- Email: [email protected]
Managing Chronic Venous Disease: An Ongoing Challenge
Eur J Vasc Endovasc Surg (2015) 49, 676e677
EDITORIAL
Managing Chronic Venous Disease: An Ongoing Challenge In this issue of the Journal, the European Society for Vascular Surgery (ESVS) Guidelines on the management of chronic venous disease (CVD) are published.1 These guidelines differ from those prepared by the Society for Vascular Surgery and the American Venous Forum2 as they include CVD associated with deep venous obstruction/incompetence and venous malformations. Although considerable progress has been made since the publication of the very first randomized clinical trial on the treatment of varicose veins,3 there is still a lack of published high-quality evidence in many fields of CVD management. The underlying pathophysiology of CVD and progression of disease with time are poorly understood, making the planning of CVD management more difficult, particularly when trying to answer the question: Which patients should be treated and when? Some issues, such as a history of recurrent deep vein thrombosis, the presence of atrophie blanche or lipodermatosclerosis (C4b, according to the CEAP classification4), and/or axial reflux from the groin to the ankle using duplex ultrasound (DUS), clearly predict an unfavourable prognosis leading to an increased risk of venous ulceration. In this subgroup of patients, the indication for treatment is clear-cut. However, there are other areas of practice in the field of CVD management which remain “grey areas”, such as the large group of patients with symptomatic varicose veins, which are classified as C2S (or C2,3S) Ep As Pr with reflux of the great saphenous vein (GSV). In the latest ESVS guidelines, there is a Class I, Level A recommendation for endovenous thermal ablation of the refluxing GSV1; however, an alternative approach consisting of phlebectomies only (without treatment of the GSV), might be equally effective.5,6 For advocates of the latter approach, evidence from randomized trials is still awaited. In addition, DUS-related predictive factors, which will be helpful for proper patient selection, require further investigation. The optimal management of recurrent varicose veins is another grey area, as it usually has a multi-factorial aetiology, leading to a variety of clinical manifestations and DUS findings.7 In the latest ESVS guidelines, extensive redo varicose vein surgery is no longer recommended as the firstline treatment strategy1 and minimally invasive interventions are now the preferred option. In practice, after carefully studying DUS anatomy and haemodynamics, an
DOI of original article: http://dx.doi.org/10.1016/j.ejvs.2015.02.007. 1078-5884/$ e see front matter Ó 2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ejvs.2015.02.014
individual patient-tailored treatment is required. This may involve a combination of phlebectomies, thermal (or nonthermal) ablation of a residual refluxing saphenous trunk, and/or ultrasound-guided foam sclerotherapy.8 These management strategies still require to be evaluated in carefully performed, prospective studies, which should include longterm follow-up and an assessment of quality of life. Another grey area of modern practice relates to the treatment of patients who have CVD secondary to chronic (mainly post-thrombotic) changes in the deep venous system. It remains to be seen how clinicians can identify which patients have “clinically relevant” deep venous lesions (as is cited in the ESVS guidelines1) and who might therefore be potential candidates for venous stenting. A number of key issues will need to be addressed in future guidelines. Firstly, the clinical diagnosis of post-thrombotic syndrome (PTS) needs to be better defined. For example, venous claudication, a common and important clinical feature in PTS patients with chronic iliofemoral or iliocaval obstruction, is not included within the venous clinical severity score9 or in the Villalta scale,10 although the latter was specifically designed for scoring PTS. Second, the correlation between symptoms/signs of CVD and haemodynamic measurements require careful study. Combining quantitative measurements of reflux and outflow resistance (resulting from the impact of obstruction and the adequacy of collateral circulation), may increase the understanding of PTS in individual patients.11 In addition, new deep venous imaging techniques, and new stent materials require further evaluation. Finally, as potential candidates for venous stenting are usually quite young, it is important that future studies report long-term outcomes in order to assess overall benefit. Venous ulcer patients still represent a significant socioeconomic burden. Accordingly, the final goal of management should be to reduce the prevalence of venous ulceration in the general population. While compression therapy remains the cornerstone of first-line treatment, the ESVS guidelines recommend “active venous intervention” to reduce ulcer recurrence.1 Apart from correction of superficial venous incompetence, this should also include treatment of deep venous obstruction12 and/or reflux. More prospective studies are required to evaluate the results of deep venous interventions in ulcer patients. Finally, in an era where health-care resources are increasingly limited, it is of the utmost importance to be able to make proper treatment choices13 while simultaneously optimizing cost-effectiveness.14 In order to achieve this balance, more basic research is required to better
677
Editorial
understand venous haemodynamics and pathophysiology. Changes in the vein wall (not only in varicose veins but also in post-thrombotic veins), the function (and dysfunction) of macroscopic valves15 and the potential role of microvalves,16 the importance of the calf and foot pump,17 and finally the natural progression of CVD over time18 require detailed evaluation. The latest ESVS guidelines represent a detailed summary of what we currently know. Improving knowledge, optimizing investigative strategies and delivering high-quality care represents an ongoing challenge, but it looks like ‘the best is yet to come’.
