By: Steve Elias MD FACS Visit VeinGlobal at http://www.veinglobal.com/ for more presentations and videos on this topic, or for more information on venous disease news, education and research.

1. VCSS: ADDS SOPHISTICATION
Steve Elias MD FACS
Director, Center for Vein Disease
Director, Wound Care Center
Englewood Hospital and Medical Center NJ
Many slides courtesy of Michael Vasquez MD

2. VCSS: WHAT IS IT?
• Venous Clinical Severity Score
• Along with CEAP – our common language
• Physician generated score – easy
• Revised VCSS – validated
• A way of documenting change
• Not perfect but really good

3. Outcome Reporting
• Guideline 7.1
• We recommend that revised Venous Clinical
Severity Score is used for assessment of
clinical outcome after therapy for varicose
veins and more advanced CVD
• Grade of recommendation: 1 (strong)
• Level of evidence: B (moderate quality)
From Gloviczki et al, “The care of patients with varicose veins and associated
chronic venous diseases: Clinical practice guidelines of the Society for Vascular
Surgery and the American Venous Forum.”

4. Revision VCSS
• Improve VCSS by acknowledging limitations and
preserving strengths
• Focus on clarifying ambiguities, updating
terminology, and simplifying application
• Use specific language of PRO
– lower end of the venous disease spectrum

5. VCSS: Quality of Life
What else matters?
• VCSS has been around for 14 years
• Revised in 2010
• Evaluated for reproducibility in 2013
• Intra and inter observer reproducibility
• Physician reported vs. patient reported
• See next paper VV Sym Q
Marston WA. Multicenter assessment of the repeatability and reproducibility
of the revised Venous Clinical Severity Score. J Vasc Surg 2013;3:219-223.

6. VCSS: Not Just For Research
• Good intra and inter-observer significance
• Should be used with a patient reported
measure
• Need to show impact on patient from MD and
patient views
• Should be part of patients record and CEAP
• Insurance companies know QoL measures

7. VCSS: Not Just For Research
• Good intra and inter-observer significance
• Should be used with a patient reported
measure
• Need to show impact on patient from MD and
patient views
• Should be part of patients record and CEAP
• Insurance companies know QoL measures

8. Revised VCSS Descriptor
Descriptor Absent (0) Mild (1) Moderate (2) Severe (3)
Pain None Occasional Daily Daily limiting
Varicose veins None Few Calf or thigh Calf and thigh
Venous edema None
Foot and
ankle
Above ankle, below
knee
To knee or
above
Skin Pigmentation None Perimalleolar Diffuse, lower 1/3 calf
Wider, above
lower 1/3 calf
Inflammation None Perimalleolar Diffuse, lower 1/3 calf
Wider, above
lower 1/3 calf
Induration None Perimalleolar Diffuse, lower 1/3 calf
Wider, above
lower 1/3 calf
No. active ulcers None 1 2 > 3
Active ulcer size None < 2 cm 2 – 6 cm > 6 cm
Ulcer duration None < 3 mo 3 – 12 mo > 1 yr
Compression Therapy None Intermittent Most days Fully comply

9. pre
Attribute Absent (0) Mild (1) Moderate (2) Severe (3)
Pain None Occasional Daily Daily limiting
Varicose veins None Few Calf or thigh Calf and thigh
Venous edema None
Foot and
ankle
Above ankle, below
knee
To knee or
above
Skin Pigmentation None Perimalleolar Diffuse, lower 1/3 calf
Wider, above
lower 1/3 calf
Inflammation None Perimalleolar Diffuse, lower 1/3 calf
Wider, above
lower 1/3 calf
Induration None Perimalleolar Diffuse, lower 1/3 calf
Wider, above
lower 1/3 calf
No. active ulcers None 1 2 > 3
Active ulcer size None < 2 cm 2 – 6 cm > 6 cm
Ulcer duration None < 3 mo 3 – 12 mo > 1 yr
Compression Therapy None Intermittent Most days Fully comply
VCSS Pre
CEAP – 3 VCSS - 13

10. Attribute Absent (0) Mild (1) Moderate (2) Severe (3)
Pain None Occasional Daily Daily limiting
Varicose veins None Few Calf or thigh Calf and thigh
Venous edema None
Foot and
ankle
Above ankle, below
knee
To knee or
above
Skin Pigmentation None Perimalleolar Diffuse, lower 1/3 calf
Wider, above
lower 1/3 calf
Inflammation None Perimalleolar Diffuse, lower 1/3 calf
Wider, above
lower 1/3 calf
Induration None Perimalleolar Diffuse, lower 1/3 calf
Wider, above
lower 1/3 calf
No. active ulcers None 1 2 > 3
Active ulcer size None < 2 cm 2 – 6 cm > 6 cm
Ulcer duration None < 3 mo 3 – 12 mo > 1 yr
Compression Therapy None Intermittent Most days Fully comply
post
VCSS Post
CEAP – 2 VCSS – 3

11. 8 weeks post oppre
VV SymQ - 12.9
VEINES-QoL – 47.4
CEAP - 3
VCSS - 13
VV SymQ – 0.1
VEINES-QoL – 87.4
CEAP - 2
VCSS - 3

12. 8 weeks post oppre
VV SymQ – 2.7
VEINES-QoL – 65.3
CEAP – 3
VCSS – 5
VV SymQ – 1.6 (week 4)
VEINES-QoL – 90.5
CEAP – 2
VCSS – 2

13. RF Segmental Ablation: 5 years
• Durable over time
• QoL measures and efficacy
• VCSS and CEAP
.
Dietzek A. Radiofrequency segmental ablation (ClosureFast) 5 year results.
VEITH Nov. 2013.

