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
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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
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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
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European J Vasc & Endovasc Surg 2013 Feb;45(2):176-7.
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• Local anesthetic infiltration at puncture site
Local anesthetic infiltration at puncture site, head up position and
and ultrasound guided venous micropuncture (4Fr sheath)
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Remove air bubbles from syringe, then connect to
white catheter and attach to the gun
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Inject cyanoacrylate into catheter
until the black marking near the tip
Gun downward
facing to avoid
air bubbles
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Gun downward
pointing to
avoid air
bubbles,
catheter
upward
pointing
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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)
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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
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Catheter Glue Dispenser gun
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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 .
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All the patients have pre-operative venous duplex
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Post-procedure duplex follow up
Distance from SFJ
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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.
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Chan YC , Law Y, Cheung GC, Ting AC, Cheng SW. Phlebology. 2017 Mar;32(2):99-106.
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57 incompetent GSVs in 29 patients
VeClose
6.3/4.9 mm
upper and
mid-thigh
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•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)
*
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Chan YC et al. Journal of Vascular Interventional Radiology 2017;28(5):665-671.
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(n=108 legs)
Chan YC et al. Journal of Vascular Interventional
2017;28(5):665-671.
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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
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< 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.
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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
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Vascular 2017 April; 25(2): 149-156.
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Gibson K. WAVES Study. Vascular 2017 April; 25(2): 149-156.
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Normal protocol ‘One extra drop’
since 21st July 2016
SFJ SFJ
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Overall closure rates of 173 legs
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< 8 mm, normal protocol
≥ 8 mm, normal protocol
Log Rank: p<0.001
Overall closure rates
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≥ 8 mm, extra-drop
protocol (n=48)
≥ 8 mm, normal protocol
Log Rank: p=0.012
Overall closure rates
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≥ 8 mm, extra-drop
protocol
< 8 mm, normal protocol
Log Rank: p=0.462
Overall closure rates
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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
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EHIT 3
Week 1 duplex: Thrombus – LMWH - No thrombus 4 days later
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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
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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