Quality of Life PROMinance Vital in Venous Interventions

Quality of life (QoL) assessments were explored in detail on Tuesday morning by Oliver Schlager, an interventional angiologist at the Medical University of Vienna, Austria, where he focuses primarily on patients with acute and chronic venous occlusions. Dr Schlager talked about the severity of venous insufficiency and post-thrombotic syndrome (PTS), which are typically assessed by the Villalta scale, or the venous clinical severity scale (VCSS). For example, Villalta— a continuous scale that ranges from 0 to 33 points—summarizes clinical signs and symptoms: the more severe, the higher the score. “The scores summarize some clinical signs that are presented by the patient and assessed by a nurse or doctor, and clinical symptoms reported by the patient,” said Dr Schlager, who noted their use in clinical trials, too.

However, scores may not be as informative as assumed, stressed Dr Schlager, who suggests they are not so well suited to patient-centered approaches. “None of these well-used scales directly address patients’ QoL when they assess severity of symptoms,” he said. “I think this is becoming more and more important to recognise.”

At LINC, Dr Schlager showed studies trying to correlate QoL and severity of symptoms. “There is quite a good correlation, but it’s not the same.”

Scores that specifically assess QoL include the ChronIc Venous Insufficiency QoL Questionnaire (CIVIQ), for example. This collects information not on pain severity, as the Villalta does, but how pain affects everyday life. For example, while Villalta may score itching or paraesthesia, CIVIQ will determine the scale of impairment in daily activities such as climbing several flights of stairs or performing household tasks such as cleaning the floor using the vacuum cleaner. “We cannot do clinical severity scoring and believe that we know about a patient’s QoL,” Dr Schlager emphasized.

When comparing such scores in patients with chronic venous disease, some QoL questionnaires work better than others according to Dr Schlager. “CIVIQ and as well as the Charing Cross venous ulcer questionnaire are most appropriate for the assessment of QoL,” he explained. Specifically, CIVIQ is more appropriate for patients with chronic venous disease and no ulcerations, and the Charing Cross venous ulcer questionnaire is more appropriate for chronic venous disease patients with ulcerations, according to a clinical study last year.¹

These patient-reported outcome measures (PROMs) are not foolproof, however. “They can be used to get quite close to a patient’s QoL, but they also have shortcomings,” said Dr Schlager. For example, patients’ walking capacity is not generally captured by any clinical disease severity scores. “And another problem which is often present in these patients is fatigue. This is something which also has an effect on QoL.”

Impairments in walking and fatigue are particularly important factors in young patients. Indeed, Dr Schlager’s group specifically assessed the walking capacity of patients with acute deep vein thrombosis.² “It’s interesting to see that this depends on the location of thrombosis. This appears to be quite clear at first sight, but on the other hand, has not been assessed or published before,” he explained.

In addition, Dr Schlager gave an overview of measures used in recent major clinical stenting trials. The primary endpoint of the ATTRACT trial—the well-known 2017 study on catheter-based thrombectomy in patients with acute deep vein thrombosis (followed by stent placement in some of these patients)—was the Villalta score. In ATTRACT, anything lower than 5 equaled the absence of venous disease or PTS, and 5 points or more represented the presence of PTS. “The problem, of course, is that when you’re trying to condense a continuous scale into a binary outcome measure, this absolutely does not reflect what’s going on with patients,” said Dr Schlager. “Nor does it recognize the broad spectrum of different symptoms these patients might have.

“Moreover, the main reason for these procedures was to improve QoL, and the Villalta scale does not reflect a patient’s QoL.” That is why weighing up these different scores becomes quite a complex discussion, explained Dr Schlager, noting that a post-hoc analysis of the ATTRACT trial did show that these interventions improved patients’ QoL.³

In the future, Dr Schlager advises moving on from a one-size-fits-all approach (predicated on Villalta VCSS) to tools that can better justify procedures and interventional treatment. “When we are coming to a decision as to whether to refer patients for an interventional procedure, we have to do better,” he said, concluding: “For an individualized therapeutic approach, one tool we can use is the PROM, e.g. QoL questionnaires, in our assessment, and of course in clinical trials.”

References

1. Cleman J, Xia K, Haider M, et al. A state-of-the-art review of quality-of-life assessment in venous disease. J Vasc Surg Venous Lymphat Disord. Published online December 19, 2023.

2. Steiner D, Nopp S, Pabinger I, et al. Impact of thrombosis location on walking capacity: a cohort study of patients with acute deep vein thrombosis. Res Pract Thromb Haemost. 2024;8(1):102324. 

3. Pop CT, Gu CS, Vedantham S, et al. Exploring the Villalta scale to capture postthrombotic syndrome using alternative approaches: A subanalysis of the ATTRACT trial. Res Pract Thromb Haemost. 2022;7(1):100032.