US and Turkish Glue for varicose vein: is there a …cacvsarchives.org/archivesite/2016/pdf/presentations...CSS, (SE) Follow-Up VSCS RFA 108 114 105 110 104 108 101 105 95 97 Morrison

US and Turkish Glue for varicose vein: is there a difference?

CACVS meeting 2016

Ian J Franklin

Consultant Vascular Surgeon

London, UK

Conflict of interest: none Disclosures: none

www.londonvascularclinic.com

Two glues

• VenaSeal (Medtronic) • Variclose (Biolas)


“Non-thermal-non-tumescent”

VenaSeal (Medtronic) and Variclose (Biolas) similarities

• Both acrylocyanate glue

• Appear to have same mechanism of action

• Identical delivery systems


VenaSeal (Medtronic) and Variclose (Biolas) differences

• Viscosity and feel

• Technique

• Evidence


VenaSeal

• Sapheon

• Covidien

• Medtronic

Rod Raabe



http://www.google.co.uk/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://www.biolas.net/products/details/38/50/156/variclose&ei=DGVxVYqrGcv-ULbzgJgF&bvm=bv.95039771,d.d24&psig=AFQjCNEvgAJjcmKQNossbu7ytrbReOE2Qw&ust=1433581180281007

https://www.google.co.uk/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=https://18reasons.org/classes-events/2015-03-01/flavors-istanbul&ei=vWRxVeeTHIqsU_6GgOgJ&bvm=bv.95039771,d.d24&psig=AFQjCNHf5oLQWUQPBeBluLF-xeP0Zb0VPA&ust=1433581053938876

Variclose glue

• N-butyl acrylocyanate glue

• Formulated for intravascular use

• CE mark awarded


http://www.google.co.uk/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://www.biolas.net/products/details/38/50/156/variclose&ei=DGVxVYqrGcv-ULbzgJgF&bvm=bv.95039771,d.d24&psig=AFQjCNEvgAJjcmKQNossbu7ytrbReOE2Qw&ust=1433581180281007

Viscosity

• VenaSeal (Medtronic)

–Like honey

–Soft after polymerisation

• Variclose (Biolas)

–More like water

–Harder after polymerisation


Endovenous glue: technique


Positioning


– 5cm back from junction


– 3cm back from junction


Pullback


–Segmental


–Continuous


VenaSeal (Medtronic) pull-back sequence

• Compress the Proximal GSV and SFJ

• Dispense two doses (0.1 ml) of glue 1 cm apart

• Immediately pull back another 3cm

• Compress 3 minutes


• Dispense further doses 3cm apart with 30 seconds pressure over each one (+/- ultrasound to localise)


VenaSeal (Medtronic) pull-back sequence


Variclose (Biolas) pullback Continuous pull back at 2cm per second Squeeze trigger every 5 seconds/10cm

Treated Saphenofemoral Junction


Before After (1week)


Timing of tributary treatment

Pitfalls (Biolas)

• Bubbles in GSV from flushing air


Pitfalls (Biolas and Medtronic)

• Multiple trunks:

– Potential to glue the catheter inside the introducer


Clinical data


–Lots of data


–Little published data at present


Clinical Studies with the VenaSealSystem

242 patients enrolled in 2013 Primary endpoint: GSV closure at 3 months (non-

inferiority study) Secondary endpoint: ecchymosis and patient-

reported pain

VeClose (U.S. pivotal trial)

V LOSE

38 Patients treated in 2011

Safety and efficacy

92% closure maintained out to 3 years

Improved VCSS

Feasibility

Study

70 patients treated in 2012

Primary endpoint: GSV closure at follow-up

93% occlusion at 1 year

Improved VCSS

eSCOPE (European

multicenter study)

VeClose (prospective RCT)


VeClose RCT Results Bruising at Day 3

Less bruising with glue (p<0.01)

67,6

26,9

2,8 1,9 0,9

48,2

33,3

14,0

3,5 0,9 0

10

20

30

40

50

60

70

80

90

100

None <25% 25-50% 50-75% 75-100%

Ecchymosis at Day 3

Pe

rce

nt

VenaSeal ClosureFast


© 2015 Medtronic, plc All rights reserved. 10086845DOC 1B

VeClose Results 3 Month Endpoint Data

Data supported non-inferiority of the VSCS procedure compared to RFA

3 Month Visit (CoreLab data)*

VenaSeal (N=108)

RFA (N=104)

P-value

99% 96%

<0.01 Number with Non-

Closure (>5cm) 1 5


VeClose Results Time to Recanalization of the Target Vein

Free from Recanalization at 12-Months

VenaSeal 97.0% P<0.0001 for non-

inferiority RFA 91.7%


Morrison N. 12-month Results of the VeClose Trial. European Venous Forum. 2015

© 2015 Medtronic, plc All rights reserved. 10086845DOC 1B

VeClose Results

VCSS Mean & (SD) by Visit and Treatment

0

1

2

3

4

5

6

7

Baseline 1-Month 3-Month 6-Month 12-Month

VC

SS, M

ean

(SE

)

Follow-Up

VSCS

RFA

108 114

105 110

104 108

101 105

95 97


Morrison N. 12-month Results of the VeClose Trial. European Venous Forum. 2015

(No adjuctive procedures before 3 months)

VeClose Results Adverse Events Through 6-Months

Venaseal (N=108)

RFA (N=114)

P-value

# Subjects with events (%) 34 (31%) 29 (25%) NS

Reported AEs

Phlebitis, any zone

Phlebitis in treatment zone

Phlebitis not in treatment zone

Phlebitis in both treatment zone

and non-treatment zone

22 (20.4%)

11 (10.2%)

8 (7.4%)

1 (0.9%)

16 (14.0%)

10 (8.8%)

4 (3.5%)

1 (0.9%)

0.3571

0.8199

0.2430

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%) 0.7157

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

NO SAEs were categorized as device- and/or procedure-related


Variclose (Biolas) data (unpublished)

• Yasim et al

– 180 patients

– 3-7 month follow up, no recanalisations

– VCSS reduced from mean of 10.2 to 3.9

• Calik et al

– 181 patients

– 97% occlusion at 6 months


Unpublished RCT: Bozkurt et al

• 310 patients randomised

• Variclose glue versus 1470 radial laser

• Primary endpoint: occlusion of target GSV anything over 5cm considered failure


Unpublished RCT: Bozkurt et al

• Mean GSV diameter 7.2 mm

• Mean length treated 30 cm

• No serious adverse events

• 4% paraesthesia in EVLT group

• Closure rate: 92% EVLT and 95% glue at one year

• Similar VCSS and AVVQ improvement in both groups


Glue differences


–Viscous

–Segmental pullback

–Lots of data


–Runny

–Continuous pullback

–Little data



Documents

US and Turkish Glue for varicose vein: is there a …cacvsarchives.org/archivesite/2016/pdf/presentations...CSS, (SE) Follow-Up VSCS RFA 108 114 105 110 104 108 101 105 95 97 Morrison