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REFERENCES 1 Wittens C, et al. Management of chronic venous disease: clinical practice guidelines. Eur J Vasc Endovasc Surg 2015;49: 678e737. 2 Gloviczki P, Comerota AJ, Dalsing MC, Eklöf BG, Gillespie DL, Gloviczki ML, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2011;53(5 Suppl.):2Se48S. 3 Hobbs JT. The treatment of varicose veins. A random trial of injection-compression therapy versus surgery. Br J Surg 1968;55:777e80. 4 Eklöf B, Rutherford RB, Bergan JJ, Carpentier PH, Gloviczki P, Kistner LR, et al. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg 2004;40: 1248e52. 5 Pittaluga P, Chastanet S, Locret T, Barbe R. The effect of isolated phlebectomy on reflux and diameter of the great saphenous vein: a prospective study. Eur J Vasc Endovasc Surg 2010;40: 122e8. 6 Biemans AA, van den Bos RR, Hollestein LM, MaessenVisch MB, Vergouwe Y, Neumann HAM, et al. The effect of single phlebectomies of a large varicose tributary on great saphenous vein reflux. J Vasc Surg Venous Lym Dis 2014;2: 179e87. 7 De Maeseneer M, Pichot O, Cavezzi A, Earnshaw J, van Rij A, Lurie F, et al. Duplex ultrasound investigation of the veins of the lower limbs after treatment for varicose veins e UIP consensus document. Eur J Vasc Endovasc Surg 2011;42:89e 102. 8 Darvall KA, Bate GR, Adam DJ, Silverman SH, Bradbury AW. Duplex ultrasound outcomes following ultrasound-guided foam sclerotherapy of symptomatic recurrent great saphenous varicose veins. Eur J Vasc Endovasc Surg 2011;42:107e14. 9 Vasquez MA, Rabe E, McLafferty RB, Shortell CK, Marston WA, Gillespie D, et al. Revision of the clinical severity score: venous outcomes consensus statement. special communication of the
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American Venous Forum Ad Hoc Outcomes Working Group. J Vasc Surg 2010;52:1387e96. Kahn SR. Measurement properties of the Villalta scale to define and classify the severity of the post-thrombotic syndrome. J Thromb Haemost 2009;7:884e8. Nicolaides A, Clark H, Labropoulos N, Geroulakos G, Lugli M, Maleti O. Quantitation of reflux and outflow obstruction in patients with CVD and correlation with clinical severity. Int Angiol 2014;33:275e81. George R, Verma H, Ram B, Tripathi R. The effect of deep venous stenting on healing of lower limb venous ulcers. Eur J Vasc Endovasc Surg 2014;48:330e6. van der Velden SK, Pichot O, van den Bos RR, Nijsten TE, De Maeseneer MG. Management strategies for patients with varicose veins (C2-C6): results of a worldwide survey. Eur J Vasc Endovasc Surg 2015;49:213e20. Caroll C, Hummel S, Leaviss J, Ren S, Stevens JW, Cantrell A, et al. Systematic review, network meta-analysis and exploratory cost-effectiveness model of randomized trials of minimally invasive techniques versus surgery for varicose veins. Br J Surg 2014;101:1040e52. Lurie F, Kistner RL. The relative position of paired valves at venous junctions suggest their role in modulating threedimensional flow pattern in veins. Eur J Vasc Endovasc Surg 2012;44:337e40. Vincent JR, Jones GT, Hill GB, van Rij AM. Failure of microvenous valves in small superficial veins is a key to the skin changes of venous insufficiency. J Vasc Surg 2011;54(6 Suppl.):62Se9S. Uhl JF, Gillot C. Anatomy of the foot venous pump: physiology and influence on chronic venous disease. Phlebology 2012;27: 219e30. Pannier F, Rabe E. The relevance of the natural history of varicose veins and refunded care. Phlebology 2012;27(Suppl. 1):23e6.
