Great uncertainty regarding treatment of varicose vein recurrence

Review 13 Great uncertainty regarding treatment of varicose vein recurrence O. Nelzén Dept. Surgical Sciences, Uppsala University & Dept. of Vascular Surgery, Skaraborg Hospital Skövde, Sweden Keywords Varicosis, recurrence, endovenous treatment, vein surgery Summary Introduction: Although varicose vein recurrence is common and 10 30 % of all varicose vein surgery is done for recurrence of some sort, there are very few studies that can guide us to the best re-treatment option. With the introduction of minimal invasive endovenous treatments there is a variety of possible options besides traditional open surgical techniques. Method: The Scandinavian Venous Forum held a symposium at the GSP meeting in Lübeck 2012 and this review article is based on data from the presentations at that symposium. Further data has been added regarding new knowledge that was not available a year ago, from PubMed search and article references. Results: The most common reasons for recurrence are discussed and also the discrepancy between neovascularization (NV) and recurrence due to technical failures. It is likely that NV is the most commonly duplex detected type of recurrence following open groin surgery, less common early after endovascular techniques. However, technical or tactical failures are the most common reasons for redo surgery because of symptomatic recurrence. NV seldom leads to symptomatic recurrences and thus a need for re- treatment. There is a risk that the stumps left following endovenous treatments will become a source for symptomatic recurrence after 5 10 years Correspondence to: Dr. Olle Nelzén Associate Professor of Vascular Surgery Dept. Surgical Sciences, Uppsala University & Head of the Dept. of Vascular Surgery, Skaraborg Hospital Skövde, 541 85 Skövde, Sweden Tel. 46-500 431 000 E-Mail: olle.nelzen@vgregion.se and indications of that have been reported in the few available 5 year RCT-reports following laser treatments. Treatment of recurrence due to stumps in the groin can be done safely within a reasonable operating time through a medial approach and the stump itself can generally not be treated with any of the endovenous alternative methods. Foam treatment can be used for most other recurrent veins but the durability is unknown. Endovascular thermal ablation can only be used for reopened or remaining saphenous veins and accessory saphenous veins while tributaries have to be treated by stab excisions or foam. Conclusion: Long term reports of results of redo surgery are limited but suggest reasonably good results from open surgical intervention and are non-existent for the endovenous techniques. So far groin recurrence seems best treated surgically by an indirect approach, preferably medial. More studies are needed to find the best treatment regime for varicose vein recurrence in general and hybrid procedures might be the way forward by combinations of different techniques. Schlüsselwörter Varikose, Rezidivvarikose, endovenöse Behandlung, Venenchirurgie Zusammenfassung Einleitung: Obwohl die Rezidivvarikose häufig ist und 10 bis 30 % aller chirurgischer Eingriffe darauf entfallen, gibt es sehr wenige Studien, die dabei zur besten Behandlungsoption raten Die große Unsicherheit im Umgang mit wiederkehrender Varikose Phlebologie 2014; 43: 13 18 DOI: 10.12687/phleb2172-1-2014 Received: September 27, 2013 Accepted: November 19, 2013 könnten. Mit der Einführung der minimal-invasiven endovenösen Behandlung gibt es eine Vielzahl möglicher Optionen neben den klassischen offenen chirurgischen Eingriffen. Methoden: Das Skandinavische Venenforum hielt auf der Tagung der Deutschen Gesellschaft für Phlebologie e.v. 2012 in Lübeck ein Symposium ab. Diese Überblicksarbeit basiert auf Daten der Präsentation, die dort gehalten wurde. Weitere Daten neueren Wissens wurden hinzugefügt, außerdem Informationen aus einer Literaturrecherche bei PubMed und anderen Artikeln. Ergebnisse: Die häufigsten Ursachen für die Rezidivvarikose werden diskutiert und auch die Diskrepanz zwischen Neovaskularisation (NV) und Rezidivierung infolge technischer Fehler. Es ist wahrscheinlich, dass NV die häufigste durch Duplexsonographie entdeckte Form des Rückfalls ist nach offener Leistenoperation, weniger häufig ist es kurz nach endovenösen Eingriffen. Aber technische oder taktische Fehler sind die häufigsten Gründe für nochmalige Operation wegen eines symptomatischen Rezidivs. NV führt selten zu symptomatischem Wiederauftreten und Bedarf für erneute Behandlung. Es besteht ein Risiko dafür, dass die Stümpfe, die man bei endovenöser Behandlung belässt, Ursache für ein symptomatisches Rezidiv nach 5 bis 10 Jahren werden. Hinweise darauf gibt es in den wenigen 5-Jahres-RCT- Studien bezüglich Laserbehandlung. Behandlungen wiederkehrender Varikosen aufgrund von Stümpfen in der Leiste können sicher innerhalb einer überschaubaren Operationszeit vorgenommen werden durch einen medialen Ansatz. Der Stumpf selber kann normalerweise nicht behandelt werden mit einer der alternativen endovenösen Verfahren. Schaumbehandlung kann bei den meisten anderen Rezidivvarikosen eingesetzt werden, aber die Nachhaltigkeit ist hier unbekannt. Die endovaskuläre Thermoablation kann nur für wiedereröffnete oder verblei- Schattauer 2014 Phlebologie 1/2014