14. Occlusion rate: 5 yrs

15. CEAP CHANGE: 5 YEARS
7/9/2014
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
C0 C1 C2 C3 C4 C5 C6
基线
Baseline
5年
Yr 5

16. VCSS: 5 yr

17. CAG:
European Multicenter Study
• 70 GSV – No tumescence – No compression
• 7 Centers
• 94% occlusion at 6 months
• VCSS – 4.3 to 1.3
Proebstle T et al. One year follow up of the European Multicenter Study on
cyanoacrylate embolization of incompetent great saphenous veins. UIP 2013
Boston MA..

18. SOPHISTICATION: OUR GOAL
WE ALL WANT TO BE: “BOND, JAMES BOND’”
• CEAP - MD generated
• VCSS – MD generated
• VV Sym Q – Patient generated
• All 3 are best

19. Patient-Reported Outcome
• CVD Disease-Specific QoL
– Aberdeen Varicose Veins Questionnaire (AVVQ)
– Venous Insufficiency Epidemiological and
Economic Study (VEINES-QoL)
– Chronic Venous Disorders Quality of Life
Questionnaire (CIVIQ)
– Specific Quality of Life and Outcome Response-
Venous (SQOR-V)
– Varicose Veins Symptom Questionnaire (VVSymQ)

20. Negatives of PRO
• Time consuming
• Cumbersome to follow in daily practice
• May be overly subjective for outcomes
– Patients forget what they felt
• Many to choose from

21. VVSymQ
• Symptom-focused PRO
• Evaluate the feasibility, reliability, and
validity before and after treatment of GSV
• PDA recording method
• Inter-correlation with known instruments
VCSS, VEINES-QoL, and CIVIQ-20
• Meets FDA Guidance for Industry

22. Creating a PRO
• Complex 43 page document

23. Symptoms: VVSymQ™
RCT = randomized, controlled trial
eDiary used in 2 RCTs
h. Itching
f. Restless Legs
g. Throbbing
e. Heat or Burning
Sensation
d. Night Cramps
c. Swelling
b. Aching Legs
a. Heavy Legs
i. Tingling Sensation
Screening

24. BTG confidential 24
– Since waking up today, how often have you
had the following problem in your treated leg?
 Achiness
 Itching
 Swelling
 Throbbing
 Heaviness
VVSymQ™
Measure Symptoms Most Important to VV
Patients
Duration Scale (0 – 5) for each Symptom
0 = None of the Time to
5 = All of the Time
VVSymQ™ – subset of symptom scores (0-25
scale)

25. Polidocanol Endovenous Microfoam (PEM)
Studies
1. A Multicenter, Randomized, Blinded Study of Endovenous
Thermal Ablation with or without Varisolve™ Polidocanol
Endovenous Microfoam (PEM) Treatment for Patients with
Great Saphenous Vein Incompetence and Visible Varicosities
2. A Randomized, Blinded, Multicenter Study to Evaluate the
Efficacy and Safety of Varisolve™ Polidocanol Endovenous
Microfoam (PEM) 0.5%, 1.0% and 2.0% Compared to Vehicle
for the Treatment of Saphenofemoral Junction (SFJ)
Incompetence

26. PEM Studies
• All three measures are highly sensitive to
change
– VVSymQ
– VCSS
– VEINES-QOL
•As these are all sensitive to change but do not correlate strongly they must be measuring different aspects of the same disease

27. PEM Studies
• Correlation with change in VVSymQ™ (Pearson
CC)
– Duplex response r = 0.26
– VCSS r = 0.33
– VEINES-QOL r = -0.72
• Measure different aspects of the same disease

28. Choice of success
• Combine patient generated and physician
generated instruments
– Patient questionnaire (PRO)
– Venous Clinical Severity Score (VCSS)
– CEAP
• Valuable baseline information
• Long term comparison

29. Example of Medical Necessity
• Example minimum requirements
– Absolute indications:
• CEAP: C4, C5 and C6, or bleeding / phlebitis
– Duplex: GSV/SSV incompetence >0.5 second
– CEAP: C2s or greater
– VCSS: Score ≥ 5
– VVSymQ: Score ≥ 5

30. True measure of success
• PRO is patient-perception, valuable, proven
• VCSS/CEAP is physician-driven, practical
These are complementary tools
It’s all about improving QoL

31. THE SOPHISTICATED VEIN EXPERT USES:
• CEAP
• VCSS
• PRO – VV Sym Q or others
• Can track change and justify intervention

32. THE REAL SOPHISTICATED VEIN EXPERTS
ELIAS ALMEIDA