should c2 disease classification be broken down further? who progresses to c4?

Nick Morrison, MD, FACS, FACPh, RPhS April 24, 2014

Should C2 Disease Classification Be Broken Down Further?: Who

Progresses to C4?

Nick Morrison, MD, FACS, FACPh, RPhS April 24, 2014

Consultant, Research Grant - Sapheon

Educational Grant, MediUSA

Consultant, Merz

Scientific Advisory Board, VenX

Medical Director, Morrison Vein/Training Institute

Ballooning in Sedona, Arizona

Should C2 Disease Classification Be Broken Down Further?

And should they be similarly considered for treatment?

Are these patients really both C2?

Revision of the CEAP classification for chronic venous disorders: Consensus statement

Varicose vein: Subcutaneous dilated vein 3 mm in diameter or larger, measured in upright position. May involve saphenous veins, saphenous tributaries or non-saphenous superficial leg veins. Varicose veins are usually tortuous, but tubular saphenous veins with demonstrated reflux may be classified as varicose veins.

Eklof B, Rutherford RB, Bergan JJ, et al. J Vasc Surg 2004;40:1248–52

C2: Varicose Veins

Clinical, aetiological, anatomical and pathological classification (CEAP): gold standard and limits

In the C2 class all kinds of varicose veins are summarized. Saphenous veins in the interfacial space, accessory saphenous veins and nonsaphenous tributaries may have different implications not only for the severity of the disease but also for the risk of progression of the disease, clinical symptoms and the choice of treatment. The anatomical classification may add this information. However varicose veins may have a small or a large diameter with implications for clinical symptoms and for the choice of treatment option.

Rabe E, Pannier F. Phlebology 2012;27 Suppl 1:114–118.

C2: Varicose Veins

Prevalence of varicose veins and chronic venous insufficiency in men and women in the general population: Edinburgh Vein Study.

Approximately one third of men and women aged 18–64 years had trunk varices.

Evans CJ, et al. J Epidemiol Community Health 1999;53:149–153

C2: Varicose Veins

What is the prevalence of varicose veins?

How about in older folks?

In a UK study, epidemiological risk factors for varicose veins in an elderly population (avg:71yrs) was studied. The prevalence of trunk varices was 63.2 in men and 57.0% in women.Clark A, et al. Phlebology 2010;25:236–240

Epidemiology of chronic venous disorders in geographically diverse populations: results for the Vein Consult Program

UIP initiative large-scale, international, observational, prospective survey carried out in 20 countries in 5 regions.

6,232 GPs screened 91,545 subjects

The results of the survey demonstrate that CVD is a global problem that does not solely affect the Western world

Rabe E, et al. Int Angiol 2012;31(2):105-15

Are Varicose Veins a Problem for Western Countries Only?

C2: Varicose Veins

Generic Health-related Quality of Life is Significantly Worse in Varicose Vein Patients with Lower Limb Symptoms Independent of Ceap Clinical Grade

Physical and mental HRQL is significantly worse in VV patients with lower limb symptoms irrespective of the clinical stage of disease. This observation confirms that VV are not primarily a cosmetic problem and that NHS rationing of treatment to those with CEAP C4-6 disease excludes many patients who would benefit from intervention in terms of HRQL. Generic HRQL instruments also allow comparison with interventions for other chronic conditions.

Darvall K, Bradbury A, et al. Eur J Vasc Endovasc Surg. 2012 Sep;44(3):341-4.

C2: Varicose Veins

Do Varicose Veins Make a Difference in Quality of Life?

Relationship between clinical classification of chronic venous disease and patient-reported quality of life: Results from an international cohort study

SF-36 Physical Component Summary scores and VEINES-QOL and VEINESSymscores decreased significantly (ie, poorer QOL) with increasing CEAP class.Kahn S, et al for VEINES Study Group. J Vasc Surg 2004;39:823-8.

Quality of life in patients with chronic venous disease: San Diego population study

Chronic venous disease in the lower extremities has a substantial effect on physical health aspects of quality of life but not on mental health components. Kaplan R, et al. J Vasc Surg 2003;37:1047-53.

C2: Varicose VeinsDo Varicose Veins Make a Difference in Quality of Life?

In an Italian study, the presence of symptoms correlated almost always positively with both worsening of visible findings (P for trend < .001) and presence of hemodynamic change in both genders.Chiesa R, et al. J Vasc Surg 2007;46:433-30.

In UK women there was a significant relation between trunk varices and the symptoms of heaviness or tension (P<0.001), aching (P<0.001), and itching (P<0.005).Bradbury A, et al. BMJ 1999;318 :353-6.

