Management of Superficial Reflux: Which option, when? Kathleen Gibson, MD Lake Washington Vascular Surgeons Bellevue, WA

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1 Management of Superficial Reflux: Which option, when? Kathleen Gibson, MD Lake Washington Vascular Surgeons Bellevue, WA

2 DISCLOSURES Kathleen Gibson, MD Consultant/Advisory Board: BTG, Medtronic Speakers Bureau: BMS Research Grants: AngioDynamics, Bard, Bayer

3 Saphenous ablation Endothermal Nonthermal nontumescent Radiofrequency Laser (multiple wavelengths) Proprietary endovenous microfoam (PEM) Mechanicochemical ablation (MOCA) Nonthermal nontumescent nonsclerosant Cyanoacrylate adhesive

4 Endothermal ablation Durable, excellent efficacy-15 years Safety profile well established Disposables can be expensive Capital equipment outlay for generator Requires tumescent anesthesia Doesn t address large side branches Sedation optimal in some patients

5 Radiofrequency Ablation 7cm heating element Shaft markings are 2.5cm apart 5 Covidien May 25, 2017 CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

6 F (ClosureFast ) Catheter Study: Occlusion Rates Through 5 Years 96.6% 90.0% Time 1 Year 2 Years 3 Years 4 Years 5 Years Vein Occlusion 96.6% 94.3% 92.8% 91.1% 90.0% Std Error 0.9% 1.2% 1.4% 1.5% 1.7% # Limbs Remaining Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (Veith Symposium) New York City; November 19, Covidien May 25, 2017

7 Endothermal laser ablation Constant pullback Various fiber types/sizes (radial, bare tip) Variable tips (covered/not covered) Water targeting v. Hemoglobin targeting wavelengths

8 Endovenous Laser Ablation - Treatment Overview How does EVLA work? Energy delivered through glass fiber into vein Absorbed by blood and tissue Creates thrombotic occlusion Wavelengths Hemoglobin-Targeted 810nm, 940nm, 980nm, and 1040nm wavelengths are designed to target hemoglobin in blood and create thrombus within the vessel. Water-Targeted 1320nm and 1470 nm wavelengths are designed to target water in the vessel. Marketed by some laser companies as more comfortable for patients due to less bruising or swelling as compared to lasers that target hemoglobin. Laser fibers Bare fiber Radial fiber Covered fiber 8 Covidien May 25, 2017

9 asmussen EVLT Study: Occlusion Rates Through 5 Years 94.2% 81.2% Time 1 Year 3 Years 5 Years # Limbs Remaining Rasmussen L, et al, Randomized clinical trial comparing endovenous laser ablation and stripping of the great saphenous vein with clinical and duplex outcome after 5 years, JVS Covidien May 25, 2017

10 Nonthermal Nontumescent Proprietary Endovenous Microfoam(Varithena, BTG PLC) Mechano-chemical ablation (Clarivein, Vascular Insights) uses sclerosant Cyanoacrylate adhesive (Venaseal, Medtronic)

11 Nonendothermal ablation Short term efficacy variable, but comparable to endothermal Safety profile well established Disposables can be expensive No capital equipment outlay for generator No tumescent anesthesia All but PEM do not address large side branches Sedation almost never needed Post compression not needed with cyanoacrylate No risk of burns, nerve injury

12 Nerve proximity! Not scary Scary

13 PEM A combination device to generate pharmaceutical-grade microfoam Delivers reproducible microfoam with small bubble size and narrow bubble size distribution Highly stable, similar to air-based sclerosing foams Benefits in vivo of an ultra-low N 2, CO 2 -O 2 based gas formulation Image courtesy of BTG International

14 Proprietary Endovenous Microfoam Two pivotal Phase III trials completed- Primary endpoints- change in patient symptoms Secondary endpoints-improvement in appearance (pt and blinded assessor) Tertiary endpoints-duplex elim. of reflux, change in VCSS and VEINES SYM/QOL All endpts highly statistically significant compared to placebo

15 Elimination of reflux Placebo PEM 0.125% Control PEM 0.5% PEM 1% Pooled PEM (0.5% + 1.0%) 2% 60% 83% 86% 85% Comparison vs. PEM 0.125% p= p= p=0.0002

16 PEM: Recent Literature Author/Journal Year N Follow up Gibson, Phlebology Todd, JVS Venous Lymphat Disord , 8, 12 weeks Closure rates 90% at 4 weeks (Varithena) Comment Randomized to Varithena v. Placebo. Significant improvement in pt symptoms and appearance in Varithena group year 73% Significant and maintained improvement in pt symptoms and appearance

17 Mechanico-chemical ablation (Clarivein )-MOCA Combination endovenous mechanical and chemical Mechanical wire > rotates > intimal damage Chemical liquid > penetrates > scar End result venous occlusion slide courtesy of Steve Elias, MD

18 MOCA: Mechanism of action slide courtesy of Steve Elias, MD

19 Elias-Completed Trial * 30 limbs, GSV only, no tumescence or sedation C2 24 C3 2 C4 4 All closed except 1 st patient btw 3-6mos 6 month 29/30 (96%) 12 month 29/30 (96%) 24 month 27/28 (96%) ( 1 died,1 no US yet) *Elias S, Raines JK. Mechanochemical tumescentless endovenous Endovenous ablation: final results of the initial clinical trial. Phlebology;27:67-72.

