陳燿志Yiu-Che CHAN

MB BS (London) BSc MD (London) FRCS (England)

FRCS (General Surgery) FCSHK

香港大學外科學系血管外科Division of Vascular & Endovascular Surgery, Department of Surgery,

University of Hong Kong Medical Centre,

Queen Mary Hospital, Hong Kong.

VenaSeal: slightly modified protocol

may improve outcome

in large diameter varicose veins

Disclosure

Speaker name:

....................Yiu Che CHAN.............................................................

I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interestX

Endovenous Cyanoacrylate Glue

Venaseal™ Sapheon Closure System, Sapheon Inc(Santa Rosa, USA) now Medtronic, Gorway, Ireland)

• A new modality for treating varicose veins with medical adhesive without thermal energy– European Conformite Europeen (CE) Mark

approval in September 2011

– United States FDA approved February 2015

– Hong Kong is the first place in Asia

– HKU is first centre in Asia to use this

– Medtronic’s VenaSeal closure system has been granted pre-market approval (PMA) from the US FDA November 2015

• The VenaSeal™ closure system is now commercially available in Europe, Australia, HongKong, Singapore, New Zealand, and Canada, Dubai... 氰基丙烯酸酯

European J Vasc & Endovasc Surg 2013 Feb;45(2):176-7.

• Local anesthetic infiltration at puncture site

Local anesthetic infiltration at puncture site, head up position and

and ultrasound guided venous micropuncture (4Fr sheath)

Remove air bubbles from syringe, then connect to

white catheter and attach to the gun

Inject cyanoacrylate into catheter

until the black marking near the tip

Gun downward

facing to avoid

air bubbles

Gun downward

pointing to

avoid air

bubbles,

catheter

upward

pointing

Measure sheath - the tip of the sheath

is 4cm from the SFJ (IFU 5cm). Insertion of guidewire beyond the SFJ under u/s

The tip of the sheath is 4cm from the

saphenofemoral junction (IFU 5cm)

When the catheter reaches the black marking, withdraw the blue

sheath to expose tip of catheter to be 4cm from SFJ (IFU 5cm)- fine

adjustment under ultrasound guidance

Catheter Glue Dispenser gun

Two injections of approximately 0.09 milliliters were given 1 cm apart 4cm from SFJ, followed by

a 3-minutes period of local compression, and then repeated injections every 3 cm with 30-second

hand compression until the entire length of the target vein segment was treated .

All the patients have pre-operative venous duplex

Post-procedure duplex follow up

Distance from SFJ

Outcome MeasuresPrimary Outcome Measures

• Procedure success rate- saphenous vein obliteration rate

• Cumulative probability of recurrent varicose veins within 24 months after treatment, with serial clinical and duplex examination of patient at 1 week, 3 months, 6 months, (1 year, 2 years).

• Definition of complete closure– Doppler ultrasound examination showing closure along entire treated

target vein segment with any discrete segments of patency

Secondary Outcome Measures at pre-op, 1 week post op, 3 months post op, 6 months post-op.

• Pain Score (at discharge) 0-10

• Quality of life Questionnaires (SF36) assessment of pain, edema, venous claudication, pigmentation, lipodermatosclerosis, ulcer size)

• Venous clinical severity score (VCSS)

• Aberdeen varicose vein questionnaire (AVVQ)

• Ecchymosis score (at 1 week: mild, moderate, severe)

• Side-effects or major events from this treatment modality

Garrett AM. BMJ. 1993; 306: 1440-1444.

Carroll C. Health Technol Assess. 2013; 17: i-xvi, 1-141.

Garrett AM. Qual Health Care. 1993; 2: 5-10.

Chan YC , Law Y, Cheung GC, Ting AC, Cheng SW. Phlebology. 2017 Mar;32(2):99-106.

