Servier – Phlebolymphology

SUMMARY

In 2000, Rutherford proposed a new tool to measure the severity of venous disease. Its aim was to quantify the progression and treatment of chronic venous disease. It consists of three scores comprising clinical aspects, anatomic and pathophysiologic abnormalities (venous segmental disease score), and disability.
French angiologists, in order to evaluate the relevance and usefulness of such scores in their daily practice, conducted an observational study.
The scores were tested on 1900 patients by 398 angiologists, who completed an opinion questionnaire.
In any class of the CEAP classification, the three scores were low, specifically the segmental score. Although considered as easy to grade and relevant by the majority of respondents, only a minority of angiologists, stated their intention to use these scoring parameters in everyday practice for C4-C5-C6 patients (71.8% of the 1900 patients): 42.0% for the clinical severity score, 32.9% for the segmental score, and 38.7% for the disability score. These figures were even lower for C1-C2 and C3 patients: 21.6%, 19.6%, and 26.9% respectively.
The new severity scores to assess chronic venous disease seem difficult to use in daily practice, in particular the venous segmental score. They seem more appropriate to evaluate the evolution and efficacy of therapy in severe chronic venous disease.

INTRODUCTION

Chronic venous disease (CVD) covers many aspects, requiring adoption of a common international language: this is the objective fulfilled by the CEAP classification.¹ The CEAP classification describes CVD in its clinical (C), etio- logical (E), anatomical (A), and pathophysiological (P) aspects. Published in 1995, and updated in 2004,² the CEAP is now internationally recognized and has been widely disseminated to physicians specializing in vascular disease. However, this classification is only of descriptive value and does not allow quantification of severity of CVD. Concomitant with this classification, a committee of experts had developed scores to determine the severity of CVD based on three items (clinical, anatomo-pathophysiological, and disability). These scores had never been validated nor tested, and therefore were not used by physicians. A few years later, in 2000, the original authors of the CEAP system and other experts proposed new scores to grade the severity of CVD and to evaluate the efficacy of different therapies.³ These scores were mainly developed for severe forms of CVD according to the CEAP clinical classification (grades C4, C5, and C6), ie, for cases designated traditionally in terms of chronic venous insufficiency (CVI).^4,5 These severity scores for CVD grade clinical severity, anatomo-pathophysiologic severity and disability. Without a doubt, these severity scores deserve to be tested and evaluated by their potential users, ie, French angiologists, in this specific case.

METHODS

Description of populations

This survey was conducted with 398 angiologists, distributed throughout France (mainland). Each angiologist had to evaluate the three severity scores for CVD in five consecutive patients who met the inclusion criteria. Then the physician had to fill out an opinion questionnaire. The inclusion criteria for patients were based on the previous CEAP clinical classification.¹ This classification system describes CVD in all of its aspects using a coding system with four subject headings:¹
– the heading C describes 7 clinical classes, ranging from C0 to C6, defined as follows:
• C0: No visible or palpable sign of venous disease
• C1: Telangiectasias or reticular veins
• C2: Varicose veins
• C3: Edema
• C4: Skin changes ascribed to venous disease: pigmentation, venous eczema, hypodermic inflammation
• C5: Skin changes as defined in C4 with healed ulceration
• C6: Skin changes as defined in C4 with active, unhealed ulceration
In this survey the basic CEAP was used; this means that only the highest clinical class was quoted. In addition, this clinical classification is supplemented by addition of a letter: (A) stands for asymptomatic, and (S) symptomatic if the patient presents with “venous” symptoms: pain, sensation of lower-limb heaviness, paresthesias, etc.
The etiology heading differentiates three types of causes of CVD (Ec for congenital, Ep for primary, Es for secondary). The anatomical heading codifies CVD according to the anatomic distribution of venous disease (As stands for superficial venous network; Ad for deep venous network, and Ap for perforator veins) and specifies the venous segment involved by addition of a number corresponding to 18 predefined segments.
Lastly, the pathophysiological heading differentiates CVD associated with reflux (Pr), obstruction (Po), or a combination of the two mechanisms (Pr + o).
To be eligible for inclusion, patients had to present with CVD and signs corresponding to classes C4, C5, or C6 of the CEAP clinical classification, be 18 years of age or older and not have peripheral arterial disease.

