 95 95 0 6 12 1 3 86 84 71 73 24 36 Follow-up Months AVVQ: a 13-question survey addressing physical symptoms, pain, ankle edema, ulcers, compression therapy use, and limitations on daily activities are examined, as well as the cosmetic effect of varicose veins and social issues. p-value comparing change scores between VSCS and RFA was based on repeated measures analysis of variance. 36 Month - EQ5D Results EQ-5D Health Thermometer, Mean (SE) Subjects experienced statistically significant improvement from baseline and improvement over time through 36 months. 100 VS 89.69 ± 12.00 RFA 88.09 ± 11.69 p-value = 0.8024* 80 Treatment VenaSeal RFA 70 108 105 104 114 110 108 99 105 95 97 0 6 12 1 3 87 84 72 74 24 36 Follow-up Months The EQ-5D includes single item measures of: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is coded using 3-levels (1 = no problems; 2 = some problems; 3 = severe problems). p-value comparing change scores between VSCS and RFA was based on repeated measures analysis of variance. Adverse Events Reported between 12 and 24 Months The majority of adverse events reported in the 12-24 month time period were determined to be unrelated to the treatment or the device across all groups. Adverse Events Reported Device Related # Reported Not Related to the Device Procedure Related Uncertain Not Related Uncertain VenaSeal 8 6 2* 5 1* RFA 4 4 0 4 0 Roll-In 2 2 0 2 0 *Erythema was reported in the medial thigh for 2 patients and a shin splint reported by 1 patient with VenaSeal. Etiology of these events could not be determined and/or directly related to treatment or device. 8 5/15/2017 36 Month Safety - Adverse Events Reported 24-36 Month AE Device or Procedure Reporting Adverse Events Reported CAC RFA Device/ Procedure Related 2* 0 *1. late onset of phlebitis, etiology unknown; 2. Scar (access site) device related VenaSeal AE’s from 0 to 36 months: No reports of deep vein thrombus No allergic events reported No unanticipated adverse events Most events occurred in the first 30 days, were mild and self-limiting Delayed adverse events were minimal to non-existent VeClose 36 Month Results Summary: ▪ VenaSeal™ procedure resulted in reported 94.4% closure rates, demonstrating continued, non-inferiority compared to RFA (P=0.005) through 36 months. ▪ VCSS, AVVQ and EQ-5D outcomes demonstrated statistically significant improvement from baseline with sustained results over time; no difference between treatment groups out to 36 months. • No reported DVT’s, allergic reactions, or other SAE’s in 36 months. Early events were mild and self-limiting; delayed events were uncommon. ▪ The VeClose RCT study, with its high level of clinical evidence and rigor continued to demonstrate the following for VenaSeal: • Safe, reliable, non-thermal, non-tumescent treatment option • Strong, consistent and durable results through 36 months The objectives of this analysis were to report the efficacy and safety outcomes of the VeClose roll-in (training) group treated with CAC by physicians who had received device use training but had no prior treatment experience with the technique and to compare the outcomes with those from the randomized RFA and CAC groups. Results: Mean procedure time 3 min longer 3-month closure rate – 100% Procedural pain, post-procedural QoL, adverse events similar to randomized group Conclusions: “Despite the physician’s lack of prior experience, initial treatment with CAC leads to comparable efficacy and safety results to RFA and is associated with a relatively short learning period”. Kolluri R, et al. J Vasc SurgVenous and Lym Dis 2016;4:407-415. 9 5/15/2017 Aim: Treatment of patients with large diameter veins (up to 20mm) and multiple incompetent vein segments in the same session Methods: 50 pts with GSV, SSV, and/or AASV No adjunctive tributary Rx No compression post procedure RTC 1,4 weeks Duplex, pain score, VCSS(r), AVVQ, return to work/normal activities Results: numerical pain rating scale 2.2 ± 1.8 All treated veins (48 great saphenous vein, 14 accessory saphenous veins, and 8 small saphenous veins) had complete closure Return to work/normal activities <1-2+ days Statistically significant improvement in VCSS, AVVQ Inflammation 20% Gibson K, et al. Vascular 2016. Jan 1:1708538116651014. doi: 10.1177/1708538116651014. [Epub ahead of print] Aim: Evaluate safety, efficacy, performance of endovenous cyanoacrylate ablate of GSV Methods: Primary outcome – GSV obliteration up to one year Secondary outcomes – VCSS, AVVQ, SF-36, Diameter of GSV, treatment length, pre-treatment clinical severity of VV used to predict recanalization Results: 57 GSVs in 29 pts Improved VCSS, AVVQ, SF-36 all improved at 1-month GSV closure rate 78.5% at 1-year No clinical recurrence at 1-year GSV diameter ≥ 8mm predictor of recanalization Chan YC, Law J, Cheung G, et al. Phlebology 2017.32(2).99-106 Aim: Mid-term safety and efficacy of endovenous cyanoacrylate ablation of GSV Methods: 38 patients Occlusion by duplex <5cms VCSS assessments Results: 94.7% occluded by Kaplan-Meier analysis 2 failures, 4 partial recanalization VCSS improved 21.1% thrombus extension – no VTE Almeida J, et al. Abstract. J Vasc Surg 2016;3(1):125. 