Reporting outcomes of new and old endovenous technologies using a standardized dataset – Now is the time for change

The management of varicose veins has undergone an industrial revolution over the past decade but the optimal treatment modality remains debatable. The initial ‘gold standard’ of high ligation, stripping and avulsions has been gradually replaced by endothermal ablation and ultrasound-guided foam sclerotherapy (USGFS), ¹ with the outcome of these procedures now having more than 10-year follow-up data showing at least comparable results to open surgery but improvement in many other parameters. The results of foam sclerotherapy have been inferior to both endovenous laser and radiofrequency ablation in terms of anatomical and clinical recurrence ² such that modifications of the technique, including catheter-directed foam sclerotherapy ³ and use of a more stable form of foam (Varithena®, BTG International, UK), ⁴ are increasingly being utilised with some success.

There has therefore been an impetus for the development of newer techniques to further enhance the patient’s peri-operative experience and avoid the need for tumescent anaesthesia and thermal ablation of the so-called non-thermal, non-tumescent (NTNT) technologies. These include mechano-chemical ablation with ClariVein™ (Vascular Insights, MA, USA) and cyanoacrylate glue embolization (VenaSeal™, Medtronic Ltd, Galway, Ireland). These relatively new techniques have shown promising results but without long-term data. At present, all these novel devices are difficult to compare due to the heterogeneous reporting of outcome measures as highlighted by several NTNT reviews and metanalyses published recently.^5,6 This may be due to selective reporting of positive results especially with new technologies where there are pressures to show that the new treatment actually works!

There have been many reports highlighting the need for standardised reporting of outcomes in endovenous surgery including publications from the society of vascular surgery (SVS) and European Society of Vascular Surgery (ESVS).^7,8 Most reported studies use a combination of outcome data, mainly immediate and medium-term truncal ablation, as confirmed by duplex ultrasound and changes in patient symptoms and quality of life, utilising a validated venous questionnaire such as the revised Venous Clinical Severity Score (rVCSS) and Aberdeen Varicose Vein Questionnaire. Not all studies report on significant complications such as deep vein thrombosis (DVT) rate or, in cases of endovenous ablation, endothermal heat-induced thrombosis (EHIT). Other confounding factors are the timing of the adjunctive treatments and how pain is quantified peri-operatively. Reporting on procedural complications such as phlebitis and skin pigmentation is also variable and clinical measures of time off work and return to normal daily activities are not routinely described. This was previously highlighted by Thakur et al., ⁹ but subsequent studies looking at newer venous ablative devices have failed to take heed of these problems.

The authors argue that there is now a need for standardisation of the main outcome measures of the differing venous ablative procedures so that the various techniques can be compared equitably. This should follow the guidelines from the various vascular societies as mentioned above and should be ‘policed’ by the editors of journals to ensure that they are followed. If there are missing datasets, then the reasons for this need to be explained. Utilising the different guidelines and adding to this from the current literature, we would recommend a minimum dataset to include indications, pre-operative duplex investigations, operative details and post-operative outcomes. Indications classified by CEAP class or VCSS score and pre-operative investigation namely duplex scan should mention the truncal vein diameters as this is known to affect outcomes. Per-operative details should look at length of vein treated and any adjunctive treatment employed, method of anaesthesia and post-operative compression regime. Operative success should be documented by duplex evidence of occlusion at 2–6 weeks post-procedure, though there is more benefits of follow-up towards the 6-week mark, which allows for the procedural discomfort to settle and some of the tributaries to be become more cosmetically acceptable and thus there may not be the need for further adjunctive treatment. ² The duplex scan should also look for the length of residual stump, DVT and EHIT.

Long-term occlusion rates are important from a procedural success viewpoint, though not necessarily from a clinical perspective, and therefore, we would recommend at least sonographic evidence at 1, 3 and 5 years especially for newer technologies though this is not mandatory. It should however be done in all cases where there is clinical recurrence to understand the causal factor(s). The other important parameter that should be standard for reporting will be the clinical outcome questionnaire. This should be rounded off with a satisfaction questionnaire of the patient’s overall experience as surgery becomes more patient-centric.

Controversy still exists about which venous technology is most cost-effective, which works best in the long-term in terms of truncal occlusion and patient satisfaction and which to use in certain types of patients. ¹⁰ The continuing introduction of new devices to the endovenous arena demands good information about them, because this will generate good comparative evidence for the future. There have been a number of initiatives to collect venous registry data from the US and from Europe, but these have generally failed because of lack of contribution to them owing to the demanding dataset required and the ambition to collect information on all aspects of the patient’s venous disease and management. ¹ As a venous community, we should now come together and devise an endovenous registry and collect a minimum dataset encompassing the patient’s treatment so that we can have meaningful data to compare to determine which is the optimal treatment for each individual with chronic venous disease.