Description of severity scores for CVD

Severity scores were compiled for patients presenting with CVD. They quantify the degree of severity of venous disease according to three criteria: clinical, anatomopathophysiological, and functional.³
The VCSS takes ten items into account represented by the following:
– Symptoms and signs of CVD: pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, and ulceration. Regarding ulceration, different items were chosen: number of active venous ulcers, their size, and duration.
– Compliance with compression therapy.
Each item was scored separately in terms of severity on a 3-point rating scale ranging from 0 (absent) to 3 (severe).
Scores obtained for each item were added up to comprise the overall VCCS, which ranges from 0 to 30 (Table I).³
– The VSDS takes into account both the pathophysiological mechanisms involved, ie, reflux and obstruction, and the anatomic distribution of the diseased veins. It contains two different and independent components: the “reflux” score and the “obstruction” score. Depending on location of the diseased veins, and since pathophysiological effects do not have the same severity, a specific coefficient ranging from 0.5 to 2 was assigned to each segment of a vein. Each of the two scores comprising the segmental score was calculated independently by adding up the coefficients assigned to the diseased segments of the vein. They ranged from 0 to 10 (Table II).³
– Lastly, the VDS provides a quantitative evaluation of the functional impact of CVD on a 4-point scale, from 0 (asymptomatic) to 3 (unable to carry out usual activities even with compression therapy and/or limbs elevated) (Table III).³
The scores could be calculated only when information was provided for all items (no missing data).

Table I. Venous clinical severity score (VCSS).

Table II. Venous segmental disease score (VSDS, based on venous segmental involvement with reflux or obstruction*).

Table III. Venous disability score (VDS).

Scores Angiologist opinion

After including five patients, the angiologist had to evaluate the ease of use, value, and usefulness for managing patients in daily medical practice, of each of the three CVD severity scores, using a six-item questionnaire. Each item was evaluated on a verbal scale according to four levels: “not at all in agreement,” “do not agree,” “agree,” “agree entirely.”
In addition, these four reply modalities were combined into two classes: “not favorable,” by adding up the modalities “not at all in agreement,” and “do not agree,” on the one hand, and “agree,” and “agree entirely,” on the other hand.

Lastly, verbatim comments were collected.

Statistical analyses The survey was designed to target solely patients in clinical class C4, C5, or C6 of the CEAP classification. But an analysis of case reports revealed that a certain number of patients recruited presented with class C1, C2, or C3 CVD. Therefore, two groups were formed based on the CEAP clinical classification, the [C4-C5-C6] group and the [C1-C2-C3] group. It appeared relevant to perform all the statistical analyses, both on all patients enrolled and also on each of the two groups thus formed. Intergroup comparison of quantitative variables was performed with a nonparametric Mann-Whitney-Wilcoxon test when two groups were compared, and with a Kruskal-Wallis test for comparisons on more than two groups. The analysis was descriptive. In terms of test results, a value of 0.05 was considered as significant.

RESULTS

Surveyed population

A total of 398 angiologists (49.8% men, 48.7% women) distributed throughout France participated in the survey between March 10 and September 4, 2001. These physicians practiced primarily in urban areas.
They recruited 1900 patients, 1365 of who were in the [C4-C5-C6] group, ie, 71.8% of all patients, and 484 patients in the [C1-C2-C3] group.
Patients, mainly women, were 61 years of age on average, but those in the [C1-C2-C3] group were significantly younger than the [C4-C5-C6] patients and the percentage of men was higher in the latter group (Table IV). Mean body mass index (BMI) was higher and significantly different between the [C1-C2-C3] and [C4-C5- C6] groups. In addition, the especially high percentage of patients who were overweight and obese in the [C4-C5- C6] group compared with the [C1-C2-C3] group should be noted (Table IV). Regarding clinical classes, based on the “C” heading of the CEAP system, the ones most often represented were classes C4, C6, and C2 (Table V).
The majority of patients were symptomatic and this was enhanced even more in the [C4-C5-C6] patients compared with those in the [C1-C2-C3] group (Table V). The etiology of CVD was mainly primary, but more frequently secondary in the [C4-C5-C6] group than in the [C1-C2-C3] group (Table V).
Although venous reflux was the cause of CVD in the majority of cases, the combination of reflux and obstruction appeared more commonly in [C4-C5-C6] patients than in the [C1-C2-C3] group (Table V).
Furthermore, in the total population as well as in the [C4-C5-C6] group, the venous segments most commonly involved were the calf perforator veins, (38.2% and 44.1% respectively) the great saphenous vein (GSV) above the knee (34.6% and 38.6%), and below the knee (18.6% and 19.9%). On the contrary, in the [C1-C2-C3] group, GSV above the knee (26.2% of cases), the reticular veins (26.0%), and the calf perforator veins (25.4%) were involved.

Table IV. Demographic characteristics of patients.

Table V. Clinical, etiological, and pathophysiological characteristics of patients according to the CEAP classification.

Lastly, 87.7% of the 1900 patients underwent Duplex scanning (DS) and 94.1% underwent DS and/or Doppler examination.

