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VeClose trialCyanoacylate closure vs. RF ablation 36-month results
LINC 2018, Leipzig 31st Jan 2018Tobias Hirsch, Halle, Germany
www.gefaessmedizin-hirsch.de
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Disclosure
Tobias Hirsch
I have the following potential conflicts of interest to report:
Consulting (Medtronic, Sigvaris, L+R, Medi, Bauerfeind)
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
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Thermal ablation
USA: American Venous Forum 2011 UK: NICE Guidelines 2013
is standard
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USA: American Venous Forum 2011 UK: NICE Guidelines 2013
High occlusion rate!Laser: 93.0% (3yr)
RFA: 93.2%
Stripping: 93.5%
Rasmussen et al., JVascSurg 2013
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USA: American Venous Forum 2011 UK: NICE Guidelines 2013
High occlusion rate!Laser: 84.8% (5yr)
RFA: 88.7%
Stripping: 93.5%
Balint et al., Vascular 2016 (862 articles, 17 RCT)
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Laser: 12 devices940nm532 – 2100nm1320nm1470nm(810nm)Bare fibreRadialRadial 2ring
RFA: 3 systemsClosureFastTM
RFiTT®EVRF® FCare
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Do we need more methodsand devices?
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Thermal ablation has side effects
Heat Tumescent anesthesia
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Thermal ablation has side effects
NeedleHeat Tumescent anesthesia
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Thermal ablation has side effects
NeedleHeat Tumescent anesthesia
Pain
Hyperpigmentation
Risk of nerve damage
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Non-thermal ablation using adhesive closure
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Methyl 2-cyanoacrylate 1960s nerve lesions
Isobutyl 2-cyanoacrylate 1970s wound closure
N-octyl-cyanoacrylate 1996 wound closure
N-butyl 2-cyanoacrylate 1989 intravascular use
History
Adhesive closure
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Methyl 2-cyanoacrylate 1960s nerve lesions
Isobutyl 2-cyanoacrylate 1970s wound closure
N-octyl-cyanoacrylate 1996 wound closure
N-butyl 2-cyanoacrylate 2011 VenasealTM
History
Adhesive closure
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Occlusion rate
Adhesive closure
Hirsch T, Phlebologie 2017(46)143-7
90,3-100,0%
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VeClose Study
Morrison N, Gibson K, McEnroe S et al., J Vasc Surg 2015. 61.985-94
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Overview
VeClose Study
Morrison N, Gibson K, McEnroe S et al., J Vasc Surg 2015. 61.985-94
TitleVenaSeal Closure System vs. Radiofrequency Ablation for Incompetent Great Saphenous Veins
PurposeDemonstrate the safety and effectiveness of the VenaSeal Closure System for the treatment of lower extremity truncal reflux compared to RFA (ClosureFASTTM 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. Effectiveness at 36 months is assessed and compared across groups.
Enrollment Sites
242 (20 roll-in and 222 randomized) subjects enrolled at 10 study sites (Sept 2013)
Follow-upFollow-up visits at 3 days post-procedure, 1, 3, 6, 12, 24, 36 and 60 months.
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Sites and Enrollments
VeClose Study
Morrison N, Gibson K, McEnroe S et al., J Vasc Surg 2015. 61.985-94
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.
SecondaryEndpoints
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
Ecchymosis at Day 3:Investigator assessment of ecchymosis along the treated area using a 0-5 point grading scale 0 - none1 - involving <25% of the treatment area2 - 25%-50%3 - 50%-75%4 - 75%-100%5 - extension above or below the treatment segment
Site # Site Name PI LocationRoll-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 Bellevue, WA 2 58
16 Radiology Imaging Associates Spencer Greenwood Village, CO 2 4
17 GBK Cosmetic Laser Dermatology Goldman San Diego, CA 2 24
18 Prairie Education & Research Cooperative Kolluri, Matos Springfield, IL 2 9
19 Maryland Laser Skin & Vein Institute Weiss Hunt Valley, MD 2 17
20 Vein Center of Virginia/Sentara Vascular Specialists
McEnroe Virginia Beach, VA 2 24
22 Venous Institute of Buffalo Vasquez Amherst, NY 2 9
20 222
242
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Endpoints
VeClose Study
Morrison N, Gibson K, McEnroe S et al., J Vasc Surg 2015. 61.985-94
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 a Doppler ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5 cm.
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Endpoints
VeClose Study
Morrison N, Gibson K, McEnroe S et al., J Vasc Surg 2015. 61.985-94
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.
SecondaryEndpoints
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
Ecchymosis at day 3:Investigator assessment of ecchymosis along the treated area using a point scale of 0-5
0 - none1 - involving <25% of the treatment area2 - 25%-50%3 - 50%-75%4 - 75%-100%5 - extension above or below the treatment segment
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Endpoints
VeClose Study
Morrison N, Gibson K, McEnroe S et al., 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-Pathophysiologyclassification; GSV, great saphenous vein; EQ-5D, EuroQoL 5 Dimension; QoL, Quality of Life; TTO, time trade-off; VCSS, vein clinical severity score.
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Design
VeClose Study
Morrison N, Gibson K, McEnroe S et al., J Vasc Surg 2015. 61.985-94
Enrolled (N=242)
RFA (n=114)CAC (n=108)
Randomized (1:1) and treatedSubjects (N=222)
Follow up at day 3; and at 1,3,6, 12, 24, 36, 60 months
CAC Roll-In groupSubjects (N=20)
Baseline assessments
Intraoperative pain
Reevaluation of clinical assessments and adverse events
Evaluation of perioperative parameters
Ecchymosis
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Demographic and Baseline Characteristics
VeClose Study
Morrison N, Gibson K, McEnroe S et al., J Vasc Surg 2015. 61.985-94
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.