It is possible to differentiate leg symptoms on the basis of CVD from other causes: sensation of heavy or swollen legs, itching, impatient legs, or phlebalgia, worsened by a hot environment or improved by a cold, not worsened by walking. Carpentier P, et al. J Vasc Surg 2007;46:991-6.

C2: Varicose VeinsQuestion: What is the relationship between varicose veins

and symptoms?

C2: Varicose VeinsQuestion: What risk factors might help differentiate patients with varicose veins?

The ascending severity of the classes was shown with the statistical association of higher severity C classes with the age of the patient, a history of previous deep vein thrombosis, the diameter class of the most dilated varicose vein, venous symptoms, and the presence of a corona phlebectatica.Carpentier P, et al.J Vasc Surg 2003:37:827-33.

A Review of Familial, Genetic, and Congenital Aspects of Primary Varicose Vein Disease

It is apparent that there is a limited understanding of the complex underlying genetic factors contributing to varicose vein formation. CVD is a complex, multifactorial disease, and this needs to be considered in the planning of future genetic and epigenetic studies.This approach has the potential to provide improved medical treatment for patients and personalized, targeted preventive measures tailored to those identified to be at high risk[and might also allow for treatment of specific patients at highest risk of disease progression].

Anwar MA, Davies AH, et al. Circ Cardiovasc Genet 2012;5(4):460-6.

A Genetic Study of Chronic Venous Insufficiency

In families with affected patients with the D16S520 marker, there was evidence of saphenofemoral junction reflux. The fact that there is linkage to a candidate marker for the FOXC2 gene suggests there is a functional variant within, or in the vicinity of, which predisposes to varicose veins.Serra R, et al. Ann Vasc Surg 2012; 26: 636–642.

Question: What risk factors might help differentiate patients with varicose veins?

Question: Can risk factors be modified to slow progression of venous disease?

Risk factors for chronic venous disease: The San Diego Population Study

Risk factors for venous disease: age, family history of venous disease, and findings suggestive of ligamentous laxity (hernia surgery, flat feet) are immutable, others can be modified, such as weight, physical activity, and cigarette smoking. Overall, these data provide modest support for the potential of behavioral risk-factor modification to prevent chronic venous disease.

Criqui M, et al. J Vasc Surg 2007;46:331-7.

Oral Bacteria are a Possible Risk Factor for Valvular Incompetence in Primary Varicose Veins

56 saphenous vein specimen (44 varicose veins and 12 control veins) were examined for 7 periodontal bacteria.Examination of the diseased vein specimens showed that 48% were positive for at least one of 7 periodontal bacterial DNA. No bacteria were detected in the control specimens.Kurihara N, et al. Eur J Vasc Endovasc Surg 2007;34:102-106

So maybe we could study a large group of patients by first doing varicose vein biopsies looking for periodontal bacteria and letting only the positive patients have intervention for their C2 disorder.

Question: Can risk factors be modified to slow progression of venous disease?

Incidence of Varicose Veins, Chronic Venous Insufficiency, and Progression of the Disease in the Bonn Vein Study II (Abstract)

1978 (84.6% of Bonn I participants) reinvestigatedParticipants with CEAP class C2 as a maximum at BVS I increased to higher C classes in 19.8% (nonsaphenous varicose veins) and in 31.8% (saphenous varicose veins).Conclusions: These results show a high incidence of about 2% for varicose veins and for CVI per year. During the same time, the incidence of progression to higher C classes seems to be very high.

Rabe E, et al. J Vasc Surg;51(3):791

Question: Do patients with varicose veins progress to higher clinical stages?

Studies of the venous reflux progression

116 legs with 2 duplex and clinical exams a mean of 19 months apart11.2% had progression of clinical stage, most from C2-C3Approx. 30% had reflux progressionLabropoulos N, et al. J Vasc Surg 2005;41:291-5.

Venous vascular reflux in symptom-flee surgeons

Venous reflux was more frequently seen among symptom-free vascularsurgeons than normal individuals of a nonmedical vocation.Labropoulos N, et al. J Vasc Surg 1995;22:150-4

Question: Do patients with varicose veins progress to higher clinical stages?

UK: 36 patients waited a median time of 20 months for intervention. We found a significant deterioration in this group of patients.Sarin D, Coleridge Smith PD, et al. J R Soc Med 1993;86:21-23.

Brazil: 92 women with GSV reflux followed for ̴ 3 yrs. Segmental reflux declined and multi-segmental reflux increased. GSV reflux worsens over time.Engelhorn CA, Sallex-Cunha SX, et al. Phlebology 2012;27:25–32.

Question: Does venous function deteriorate in patients waiting for varicose vein intervention?

