VCSS: Adds Sophistication

VCSS: ADDS SOPHISTICATION

Steve Elias MD FACSDirector, Center for Vein Disease

Director, Wound Care CenterEnglewood Hospital and Medical Center NJ

Many slides courtesy of Michael Vasquez MD

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

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.”

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

VCSS: Quality of LifeWhat 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 reproducibilityof the revised Venous Clinical Severity Score. J Vasc Surg 2013;3:219-223.

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

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

Revised VCSS DescriptorDescriptor 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

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

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

8 weeks post oppre

VV SymQ - 12.9VEINES-QoL – 47.4CEAP - 3VCSS - 13

VV SymQ – 0.1VEINES-QoL – 87.4CEAP - 2VCSS - 3

8 weeks post oppre

VV SymQ – 2.7VEINES-QoL – 65.3CEAP – 3VCSS – 5

VV SymQ – 1.6 (week 4)VEINES-QoL – 90.5CEAP – 2 VCSS – 2

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.

Occlusion rate: 5 yrs

CEAP CHANGE: 5 YEARS

04/12/2023

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

VCSS: 5 yr

CAG: European Multicenter Study

• 70 GSV – No tumescence – No compression

• 7 Centers

• 94% occlusion at 6 months

• VCSS – 4.3 to 1.3Proebstle T et al. One year follow up of the European Multicenter Study oncyanoacrylate embolization of incompetent great saphenous veins. UIP 2013Boston MA..

SOPHISTICATION: OUR GOALWE ALL WANT TO BE: “BOND, JAMES BOND’”

• CEAP - MD generated

• VCSS – MD generated

• VV Sym Q – Patient generated

• All 3 are best

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)

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

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

Creating a PRO

• Complex 43 page document

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

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 Symptom0 = None of the Time to

5 = All of the Time

VVSymQ™ – subset of symptom scores (0-25 scale)

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

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

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

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

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

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

THE SOPHISTICATED VEIN EXPERT USES:

• CEAP

• VCSS

• PRO – VV Sym Q or others

• Can track change and justify intervention

THE REAL SOPHISTICATED VEIN EXPERTS

ELIAS ALMEIDA