Results of UK study find that Villalta scale is not disease-specific

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Evidence from a recent study conducted by Imperial College London, UK has further demonstrated that the Villalta scoring system is not disease-specific and correlates with other tools for measuring venous outcomes. The results of the study have implications for the ATTRACT trial, affirming that the Villalta scale is an imperfect method of identifying and measuring post-thrombotic syndrome.

Presented by Kemal Kemal (London, UK) at the International Union of Phlebology chapter meeting (UIP; 25–27 August, Krakow, Poland), the findings of the study contributed to extensive discussions in Krakow on whether the Villalta scale remains fit for purpose. While the use of Villalta scores is still the gold standard for diagnosing and classifying post-thrombotic syndrome, “providing it is used with a venous-specific quality of life (QoL) score,” there are limitations to this classification.

Kemal said: “One of the main issues seems to be that the signs and symptoms looked at by the Villalta score questionnaire are not specific to post-thrombotic syndrome and in fact exist in chronic venous disease also. The other issue we are finding is that patients who have deep venous disease but no duplex evidence of obstruction, are getting a false positive diagnosis of post-thrombotic syndrome.” In addition to this, patients without deep-vein thrombosis (DVT) have also scored highly with the Villalta system.

Given the criticism faced by the classification scale, which was originally designed to be disease-specific, the Imperial College study aimed to compare Villalta to other clinical severity and QoL tools in a group of patients with no history of post-thrombotic syndrome. Of the 110 patients enrolled in the prospective single-centre study (43 male, 67 female), all had duplex evidence of superficial venous disease or deep venous disease.

As part of the study, a clinician filled out a series of classifications, including the Villalta scale, CEAP classification and venous clinical severity scores (VCSS), while the patient themselves filled out the Aberdeen Varicose Vein Questionnaire (AVVQ) and VEINES-QoL/SYM questionnaire. Regarding the latter assessment tools, Kemal commented: “VEINES-QoL has been used extensively and has been validated in chronic venous disease, as well as in patients who have DVT, and so has AVVQ.”

Turning his attention to the results of the study, Kemal highlighted that the mean Villalta score of the cohort (median age of 59 years) was eight, indicating mild post-thrombotic syndrome despite the fact that none of the patients have ever had DVT. In terms of the relationship between different scoring systems, results also showed a moderate correlation between Villalta scores and the CEAP classification, as well as between Villalta and the VEINES-SYM questionnaire. In addition, a moderate correlation was noted between Villalta and VCSS, and Villalta and AVVQ.

The only clinical severity and QoL tool which the Villalta scale did not have a moderate correlation with was the VEINES-QoL questionnaire, which correlated strongly with the VEINES-SYM questionnaire but “rather weakly” with other classification systems.

Kemal concluded: “Our results demonstrate and provide further evidence that Villalta correlates well with chronic venous disease assessment tools, which implies it is not disease-specific. We know that pre-existing chronic venous disease plays a big role in patients who have DVT, and 50% of patients who have a DVT will also have pre-existing chronic venous disease, and this may indicate the outcome with Villalta.

“This does have implications for studies such as ATTRACT, which use Villalta to assess outcomes, and we believe that it may be more beneficial to be used as a dynamic marker, rather than something static, so to look at something different over a period of time.”

In response to an audience question about the continued use of the Villalta scale and whether it remains the gold standard, Kemal added: “I think the problem we have is that we don’t have an alternative currently, so we will continue to use Villalta until something else is established. Some small studies have validated it, so although not disease-specific as it was designed to be, it has some use.”

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