Journal of The Association of Physicians of India Vol. 64 August 2016 53

Executive Summary: A Consensus Statement – Part I: Recommendations for the Management of Chronic Venous Disease (CVD) in India and Key Role of Primary Care DoctorsDB Dekiwadia1, Ravul Jindal2, Roy Varghese3, HS Bedi4, Shoaib Padaria5, Malay D Patel6, Sunil Agarwal7, Sunderaraj Saravanan8, U Vasudev Rao9, Ramakrishna Pinjala10, Gulshanjit Singh11

1Dekiwadia Hospital, Rajkot, Gujarat; 2Fortis Hospital, Mohali, Punjab; 3Vascular Surgeon – Daya Hospital, Jubilee Mission Medical College, Trichur, Kerala; 4Department of Cardiothoracic and Vascular Surgery, Christian Medical College & Hospital, Ludhiana, Punjab; 5Interventional cardiologist - Jaslok Hospital, Breach Candy Hosptial, Sir H.N. Hospital, Saifee Hospital, Mumbai.; 6First Choice Vascular Clinic, Ahmedabad, Gujarat; 7Vascular Surgery Unit, Christian Medical College, Vellore, Tamil Nadu; 8Madras Medical Mission Hospital – Institute of Cardio Vascular Diseases, Chennai, Tamil Nadu; 9The Bangalore Hospital, Bangalore, Karnataka; 10Head, Dept. of Vascular Surgery, NIZAMS Institute of Medical Sciences, Hyderabad, Telangana; 11Apollo Spectra Hospitals, Apollo Clinic, New Delhi

c o n s e n s u s s t a t e m e n t

The high prevalence of CVD, cost o f t reatment and loss of working days implies that CVD has a considerable socio-economic impact.4

Need for a Common Language in Understanding and Managing Chronic Venous Disease in India

In a consensus, it is important to have a common language while describing the disease.

A leap forward was recently m a d e t h a n k s t o a c o m m o n terminology on venous anatomy, t h e C l i n i c a l , E t i o l o g i c a l , Anatomical, Pathophysiological (CEAP) classification (Table 1, Figure 1) proposed by the adhoc committee of the American Venous Forum in 1994 and revised in 2004, which was subsequently adopted worldwide including India, as a basis for improved patient description.

What does the Term “Chronic Venous Disease (CVD)” Cover?

Th e t e r m “ C h r o n i c Ve n o u s Disease” covers a full spectrum

of venous conditions of lower limbs ranging from patients with early symptoms like telangiectasia or reticular veins, leg pain or oedema of the foot to complications like venous leg ulcers.

In the ear ly s tages usual ly o n l y s y m p t o m s a p p e a r , t h e n as the disease progresses i t is accompanied with signs.

Venous symptoms are defined a s t i n g l i n g , a c h i n g , b u r n i n g sensation, pain, muscle cramps, swelling, sensations of throbbing or heaviness, itching skin, restless legs, leg tiredness and/or fatigue. These may be exacerbated during the course of the day by prolonged standing or by heat and relieved with leg rest, elevation or both.1

Ve n o u s s i g n s a r e v i s i b l e manifestations of chronic venous disease, which include:1

• Oedemaofthedorsumoffoot,entire foot and may extend to the leg

• Frank varicose veins : Thismay or may not be associated with telangiectasia or reticular veins.

• Skin changes: Dryness, frankeczema, darkened, thickened, hard, scarred and ulcers.

Burden of Chronic Venous Disease

Onaglobalperspective1outof5 people in the world suffer from CVD.2

This can be mainly attributed to occupation, lifestyle changes, some environmental factors, a familial tendency and post-partum.2

In India a patient seeks treatment only when it affects his/her quality of l i fe and begins to l imit the functioning of the lower l imb, thus indicating that CVD remains an iceberg phenomenon in the country.2

In developed nations, often CVD is additionally a cosmetic concern.2

I n a l a r g e I n d i a n s t u d y distributed in 11 major cities of India, it was found that CVD is more prevalent at the average age of 43 years and it affects women more than men.3