M.G.R. De Maeseneer* Department of Dermatology, Erasmus MC, Rotterdam, The Netherlands Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium S.K. van der Velden Department of Dermatology, Erasmus MC, Rotterdam, The Netherlands *Corresponding author. Phlebology, Department of Dermatology, Erasmus MC, Burg s’ Jacobplein 51, 3015 CA Rotterdam, The Netherlands. Email-addresses: [email protected], [email protected] (M.G.R. De Maeseneer)
EDITORIAL
Managing Chronic Venous Disease: An Ongoing Challenge In this issue of the Journal, the European Society for Vascular Surgery (ESVS) Guidelines on the management of chronic venous disease (CVD) are published.1 These guidelines differ from those prepared by the Society for Vascular Surgery and the American Venous Forum2 as they include CVD associated with deep venous obstruction/incompetence and venous malformations. Although considerable progress has been made since the publication of the very first randomized clinical trial on the treatment of varicose veins,3 there is still a lack of published high-quality evidence in many fields of CVD management. The underlying pathophysiology of CVD and progression of disease with time are poorly understood, making the planning of CVD management more difficult, particularly when trying to answer the question: Which patients should be treated and when? Some issues, such as a history of recurrent deep vein thrombosis, the presence of atrophie blanche or lipodermatosclerosis (C4b, according to the CEAP classification4), and/or axial reflux from the groin to the ankle using duplex ultrasound (DUS), clearly predict an unfavourable prognosis leading to an increased risk of venous ulceration. In this subgroup of patients, the indication for treatment is clear-cut. However, there are other areas of practice in the field of CVD management which remain “grey areas”, such as the large group of patients with symptomatic varicose veins, which are classified as C2S (or C2,3S) Ep As Pr with reflux of the great saphenous vein (GSV). In the latest ESVS guidelines, there is a Class I, Level A recommendation for endovenous thermal ablation of the refluxing GSV1; however, an alternative approach consisting of phlebectomies only (without treatment of the GSV), might be equally effective.5,6 For advocates of the latter approach, evidence from randomized trials is still awaited. In addition, DUS-related predictive factors, which will be helpful for proper patient selection, require further investigation. The optimal management of recurrent varicose veins is another grey area, as it usually has a multi-factorial aetiology, leading to a variety of clinical manifestations and DUS findings.7 In the latest ESVS guidelines, extensive redo varicose vein surgery is no longer recommended as the firstline treatment strategy1 and minimally invasive interventions are now the preferred option. In practice, after carefully studying DUS anatomy and haemodynamics, an
DOI of original article: http://dx.doi.org/10.1016/j.ejvs.2015.02.007. 1078-5884/$ e see front matter Ó 2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ejvs.2015.02.014
individual patient-tailored treatment is required. This may involve a combination of phlebectomies, thermal (or nonthermal) ablation of a residual refluxing saphenous trunk, and/or ultrasound-guided foam sclerotherapy.8 These management strategies still require to be evaluated in carefully performed, prospective studies, which should include longterm follow-up and an assessment of quality of life. Another grey area of modern practice relates to the treatment of patients who have CVD secondary to chronic (mainly post-thrombotic) changes in the deep venous system. It remains to be seen how clinicians can identify which patients have “clinically relevant” deep venous lesions (as is cited in the ESVS guidelines1) and who might therefore be potential candidates for venous stenting. A number of key issues will need to be addressed in future guidelines. Firstly, the clinical diagnosis of post-thrombotic syndrome (PTS) needs to be better defined. For example, venous claudication, a common and important clinical feature in PTS patients with chronic iliofemoral or iliocaval obstruction, is not included within the venous clinical severity score9 or in the Villalta scale,10 although the latter was specifically designed for scoring PTS. Second, the correlation between symptoms/signs of CVD and haemodynamic measurements require careful study. Combining quantitative measurements of reflux and outflow resistance (resulting from the impact of obstruction and the adequacy of collateral circulation), may increase the understanding of PTS in individual patients.11 In addition, new deep venous imaging techniques, and new stent materials require further evaluation. Finally, as potential candidates for venous stenting are usually quite young, it is important that future studies report long-term outcomes in order to assess overall benefit. Venous ulcer patients still represent a significant socioeconomic burden. Accordingly, the final goal of management should be to reduce the prevalence of venous ulceration in the general population. While compression therapy remains the cornerstone of first-line treatment, the ESVS guidelines recommend “active venous intervention” to reduce ulcer recurrence.1 Apart from correction of superficial venous incompetence, this should also include treatment of deep venous obstruction12 and/or reflux. More prospective studies are required to evaluate the results of deep venous interventions in ulcer patients. Finally, in an era where health-care resources are increasingly limited, it is of the utmost importance to be able to make proper treatment choices13 while simultaneously optimizing cost-effectiveness.14 In order to achieve this balance, more basic research is required to better
677
Editorial
understand venous haemodynamics and pathophysiology. Changes in the vein wall (not only in varicose veins but also in post-thrombotic veins), the function (and dysfunction) of macroscopic valves15 and the potential role of microvalves,16 the importance of the calf and foot pump,17 and finally the natural progression of CVD over time18 require detailed evaluation. The latest ESVS guidelines represent a detailed summary of what we currently know. Improving knowledge, optimizing investigative strategies and delivering high-quality care represents an ongoing challenge, but it looks like ‘the best is yet to come’.
