Kathleen Gibson, MD. Lake Washington Vascular Surgeons Bellevue, WA

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1 Cyanoacrylate Closure of Incompetent Great, Small and Accessory Saphenous Veins without the use of Post-Procedure Compression: a Post-Market Evaluation of the VenaSeal System (WAVES trial): Three Month Data Kathleen Gibson, MD Lake Washington Vascular Surgeons Bellevue, WA

2 Disclosures/Acknowledgements Consultant for BTG and Medtronic, Principal investigator for BTG, Medtronic, Angiodynamics, and Bayer, Speaker s Bureau for BMS Study was investigator initiated and protocol authored by investigator, but funded with a grant from Medtronic

3 WAVES Study Overview Purpose Demonstrate the safety and effectiveness, of the VenaSeal Closure System for the treatment of one or more incompetent truncal veins (GSV, SSV, AASV) in a single setting with no compression stockings Study Design US single-center, multiple provider. Vein closure, VCSS, AVVQ, pain, and return to normal activities and work assessed Enrollment / Sites 50 subjects enrolled at a single site, 5 providers, 3 previously participated in VeClose trial Follow-up Follow-up visits at one week, one month and three months post procedure. 12 month follow up in process.

4 WAVES Primary Endpoint Primary Endpoint Complete closure of the primary target vein at 3 months after index. 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.

5 Secondary Endpoints Secondary Endpoints Intraoperative Pain evaluation and evaluation of pain at each visit: Following procedure, self rated pain experienced during 2 phases of the treatment procedure on a 0-10 NRS Return to work (days), return to full normal activity (including full exercise routine)

6 Additional Endpoints Assessments related to venous disease severity: Change in VCSS scores Change in CEAP clinical class Assessments related to QoL: Change in AVVQ scores Change in EQ-5D scores Comparison of adverse event rates in relationship to days to work and normal activities Comparison of predicted and actual need for adjunctive treatment at treatment day and at 3 months

7 Differences from VeClose Trial Veins up to 20 mm allowed (12 mm for VeClose) Could treat multiple segments in one session Length of epifascial segments tracked Pain scores beyond the day of the procedure CEAP clinical class 5 allowed No compression stockings

8 Demographics and Baseline Characteristics Baseline Characteristics Mean, + SD (range) Age (years) 49.5 ± 12.1 (26-68) Body Mass Index 26.9 ± 5.5 ( ) Gender (female) 35 (70%) Mean largest GSV diameter (mm) 10.0 ± 3.8 ( ) Mean largest SSV diameter (mm) 5.1 ± 2.6 ( ) Mean ASV diameter (mm) 8.1 ± 2.4 ( ) Mean VCSS 6.5 ± 2.4 (3-14) Mean AVVQ 17.3 ± 7.9 ( ) Veclose: CEAP Clinical class ± C2: 56% C3: 30% C4:14% C2 18 (36%) C3 14 (28%) C4 a/b 17 (34%) C5: Excluded C5 1 (2%) 8

9 Treated Veins-Length, Volume and Closure N Length (cm) Volume Cyanoacrylate (cc) Duplex Closure 1 month Duplex Closure 3 Months GSV (100%) 48 (100%) ASV (100%) 13 (93%) SSV (100%) 8 (100%) All (100%) 69 (99%) 12 patients had epifascial (superficial) segments treated, mean length 16cm ± 9.8 cm (range 3-32 cm)

10 Procedure Duration Mean ± SD (range) Procedure duration Minutes 1 treated vein (11-43) 2 treated veins (13-54) 3 treated veins 55 (one case) All (11-55) No side branch/concomitant procedures allowed until after 3 month visit

11 Pain Procedure Mean ± SD (range) Procedural pain (NRS 0-10) During Access (0-8) During procedure (0-8) Post-procedure pain 1 week (0-7)* 1 month (0-4)* *NRS % patients had a pain score of 0 at one week 86% had a pain score of 0 at one month

12 Quality of Life Indices Baseline 30 days 3 months P value (baseline- 3 mo) rvcss 6.5 ± 2.4 (3-14) 1.8 ± 1.4 (0-6) 1.8 ± 1.4 (0-6) <.001 AVVQ 17.3 ± 7.9 ( ) 8.9 ± 6.6 (0-24.8) 6.5 ± 7.2 (0-28.1) <.001 EQ VAS 84 ± 12 (30-100) 88.3 ± 8.7 (65-100) 88.6 ± 10.6 (40-100).002 rvcss, revised Venous Clinical Severity Score; AVVQ, Aberdeen Varicose Vein Questionnaire; EQ VAS, EQ Visual Analogue Scale.