20 MOCA: Recent Literature Author/Journal Year N Follow up Witte, J Endovasc Ther Deijen, Phlebology Closure rates Comment , 2, 3 yrs 92%, 90%, 87% AVVQ, VCSS improvement, but deteriorate from 2 to 3 yrs ,12 wks 90% Failures assoc. with SFJ incompetence van Eekeren, JVS yr 88.2% Significant improvement in QOL

21 Cyanoacrylate Closure System VenaSeal Sapheon Closure System 1) Access GSV using catheter technique 2) Position 5 cm from SFJ 3) Compress cephalad to catheter

22 VeClose Primary Endpoint Complete Closure Timepoint VenaSeal RFA Day 3 100% (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 % (95) 95.9% (97) Month % (86) 94% (84) Month % (72) 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. Gibson K, VECLOSE 36 month results presented at Charing Cross, London; April 24, 2017

23 36 Month - Aberdeen Varicose Vein Questionnaire Subjects experienced statistically significant improvement from baseline and improvement 25 (decreasing total AVVQ score) over time through 36 months. AWQ, Mean (SE) RFA 8.21 ± 7.76 VS 7.33 ± 6.19 p-value = * Treatment VenaSeal RFA 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

24 CAC*: Recent Literature Author/Journal Year N Follow up Kolluri, JVS Venous Lymphat Disord Closure rates Comment months 100% Roll-in patients from VeClose, significant QOL and VCSS improvement Gibson, Vascular mo, 3 mos, 1 year 100%, 99%, 98% WAVES trial: included SSV, AASV, and large veins up to 20 mm. Significant QOL and VCSS improvement *Other CAC systems are available outside US, and are not FDA approved

25 Closure comparisons ClosureFast Study, Veclose study Rasmussen Study VANISH 2 Study Elias Study, Witte Study Veclose study Modality RFA EVLT PEM MOCA CAC Short term 96.6% one year Long term 91.9% at 3 years and at 5 years 94.2% one year 81.2% at 5 years 87.9% 8 weeks 73% at one year 96% one year 87% at 3 years 96.8% one year 94.4% at 3 years

26 > 12 mm vein (modified IFU) Which technique is superior? Modality RFA EVLT PEM MOCA CAC Standard GSV Tortuous Below knee SSV +/- +/-

27 Summary Lots of excellent choices for treatment of the saphenous veins In order to replace existing technologies, the new technologies must have: Good safety profile (yes) Close, better, or acceptable efficacy (yes) $ outlay to get started must be reasonable (mixed) Must have FDA approval (yes) Ideally, will have own reimbursement codes or ability to use existing ablation codes (yes/coming) If insurance coverage tightens, the technology most economical to the patient may win!

28 Trial Comparing EVLA, RFA, Foam Sclerotherapy and Surgical Stripping for GSV: Rasmussen Study Study Design Prospective, randomized study conducted at two surgical centers Subjects 500 patients (580 limbs) with GSV reflux were randomized to receive either Endovenous Laser Ablation Radiofrequency Ablation Ultrasound Foam Sclerotherapy Surgical Stripping 980nm (17 patients) and 1470nm (108 patients) 125 patients 124 patients 124 patients Follow-up Patients assessed at 3 days, 1 month, and 1 year post-intervention Rasmussen et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. BJS 2011;98: Covidien May 25, 2017

29 Trial Comparing EVLA, RFA, Foam Sclerotherapy and Surgical Stripping for GSV: Rasmussen Study Primary endpoint GSV closure expressed in vessel patency (treatment failure) one year post procedure Secondary endpoints Pain scores post intervention-visual analog scale 0-10 Scores of SF-36 * Aberdeen Varicose Vein Symptom severity Score (AVVSS) Venous Clinical Severity Score (VCSS) Rasmussen et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. BJS 2011;98: Covidien May 25, 2017

30 Rasmussen Study - Results Efficacy at 1 year (reflux-free rate) Post Intervention Pain Scores* (1 10) Time to return to normal activities (days) Time to resume work (days) Indirect cost ( ) Lost work RF Ablation (n=124*) Endovenous Laser Ablation (n=124*) Vein Stripping (n=123*) Ultrasound-Guided Foam Sclerotherapy (n=123*) 95.2% 94.2% 95.2% 83.7% (p<0.001) 1.21 (p<0.001) 1 (p<0.001) 2.9 (p<0.001) (p<0.001) (p<0.001) (p<0.001) Total costs ( ) *In the 10-day period post-procedure. Rasmussen et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. BJS 2011;98: Covidien May 25, 2017

31 Rasmussen Study Patient Experience Post Treatment RFA (n=124*) EVLA (n=124*) P<0.001 P<0.001 P<0.001 Post Intervention Pain Score* (1-10) *In the 10-day period post-procedure. Time to return to normal activitied (days) Time to resume work (days) Rasmussen et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. BJS 2011;98: Covidien May 25, 2017

32 Rasmussen Study- Summary qrf thermal ablation was superior to EVLA in the following qsignificantly less pain with use of RFA vs. EVLA qfaster return to activities and work for patients treated with RFA vs. EVLA qof note, although not an endpoint of the study, the authors concluded anecdotally that they observed no differences between the two laser wavelengths (980nm/17 patients and 1470nm laser/108 patients) used in the study Rasmussen et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. BJS 2011;98: Covidien May 25, 2017

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