The European Society for Vascular Surgery (ESVS) has released 2022 clinical practice guidelines on the management of chronic venous disease (CVD) of the lower limbs to update its 2015 recommendations. The document, authored by Marianne G De Maeseneer (Erasmus Medical Centre, Rotterdam, The Netherlands) and colleagues, was published online ahead of print in the European Journal of Vascular and Endovascular Surgery (EJVES).
In this interview, De Maeseneer outlines the central takeaway messages from the paper, highlights what is new in the 2022 guidelines compared with the 2015 recommendations, and suggests where future research in the space should focus.
What are the key takeaway messages from these new recommendations?
The new ESVS guidelines document contains 94 recommendations (of which 65 are new). These should help the physician to make appropriate decisions for / together with an individual patient with CVD. Obviously there are many new recommendations of interest. For instance, abdominal duplex ultrasound should be considered in patients with suspected supra-inguinal pathology, as part of the initial assessment. Whereas not all patients with CVD and superficial venous incompetence require interventional treatment, in those presenting with symptomatic varicose veins with or without oedema (CEAP clinical class C2s, C2,3s) and those with skin changes, including healed or active venous leg ulcer (CEAP clinical class C4–C6) intervention is recommended. The important role of endovenous thermal ablation (EVTA) for treating superficial vein incompetence has been confirmed, while several non-thermal techniques have now become available: the use of cyanoacrylate glue should be considered and other techniques, like ultrasound guided foam sclerotherapy, catheter directed foam sclerotherapy and mechanochemical ablation, may be taken into consideration, always as part of a shared decision-making process between the patient and the handling physician. Patients with iliac vein outflow obstruction requiring intervention should be treated by a multidisciplinary team and endovascular intervention (stenting) should be considered, as the first choice treatment. For patients with venous leg ulceration, early endovenous ablation is recommended to accelerate ulcer healing and reduce recurrence. Finally, for women with symptomatic varicose veins of pelvic origin without pelvic symptoms (such as chronic pelvic pain, dyspareunia etc.) the first choice treatment to be considered consists of local procedures for varicose veins and pelvic escape points and hence embolisation should not be part of the initial treatment.
Why are these guidelines important?
The importance of these guidelines lies in the original approach, as we have put the patients suffering from CVD at the very centre of our attention. You will see that any management strategy in the guidelines document (e.g. diagnostic pathway, conservative management strategy, interventional treatment options…) starts with ‘Patients with…’ which will help the handling physician to make the right decisions, in agreement with the patient’s values and preferences. When we had our ‘kick-off’ meeting (Amsterdam, November 2019), together with Stavros Kakkos, my co-chair, and 15 more members of a multidisciplinary guideline writing committee, there was a general agreement that every chapter of the guidelines should end with a strategy subsection, illustrated with a clear flowchart. We eventually managed to summarise the most appropriate management strategies in a way they will really be useful and applicable in daily clinical practice.
What are the main updates from the 2015 document?
First of all, these 2022 ESVS guidelines are much more than just an ‘update’ of the previous edition of the ESVS CVD guidelines and almost nothing was copy-pasted from the previous edition. From the very beginning, the guideline writing committee decided to entirely renew the structure of the guidelines document, not subdividing the guidelines according to the available techniques, but focusing on the particularities of the patients to be treated. This resulted in a separate chapter about patients with superficial venous incompetence (including perforating vein incompetence and recurrent varicose veins), a separate chapter about patients with symptoms and signs of deep vein obstruction (and some other deep venous pathology), another chapter entirely dedicated to patients with venous leg ulcers (in contrast to the previous edition, where this information was scattered throughout the document), then a chapter focusing on mainly female patients with varicose veins related to underlying pelvic vein incompetence (which were hardly mentioned in the previous edition), to end with a chapter containing some special considerations, about acute complications in CVD patients and about treatment of patients with special characteristics, such as obese patients, pregnant women, those chronically anticoagulated and elderly patients with comorbidities. We come across all these patients a lot in our daily phlebological practice and therefore they became part of the 2022 guidelines document.
Which new data have informed these updated guidelines?
As the literature search for the 2015 document had been performed only until 1 January 2013, many new publications including several randomised clinical trials (RCTs), systematic reviews and meta-analyses were available for analysis of the evidence (until June 2021). For EVTA of the great saphenous vein, evidence of its beneficial outcome is now available after a follow up of more than 5 years, with a maintained positive effect on clinical outcome (r-VCSS, revised venous clinical severity score) and quality of life, equal to high ligation and stripping (the latter causing more postoperative complications and needing a longer recovery/days off work). For cyanoacrylate adhesive closure, the first five year extension study of the VeClose RCT, comparing cyanoacrylate glue with radiofrequency ablation, has been published in 2020. For mechanochemical ablation, a RCT with three years follow up is now available (Vähäaho et al, 2021). A recent meta-analysis, performed by the youngest member of our writing committee (Aherne et al, 2020) lead to the recommendation to consider concomitant tributary treatment in patients with an incompetent saphenous trunk treated with EVTA or non-thermal ablation. The results of endovascular treatment (stenting) of CVD remain difficult to interpret, categorise and appraise because of large heterogeneity across trials and reports, as has been concluded in several systematic reviews. There is only one small RCT comparing iliac vein stenting with medical treatment available to date (Rossi et al, 2018) Nevertheless, most studies support a role for venous stenting in properly selected patients. Finally, an important trial in the management of venous leg ulcers has been published by one of our writing committee members, the EVRA trial, which proved that early endovenous ablation (within two weeks) for treating saphenous trunk incompetence accelerates ulcer healing and reduces ulcer recurrence (Gohel et al, 2018 and 2020).
Where are the gaps in the literature on this topic/where should future research in the space focus?
We identified several issues, where the available evidence is currently insufficient, and more research is needed to guide clinical practice (see Chapter 9 of the guideline document). There is no strong evidence to guide which patients/limbs with C2 disease will develop skin changes, or which limbs classified as ‘C4’ will eventually develop ulceration. The role of exercise therapy and specific exercise programmes is poorly understood, also in patients with post-thrombotic syndrome. For treatment of superficial venous incompetence further guidance is needed to understand the optimal strategic approaches to different clinical presentations and anatomical reflux patterns. The available evidence on postoperative compression after endovenous saphenous trunk ablation is very contradictory. Validated criteria for quantification of post-thrombotic deep venous obstruction on duplex ultrasound, MRV and CTV are lacking. Clear and evidence based criteria are needed for proper patient selection for deep venous intervention. In patients with venous leg ulceration, more RCTs are needed to evaluate different strategies (superficial reflux ablation, stenting for iliac vein outflow obstruction, etc.) on ulcer healing and recurrence. For women with pelvic venous disorders, a clinical scoring system and well established imaging criteria are needed for proper patient selection and well performed RCTs are still lacking in this field.
Could you tell us about any research you are involved in in the space?
Since the end of June 2017, I retired from clinical work at Erasmus Medical Center in Rotterdam, The Netherlands, where I passed the torch to the younger generations. At this point, after a long clinically active career, I primarily want to act as facilitator for young promising colleagues, helping them to develop their scientific and academic skills where needed. I am convinced they will continue the research in CVD, to further improve this 2022 ESVS guidelines document on management of CVD, for the benefit of our CVD patients around the world.