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 Kathleen Gibson, MD FACS Lake Washington Vascular Surgeons, Bellevue, WA, USA
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, three months and one year
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.
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)
Additional Endpoints Assessments related to venous disease severity: Change in VCSS scores 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
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
Demographics and Baseline Characteristics Baseline Characteristics Mean, + SD (range) Age (years) 49.5 ± 12.1 (26-68) Body Mass Index 26.9 ± 5.5 (18.0-40.0) Gender (female) 35 (70%) Mean largest GSV diameter (mm) 10.0 ± 3.8 (4.0-20.0) Mean largest SSV diameter (mm) 5.1 ± 2.6 (4.0-12.7) Mean ASV diameter (mm) 8.1 ± 2.4 (3.6-11.6) Mean VCSS 6.5 ± 2.4 (3-14) VeClose: C2: 56% C3: 30% C4:14% C5: Excluded Mean AVVQ 17.3 ± 7.9 (2.5-47.1) CEAP Clinical class 0.935 ± 0.113 C2 18 (36%) C3 14 (28%) C4 a/b 17 (34%) C5 1 (2%) 7
Treated Veins-Length, Volume and Closure N (Start/ 12 mos) Length (cm) Volume Cyanoacry late (cc) Duplex Closure 1 month Duplex Closure 3 Months Duplex Closure 12 Months GSV 48/43 42 + 16 1.6 + 0.6 ASV 14/12 13 + 4 0.6 + 0.1 48 (100%) 14 (100%) SSV 8/8 17 + 5 0.6 + 0.3 8 (100%) All 70/63 47 + 19 1.7 + 0.7 70 (100%) 48 (100%) 13 (93%) 8 (100%) 69 (99%) 43(100%) 11(92%) 8 (100%) 62(98%) 12 patients had epifascial (superficial) segments treated, mean length 16cm ± 9.8 cm (range 3-32 cm)
Pain Procedure Procedural pain (NRS 0-10) Mean ± SD (range) During Access 2.0 + 1.9 (0-8) During procedure 2.1 + 1.8 (0-8) Post-procedure pain 1 week 1.6 + 1.8 (0-7)* 1 month 0.3 + 0.8 (0-4)* *NRS 0-10 34% patients had a pain score of 0 at one week 86% had a pain score of 0 at one month
VCSS and Quality of Life Indices Baseline 30 days 3 months 12 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) 1.1 ± 1.3 (0-4) <.001 AVVQ 17.3 ± 7.9 (2.5-47.1) 8.9 ± 6.6 (0-24.8) 6.5 ± 7.2 (0-28.1) 5.6 ± 7.3 (0-38.1) <.001 EQ VAS 84 ± 12 (30-100) 88.3 ± 8.7 (65-100) 88.6 ± 10.6 (40-100) 90.1 ± 10.1 (45-100).002 rvcss, revised Venous Clinical Severity Score; AVVQ, Aberdeen Varicose Vein Questionnaire; EQ VAS, EQ Visual Analogue Scale.
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: 0.2 + 1.1 days Mean return to normal activities: 2.4 + 4.1 days
Patient Satisfaction at One Year 45/50 patients returned for follow up 35 completely satisfied 9 somewhat satisfied 1 dissatisfied but would do procedure again
Adverse Events: 3 to 12 Months One episode of non-treatment zone thrombophlebitis One recurrent itchy rash at one year Patient with rash after initial treatment Responded to course of oral steroids Workup by allergist Reacted to skin test Vein excised with three small incisions
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
Need for Adjunctive Procedures Predicted Actual-3 months 3-12 months P-value Phlebectom y Sclerothera py Any procedure Procedure score (avg, std dev) 37 (74%) 7 (14%) 0.0001 45 (90%) 33 (66%) 4 (8%).018 48 (96%) 33 (66%) 4(8%).0001 17.5 + 12.7 3.1 + 6.8 ---.0001
Predicted v. Actual Procedure Score 50 45 40 Predicted score Actual Score 35 30 25 20 15 10 5 0 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49
Conclusions Closure rate remains high at 12 months, despite including large veins (up to 20 mm), multiple segments, and the SSV Patients had continued improvement in VCSS, AVVQ between 3 and 12 months New adverse events were infrequent between 3 and 12 months-possible allergy should be listed in informed consent Patient satisfaction was high
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