13 Multivariate Analysis: Duration, rvcss, AVVQ Dependent variable Predictors Coeff. P value Procedure Duration Physician Experience # segments treated Vein length < rvcss change (30 days) Baseline rvcss Baseline CEAP < AVVQ change (30 days) Physician Experience # segments treated Largest diameter Subfascial length Suprafascial length

14 Time to Return to Work and Normal Activities Normal activities = return to all normal activities including exercise routine Mean return to work the day after procedure: days Mean return to normal activities: days

15 Multivariate Analysis-Return to Work & Normal Activity Dependent variable Predictors Coeff. P value Return to work Age Length of GSV treated Baseline CEAP Return to normal activity Body Mass Index Phlebitis post treatment Length of GSV treated Volume of CA delivered < <.001

16 Adverse Events Reaction When noted When resolved Notes Vasovagal reaction During procedure After procedure Hives (body) Within 1 week One week Steroids given Gastroenteritis 2 days 4 days Not related Thrombus extension Phlebitis* P1 P2 P3 One week Two weeks 2 mm, asymptomatic Number Present at 1 mo P1: Pain and tenderness over target vein P2: Pain and tenderness over tributary veins P3: Nonspecific erythematous reaction

17 Impact of Phlebitis 7 day NRS 30 day NRS Return to work (days) Return to normal activity (days) Phlebitis ± ± 3.7 No Phlebitis ± ± 4.2 P value <.001* * Difference driven by two patients with high pain scores

18 Need for Adjunctive Procedures Physicians asked to estimate how many phlebectomy incisions and/or injection sites would be needed if done at same time of truncal closure Actual treatments performed at three month visits recorded (performed after 3 mo data acquisition) Patients had discretion to accept or decline adjunctive procedures, only actual procedures done counted Procedure score=# phlebectomies x2 + # injections

19 Need for Adjunctive Procedures Predicted Actual P-value Phlebectomy 37 (74%) 7 (14%).0001 Sclerotherapy 45 (90%) 33 (66%).018 Any procedure 48 (96%) 33 (66%).0001

20 Predicted v. Actual Procedure Score Predicted score Actual Score

21 Conclusions Rate of closure not lower without the use of compression compared to the VeClose trial (99% for both) No difference in closure rates, rvcss, in patients with and without multiply treated segments. AVVQ improvement greater with larger diameters and multiple segments treated. Multiple segment treatment, vein diameter, treatment below knee, and epifascial segments did not increase time to work or normal activities Extent of adjunctive procedures needed at 3 months less than predicted by treating physicians

22 Summary: WAVES Three Month Results At three months 99% of treated veins showed complete closure with duplex ultrasound VCSS, AVVQ and EQ5D outcomes demonstrate statistically significant improvement. Return to work was short, as was return to normal activities Phlebitis was the most common adverse event, but it was in most cases of short duration, with impact on normal activities, but not return to work Treatment of multiple segments in one setting, large veins, and superficial veins as well as the SSV feasible, safe Further follow-up data being analyzed (one year)

23 THANK YOU!

24 Cyanoacrylate Closure of Incompetent Great, Small and Accessory Saphenous Veins without the use of Post-Procedure Compression: a Post-Market Evaluation of the VenaSeal System (WAVES trial): Three Month Data Kathleen Gibson, MD Lake Washington Vascular Surgeons Bellevue, WA

Kathleen Gibson, MD FACS Lake Washington Vascular Surgeons, Bellevue, WA, USA

Kathleen Gibson, MD FACS Lake Washington Vascular Surgeons, Bellevue, WA, USA Cyanoacrylate Closure of Incompetent Great, Small and Accessory Saphenous Veins without the use of Post-Procedure Compression: Post-Market Evaluation of the VenaSeal System (WAVES trial): 12 Month Data

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