10 5/15/2017 Aim: Explore feasibility of CAPE Methods: 33 incompetent perforator veins (IPV) in 27 legs in C3-C6 patients >0.34sec reflux ≥3mm diameter Occlusion thigh cuff to 70mmHg Results: 76% occlusion at 3-months 24% persistent reflux 9% wound infection No DVT Toonder IM, et al. Phlebology 29.49-54 Aim: Case report Methods: 73 y/0 male on Warfarin for Afib – INR 2.3 C4bS Ep As Pr Bleeding varicosities Reflux in deep venous system, SFJ, and GSV GSV 15 mm in diameter Results: 6-months – significant edema and symptoms Duplex – GSV recanalized up to 7.2mm diameter Treated with foam sclerotherapy Lane TRA, et al. J Vasc SurgVenous and Lym Dis 2013;1:298-300. Aim: Comparison of NBCA with EVLA in ablation of GSV Methods: Retrospective review of 339 non-randomized patients treated with NBCA or EVLA Results: Avg procedure time 7min vs 18min (NBCA vs EVLA) 12-month occlusion rates 98.6% vs 97.3% (NBCA vs EVLA) Fewer adverse events (pigmentation/phlebitis) with NBCA Koramaz I, et al. J Vasc SurgVenous and Lym Dis 2017 Mar;5(2):210-215 11 5/15/2017 Aim: Safety and efficacy of cyanoacrylate adhesive for GSV occlusion Methods: single-center prospective study of 62 pts Local anesthesia No NSAIDs Compression wrap for 1 day Successful occlusion <10cms recanalization Results: 6-months, 90% occlusion, 3.2% subtotal occlusion, 6.5% no occlusion <16% phlebitis (exact incidence not specified) Tekin A, et al. Ann Vasc Surg 2016;36:231-5 Aim: Prospective comparison of cyanoacrylate vs laser ablation Methods: 310 pts non-randomized w/o adjunctive therapy Primary endpoint: occlusion Secondary endpoints: procedure time, pain, ecchymosis at day 3, changes in VCSS, AVVQ Results: Procedure time, pain, and day 3 ecchymosis less with cyanoacrylate No paresthesia with cyanoacrylate, 2% with laser 1-month closure rates better with cyanoacrylate 12-month 95.8% cyanoacrylate, 92.2% laser VCSS, AVVQ improved similarly in both Bozkurt AK, et al. Phlebology 2016;31(1S):106-13. UIP World Congress 4-8 February, 2018 Melbourne, Australia www.uip2018.com 12 5/15/2017 Thank you for your kind attention Canyon Lake, Arizona nickmorrison2002@yahoo.com 13 5/15/2017 What’s new in RF ablation for Superficial venous disease Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship • • • • • • • Company • • • • • • • Grant/Research Support Consulting Fees/Honoraria Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit Company Names Company Names Company Names Company Names Vascular Device Partners Company Names Company Names Prevalence and Etiology of Venous Insufficiency Venous Reflux Disease Coronary Heart Disease Peripheral Arterial Disease <2% of 30MM patients with CVI are treated Congestive Heart Failure Stroke Annual U.S. Incidence U.S. Prevalence Cardiac Arrhythmias Heart Valve Disease 0 5 10 15 20 25 30 35 Millions of patients 1 5/15/2017 Photos courtesy of Rajabrata Sarkar, MD, PhD. Leading Competitors in the Venous insufficiency Treatment Device Market 2 5/15/2017 Compression Stockings Pain & Bruising Tumescent Anesthesia Thermal Non-thermal Radiofrequency Covidien MOCA Radiofrequency FP-system Varythema WSWL/HSLA Laser Cyanoacrilate Steam Ablation Vblock* VEnclose Balloon Occlusion Sclerotherapy 3 5/15/2017 van Eekeren et al. Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg 2012. Luebke T, BrunkwallJ J Cardiovasc Surg (Torino) 2008 Apri;49 (2) 4 5/15/2017 Van Den Bos R, Arends L, Kockbaert M, et al J Vasc Surg 2009, 49 230-239 Nesbit C, Eifel RK, Coyne P, Badi H et al Kalluri R, 5 5/15/2017 A. Naymana, , , I. Yildizb, N. Kocac, S. Denizd, M. Koplaya, L. Oguzkurte Conclusion Our results show that pre-procedure diameter of the GSV is the single risk factor for recanalization after RFA. Predictors of Recanalization of the Great Saphenous Vein in Randomized Controlled Trials 1 Year After Endovenous Thermal Ablation European Journal of Vascular and Endovascular Surgery Volume 52, Issue 2, August 2016, Pages 234–241 S.K. Van der Veldena, , , M. Lawaetzb, M.G.R. De Maeseneera, L. Hollesteina, T. Nijstena, R.R. van den Bosa, 6 5/15/2017 Product Features and Benefits • Switchable heating length between 10 cm or 2.5 cm • Fast treatments with 10 cm vein sections • 2.5 cm for precise treatment of short vein sections 2.5 cm 10 cm (default) • Small 6F profile • Flexible, steerable, and easy to navigate • Fast product setup and generator start up 7 5/15/2017 Typical 40cm thigh GSV vein 5cm Tributary plus 40cm GSV 3cm element 3x, plus 3cm element 17x, total of twenty 20-sec ablations Medtronic ClosureFast™ catheter 7cm heating element, seven 20sec ablations Venclose EVSRF™ catheter 10cm heating element, five 20-sec 2.5cm element 3x, plus 10cm element 5x, total of ablations eight 20-sec ablations 28% faster with Venclose 60% faster with Venclose 8
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