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C1: Telangiectasia C2: Varicose veins C3: Oedema

C4a: Pigmentation C4a: Eczema C4b: Lipodermatosclerosis

C4b: Atrophie blanche C5: Healed venous ulcer C6: Active venous ulcer

Table 1: Clinical classification system for CVD5

CEAP clinical classification of

CVD

Clinical classification

C0 No visible or palpable signs of venous disease

C1 Telangiectasia or reticular veins

C2 Varicose veinsC3 OedemaC4a Pigmentation or eczemaC4b Lipodermatosclerosis or

atrophie blancheC5 Healed venous ulcerC6 Active venous ulcerS Symptomatic-pain,

tightness, skin irritation, heaviness, and muscle cramps

A Asymptomatic

Fig. 1: Clinical features of CVD6

• Th e CEAP c l a s s i f i c a t i o nincludes a Clinical assessment (C),

• An Etiological assessment ofthe patient’s disease (E),

• AnAnatomical assessment oflocation of the pathology (A),

• And the Pathophysiologicalbasis for the underlying disease (P).

I t prov ides a broad-based , objective, anatomic and physiologic basis for classification of venous d i s e a s e . C E A P h a s i m p r o ve d standardization, communication, decision making and reporting of venous disease.

In most of the centres in India a practical route is taken and a dominant use of the `C’ component of the CEAP is used. The `E’ part is used, but sporadically.1

Recommended Process for Diagnosis of CVD by a Primary Care Doctor

A s i m p l e m e t h o d p r i o r t o selecting an appropriate test is to grade the diagnostic investigations into 2 levels:7

A past history of Deep Vein Thrombosis (DVT) does not always rule out treatment option of varicose veins (Table 2). Often these veinsare not the collateral channels and

they could be those varicose veins where various surgical treatments can be offered.7

Treatment Options Proposed by Indian Experts in Chronic Venous DiseaseLifestyle Management

• E x e r c i s e p r o g r a m m e : O u t p a t i e n t e x e r c i s eprogrammes commenced at an early stage can avoid the first symptoms such as pain, swelling and oedema.8

• Leg elevation: Leg elevationamel iorates venous s tas is , provides symptomatic relief,

r e d u c e s l e g o e d e m a , a n d promotes healing of ulcers in patients with CVD.9

• Legmassage(gentle):Reducestissue oedema around the ulcer area.9

Pharmacological Treatments Available in India

• MPFF: Micronized PurifiedFlavonoid Fraction:

Route:Oraladministration Formulation: 1000 mg tablet;

500 mg tablet D o s e : 1 0 0 0 m g / d a y f o r a

minimum of 2 months ⁻ MPFF is a natural origin

drug obtained from sun dried oranges.MPFF has

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Table 2: History and physical examination in CVD

HistoryA positive family history of varicose veins is seen in over one third of patients.Symptomsofvenousinsufficiencyincludepain,tightness,skinirritation,pruritus,heaviness,

tingling, muscle cramps and cosmetically unsatisfying varicose veins.Specificfeaturesofthepainthatshouldbenotedincludethedegreetowhichthepain

interferes with the patient’s occupation or lifestyle as well as the amount of time that the patient can stand before the onset of pain or swelling.

Physical examinationExamine the limbs of the patient in the standing position from the groin to the toes for any

visible signs. Initial examination begins with a careful inspection and palpation of the legs.Varicosities in the main saphenous trunk and spider veins should be noted.Palpationofthelegsshouldalsobeperformedtodetecttemperaturedifferencesbetweenthelegs.

its unique composition of diosmin with flavonoids. Clinical data exists for its benefi ts r ight from the early stage (C0) to venous leg ulcers (C6).

⁻ MPFF acts by reducingi n f l a m m a t i o n a t microc i rculatory leve l , increasing venous tone and improving lymphatic drainage.

⁻ MPFFhasbeenapreferredc h o i c e e v e n i n l o n g standing ulcers.

⁻ MPFF is commonly usedwith procedures such as endovenous laser ablation, radio frequency ablation, h o o k p h l e b e c t o m y , c r o s s e c t o m y a n d sclerotherapy.

