TY - JOUR AU - Baker, S J A AB - Abstract Background The aim was to assess the early efficacy and complications of ultrasound-guided foam sclerotherapy (UGFS) in a cohort of patients with varicose veins. Methods Of 192 consecutive patients referred with varicose veins over 15 months, only 11 chose surgery; the rest underwent UGFS treatment. Polidocanol was foamed 1:3 with air. Under ultrasound control via butterfly or Seldinger cannulation, 1 per cent foam was injected into superficial veins and 3 per cent foam into saphenous trunks, up to a total volume of 14 ml. Outcome was defined as complete when occlusion of the saphenous trunk and/or over 85 per cent of the varicosities was achieved, and partial closure when less. Results In 163 legs, complete occlusion occurred after one intervention, a further 32 after a second, and one after a third (overall 91 per cent). Of the remainder, all other legs achieved partial occlusion after up to three interventions, apart from two legs with great saphenous vein (GSV) incompetence, which failed. All 23 legs with small saphenous veins had complete occlusion after one intervention compared with 64 of 97 legs with GSV incompetence (P < 0·010). Occlusion rates were also higher when the GSV was cannulated directly: 56 of 70 versus 8 of 27 (P < 0·001). Conclusions UGFS achieved early complete occlusion safely in over 90 per cent of legs with varicose veins. Introduction Although sclerotherapy treatment for varicose veins has been recognized for many years, enthusiasm for its use, in the UK at least, has been limited and varied. More recently, the introduction of vascular ultrasound has generated new interest because it facilitates the more accurate placement of injections, particularly into the saphenous trunk1–3. To complement this has been the emergence of a number of alternative endovenous techniques to obliterate these saphenous trunks. Orbach4 is credited as the first to enhance the effect of sclerosants in treating varicose veins by mixing them with air. However, the concept seems to have remained dormant until nearly 10 years ago, when foam was shown to be more effective than liquid sclerosant5–7, especially when combined with ultrasound guidance5,8–14. Reports on this new technique have focused particularly on the saphenous systems8–14 as opposed to the outcome of its use in the wider morphology of venous disease, including recurrent varicose veins. This article reports early outcomes in a representative cohort of patients with varicose veins. This was a consecutive series of all patients referred to a single consultant vascular surgeon and treated under the UK National Health Service. Materials and methods Ultrasound-guided foam sclerotherapy (UGFS) was offered to 192 consecutive patients referred to a single vascular surgeon for treatment of varicose veins over 15 months in whom intervention was considered appropriate. This was accepted in all but 11, who opted for surgery. The rest all had UGFS: 108 women and 73 men, with a median age of 52 years. Thirty-nine patients had bilateral veins, resulting in 220 legs for treatment. Morphological definitions Primary varicose veins were defined as those presenting without previous surgical intervention. Those with a history of previous liquid sclerotherapy were still regarded as primary. On the basis of clinical and continuous wave Doppler, and where indicated duplex ultrasound imaging, legs were classified as great saphenous veins (GSVs), small saphenous veins (SSVs) and other (non-saphenous), according to criteria described previously15. Briefly, GSV and SSV varicose veins had evidence of reflux with continuous wave Doppler, subsequently confirmed at the time of the intervention on duplex ultrasound. At this stage, the maximum diameter of the trunk in the thigh or calf was measured with the patient supine. Other veins were predominantly isolated anterior thigh veins or posterior thigh veins, which were found to arise independently and in the presence of a normal GSV. Anterior thigh veins or posterior thigh veins co-existing with GSV incompetence were classified as GSV. Recurrent varicose veins were defined as those developing after previous surgical