14 O. Nelzén: Treatment of varicose vein recurrence bende Saphena-Venen und accessorische Saphena-Venen genutzt werden, während Nebengefäße mit Exzision oder Schaum behandelt werden müssen. Schlussfolgerung: Berichte zu Langzeitergebnissen von erneuten Behandlungen sind selten, aber sie deuten auf recht gute Resultate aus der offenen chirurgischen Intervention hin. Keine Daten hierzu gibt es bislang für endovenöse Techniken. Bislang ist eine Rezidivvarikose in der Leiste am besten operativ zu behandeln durch einen indirekten Ansatz, vorzugsweise medial. Mehr Studien sind notwendig, um die beste Behandlungsoption für Rezidivvarikose zu finden. Hybrid- Techniken könnten ein zukünftiger Weg sein durch Kombination verschiedener Ansätze. Varicose veins have been considered as an ongoing disease and recurrence has more or less been considered as inevitable. Whether that is perfectly true can however be questioned since a lot of recurrences in the past was undoubtedly caused by bad or incomplete surgery. Real long term duplex detected recurrence of some form can be observed in 40 60% of all patients (1 3), but far from all are visible or symptomatic. For the patients a recurrence leads to a worse quality of life compared to primary varicose veins (4, 5) and it is very difficult to completely correct previously performed surgical mistakes leading to a recurrence. There are various causes of recurrences, technical or tactical failures, neovascularization (NV) and disease progression. But which type is the dominating cause for symptomatic recurrence leading to the need for retreatment? With the introduction of the minimal invasive endovenous techniques there was hope for better treatments leaving fewer recurrences a thought that has turned out not to be true (6). The need for redo procedures has unfortunately not gone down and might become even greater following increased use of endovenous treatments. If you need to do a redo procedure, which treatment option or combinations should you choose? All of these issues were discussed at the Scandinavian Venous Forum symposium at the GSP meeting in Lübeck 2012. This article is based on what was presented at that symposium and recent publications in the literature. Types of recurrence There are various types of recurrences and these are listed in table 1. The most common groin recurrences seem to be NV or recurrence due to improper primary surgery. There has been some disagreement regarding whether NV or bad primary surgery is the most common cause of recurrent varicose veins. In fact, booth views seem to be correct depending on how you are looking at the problem. Promoters of NV as the major cause base their view on case series that were followed with repeated duplex assessments and there most series following open primary great saphenous vein (GSV) surgery show that NV is the dominating finding (7, 8). The relative contribution of NV is of course depending on how accurate the prior primary surgery was, and NV is greatly dominating in series where good primary surgery had been undertaken. The opposite, with a lower relative contribution of NV, is noted in series where primary surgery was less accurately performed. Although according to the literature duplex detected NV seldom leads to symptomatic recurrences requiring a redo procedure (1, 3, 9). A recent report has shown very low early recurrence following modern high ligation and stripping (10), leaving doubts regarding the quality of the open surgery performed in some RCTs reporting much higher recurrence rates at one year for open surgery. The promoters of bad primary surgery as the principal cause have looked at the problem from a different angle. In those studies they looked at patients presenting Tab. 1 Different types of varicose vein recurrence to consider. Technical/tactical errors Neovascularisation Residual varicose veins Disease progression with a symptomatic recurrence requiring a redo procedure (11 14). In these series around 70 80 % is then caused by incomplete primary surgery, by technical or tactical errors. Remaining sapheno-femoral junctions (SFJs) causing stump formation seems to be the major reason following GSV surgery. So both ways of looking at the problem seems correct although they look at the problem from different angles. As it seems today NV is more of an innocent bystander whilst bad primary surgery seems to be the big villain when symptomatic recurrence is concerned (11, 14). When endovascular techniques are concerned technical errors or insufficient technique seem to be dominating since NV appears less common at least after up to a median term follow-up (6). That it may appear later even after thermal techniques has, however, recently been reported (15). Following this it is questionable to equate recurrence from technical/tactical errors with NV since the former seems to be the major