⁻ MPFF is themost studiedveno-active drug and is strongly recommended in all stages of chronic venous disease.

⁻ Importantly, due to i tsveno-protective action we recommend MPFF eveni n p a t i e n t s w i t h o n l y s y m p t o m s ( a b s e n c e o f signs) or cases of suspicion of CVD (pre-diagnostic confirmation).10

• Calciumdobesilate Route:Oraladministration Formulation: 500 mg tablet Dose: 1000 mg/day for 2 months ⁻ A c a l c i u m s a l t

o f d o b e s i l i c a c i d

(2 ,5 -d ihydroxybenzene sulfonate), is a synthetic ve n o - a c t i ve d r u g w i t h p r e s u m e d e f f e c t s o n e n d o t h e l i a l i n t e g r i t y , capillary permeability and blood viscosity. It is used in the treatment of chronic venous disease which helps in reducing cramps and restless legs.11

⁻ Calcium dobesi late hasbeen associated with risk of agranulocytosis.12

• Horse chestnut seed extract(HCSE)

Route:Oraladministration Formulation: Equivalent to

50mg escin tablet Dose: 100mg / day for 3 months - HCSE is obtained from

seeds of horse chestnut and is used for its veno-tonic property. Evidence sugges t s tha t HCSE i sef f icac ious and safe in short-term treatment for chronic venous disease but definitive randomized c o n t r o l l e d t r i a l s a r e r e q u i r e d t o c o n f i r m efficacy. 13

Compression Therapy

• I n t e rm i t t e n t p n e um a t i ccompression (IPC) for improves venous flow in patients in all the stages.

• RapidIPCheals86%ofvenousulcerscomparedwith61%withslow IPC at 6 months.

• IPC is linkedwithgreater leg

volume reduction in patients with chronic venous oedema.9

• F o u r l a y e r c omp r e s s i o nb a n d a g e r e s u l t i n f a s t e r healing of ulcers. A pressure of 30–40 mmHg at the ankle i s recommended for u lcer healing.

• If used daily, compressionstockings should be replaced after 3–6 months.

• Regulardailyuseofcompressions t o c k i n g s fo r a t l e a s t twoyears after DVT can reduce theincidence and severity of thepost-thromboticsyndrome.

Procedural Treatment for CVD

Endoablation9

a. Thermal ablations - Endovenous laser ablation

(EVLA) • Itisusedfortreatment

of insufficient Great SaphenousVein(GSV)and Small SaphenousVein(SSV).

• EVLA has the highestsuccessrateof93%.

- E n d o v e n o u s radiofrequency ablation (RFA)

• I t i s u s ed t o t r e a tsaphenous var icose veins.

• I t s su c c e s s r a t e i sknowntobe90%.

b. Chemical ablation - Foam sclerotherapy • T o o b l i t e r a t e t h e

v a r i c o s e v e i n s , injection sclerotherapy is used for superficial varicose veins, residual or recurring varicose veins.

• G lue s c l e ro therapyis also used in some cases.

c. Combination - Sometimes a combination

of the 2 is also used.

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Surgerya. Phlebectomy9

- It is a minimally invasive p r o c e d u r e t h a t u s e s a small scalpel or needle to remove varicose veins on the surface of the leg.

T r e n d e l e n b e r g o p e r a t i o n o f stripping the varicose veins and excision of thrombosed localised venous bunches are some latest options.

Indian Experts’ Proposal of Another Way of Understanding the Disease

In spite of various methods of reporting/classifying the disease it becomes inadequate to understand the disease pattern.

The Indian experts propose another way of understanding the disease as congenital and acquired CVD.

Acquired could be either primary acquired CVD or secondary (Post Thrombotic Syndrome) acquiredCVD.

This consensus intentionally focuses only on the acquired CVD. One of the biggest risk factorsfor CVD is prolonged standing. Certain occupations that require people to stand for a long time (like nurses, teachers, traffic police, office-workers, housewives etc.) increases the risk of acquired CVD.