intervention to that system and classified according to criteria previously described16. Persistent or reconstituted GSV trunks were at least 3 mm in diameter and in continuity with the superficial varicosities and usually with the femoral vein in the groin. SSV recurrence was defined as reconnection with the popliteal vein, with or without a recurrent or persistent incompetent SSV trunk. Recurrent other veins were defined as those occurring through independent perforators without recurrence in either saphenous system. Where incompetence occurred in a second previously unoperated saphenous system (such as the SSV after previous GSV surgery), this was regarded as primary16. A detailed classification of the veins treated with UGFS is shown in Table 1. Most were treated for symptomatic, uncomplicated varicose veins, but seven legs were ulcerated and three were treated primarily for bleeding from superficial veins. Table 1 Morphology of varicose veins treated by ultrasound-guided foam sclerotherapy (220 legs) Morphology . No. of legs . Men:Women . Median (range) age (years) . Ulcer . Median trunk diameter (range) (mm) . Primary GSV* 97 30:67 55 (21–84) 6 5·5 (3·8–10·5) Primary SSV* 23 5:18 53·5 (33–86) 1 5·5 (4·4–10·2) Primary other† 38 4:34 41 (19–73) 0 Recurrent GSV 18 7:11 57 (34–75) 0 4·5 (3·2–7·5) Recurrent SSV 5 2:3 63 (56–80) 0 5·0 Recurrent other 39 5:34 58 (25–75) 0 Morphology . No. of legs . Men:Women . Median (range) age (years) . Ulcer . Median trunk diameter (range) (mm) . Primary GSV* 97 30:67 55 (21–84) 6 5·5 (3·8–10·5) Primary SSV* 23 5:18 53·5 (33–86) 1 5·5 (4·4–10·2) Primary other† 38 4:34 41 (19–73) 0 Recurrent GSV 18 7:11 57 (34–75) 0 4·5 (3·2–7·5) Recurrent SSV 5 2:3 63 (56–80) 0 5·0 Recurrent other 39 5:34 58 (25–75) 0 * Four legs had both GSV and SSV, regarded as separate interventions. † Anterior thigh vein, 26; Posterior thigh vein, seven; Thigh/Calf perforators arise locally. GSV, great saphenous vein; SSV, small saphenous vein. Open in new tab Table 1 Morphology of varicose veins treated by ultrasound-guided foam sclerotherapy (220 legs) Morphology . No. of legs . Men:Women . Median (range) age (years) . Ulcer . Median trunk diameter (range) (mm) . Primary GSV* 97 30:67 55 (21–84) 6 5·5 (3·8–10·5) Primary SSV* 23 5:18 53·5 (33–86) 1 5·5 (4·4–10·2) Primary other† 38 4:34 41 (19–73) 0 Recurrent GSV 18 7:11 57 (34–75) 0 4·5 (3·2–7·5) Recurrent SSV 5 2:3 63 (56–80) 0 5·0 Recurrent other 39 5:34 58 (25–75) 0 Morphology . No. of legs . Men:Women . Median (range) age (years) . Ulcer . Median trunk diameter (range) (mm) . Primary GSV* 97 30:67 55 (21–84) 6 5·5 (3·8–10·5) Primary SSV* 23 5:18 53·5 (33–86) 1 5·5 (4·4–10·2) Primary other† 38 4:34 41 (19–73) 0 Recurrent GSV 18 7:11 57 (34–75) 0 4·5 (3·2–7·5) Recurrent SSV 5 2:3 63 (56–80) 0 5·0 Recurrent other 39 5:34 58 (25–75) 0 * Four legs had both GSV and SSV, regarded as separate interventions. † Anterior thigh vein, 26; Posterior thigh vein, seven; Thigh/Calf perforators arise locally. GSV, great saphenous vein; SSV, small saphenous vein. Open in new tab Intervention Patients were treated in a Day Surgery Unit at 30-min intervals, usually six to eight in one session. Superficial varices were cannulated at up to three different sites with 23 gauge butterfly cannulas, usually with the legs dependent. After insertion they were flushed with saline to confirm intraluminal placement and to prevent thrombosis within the cannula. The saphenous trunks were cannulated with a Seldinger catheter (Leader Cath arterial 20G 8 cm; Vygon Ecquen, France) under ultrasound guidance (SonoSite Titan® 5 MHz Probe, SonoSite, Bothell, Washington, USA) and similarly flushed. Occasionally, a butterfly was also used for an obviously superficial and palpable GSV trunk. Polidocanol (Sclerovein®; Resignag AG, Zug, Switzerland) foamed in a ratio of 1:3 with air was mixed using a three-way tap and a 5- and 2-ml syringe with not less than 20 passages using the Tessari technique17. Generally speaking, this was injected using either 1 per cent for superficial veins or 3 per cent for saphenous trunks, according to the standard protocol (See Table 2). Each injection was limited to 2 ml aliquots to a total