venaseal: slightly modified protocol may improve outcome in large diameter varicose … · outcome...
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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