cause for symptomatic recurrence requiring a repeat intervention (11 14). Symptomatic recurrence from NV alone is much less frequent (1, 3, 9). Prevention of recurrence It is very difficult and today not possible to prevent recurrence completely since there are many types of recurrences. Disease progression is difficult to prevent, NV can be minimized by certain techniques but technical mistakes are probably, in most cases, preventable and the most important thing to minimize. When open GSV surgery is concerned the most common reasons for a recurrence are remaining stumps and remaining segments of saphenous veins or even sometimes intact entire saphenous veins. To avoid this it seems important to stick to the old concept of performing a true high ligation at the level of the common femoral vein following a preoperative mapping with duplex. This requires good exposure and knowledge of the anatomy. Failure to do this seems to increase the risk of a symptomatic recurrence although it may take a decade to develop. It is also mandatory today to use duplex as a roadmap for Phlebologie 1/2014 Schattauer 2014

O. Nelzén: Treatment of varicose vein recurrence 15 the surgery planned to avoid mistakes (9) and duplex intra-operatively is also necessary for the endovenous procedures. NV has been reduced in some series by patch techniques to cover the opening of the fascia (16) and over sewing the stump endothelium is another technique that has been claimed as effective (17, 18). A silicone patch technique was also shown effective although that lead to a few serious infectious complications limiting its general usability (19). It seems that a correctly performed primary intervention is the most effective way of avoiding a symptomatic recurrence and thus the surgeon seems to be the major risk factor for recurrence (3). This is probably true for all the primary treatment techniques. The stump problem When GSV surgery is concerned stumps formed by an intact SFJ seem to be the major reason for redo procedures. The difference between a stump recurrence and pure NV is shown in figure 1. Probably most such recurrences are caused by failure to ligate high enough, often leaving the anterior accessory vein or other tributaries in connection with the stump allowing substantial reflux down through these veins. A stump is generally considered present if the stump length is 5 mm or more on duplex. On rare occasions a stump may probably be able to develop despite a flush high ligation by weakness in the vein wall in the area of the SFJ and might thus not always be possible to prevent. The problem of remaining stumps has largely been neglected and has been minimalized, without any real evidence, by proponents of endovascular techniques (13). The controversy of what is considered a successful duplex result following surgical treatment contrary to endovenous ablation is shown in figure 2. This ought to be a matter of more concern when more and more primary saphenous interventions are performed with endovenous techniques. It seems that the lesson learned from open GSV surgery has been disregarded completely despite overwhelming facts regarding stumps causing most of the recurrences requiring re-interventions (11 14). Fig. 1 The difference between recurrence due to a remaining stump (a) and neovascularization (b) in the groin CFV Normal groin SFJ AASV aa GSV stripped Correct high ligation/stripping Basically all endovenous techniques, laser, RF and foam are performed with the intention of leaving a stump in the groin, mainly because of fear of endovenous heat induced thrombosis (EHIT) and/or deep venous thrombosis (DVT). Short term this appears not to cause any problems although we know that it may take much longer for serious problems to appear. There are only a few reports from RCTs followed long term (5 years) comparing laser with open surgery, showing overall equal recurrence rates (20 23). However the majority of recurrences in the surgical arms were caused by NV whilst laser showed more incompetent SFJs and anterior accessory veins, which are more likely to become symptomatic. Interestingly, a low frequency of NV in the surgical arm was reported from the Danish study (22). It is necessary to follow this closely because it may develop into a huge problem and actually an increased demand for redo procedures in the future. From open surgery we have learned that it might take a decade or more to develop symptoms so we will probably be able to detect this during the next decade (13, 24). How to deal with a recurrence? There are surprisingly little data to guide us and there are merely case series, leaving some but insufficient knowledge. The options today include many more techniques than before when open surgery or liquid sclerotherapy were the main options. The strategy to treat is largely based on what kind of recurrence we are dealing with. Combinations of treatment techniques are a possibility today that may help to improve the outcomes. Physiologic stump Fibrotic Correct result GSV ablation Fig. 2 The difference between the normal SFJ and the results following correctly performed high ligation/stripping and endovenous GSV ablation. (CFV=Common femoral vein, AASV=Anterior accessory saphenous vein, GSV=Great saphenous vein) bc AASV Schattauer 2014 Phlebologie 1/2014

