Published: 30th September
Author: Mr Alastair Lewis MD, FRCSI | President, British Association of Sclerotherapists
TL;DR
- Anatomical closure of the great saphenous vein remains an important outcome after varicose vein treatment, but it should not be equated with clinical success.
- Recent evidence suggests that higher occlusion rates with thermal ablation do not necessarily translate into better symptoms, function or disease-specific quality of life compared with non-thermal techniques.
- Recanalisation may have little clinical consequence in an asymptomatic patient, while complete vein closure does not guarantee a good outcome if symptoms or varicosities persist.
- Treatment success should therefore be judged using a combination of anatomical findings, patient-reported outcomes, recurrence and the need for further intervention.
Introduction
In a landmark 2009 study, Chapman-Smith [1] reported 100% patient satisfaction at five years following ultrasound-guided foam sclerotherapy, despite failure of complete truncal closure in 17% of patients and the development of new reflux in a further 17% after one year.
This observation remains highly relevant. Anatomical closure has increasingly become the principal outcome by which endovenous interventions are compared, and differences in occlusion rates have contributed to guideline recommendations favouring thermal ablation over foam sclerotherapy. However, anatomical and clinical success are not synonymous.
Great saphenous vein (GSV) occlusion is fundamentally an anatomical surrogate outcome. From the patient’s perspective, the more relevant endpoints are improvement in symptoms, functional status, disease-specific quality of life, cosmetic outcome and, importantly, freedom from clinically significant recurrence or further intervention.
This month’s blog highlights a contemporary study examining whether the modality used to treat GSV incompetence materially alters clinical outcome [2]. I have also included a second recent publication addressing a similar question in a much larger real-world population [3].
Paper 1
Shahat and colleagues [2] performed a prospective, non-randomised cohort study comparing thermal ablation with catheter-directed ethanolamine oleate foam sclerotherapy for GSV incompetence.
As expected, thermal ablation achieved superior anatomical occlusion at one year: approximately 93.5% compared with 81.5% in the foam-treated group. Despite this approximately 12% difference in anatomical durability, there were no statistically significant differences between the groups in symptoms, disability or disease-specific quality of life at one year.
That finding deserves attention. It suggests that a measurable difference in truncal occlusion does not necessarily translate into a corresponding difference in clinical benefit over the same period.
There are, however, important limitations.
First, treatment allocation was not randomised. The procedure performed was influenced by patient and surgeon preference, equipment availability and insurance coverage. Although the reported baseline characteristics were similar, residual and unmeasured confounding cannot therefore be excluded.
Second, all patients underwent concomitant phlebectomy. This makes it difficult to determine how much of the improvement in symptoms and quality of life resulted from treatment of the truncal vein itself and how much resulted from removal of the associated varicosities.
Third, the foam technique has limited direct applicability to contemporary UK practice. Ethanolamine oleate was used rather than sodium tetradecyl sulphate (STS) or polidocanol, and treatment was delivered without perivenous tumescence or irrigation. The anatomical results should therefore not be interpreted as representative of an optimised modern foam sclerotherapy technique.
Nevertheless, the study illustrates an important principle. Thermal ablation produced superior anatomical closure, but this did not translate into demonstrably superior clinical outcomes at 12 months.
Paper 2
A second recent published abstract [3] addresses a closely related question: whether thermal or non-thermal ablation is associated with superior patient outcomes in superficial venous disease.
Its principal strength is scale. The analysis draws on the Vascular Quality Initiative and includes 21,877 patients, providing substantial statistical power and reflecting real-world clinical practice.
Large datasets, however, require careful interpretation. With sufficiently large numbers, relatively small differences may achieve statistical significance without necessarily representing clinically important effects.
There are also limitations to what can currently be concluded from the published abstract. Although the study is described as assessing patient-reported outcomes, the outcomes presented predominantly comprise CEAP classification, pain categories, ulcer status and recanalisation rather than established disease-specific quality-of-life instruments.
One particularly notable observation was improvement in CEAP classification from C3 to C0 in both treatment groups, with greater reported symptom resolution in the non-thermal cohort.
The full publication will be important before firm conclusions can be drawn. In particular, the abstract does not provide a breakdown of the individual modalities included within the non-thermal group, and validated quality-of-life measures are not reported.
For now, the findings should therefore be regarded as hypothesis-generating rather than definitive. Nevertheless, they again lend weight to the argument that differences in recanalisation rates do not necessarily correspond directly with differences in patient-centred outcomes.
Conclusion
Taken together, these studies add weight to the argument that anatomical closure of the GSV should not be used as the sole definition of treatment success or failure.
The first study provides the stronger evidence for this proposition. Thermal ablation produced clearly superior 12-month anatomical durability—approximately 93.5% versus 81.5% closure—yet VCSS, VDS and AVVQ outcomes at one year were essentially indistinguishable between the treatment groups.
This does not mean that GSV closure is unimportant. Anatomical durability remains a relevant outcome and should continue to be measured. Persistent or recurrent reflux may contribute to recurrent varicosities, symptoms and the need for further treatment.
The important distinction is that recanalisation is not necessarily synonymous with clinical failure.
A partially or completely recanalised GSV in an asymptomatic patient who has experienced sustained symptomatic and cosmetic improvement is difficult to regard as an unequivocal treatment failure. Conversely, complete anatomical obliteration of the GSV in a patient with persistent pain, residual varicosities or dissatisfaction cannot reasonably be regarded as complete clinical success.
Perhaps the more useful question is therefore not simply:
Is the vein open or closed?
But rather:
Is there clinically significant recurrent reflux? Does it contribute to recurrent varicosities or symptoms? Has the patient’s quality of life deteriorated? And does the patient require further intervention?
This distinction is particularly relevant when assessing foam sclerotherapy, where duplex ultrasound may demonstrate partial recanalisation with little or no apparent clinical consequence.
Future comparative studies of venous interventions should therefore continue to report anatomical occlusion, but alongside outcomes that are directly meaningful to patients: symptoms, quality of life, recurrence, retreatment and patient satisfaction.
Ultimately, successful treatment of venous disease should be judged not simply by what the duplex scan looks like, but by what that anatomical finding means for the patient.
References
- Chapman-Smith P. Prospective five-year study of ultrasound-guided foam sclerotherapy in the treatment of great saphenous vein reflux. Phlebology. 2009;24(4):183–188.
- Shahat M, et al. Endovenous ablation of the great saphenous varicose veins: Does the modality matter? A prospective cohort study. Phlebology. 2026;0:1–12.
- K A. Patient-reported outcomes after thermal vs nonthermal ablation for treatment of lower extremity superficial venous disease. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2026;14(2):20.
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