Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous vein
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1 Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous vein Raghu Kolluri, MD, Director Vascular Medicine OhioHealth Riverside Methodist Hospital Columbus, OH
2 Disclosures Current Medtronic Consultant/ Speaker Bard Data Safety Committee Cook Consultant Volcano Consultant Boston Scientific Consultant/ Speaker
3 Adhesives in Medicine 1 Date Use Cyanoacrylate Adhesives s Wound adhesives Histoacryl Blue * 1980s Skin incisions Dermabond * 1998 Skin incisions/ lacerations Ethicon OMNEX * 1998 Surgical adhesives Trufill * 2000 Indermil * 2002 Liquid Embolic System, AVM embolization Skin incisions/ lacerations 1 Not a complete listing 2. Pollak J, White R. The use of cyanoacrylate adhesives in peripheral embolization. J Vasc Interv Radiol 2001; 12: p.908
4 Cyanoacrylate Use in vascular Vascular closing agent for:! Cerebral Arteriovenous malformations (AVM)! Pelvic congestion syndrome and Varicoceles! Gastric varices! Aortic aneurysms
5 VenaSeal Closure System CYANOCRYLATE ADHESIVE TO CLOSE THE DISEASED VEIN! Proprietary formulation of advanced medical cyanoacrylate-based adhesive! Proprietary catheter engineered to be inert to adhesive doesn t stick! Proprietary dispenser gun designed to deliver adhesive precisely DC
6 Properties of Ideal Cyanoacrylate for Venous Closure! Ideal viscosity! Polymerize quickly! Soft and elastic (dynamic part of body)! Maintains a strong bond
7 VenaSeal Closure System PROCEDURE VenaSeal Closure System Access GSV using catheter technique Position catheter 5 cm from SFJ Compress cephalad to catheter
8 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
9 Ultrasound Images 8 weeks post treatment VenaSeal Procedure Closure RFA Procedure Closure Images courtesy of Dr. R. Raabe
10 Clinical Studies with VenaSeal System Feasibility Study! 38 Patients, enrollment completed August 2011! 1, 3, 6, 12, 24 and 36 month follow-ups! Primary endpoint: Safety: rate of serious adverse events, Efficacy: vein closure during follow-up escope (European multicenter study)! 70 patients, enrollment completed September 2012! 2 day, 1, 3, 6, 12, 24 and 36 month follow-ups! Primary endpoint: closure w/o use of sedation, tumescent anesthesia,or compression stockings VeClose (U.S. pivotal trial) V LOSE! 242 patients, enrollment completed September 2013! 3 day, 1, 3, 6, 12 months & 2, 3 year follow-ups! Primary endpoint: non-inferior to RFA in GSV closure! Secondary endpoint: superiority in reduction of post procedural pain and bruising
11 Feasibility Study Results FOLLOW-UP THROUGH 36-MONTHS Sample Size Rate of Occlusion 1-Year 1 N=36 92% 2-Year 2 N=29 92% 3-Year 3 N=29 92% Sample Size VCSS Scores Baseline N= Year1 N= Year3 N= Year3 N= Almeida, J et al., First human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. JVS: Venous and Lymphatic Disorders 2013;1: 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 Almeida J. Three-year follow-up of first human us of cyanoacrylate adhesive for treatment of saphenous vein incompetence. AVF 2015
12 escope EUROPEAN MULTI-CENTER STUDY Study Design! Prospective, non-randomized, multicenter study! To evaluate safety, efficacy of the VenaSeal closure system for the treatment of refluxing great saphenous veins! 70 patients enrolled! Follow-up assessments at 48 hours, 1, 3, 6, 12, 24 and 36 months! Duplex ultrasound closure without use of sedation, tumescent anesthesia or compression stockings Endpoint No adjunctive treatments for 3 months Proebstle TM, Alm J, Dimitri S et al. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. Journal of Vascular Surgery: Venous and Lymphatic Disorders. J Vasc Surg: Venous and Lym Dis 2015;3:2-7.
13 escope Study- Results FOLLOW-UP THROUGH 12-MONTHS Follow-up Time Rate of Occlusion 6-Month 94.3% 12-Month 92.9% Mean VCSS Scores Baseline Month 1.1 Proebstle TM, Alm J, Dimitri S et al. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. Journal of Vascular Surgery: Venous and Lymphatic Disorders. J Vasc Surg: Venous and Lym Dis 2015;3:2-7.