Severity scores for CVD

The analysis revealed a markedly lower clinical severity score in the [C1-C2-C3] group compared with the [C4- C5-C6] group (Figure 1).
Furthermore, regarding the two components of the VSDS:
• The mean “reflux” score obtained on all 1900 patients was low; it was slightly higher in the [C4-C5-C6] group compared with the [C1-C2-C3] group,
• The mean “obstruction” score obtained was even lower, whatever the group of patients involved (Figure 2),
• The VDS most commonly was of level 1 (38.6% of 1900 patients), and 2 (44.6% of them), with a majority of score 1 in the [C1-C2-C3] group (60.1% of patients), and score 2 in the [C4-C5-C6] group (53.0%) (Figure 3).

Figure 1. VCCS.
score: 0 – 30

Figure 2. VSDS.

Figure 3. VDS.
 No information given,
 Symptomatic, but able to carry out usual activities conducted
without compression therapy,
 Unable to carry out usual activities even with compression
therapy and/or limb elevation,
 Asymptomatic,
 Can carry out usual activities only with compression therapy
and/or limb elevation.
* Usual activities = patient activities before onset of disability from
venous disease

Figure 4. Evaluation of VCCS by angiologists.

Angiologists’ opinion

The majority of angiologists considered the three scores as easy to grade, and the items comprising them appeared relevant, especially for the VCCS (Figure 4) and VDS Figure 5).
Far fewer angiologists planned to use them in daily practice and to expect an advantage from using them in therapeutic monitoring of their patients. In their opinion, the usefulness of these scores seemed lower for C1-C2- C3 patients compared with C4-C5-C6 patients (Figures 4, 5, 6).
In terms of all criteria evaluated, the percentage of physicians favourable to VSDS was lower than for the other two scores (Figure 6).
Furthermore, 34.2% of the angiologists commented on this new measurement instrument for angiologists who provided verbatim comments, 56.6% of them considered that it was not suited to their daily practice, and 16.9% said it should be reserved for clinical studies.
In addition, they reported that severity scores for CVD did not take into account all the diseased veins nor concomitant disease in both lower limbs. Lastly, in the physicians’ opinion, the VCCS was not precise enough with regard to skin changes such as dermatitis or hypodermic inflammation.

Figure 5. Evaluation of VDS by phlebologists.

Figure 6. Evaluation of VSDS by angiologists.

DISCUSSION

The 398 angiologists who participated in this survey, ie, about one fourth of all angiologists in France, comprised a representative sample.
Regarding patients’ demographic characteristics, traditionally the [C1-C2-C3] patient population was younger and less commonly overweight than that of the [C4-C5- C6] group. However, these characteristics cannot be compared with those of epidemiological surveys generally conducted on CVD because the study population was selected in a manner so as to recruit patients in class C4, C5, and C6, according to the CEAP classification, ie, patients presenting with CVI.
It should be kept in mind that at this time in France CVD was not differentiated from CVI, unlike the definitions of these terms used in the United Kingdom.^4,5
Out of 1900 patients enrolled, 71.8% were classified C4, C5, or C6, and thus met planned inclusion criteria, which is important since the three severity scores for CVD are designed for these clinical classes of the CEAP. However, the C4 class was dominant (40.9% of the total sample size). However, it should be noted that this class combines sufficiently different signs some of which (eczema, etc) are not of a severity such that the patient can be considered as presenting with severe CVI. Theupdated CEAP has divided C4 into 2 subgroups C4a and C4b to improve the identification of the clinical class.
Furthermore, interobserver reproducibility of the CEAP clinical classification was not very good for some items.⁶ Therefore, even though patients belonged to all grades of the CEAP classification, we considered it relevant to analyse both the overall patient population as well as the two groups of patients [C1-C2-C3] and [C4-C5-C6].