volume not exceeding 14 ml. The saphenous trunk was usually treated first, with the patient supine and the leg flat initially. Ultrasound imaging was used to track foam within the vein, and when it reached the saphenofemoral junction, the leg was elevated to limit further cephalad progress and facilitate filling of the distal component of the varicose system. Elevation also had the effect of emptying the superficial varices. More recently, the degree of spasm seen in the saphenous trunks was noticed, since it is very variable. In some patients where attempted Seldinger catheterization had failed or was not attempted being too deep or otherwise inaccessible, saphenous trunks were filled via the adjacent butterflies placed in the superficial varicosities. Table 2 Guideline protocols for injection of polidocanol foam Morphology . Cannulation . Strength (%) . Volume (ml) . Comments . GSV trunks Seldinger 3 2–8 Elevate leg when foam reaches groin Watch for spasm SSV trunks Seldinger 1 or 3 2–4 Watch for foam entering popliteal vein Superficial varicosities Butterfly 1–3 ports 1 2–6 per port If possible to point of sealing from ‘bleed back’ Thigh veins Butterfly 1–3 ports 1 2–8 per port Large volumes may be required Recurrent superficial varicosities Butterfly 1–5 ports 1 2–4* Caution over foam destination Morphology . Cannulation . Strength (%) . Volume (ml) . Comments . GSV trunks Seldinger 3 2–8 Elevate leg when foam reaches groin Watch for spasm SSV trunks Seldinger 1 or 3 2–4 Watch for foam entering popliteal vein Superficial varicosities Butterfly 1–3 ports 1 2–6 per port If possible to point of sealing from ‘bleed back’ Thigh veins Butterfly 1–3 ports 1 2–8 per port Large volumes may be required Recurrent superficial varicosities Butterfly 1–5 ports 1 2–4* Caution over foam destination * This amount was exceeded in early experience and subsequently modified in light of embolic events. GSV, great saphenous vein; SSV, small saphenous vein. Open in new tab Table 2 Guideline protocols for injection of polidocanol foam Morphology . Cannulation . Strength (%) . Volume (ml) . Comments . GSV trunks Seldinger 3 2–8 Elevate leg when foam reaches groin Watch for spasm SSV trunks Seldinger 1 or 3 2–4 Watch for foam entering popliteal vein Superficial varicosities Butterfly 1–3 ports 1 2–6 per port If possible to point of sealing from ‘bleed back’ Thigh veins Butterfly 1–3 ports 1 2–8 per port Large volumes may be required Recurrent superficial varicosities Butterfly 1–5 ports 1 2–4* Caution over foam destination Morphology . Cannulation . Strength (%) . Volume (ml) . Comments . GSV trunks Seldinger 3 2–8 Elevate leg when foam reaches groin Watch for spasm SSV trunks Seldinger 1 or 3 2–4 Watch for foam entering popliteal vein Superficial varicosities Butterfly 1–3 ports 1 2–6 per port If possible to point of sealing from ‘bleed back’ Thigh veins Butterfly 1–3 ports 1 2–8 per port Large volumes may be required Recurrent superficial varicosities Butterfly 1–5 ports 1 2–4* Caution over foam destination * This amount was exceeded in early experience and subsequently modified in light of embolic events. GSV, great saphenous vein; SSV, small saphenous vein. Open in new tab The superficial varicosities were then injected with 1 per cent polidocanol foam. Ultrasound guidance was used to milk the foam to fill any remaining segments. Sealing of superficial varicosities was checked by leaving the butterfly cannula open after the foam injection. Throughout the procedure the patients were asked to perform intermittent foot flexion to maintain deep venous flow. Self-adhesive elastic bandages were applied over cotton wool pads at the site of the injected varicosities. An antithromboembolism stocking was then put on over the top. Patients were allowed to drive home if they wished and return to work the next day unless they had a particularly heavy job, when 2 or 3 days off work was advised. After 5 days, the bandaging was removed by the patient and the antithromboembolism stocking worn during the day for a further 2 weeks. Patients were warned to expect tender lumpiness and discolouration at the site of the injections. Where large varicosities had been injected, patients