14 VeClose U.S. PIVOTAL TRIAL Study Design! Prospective, randomized 1:1 comparing VenaSeal system (VS) 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. Subjects! 242 patients were enrolled! 20 Roll-in/Training on VSCS, the rest randomized to! 108 VSCS, 114 RFA = Randomized Cohort Morrison N, Gibson K, McEnroe S, Goldman M, King t, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). Journal of Vascular Surgery 2015; 61:
15 VeClose (U.S. PIVOTAL TRIAL) Primary Endpoint! Duplex ultrasound determined closure of the GSV, non-inferiority of VenaSeal closure system to RFA with the ClosureFast catheter Secondary Endpoints! Intraoperative pain, rated on a 0-10 numeric rating scale! Ecchymosis at day 3, rated on a 0-5 ordinal scale! Adverse events at 1 month Follow-up occurred at! Day 3, and! 1, 6 and 12 months post-procedure & 2, 3 year follow ups No adjunctive therapy before 3 months Morrison N, Gibson K, McEnroe S, Goldman M, King t, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). Journal of Vascular Surgery 2015; 61:
16 Follow-up Compliance Through 12-Months 190 Subjects completed the 12-month visit 222 Subjects Randomized (1:1) and Treated VSCS N=108 1-Month Followup Compliance N=105 3-Month Followup Compliance N=104 6-Month Followup Compliance N= Month Follow-up Compliance N=95 RFA N=114 1-Month Followup Compliance N=110 3-Month Followup Compliance N=108 6-Month Followup Compliance N= Month Follow-up Compliance N=95 Morrison N. Use Of Cyanoacrylate Adhesive For Treatment Of Incompetent Great Saphenous Veins: 12-month Results of the VeClose Trial. European Venous Forum. 2015
17 VeClose Results BASELINE CHARACTERISTICS VSCS (N=108) RFA (N=114) P-value Age (years) Body Mass Index Mean GSV diameter (mm) Mean Treatment Length (cm) Proximal Mid-thigh (108) 35.1 (114) 0.17 Mean VCSS 5.5 ± ± Mean AVVQ 18.9 ± ± Mean EQ-5D TTO ± ± VCSS: Venous Clinical Severity Score; AVVQ: Aberdeen Varicose Vein Questionnaire
18 VeClose Results PROCEDURAL CHARACTERISTICS AND INTRAOPERATIVE PAIN Tumescent Anesthesia Volume (ml) Lidocaine Use During Procedure (ml) Cyanoacrylate delivered, (ml) Intraoperative pain During Vein Access VSCS (N=108) Not applicable RFA (N=114) P-value Not applicable During Treatment
19 VeClose Results ECCHYMOSIS AT DAY 3 Percent VCSC RFA 67,6 48,2 33,3 26,9 14,0 2,8 1,9 3,5 0,9 0,9 None <25% 25-50% 50-75% % Ecchymosis at Day 3 Ecchymosis assessed by investigators with a 5-point scale on Day 3. Subjects treated with VenaSeal system had significantly less ecchymosis at Day 3 compared to RFA (p< 0.01 Wilcoxon test).
20 VeClose Complete Closure Definition Sites and CoreLab Complete closure = Doppler ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5 cm. Ultrasound exams used 2D imaging, Color Doppler and Pulsed Doppler.
21 VeClose Results 3 MONTH ENDPOINT DATA 3 month closure data were adjudicated by an independent ultrasound core laboratory (VasCore) Data supported non-inferiority of the VSCS procedure compared to RFA 3 Month Visit (CoreLab data)* VSCS RFA P-value % 99% 96% Number with Non-Closure (>5cm) 1 5 <0.01 *There was complete agreement between sites and the CoreLab. Both were blinded to the results from each other. Predictive method for imputing missing data was utilized for analysis.
22 VeClose Results KAPLAN-MEIER ANALYSIS OF CLOSURE THROUGH 12-MONTHS Closure Rate at 12-months VSCS 97.2% RFA 97.1% VSCS RFA Morrison N. Use Of Cyanoacrylate Adhesive For Treatment Of Incompetent Great Saphenous Veins: 12-month Results of the VeClose Trial. European Venous Forum. 2015
23 VeClose Results TIME TO RECANALIZATION OF THE TARGET VEIN 97.0% 91.7% Survival Free from Recanalization at 12- Months VSCS 97.0% RFA 91.7% VSCS P< for non-inferiority RFA Morrison N. Use Of Cyanoacrylate Adhesive For Treatment Of Incompetent Great Saphenous Veins: 12-month Results of the VeClose Trial. European Venous Forum. 2015
24 VeClose Results VCSS MEAN & (SD) BY VISIT AND TREATMENT VCSS, Mean (SE) VSCS RFA Baseline 1-Month 3-Month 6-Month 12-Month Follow-Up Morrison N, et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). Journal of vascular surgery 2015.