Severity scores

It emerged from this study that severity scores for CVD were not distributed over all of the proposed scales: 0 to 30 for VCCS, 0 to 10 for VSDS (separately both for reflux, and obstruction), and 0 to 3 for VDS, and that the mean values obtained for each of the three scores were not very high.
It is important to note that the authors of the severity scores for CVD specify that these scores were designed to evaluate the most severe forms of CVD. And yet, patients in classes C1, C2, and C3 were also analyzed in this study. However, it is no less true that scores for patients in classes C4, C5, and C6 were also low, which can be explained in particular by the fact that the C4 class included relatively heterogeneous cases, involving patients whom it is difficult to define as presenting with CVI. These results confirm the fact that severity scores are not adapted to grade non severe CVD.
In addition, it is necessary to differentiate the results of VCCS and VDS from those of the VSDS.Indeed, in the first place, the VSDS obtained was lower than the other two scores. Second, the percentage of “reflux” and “obstruction” scores that were invaluable (due to missing data) was higher than for VCCS and VDS (about 30% of cases for VSDS versus less than 10% for the other 2 scores).
Therefore, the VCCS and VDS seem easier to grade than the VSDS.
Furthermore, it should be noted that no complementary investigation was required during this study. However, Doppler and duplex scanning examinations were performed in the majority of cases. But these methods cannot evaluate with sufficient quality all the venous segments inventoried for the VSDS,⁷ whether in terms of reflux or obstruction.
Logically, the VSDS posed technical problems for angiologists.
Furthermore, as could be expected, the clinical severity score increased with the CEAP clinical classification (Figure 1). It was also noted that patients classified as C4- C5-C6 had a more severe VDS (Figure 2). Thus, only 29.9% of symptomatic patients in the C4-C5-C6 group had normal activity without compression therapy, while this figure was 60.1% of patients in the C1-C2-C3 group. Therefore, the VDS was a good indicator of disease severity.
Lastly, no parallel can be drawn between VSDS and CEAP clinical class for the following reasons:
– First, the scores for reflux and obstruction were very low, and consequently, the differences between the scores were very low, many data were missing, and the number of cases of obstruction in this survey was low (less than 15%): therefore, an analysis would have little relevance;
– Second, hemodynamic data evaluated by the VSDS were hard to interpret because it is difficult to correlate the number or degree of involvement of venous segments producing a reflux or obstruction and its clinical impact.

The opinion of angiologists

In this context, a review of the angiologists’ opinion is of considerable interest.
Clinical severity and disability scores were considered easy-to-rate and relevant according to about two-thirds of angiologists (Figures 4 and 5). They were good indicators of the severity of CVD. However, even though for almost half of the angiologists these two scores provided more precise monitoring of therapy of [C4-C5-C6] patients, the percentages fell when the question of using them arose.
On the contrary, evaluation of the VSDS was less favourable. Even for patients in the [C4-C5-C6] group, less than 40% of angiologists considered that the score provides an advantage, and only one third of them plan to use it in their daily practice (Figure 6).
Furthermore, the coefficients assigned to the different venous segments comprising the “reflux” and “obstruction” scores were subject to criticism. They seem to take more into account the number of segments involved rather than the degree of involvement, even though different figures were assigned to different segments. Furthermore, in addition to the overall evaluation of the VSDS and the technical difficulties in providing information on it, the difficulty in interpreting it also is an issue. Besides, some angiologists propose incorporating the following items in the VCCS for CVD: previous venous surgery, the recurring nature of CVD, and possible involvement of both lower limbs. Furthermore, they consider that these items do not take into account all the skin changes observed in patients classified as C4.
All these suggestions do not necessarily appear suited to the objective of severity scores insofar as their purpose is to evaluate a patient at a given time, in a reproducible manner and to follow disease progression, above all in the setting of evaluation of therapeutic management. On the other hand, although clinical and VSDS involve only one lower limb, involvement of both lower limbs logically has an impact on VDS. Furthermore, more precise evaluation of skin changes, in terms that they signify a level of severity, may favourably have a place in these scores, specifically for class 4 in the CEAP clinical classification.

CONCLUSION

In conclusion, 398 French angiologists, evaluated 1900 patients, the majority of whom had class C4, C5, and C6 venous disease based on the CEAP classification, and they evaluated the new severity scores for CVD developed by Rutherford et al.³
They determined that these scores do not seem very well suited to their daily practice. Nevertheless, VCCS and VDS, easy-to-rate and relevant, comprise an instrument whose measurement varies with the severity of venous disease, but above all they were intended to evaluate the efficacy of treatment of CVI. Lastly, the VSDS is especially hard to score and interpret. In particular, it requires complementary investigations, which cannot be performed in angiologist’s office. This score clearly seems to be reserved for clinical studies. However, to facilitate its interpretation, it can be useful to study its correlation with the VCCS.
This work was made possible by a research grant from Abbott Laboratories France.
Adapted from the article Perrin M, Dedieu F, Jessent V, Blanc M-P. Une appréciation des nouveaux scores de sévérité de la maladie veineuse chronique des membres inférieurs. Résultats d’une enquête auprès d’angiologues français. Phlébologie. 2003;56:127-136.

AKNOWLEDGMENTS

We thank Jean-Paul Henriet, MD, Cabourg, France for his kind authorization to adapt this article from the original version previously published in Phlébologie. 2003; 56:127-136. This work was supported by a research grant from Les Laboratoires Abbott, France.

REFERENCES