Assessing the outcomes of venous interventions

Manj Gohel

These are exciting times for physicians involved in the management of venous disease. There have been important advances in basic scientific research and crucial developments in venous imaging and diagnostics. Most importantly, however, writes Manj Gohel, physicians now have an excellent choice of minimally invasive interventions to manage the range of superficial and deep venous pathologies that are encountered in daily clinical practice.

For superficial venous disease, we have come a long way after nearly a century of ligation and stripping. Non-thermal endovenous procedures offer the latest in a series of recent treatment advances. The latest deep venous stents are closing in on the “holy grail” of good flexibility, high radial force and durable resistance to extrinsic compression. For the treatment of deep venous reflux, tremendous advances in materials engineering mean that even the seemingly impossible deep vein valve prosthesis may be within reach.

In this era of innovation and novel procedures, the importance of measuring outcomes has never been greater. Objective evidence of the benefits of venous treatments offers powerful reassurance to patients, clinicians and commissioners. Robust outcome assessment can also help optimise case selection and provides some protection for physicians to counter peer scepticism and medicolegal concerns. However, outcome evaluation is time-consuming and deciding on which outcome measures should be routinely assessed is difficult. Moreover, an enormous range of potential outcome measures exist, including anatomical, clinical, haemodynamic, patient-reported and health economic tools (Figure 1). Clinical (usually physician-assessed) outcomes are widely accepted, with the CEAP, VCSS and Villalta systems in widespread use. Assessing outcomes is time- and resource-consuming, so measuring everything is simply not feasible.

Some may argue that assessing technical success (usually with duplex ultrasound scanning) is adequate for outcome evaluation. Assessment of anatomical success is certainly important, but our obsession with closure and patency rates must be challenged. The relationship between anatomical venous disease and clinical severity (or patient symptoms) is notoriously poor. Many clinicians will recognise the (often male) patient with spectacular varicose veins (with severe truncal reflux), without symptoms or skin changes or the patient with extensive iliocaval occlusive disease, but no leg swelling or symptoms. Anatomical outcomes may be easy to assess and are important, but do not give a full assessment of the patient clinical status. In each individual patient, the superficial or deep venous component may be only one of many factors contributing to the burden of venous hypertension. A patient is unlikely to be content with a “successful” saphenous endovenous ablation procedure if the symptomatic varicosities are still present, or the venous ulcer remains unhealed.

In recent years, there has been a growing interest in patient-reported outcome measures (PROMs) and recognition that the primary aim of treatments is to improve patient quality of life. A wide range of validated and widely accepted quality of life tools (both generic and disease-specific) are easily available. In the UK National Health Service, there has been an initiative to measure generic (EuroQuol 5D; EQ5D) and disease-specific (Aberdeen Varicose Vein Questionnaire; AVVQ) quality of life before and after superficial venous interventions. Other disease specific quality of life tools for venous disease include CIVIQ, SQOR-V, CXVUQ and the Veines Sym/Qol tool. The Veines Sym/Qol is worthy of specific mention as this is likely to be the most validated disease specific quality of life measure in patients with deep venous occlusive disease.

There is a strong argument for the routine assessment of a range of outcomes in standard clinical practice. Whether the primary disease process is superficial venous reflux or deep venous disease (or both), a combination of anatomical (duplex ultrasound), clinical (ulcer healing/recurrence, CEAP, VCSS, Villalta) and patient-reported (AVVQ, CIVIQ or Veines Sym/QOL) outcomes should be assessed where possible. Increasing use of registries and outcome publication/benchmarking may act as encouragement for clinical teams to collect these data. There is no doubt that the routine evaluation of patient-reported outcomes for patients with venous disease would represent a significant paradigm shift from traditional practice. Greater consistency and standardisation is needed. However, outcome assessment is essential to define the effectiveness and role of the plethora of venous treatments now available. Only then can we truly optimise and individualise venous interventions for the benefit of patients now and for years to come.

Manj Gohel is a consultant vascular and endovascular surgeon at Cambridge University Hospitals, Cambridge, UK