10
11
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REFERENCES 1 Wittens C, et al. Management of chronic venous disease: clinical practice guidelines. Eur J Vasc Endovasc Surg 2015;49: 678e737. 2 Gloviczki P, Comerota AJ, Dalsing MC, Eklöf BG, Gillespie DL, Gloviczki ML, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2011;53(5 Suppl.):2Se48S. 3 Hobbs JT. The treatment of varicose veins. A random trial of injection-compression therapy versus surgery. Br J Surg 1968;55:777e80. 4 Eklöf B, Rutherford RB, Bergan JJ, Carpentier PH, Gloviczki P, Kistner LR, et al. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg 2004;40: 1248e52. 5 Pittaluga P, Chastanet S, Locret T, Barbe R. The effect of isolated phlebectomy on reflux and diameter of the great saphenous vein: a prospective study. Eur J Vasc Endovasc Surg 2010;40: 122e8. 6 Biemans AA, van den Bos RR, Hollestein LM, MaessenVisch MB, Vergouwe Y, Neumann HAM, et al. The effect of single phlebectomies of a large varicose tributary on great saphenous vein reflux. J Vasc Surg Venous Lym Dis 2014;2: 179e87. 7 De Maeseneer M, Pichot O, Cavezzi A, Earnshaw J, van Rij A, Lurie F, et al. Duplex ultrasound investigation of the veins of the lower limbs after treatment for varicose veins e UIP consensus document. Eur J Vasc Endovasc Surg 2011;42:89e 102. 8 Darvall KA, Bate GR, Adam DJ, Silverman SH, Bradbury AW. Duplex ultrasound outcomes following ultrasound-guided foam sclerotherapy of symptomatic recurrent great saphenous varicose veins. Eur J Vasc Endovasc Surg 2011;42:107e14. 9 Vasquez MA, Rabe E, McLafferty RB, Shortell CK, Marston WA, Gillespie D, et al. Revision of the clinical severity score: venous outcomes consensus statement. special communication of the
14
15
16
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American Venous Forum Ad Hoc Outcomes Working Group. J Vasc Surg 2010;52:1387e96. Kahn SR. Measurement properties of the Villalta scale to define and classify the severity of the post-thrombotic syndrome. J Thromb Haemost 2009;7:884e8. Nicolaides A, Clark H, Labropoulos N, Geroulakos G, Lugli M, Maleti O. Quantitation of reflux and outflow obstruction in patients with CVD and correlation with clinical severity. Int Angiol 2014;33:275e81. George R, Verma H, Ram B, Tripathi R. The effect of deep venous stenting on healing of lower limb venous ulcers. Eur J Vasc Endovasc Surg 2014;48:330e6. van der Velden SK, Pichot O, van den Bos RR, Nijsten TE, De Maeseneer MG. Management strategies for patients with varicose veins (C2-C6): results of a worldwide survey. Eur J Vasc Endovasc Surg 2015;49:213e20. Caroll C, Hummel S, Leaviss J, Ren S, Stevens JW, Cantrell A, et al. Systematic review, network meta-analysis and exploratory cost-effectiveness model of randomized trials of minimally invasive techniques versus surgery for varicose veins. Br J Surg 2014;101:1040e52. Lurie F, Kistner RL. The relative position of paired valves at venous junctions suggest their role in modulating threedimensional flow pattern in veins. Eur J Vasc Endovasc Surg 2012;44:337e40. Vincent JR, Jones GT, Hill GB, van Rij AM. Failure of microvenous valves in small superficial veins is a key to the skin changes of venous insufficiency. J Vasc Surg 2011;54(6 Suppl.):62Se9S. Uhl JF, Gillot C. Anatomy of the foot venous pump: physiology and influence on chronic venous disease. Phlebology 2012;27: 219e30. Pannier F, Rabe E. The relevance of the natural history of varicose veins and refunded care. Phlebology 2012;27(Suppl. 1):23e6.
M.G.R. De Maeseneer* Department of Dermatology, Erasmus MC, Rotterdam, The Netherlands Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium S.K. van der Velden Department of Dermatology, Erasmus MC, Rotterdam, The Netherlands *Corresponding author. Phlebology, Department of Dermatology, Erasmus MC, Burg s’ Jacobplein 51, 3015 CA Rotterdam, The Netherlands. Email-addresses: [email protected], [email protected] (M.G.R. De Maeseneer)