Modelling the effect of venous disease on quality of life

Increasing clinical grade corresponded strongly with deterioration in disease specificQoL (P < 0·001). The physical impairment seen with venous ulceration was comparable with that seen in congestive cardiac failure and chronic lung disease.Carradice D, et al. Br J Surg 2011; 98: 1089–1098

Towards an evidenced package of care for venous ulceration

$2500/year for unhealed ulcer – mostly for dressingsBevis PM, Earnshaw JJ. Phlebology 2012;27:45–47

Questions: What happens with venous disease progression?

The relevance of the natural history of varicose veins and refunded care Bonn Vein Study3072 participants from general populationC2 in 14.3%VVs may progress from a symptomatic or asymptomatic C2 class to higher clinical classes and CVI in a relevant percentage – up to 4% per year.Quality of life (QOL) is also reduced in uncomplicated VV in C2 patients. ConclusionThere is evidence that a high proportion of patients with uncomplicated VVs in the clinical, aetiological, anatomical and pathophysiological classification (CEAP Clinical Class 2) will progress to CVI if untreated. VV patients with CVI (C3–C6) as well as those C2 patients with severe clinical symptoms and impaired QOL due to CVD should be treated with ablation of the VVs in a refunded care system.

Pannier F, Rabe E. Phlebology 2012;27 Suppl 1:23–26

Questions: What happens with venous disease progression?

Costs of venous disease in UK, France, Germany 1.5-2% of total health care expenditureBosanquet N, Franks P. Phlebology 1996; 11:6-9

Nurse-led varicose vein assessment and implementation of guidelines for treatment [UK]

Objective: offer treatment only to those patients with skin changes and ulcers in order to reduce the number of patients listed for surgery

Results: Surgery was considered necessary for 38% of those with varicose veins. The remaining 62% were not listed for treatment. 53% fewer patients were listed for surgery and the number on the waiting list had fallen by 62%.Holdsworth J, et al. Phlebology 2004; 19: 69–71

Question: So how should we handle C2 patients?

Or we could adopt an entirely different way to look at varicose veins:

Varicose veins may be “the price we pay” for an enhanced ability to form [other] collateral vessels when necessary.Rooke T, Felty C. J Vasc Surg: Venous and Lym Dis 2013



Mapping the future: Organizational, clinical, and research priorities in venous disease

Assessment of reflux and symptomatic evaluation (ARSE)This study proposes to evaluate the anatomic patterns of reflux and hemodynamic parameters that most accurately identify individual CEAP categories, forecast disease progression to higher CEAP classes, and predict response to therapy (quality of life, ulcer healing).Meissner, et al. J Vasc Surg 2007;46(5):84S-93S.

OR…

There are many QoL instruments that have been validatedGeneric QoL Disease-specific QoLShort Form 36 AVVQEuroQol 5D VEINES-QOL

VEINES-SYMCIVIQ

Question:Insurers are desperately looking for ways to limit access to care for C2 patients - so rather than have them arbitrarily cut off funding for all C2 patients, what about combining the C2 classification with a QoL score and setting a clear standard by which the necessity of treatment is judged?

Generic Health-related Quality of Life is Significantly Worse in Varicose Vein Patients with Lower Limb Symptoms Independent of Ceap Clinical Grade

Physical and mental HRQL is significantly worse in VV patients with lower limb symptoms irrespective of the clinical stage of disease. This observation confirms that VV are not primarily a cosmetic problem and that NHS rationing of treatment to those with CEAP C4-6 disease excludes many patients who would benefit from intervention in terms of HRQL. Generic HRQL instruments also allow comparison with interventions for other chronic conditions.

Darvall K, Bradbury A, et al. Eur J Vasc Endovasc Surg. 2012 Sep;44(3):341-4.



The relevance of the natural history of varicose veins and refunded care Bonn Vein Study3072 participants from general populationC2 in 14.3%VVs may progress from a symptomatic or asymptomatic C2 class to higher clinical classes and CVI in a relevant percentage – up to 4% per year.Quality of life (QOL) is also reduced in uncomplicated VV in C2 patients. ConclusionThere is evidence that a high proportion of patients with uncomplicated VVs in the clinical, aetiological, anatomical and pathophysiological classification (CEAP Clinical Class 2) will progress to CVI if untreated. VV patients with CVI (C3–C6) as well as those C2 patients with severe clinical symptoms and impaired QOL due to CVD should be treated with ablation of the VVs in a refunded care system.

Pannier F, Rabe E. Phlebology 2012;27 Suppl 1:23–26

Thank you for your kind attention

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should c2 disease classification be broken down further? who progresses to c4?

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