16 O. Nelzén: Treatment of varicose vein recurrence Type of intervention Duplex intraop Anaesthesia Treating stem/ tributary Versatility Costs Documentation Open surgery No / () Laser /No Radiofrequency /No () Foam No / Various techniques have their benefits and shortcomings and this is summarized in table 2. The endovenous thermal techniques can be used for dealing with mainly fairly large and straight veins, such as re-canalized saphenous veins or new incompetence in accessory saphenous veins (25). Also perforating vein treatments are possible. Endo-thermal treatment of a remaining stump or serpentine tributaries is currently not advisable. Ultrasound guided sclerosing foam treatment appears as a more versatile choice that could be used for almost any type of recurrence apart from eradication of the actual stump, because the risk of DVT (26). Open surgery is most commonly used for stab phlebectomies also in combination with thermal ablation but can be used for most other types of recurrences apart from clusters of neovascularization. It is not ideal for redo perforator surgery where a SEPS technique appears a more safe choice (3). Redo groin surgery has got a reputation of being difficult, time consuming and with a high risk of wound complications. It is however the only way of eradicating a stump completely, why it appears as the method of choice for most symptomatic groin recurrences. There are several techniques to operate a groin recurrence, where the direct approach through the scar tissue should be avoided because the risk of bleeding and lymphatic damage. There is also a lateral approach by first visualizing the artery and the femoral vein but the risk of lymphatic leakage has been reported high (27). Another way is to make the incision high above the groin crease and locating the femoral vein and then following the vein down to the SFJ. Hach described access to the stump through a superior approach from the inguinal ligament ( präfe- morale Saphena magna Stumpfligatur ). Lastly there is the medial approach that has been reported to be fairly easily done with a low risk of complication (28). I have recently reported good one year results from a modified standardized medial approach with low risk of complications (29). That operation can be done in around 70 min, including stab phlebectomies and eventual stripping of remaining stem vein segments. You do not have to be an expert to use this technique. Figure 3 shows an isolated stump through a medial approach. Results from redo interventions The literature is limited regarding the results of redo interventions and there are no comparative randomized studies that can guide us. Regarding redo groin surgery there are a few reports giving favourable results from using a medial approach (28, 29) whereas the lateral approach appears more difficult and risky (27). Foam has also been reported as a good short term treatment of GSV recurrence, although it appears to Fig. 3 A saphenous stump isolated in the right groin through a medial approach procedure. Tab. 2 Benefits and shortcomings regarding treatment alternatives for varicose vein recurrence. mostly have been used for remaining saphenous veins and accessory veins, probably without being able to occlude stumps (26). Regarding foam, its durability is being questioned. Laser has been used for treating saphenous vein recurrence, apparently mostly for ablation of re-canalized or remaining saphenous veins (25). Two retrospective case series from the Netherlands showed that surgery was still used for the majority of saphenous vein recurrences (30, 31). The groups and treatments were obviously selected and the results therefore not comparable. The reports might indicate the usability of laser and surgery respectively in regard to recurrences. In a report from the UK (25) it was mostly used for retreatment of re-canalized GSVs, maybe indicating a high frequency of re-canalization from laser treatment in their area and a tradition of not performing stripping of the GSV. We have a long term follow-up a median of 12 years following varicose vein surgery, where 28 % were redo procedures (3). The redo procedures required more repeat procedures during follow-up but at the last follow-up the duplex detected recurrence rate was not significantly worse than following primary surgery, indicating a fairly good long term prognosis even after open redo procedures. Regarding groin recurrences a medial approach to deal with a remaining stump seems to be a safe and fairly uncomplicated way of dealing with the problem. This combined with foam treatment distally to occlude incompetent accessory veins or remaining stem veins and associated tributaries looks like a promising combination. To test such a combination against foam treatment alone in a randomized trial would be of great interest for the future. Endothermal techniques seem to be of Phlebologie 1/2014 Schattauer 2014