were seen to aspirate clot under local anaesthetic 2 to 4 weeks later. Outcome measures Patients were reviewed within 6 weeks of treatment. They were assessed clinically for the occlusion of superficial varicosities by palpation and ultrasound imaging. On this basis, categories of outcome were graded as follows: complete occlusion was closure of relevant saphenous and/or at least 85 per cent of varicosities; partial occlusion was less than the above but with patients satisfied (for example, GSV still open but varicosities all closed, or less than 85 per cent varicosity closure); failed occlusion was any outcome less than the above. Patients underwent further foam treatment as necessary, usually about 6 weeks later. In this respect, patient preference did play some part in as much that some were already been satisfied with what had been achieved. As a consequence, some patients who had a partial occlusion might have achieved a complete occlusion with further intervention. Results Overall, complete occlusion occurred in 163 legs after one intervention with a further 33 after a second intervention, and one after a third (overall 91 per cent). (Fig. 1) Fig. 1 Open in new tabDownload slide Leg of a 39-year-old woman (a) before and (b) 1 month after treatment of posterior thigh vein with 6 ml of 1 per cent polidocanol foam. This shows a good early cosmetic outcome with closure of the vein on ultrasound Of the remaining legs, all achieved partial occlusion after up to three interventions apart from three. Two of these had GSV incompetence, which failed to close in spite of three interventions. One of these patients was on warfarin anticoagulation. Finally, one patient with widespread recurrent varicose veins decided to defer further intervention after one treatment that resulted in partial occlusion. Complications One ulcer occurred in the thigh, at the site of the trunk cannulation. This patient was on warfarin therapy and the foam was seen on ultrasound to leak from the GSV puncture site and extravasate after removal of the cannula. The ulcer healed fully within a few weeks. Two patients experienced transient visual disturbance for about 5 min and one had chest discomfort for a similar interval. These three patients were being treated for recurrent varicose veins arising from multiple perforators and had all received 1 per cent polidocanol into superficial varicosities totalling 14, 10 and 6 ml, respectively. One further patient experienced visual disturbance, which seemed more likely to have been migrainous as has been described18. She had received a total of 10 ml divided between the GSV trunk and superficial varicosities. Phlebitis and pigmentation were common, especially soon after treatment (Fig. 2). This was difficult to quantify and was not recorded but is obviously an important cosmetic consideration in the longer term. Four legs were lost to follow-up. Fig. 2 Open in new tabDownload slide Leg of a 54-year-old woman 1 month after treatment of incompetent great saphenous vein with 6 ml of 3 per cent polidocanol foam, and calf varicosities with 6 ml of 1 per cent polidocanol foam. This reaction is common in large veins and usually resolves. Clot aspiration may speed recovery Primary GSV The practice of filling the saphenous trunks with foam indirectly via butterfly cannulation of adjacent varicosities has already been mentioned. In 27 of 97 legs, the GSV trunks were filled in this way via adjacent varicosities. In 13, this was because attempted direct Seldinger cannulation of the trunk had failed for technical reasons. In the remaining 14, the size or depth of the GSV made it potentially difficult. The trunk was nonetheless filled by these means, as confirmed on ultrasound imaging. Eight of these 27 trunks were found to be completely occluded at first follow-up. Seven of those that remained open subsequently underwent a further injection, this time directly into the GSV trunk, after which closure was secured. Of the rest, either further injections also failed or the patients were satisfied with the outcome and an expectant policy was followed (Table 3). In contrast, 56 of 70 trunks injected directly via a Seldinger placement