In the female gender there is an increased risk of post-partum CVD.

Based on this we will conduct a n a t i o n w i d e s t u d y o f t h e disease prevalence, pattern and epidemiological survey to give a guideline useful for Indian set up and many countries other than India having diversified conditions.

Conclusion

I n I n d i a , a wa r e n e ss o f t h e warning symptoms of CVD among the general population is far from

satisfactory.This lack of awareness leads to a

delay in receiving medical advice from primary care doctors and a delay in adequate treatment.

A high prevalence of CVD has been documented in India and hence studies need to be conducted in different parts of India to develop an understanding at national level of chronic venous disease pattern and our Indian observation.

This will help us search in our country a better way to understand and treat the disease.

This is because India is a multi-ethnic , mult i -cultural country with vast geographic variance, which could influence the patients’ lifestyle and its impact on CVD. There is now an urgent need for undertaking heal th educat ion measures about the awareness of risk factors and early warning signs of CVD in the community, so that people in general and affected subjects specifically, can receive early and effective therapy through modern means.

Consensus Part II

A nationwide study from various centresinIndia:NorthtoSouthandEast to West and analysis of the information based on conclusion.

Document Declarants

President VAI India: Dr. D. B. Dekiwadia; Vice President VAI: Dr. Ravul Jindal;HonorarySecretary:Dr . Roy Varghese ; HonoraryTreasurer:Dr.H.S.Bedi;ChairmanofGoverningCouncil:Dr. ShoaibPadariaMembersof governing council:

D r . Ma l a y Pa t e l ( F ound i n gPresidentVAI);Dr.SunilAgarwal;Dr. Sunderaraj Saravanan; Dr U.Vasudev Rao; Dr. RamakrishnaPinjala;Dr.GulshanjitSinghOndate:13/02/2016atVAICON

2016atJaipur,Rajasthan.

References1. Pitsch F. The place of Micronized Purified

Flavonoid Fraction in recent international guidelines on the management of symptomatic chronic venous disorders. Medicographia 2015; 37:71-79.

2. Mukunda NK. Clinical evaluation and management of lower limb varicose veins: A study at KIMS. Unpublished doctoral dissertation submitted to Rajiv Gandhi University of Health Sciences; 2006.

3. Pinjala RK, Abraham TK, Chadha SK, et al. Long-term treatment of chronic venous insufficiency of the leg with micronized purified flavonoid fraction in the primary care setting of India. Phlebology 2004; 19:179-184.

4. Milic DJ. Prevalence and socioeconomic data in chronic venous disease: how useful are they in planning appropriate management? In: Chronic Venous Disease Guidelines and Daily Clinical Practice 2011; 33:253-258.

5. Eklof B, Rutherford RB, Bergan JJ, et al. Revision of the CEAP classification for chronic venous disorders: Consensus statement. J Vasc Surg 2004; 40:1248-52.

6. Reeder SW, Roos KP, Neumann HAM. Chronic Venous Disease under pressure. Wednesday, September 25th, 2013.

7. Krishnan S, Nicholls SC. Chronic Venous Insufficiency: Clinical Assessment and Patient Selection. Seminars in Interventional Radiology 2005; 22:169-177.

8. Eberhardt RT, Raffetto JD. Chronic Venous Insufficiency. Circulation 2005; 111:2398-2409.

9. Wittens C, Davies AH, Bækgaard N, et al. Editor’s Choice: Management of Chronic Venous Disease Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg 2015; 49:678-737.

10. Lyseng-Williamson KA, Perry CM. Micronised purified flavonoid fraction: a review of its use in chronic venous insufficiency, venous ulcers and haemorrhoids. Drugs 2003; 63:71-100.

11. Tejerina T, Ruiz E. Calcium dobesilate: pharmacology and future approaches. Gen Pharmacol 1998; 31:357-60.

12. Bergan J, Paquette NB, The vein book. second edition. Oxford University Press 2014.

13. Szapary PO, Cirigliano MD. Horse Chestnut Seed Extract for the Treatment of Chronic Venous Insufficiency. AHC Media. 1999; 2:25-28.