57 incompetent GSVs in 29 patients

VeClose

6.3/4.9 mm

upper and

mid-thigh

•Closure rates (n=57)

1 week 100%

1 month 95.3%

6 months 90.3%

12 months 78.5%

< 8mm diameter

>=8mm diameter

Predictors of Recanalisation

(Cox Regression analysis)

*

Chan YC et al. Journal of Vascular Interventional Radiology 2017;28(5):665-671.

(n=108 legs)

Chan YC et al. Journal of Vascular Interventional

2017;28(5):665-671.

Successful GSV (n=108) Closure over Time

Treatment length <28cm vs >=28cm Competent vs incompetent perforators

(Log-rank test, p=0.116) (Log-rank test, p=0.364)

Successful GSV (n=108) Closure over Time

Simple (C3) vs Complicated C4-6) Varicose Veins Consultants vs Fellows/ Trainees

(Log-rank test, p=0.221) (Log-rank test, p=0.771)

Cox Regression analysis

< 6.6 mm

≥ 6.6 mm

Log rank: p = 0.010

<6.6 mm >=6.6 mm

n 67 48

1 week 61 98.4% 47 100.0%

1 month 60 98.4% 40 89.3%

6 months 52 96.6% 37 84.8%

12 months 35 94.7% 25 79.5%

24 months 6 78.2% 8 67.9%

Successful GSV (n=108) Closure over Time

Great Saphenous Vein Diameter

Chan YC et al. Journal of Vascular Interventional Radiology 2017;28(5):665-671.

Patterns of

Recanalisation

• All of the recanalisation

were continuous with

the SFJ except for 3

cases with

recanalisation at one-

year Duplex follow up

where

– two cases were from mid

to lower thigh

– one was at mid thigh at

level of perforator

Recanalisation continuous with SFJ 6 months

Recanalisation in mid-thigh with SFJ 12 months

Vascular 2017 April; 25(2): 149-156.

Gibson K. WAVES Study. Vascular 2017 April; 25(2): 149-156.

Normal protocol ‘One extra drop’

since 21st July 2016

SFJ SFJ

Overall closure rates of 173 legs

< 8 mm, normal protocol

≥ 8 mm, normal protocol

Log Rank: p<0.001

Overall closure rates

≥ 8 mm, extra-drop

protocol (n=48)

≥ 8 mm, normal protocol

Log Rank: p=0.012

Overall closure rates

≥ 8 mm, extra-drop

protocol

< 8 mm, normal protocol

Log Rank: p=0.462

Overall closure rates

No DVT cases

• The mean length of the GSV stump in

closed GSV (for GSV <8mm diameter, n>=8mm

diameter- normal protocol, and n>=8mm diameter-“extra-

drop” protocol ) at 1-week and 6-months

– 2.18, 2.95, 2.07 cm at week 1

– 2.33, 4.59, 2.74 cm at 6 months

– Thombus extension from GSV to deep vein

appeared in 4, 2, and 3 legs respectively,

– The “extra-drop protocol” did not predispose

to development of post-procedure deep vein

thrombosis

EHIT 3

Week 1 duplex: Thrombus – LMWH - No thrombus 4 days later

Summary

• Endovenous cyanoacrylate treatment is safe and effective

• A GSV diameter of >=8mm,

and >=6.6mm were

statistically significant

predictors for late

recanalization– with great majority seemed to be from the SFJ

downward

• Our modified “extra-drop”

proctocol have improved the

closure rates for GSV >=8mm

– did not predispose to

development of thrombus

extrusion into the deep vein or

deep vein thrombosis

陳燿志Yiu-Che CHAN

MB BS (London) BSc MD (London) FRCS (England)

FRCS (General Surgery) FCSHK

香港大學外科學系血管外科Division of Vascular & Endovascular Surgery, Department of Surgery,

University of Hong Kong Medical Centre,

Queen Mary Hospital, Hong Kong.

VenaSeal: slightly modified protocol

may improve outcome

in large diameter varicose veins