25 VeClose Results AVVQ MEAN & (SD) BY VISIT AND TREATMENT AVVQ, Mean (SE) VSCS RFA Baseline 1-Month 3-Month 6-Month 12-Month Follow-Up Morrison N, et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). Journal of vascular surgery 2015.
26 VeClose Results EQ-5D MEAN & (SD) BY VISIT AND TREATMENT 1 EQ-5D, Mean (SD) 0,95 0,9 0, VSCS RFA 0,8 Baseline 1-Month 3-Month 6-Month 12-Month Follow-up Morrison N, et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). Journal of vascular surgery 2015.
27 VeClose Results ADVERSE EVENTS THROUGH 6 MONTHS *No serious AEs were categorized as device and/or procedure-related VSCS (N=108) RFA (N=114) P-value # Subjects with events (%) 34 (31%) 29 (25%) NS Reported AEs Phlebitis, any zone 22 (20.4%) 16 (14.0%) Phlebitis in treatment zone 11 (10.2%) 10 (8.8%) Phlebitis not in treatment zone 8 (7.4%) 4 (3.5%) Phlebitis in both treatment zone and non-treatment zone 1 (0.9%) 1 (0.9%) 1.0 Paresthesia in treatment zone 3 (2.8%) 3 (2.6%) 1.0 Stocking irritation 2 (1.9%) 3 (2.6%) 1.0 Access site infection 1 (0.9%) 1 (0.9%) 1.0 Superficial thrombophlebitis 4 (3.7%) 3. (2.6%) Access site burn 0 (0%) 1 (0.9%) 1.0 Paresthesia not in treatment zone 0 (0%) 1 (0.9%) 1.0 Paresthesia in treatment zone 3 (2.8%) 3 (2.6%) 1.0 Morrison N. Use Of Cyanoacrylate Adhesive For Treatment Of Incompetent Great Saphenous Veins: 12- month Results of the VeClose Trial. European Venous Forum. 2015
28 Summary of Clinical Evidence with VenaSeal System! The VenaSeal procedure is safe and effective, (three clinical trials)! High closure rate: 92% in Feasibility study through 3 year follow-up, 92.9% at 12 months in escope study and 97.2% in VeClose trial at 12 months.! Acceptable safety profile: Side effects are minor and infrequent.! Use of the VenaSeal system does not require post procedure compression stockings as shown in FIH and escope studies.
29 Thank you
30 Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous vein Raghu Kolluri, MD, Director Vascular Medicine OhioHealth Riverside Methodist Hospital Columbus, OH
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Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided
Al-Metwaly Ragab Ibrahim Vascular Surgery; Al-Azhar faculty of Medicine- New Damietta, Egypt.
International Journal of Basic and applied Sciences. Vol. 4. No. 4. 2015. Pp. 259-264 Copyright by CRDEEP Journals. All Rights Reserved Full Length Research Paper Comparative Study between Endovenous Laser
From the American Venous Forum. Thomas Michael Proebstle, MD, MSc, a Thomas Moehler, b and Sylvia Herdemann, MD, a,b Heidelberg and Mainz, Germany
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MedStar Health, Inc. POLICY AND PROCEDURE MANUAL Policy Number: MP.066.MH Last Review Date: 11/08/2018 Effective Date: 01/01/2019
MedStar Health, Inc. POLICY AND PROCEDURE MANUAL This policy applies to the following lines of business: MedStar Employee (Select) MedStar CareFirst PPO MedStar Health considers the treatment of Varicose
Table XI. Reference Abstracts corresponding to references can be found using the listing RCTs by alphabetical order or RCTs by topic.
Table XI. Operative procedure EVLA with different wavelengths HL+ EVLA EVLA without HL EVLA GSV ablation AK GSV ablation AK+BK Reference Abstracts corresponding to references can be found using the listing
Page 1. Ruling out deep venous obstruction prior to superficial vein treatment. Disclosures. Indications for saphenous vein ablation (SVA)
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MEDICAL POLICY SUBJECT: VARICOSITIES, TREATMENT ALTERNATIVES TO VEIN STRIPPING AND LIGATION. POLICY NUMBER: CATEGORY: Technology Assessment
MEDICAL POLICY PAGE: 1 OF: 9 If the member's subscriber contract excludes coverage for a specific service it is not covered under that contract. In such cases, medical policy criteria are not applied.
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Three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great saphenous vein with or without treatment of calf varicosities Thomas M. Proebstle, MD, PhD, a
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Phlebogriffe a new device for mechanochemical ablation of incompetent saphenous veins: a pilot study
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Treatment of Varicose Veins/Venous Insufficiency Corporate Medical Policy
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