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Multi-Centre Registry to Investigate the Efficacy
and Safety of VenaSeal Endovenous Ablation for
Varicose Veins in Singapore –3 Month Results
A/Prof Tjun Tang MD FRCS (Gen) FAMS
Senior Consultant
Department of Vascular Surgery
Singapore General Hospital
LINC 2020
A Singapore VenaSeal real world post-market evaluation Study (ASVS)
Disclosures
Speaker name:
Tjun Y TANG MD FRCS(Gen)
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) – Investigator-initiated grants from Medtronic US & Singapore
I do not have any potential conflict of interest
VenaSeal™
• Innovative option developed to reduce patient discomfort
• Performed under LA
• NTNT – Non-Thermal and Non-Tumescent Technique
• Uses cyanoacrylate adhesive
• Polymerize into a solid material upon contact with body fluids or tissue
• Durable, chronic occlusion of treated vein
• Similar efficacy as thermal ablation techniques
• First case series from Singapore assessing efficacy/safety of VenaSeal™
• Retrospective and prospective in nature
• Incomplete follow-up
• No QoL assessment
• Asians present with higher CEAP score and older age
• Asians had more total GSV reflux
• Vein diameters larger in Caucasians
• Asians more suprafascial extension
CVI Spectrum in Singapore
Primary Objective ASVS Trial
To assess the efficacy of the VenaSeal™ Closure
System (VCS) for the treatment of lower extremity
superficial truncal veins in a real-world clinical setting
in a multi-racial Asian population in Singapore.
Study Aim
1. Technical success at the time of the procedure
2. Anatomical success, reported as complete closureat 2-weeks, 3 months, 6 months and 12 months.
ClinicalTrials.gov (NCT03893201)
SGH/SKH VenaSeal™ Experience
• >1100 VenaSeal™ ablations performed from February 2016
• Recruitment March 2018 – December 2018
• Cohort size = 100 (5 experienced endovenous surgeons)
• One year follow-up just completed December 2019
• Tight Data set
Trial Flow Design
Symptomatic patients with varicose vein reflux > 0.5 /seconds on venous Duplex
2 week F/UPain score over first 10 days, time to return to normal activities/work, VCSS, AVVQ,
CIVIQ and EQ-5D, venous duplex, patient satisfaction
BaselineConsenting patients complete VCSS, AVVQ, CIVIQ and EQ-5D
3,6,12 months F/U VCSS, AVVQ, CIVIQ and EQ-5D, Venous Duplex, patient satisfaction
Exclusion Criteria
• Current or history of DVT
• Recurrent varicose veins
• Pregnant patients
• Arterial Disease (ABPI<0.8)
• Sepsis
• Patient who are unwilling to participate
• Inability / unwillingness to complete questionnaire
• Adverse reaction to CAE
• GSV/SSV/AASV severely tortuous
• Life expectancy < 1 year
• Active treatment for malignancy other than non-melanoma skin cancer
• Current regular use of systemic anticoagulation (e.g. warfarin / heparin)
• Daily use of narcotic analgesia or NSAIDS to control pain associated with venous
disease
• Age > 21, able to give informed consent
• CEAP C2 – C5 Varicose Veins
• GSV, SSV or AASV diameters of 3mm to 12mm in standing position
• Symptomatic primary GSV, SSV, AASV incompetence with reflux >0.5 seconds on
colour Duplex
Patient Recruitment Criteria
Inclusion Criteria
Patient Demographics(n=100)
Male41% Female
59%
Race
71% Chinese
16% Indian
11% Malay
2% Others
84% non-smoker
68% working
Mean Age:
60.1 ± 12.8
Mean BMI:
26.7 ± 4.6
45
37
16
6
1
26
HTN HLD Diabetes IHD PE/DVT PVD
Patient Comorbidities (n=100)
37
43
57
46
2
26
5
30
Pain Aching Swelling Heaviness Burning Itch Ulcer Others
Primary Symptoms
Others
include:-
Skin Changes,
Cramps
Prominent
Varicosity
Numbness
24
3332
4
7
C2 C3 C4a C4b C5
CEAP category
= 65% of subjects
• Total number of legs operated on: 151 legs (81L, 70R)
• 49 (32.5%) legs for GSV incompetence
• 96 (63.6%) legs for bilateral GSV incompetence,
• 1 (0.7%) leg for small saphenous vein (SSV)
• 5 (3.3%) legs for combined unilateral GSV and SSV reflux
• Average operating time: 58.5 mins
• 67/151 (44.4%) had concomitant phlebectomies
Procedural Characteristics
In summary,
100 Patients
151 Legs
156 Truncal Vein
(GSV)
= 45% of puncture sites!
AASV
Pain Scores• Mean post-operative (POD 0) pain score: 2.9 (range: 0–9)
Complete Closure Rates:
Adverse events
Bruising – at treated
area
Ecchymosis (%) to
measure extent of
bruising with respect
to treated area
VenaSeal™ Red Reaction – Phlebitis?
19
83
8993
5
13
20
36
58
71 7378
Day of Procedure 3 5 10
PER
CEN
TAG
E (%
)
NUMBER OF DAYS POST-OP
Resume Activities
Return to Work
Stop Compression Socks
Day of procedure:
- 19% Resume daily activities
- 5% Returned to work
- 58% did not wear compression
socks
10 days post-op:
- 93% Resume daily activities
- 36% Returned to work ^
- 78% did not wear compression
socks ^Patients usually given 10 days MC post-op
Return to Normal Activities
* p < 0.001, ** p = 0.0023, *** p = 0.0012, **** p = 0.001.
^Values for ED-5D TTO SG have been scaled up by a factor of 10 for illustrative purposes
Clinical Measures (Baseline - 2 weeks - 3 months )
Patient Satisfaction Survey
- Early results are promising but we await further prospective
long-term follow-up from the study
- Data analysis for 6 and 12 months follow-up to follow
ASVS Conclusions
• Closure rates excellent in the short term
• Effective procedure – improvement in QoL
• Safe procedure
• Can be performed in combination with avulsions
• Good functional and cosmetic results
• High patient satisfaction
ASVS VenaSeal™ Experience
• Patients with multiple allergies – higher
chance of phlebitis reaction ✗
• Effective for tributaries –”milk” technique ⩗
• Supra-fascial GSV extension (N3)? ✕
• Thin young women – “tugging sensation”? ✗
• Venous ulcer setting ⩗
• Patients on Anticoagulation ⩗
BTK GSV
Go the distance…through a bad field
The Future of Non-Thermal
Ablation is The Future of
Endovenous Ablation
Thank Youtang.tjun.yip@singhealth.com.sg
Multi-Centre Registry to Investigate the Efficacy
and Safety of VenaSeal Endovenous Ablation for
Varicose Veins in Singapore –3 Month Results
A/Prof Tjun Tang MD FRCS (Gen) FAMS
Senior Consultant
Department of Vascular Surgery
Singapore General Hospital
LINC 2020
A Singapore VenaSeal real world post-market evaluation Study (ASVS)
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