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)