O. Nelzén: Treatment of varicose vein recurrence 17 more limited value in the recurrence situation since they are more costly and can be used mainly for remaining stem veins or accessory veins that are fairly straight and need to be combined with stab excisions or foam to deal with tributaries. Perforator treatment Incompetent perforators (IPs) are commonly encountered in patients with varicose vein recurrence and the value of treating IPs is under debate. The need for treatment is likely to increase with the number of IPs encountered and with the severity of venous disease. Open surgical treatment leads to more incisional wound complications and has been reported to produce quite high recurrence figures (32). SEPS has been proven to be safe and is the most documented technique although true evidence based results supporting the use of this technique are lacking (33, 34). Newly emerged endovenous techniques such as foam, radiofrequency and laser, have shown high rates of immediate treatment failures with a substantial need for early re-treatments (35 37). The endovenous techniques seem to show recurrence rates around 20 % already after one year. All techniques are technically demanding and this goes especially for the endovenous techniques, which makes it difficult to get sufficient training and experience since these patients are not so common. There are case reports of foam treatment causing gangrene by accidental intra-arterial injection so it is not done without risk of major complications. If you have more than one IP SEPS appears to be maybe the best treatment alternative so far, with a documented low long term risk of recurrence (3). For the future Since new endovenous techniques are no better than average open surgery when recurrences are concerned we must improve our knowledge regarding treatment of recurrence. With the rapid spread of the popular endovenous techniques to deal with primary varicose veins it is mandatory to watch the long term outcomes following these treatments. Mainly this goes for what happens with the often called physiological stumps left (38). If we are lucky they will not render as much symptomatic recurrence as stumps caused by inadequate surgery although available 5-year results from laser treatments tend to indicate the opposite (20 23). It will probably take another 5 years or more before we know for sure and it is crucial that we monitor and report treatment results correctly (39). If stumps from endovenous treatments act as stumps left from surgery we are likely to face a steadily increased demand for retreatments. But how should we best treat such recurrences? Today we really do not know the best treatment for recurrence and this is a virtually an untouched field for future research. If we do not start studying this problem we will not cope with the problem of recurrence in the future, which might become an even bigger problem than it is today. The treatment options have never been greater, which opens for a wider use of combined treatments, since the various techniques have their own strengths and weaknesses. Hybrid procedures to deal with not least varicose vein recurrence, tailored by each patient s particular problems, might be the way forward. If we introduce endovenous techniques widely without knowing the long term results we need to be prepared to deal with the recurrences that appear with the most appropriate technique. We owe our patients to provide scientifically proven treatments also when recurrences are concerned. References 1. Fischer R, Linde N, Duff C, Jeanneret C, Chandler JG, Seeber P. Late recurrent saphenofemoral junction reflux after ligation and stripping of the greater saphenous vein. J Vasc Surg 2001; 34: 236 240. 2. 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The effect of ultrasoundguided sclerotherapy of incompetent perforator veins on venous clinical severity and disability scores. J Vasc Surg 2006; 43: 551 557. 36. Hissink RJ, Bruins RMG, Erkens R, Castellanos Nuijts ML, van den Berg M. Innovative treatments in chronic venous insufficiency: endovenous laser ablation of perforating veins: a prospective shortterm analysis of 58 cases. Eur J Vasc Endovasc Surg 2010; 40: 403 406. 37. Marsh P, Price BA, Holdstock JM, Whiteley MS. One-year outcomes of radiofrequency ablation of incompetent perforator veins using the radiofrequency stylet device. Phlebology 2010; 25: 79 84. 38. Proebstle TM, Alm J, Göckeritz O, Wenzel C, Noppeney T, Lebard C, Pichot O, Sessa C, Creton D, for the European Closure Fast Clinical Study Group. Three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great saphenous vein with or without treatment of calf varicosities. J Vasc Surg 2011; 54: 146 152. 39. De Maeseneer M, Pichot O, Cavezzi A, Earnshaw J, van Rij A, Lurie F, Smith PC. Duplex ultrasound investigation of the lower limbs after treatment for varicose veins UIP consensus document. Eur J Vasc Endovasc Surg 2011; 42: 89 102. www.phlebologieonline.de Jede Ausgabe mit Volltext im Internet auch in Englisch! Phlebologie 1/2014 Schattauer 2014