Baseline Characteristics CAC (N=108)
RFA (N=114)
P-value
Age (years) 49.0 50.5 0.34
Body Mass Index 27.0 27.0 0.95
Mean GSV diameter (mm)
Proximal 6.3 6.6 0.15
Mid-thigh 4.9 5.1 0.28
Mean treatment length (cm) 32.8 (108) 35.1 (114) 0.17
Mean VCSS 5.5 ± 2.6 5.6 ± 2.6 0.99
Mean AVVQ 18.9 ± 9.0 19.4 ± 9.9 0.72
Mean EQ-5D TTO 0.935 ± 0.113 0.918± 0.116 0.29
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Pain Scores
VeClose Study
Morrison N, Gibson K, McEnroe S et al., J Vasc Surg 2015. 61.985-94
CAC (N=108)
RFA (N=114)
P-value
Tumescent anesthesia volume (mL)
Not applicable
272 -
Lidocaine use (mL) 1.6 2.7 0.1
Cyanoacrylate delivered (mL) 1.2 N/A -
Intraoperative pain
During vein access 1.6 2.0 0.13
During treatment 2.2 2.4 0.11
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Ecchymosis at Day 3
VeClose Study
Morrison N, Gibson K, McEnroe S et al., J Vasc Surg 2015. 61.985-94
Assessed by investigators with a 5-point scale on day 3
Subjects treated with VenaSeal™
system had significantly less ecchymosis on day 3 compared to RFA (p< 0.01).
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Primary Endpoint – Complete Closure
VeClose Study
Morrison N, Gibson K, McEnroe S et al., J Vasc Surg 2015. 61.985-94
Time Point 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 12 96.8% (95) 95.9% (97)
Month 24 95.3% (86) 94% (84)
Month 36 94.4% (72) 91.9% (74)
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Primary endpoint – Complete Closure
VeClose Study
Morrison N, Gibson K, McEnroe S et al., J Vasc Surg 2015. 61.985-94
Time Point 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 12 96.8% (95) 95.9% (97)
Month 24 95.3% (86) 94% (84)
Month 36 94.4% (72) 91.9% (74)
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Primary endpoint – Complete Closure
VeClose Study
Morrison N, Gibson K, McEnroe S et al., J Vasc Surg 2015. 61.985-94
Month 36 94.4% (72) 91.9% (74)
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VCSS: disease severity over time
VeClose Study
Morrison N, Gibson K, McEnroe S et al., J Vasc Surg 2015. 61.985-94
0 1 3 6 12 24 36
2
4
6
8
Follow-up Months
VC
SS
, M
ea
n (
SE
)
108
114
105
110
104
108
9
5
9
7
87
84
72
74
101
105
108
114
RFA 1.69 ± 2.42
VS 1.25 ± 1.60
p=0.5643
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AVVQ: pain, edema, skin changes, compression use
VeClose Study
Morrison N, Gibson K, McEnroe S et al., J Vasc Surg 2015. 61.985-94
RFA 8.21 ± 7.76
VS 7.33 ± 6.19
p=0.6778
0
5
1
0
1
5
2
0
2
5
0 1 3 6 12 24 36
107
111
102
109
104
108
100
105
95
95
86
84
71
73
Follow-up Months
AW
Q,
Me
an
(S
E)
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EQ-5D: mobility, self-care, usual activities, pain, anxiety
VeClose Study
Morrison N, Gibson K, McEnroe S et al., J Vasc Surg 2015. 61.985-94
VS 89.69 ± 12.00
RFA 88.09 ± 11.66
p=0.8024
0 1 3 6 12 24 36
70
80
100
Follow-up Months
EQ
-5D
Hea
lth
Th
erm
om
ete
r, M
ea
n (
SE
)
108
114
105
110
104
108
99
105
95
97
87
84
72
74
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Adverse Events
VeClose Study
Morrison N, Gibson K, McEnroe S et al., J Vasc Surg 2015. 61.985-94
24-36 Month AE Device or Procedure Reporting
Adverse Events Reported Device/ Procedure Related
CAC 2 (phlebitis, scar at access site)
RFA 0
VenaSeal AEs from 0 to 36 months:No reports of deep vein thrombusNo allergic events reportedNo unanticipated adverse eventsMost events occurred in the first 30 days, were mild and self-limitingDelayed adverse events were minimal to non-existent
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Objectives: Efficacy and safety outcomes of the VeCloseroll-in (training) group vs. randomized CAC/RFA
Results: Mean procedure 3min longer
3-month closure rate – 100%
Procedural pain, post-procedural QoL, AE similar
of clinical study of CAC for incompetent GSV
Roll-in Phase Analysis
Kolluri R, et al. J Vasc Surg and Lym Dis 2016;4;407-15
“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.”
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1. VenaSeal™ procedure resulted in a reported closure rate of 94.4%, demonstrating continued, non-inferiority compared to RFA (P=0.005)
2. VCSS, AVVQ and EQ-5D outcomes demonstrated statistically significant improvement from baseline with sustained results over time; no difference between treatment groups
3. No reported DVTs, allergic reactions, or other SAEs. Early events were mild and self-limiting; delayed events were uncommon
4. VenaSeal™ is easy to learn
Summary at 36 Months
VeClose Study
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Thank you for your attention!
Tobias HirschVein Competency Centre Hallewww.gefaessmedizin-hirsch.de
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See you at the social dinner!
Tobias Hirschand his marvellous ”Valentine B”Live at Moritzbastei Feb 1st 2018