were completely occluded. The difference in outcome between the two methods was statistically significant (χ2 test, P < 0·001). Table 3 Early outcome of ultrasound-guided foam sclerotherapy Morphology . No. of limbs treated . Complete after one intervention . Complete after two interventions . Complete after three interventions . Partial after one intervention . Partial after two interventions . Partial after three interventions . Fail after three interventions . Lost to follow-up . Primary GSV 97 64 19 1 5 3 2 2 1 Primary SSV 23 22 1 Primary other 38 33 2 2 1 Recurrent GSV 18 10 5 1 1 1 Recurrent SSV 5 5 Recurrent other 39 28 7 3 1 Morphology . No. of limbs treated . Complete after one intervention . Complete after two interventions . Complete after three interventions . Partial after one intervention . Partial after two interventions . Partial after three interventions . Fail after three interventions . Lost to follow-up . Primary GSV 97 64 19 1 5 3 2 2 1 Primary SSV 23 22 1 Primary other 38 33 2 2 1 Recurrent GSV 18 10 5 1 1 1 Recurrent SSV 5 5 Recurrent other 39 28 7 3 1 GSV, great saphenous vein; SSV, small saphenous vein. Open in new tab Table 3 Early outcome of ultrasound-guided foam sclerotherapy Morphology . No. of limbs treated . Complete after one intervention . Complete after two interventions . Complete after three interventions . Partial after one intervention . Partial after two interventions . Partial after three interventions . Fail after three interventions . Lost to follow-up . Primary GSV 97 64 19 1 5 3 2 2 1 Primary SSV 23 22 1 Primary other 38 33 2 2 1 Recurrent GSV 18 10 5 1 1 1 Recurrent SSV 5 5 Recurrent other 39 28 7 3 1 Morphology . No. of limbs treated . Complete after one intervention . Complete after two interventions . Complete after three interventions . Partial after one intervention . Partial after two interventions . Partial after three interventions . Fail after three interventions . Lost to follow-up . Primary GSV 97 64 19 1 5 3 2 2 1 Primary SSV 23 22 1 Primary other 38 33 2 2 1 Recurrent GSV 18 10 5 1 1 1 Recurrent SSV 5 5 Recurrent other 39 28 7 3 1 GSV, great saphenous vein; SSV, small saphenous vein. Open in new tab Primary SSVs versus GSVs Of 23 legs with SSV incompetence, 10 had direct injections into the distal incompetent dilated SSV trunk. Half received 1 per cent polidocanol and half 3 per cent; this distinction was empirical and based on trunk size. In the remainder, injections were confined to adjacent varicosities. As has been previously reported, this is because, unlike the GSVs, these legs exhibited focal saphenopopliteal reflux and the distal trunks were small and competent19. In all these legs, satisfactory closure occurred to the saphenopopliteal junction and in the incompetent trunk where relevant. There was a better outcome in the SSVs than the GSVs overall (Table 3). All the patients with SSV incompetence were occluded after one injection, whereas only 64 of 97 patients with GSV incompetence were occluded (χ2 test, P < 0·010), despite the use of lower volumes of foam (median 3 ml versus 6 ml). Discussion This study addressed the efficacy of UGFS in achieving the immediate technical objective of varicose vein occlusion. This was attainable in most patients with safety not only in GSVs but in SSVs and recurrent varicose veins as well. Similarly, Cabrera et al.8 reported successful saphenous trunk closure up to 3 years after a single treatment in 81 per cent and a further 11 per cent with a second treatment. Superficial varices disappeared in 96·5 per cent, although some patients had further treatments. These results are in keeping with the experience of other authors9–14, some of whom also emphasized the need for subsequent supplementary injections to maintain closure12. The results reported here are very early, although it is clearly of fundamental importance that initial efficacy is demonstrable. It remains uncertain whether these early results will translate into similarly satisfactory longer-term outcomes, even if further injections are necessary. As yet, no comparative trial of surgery against UGFS has been published. This would be of considerable interest, particularly the relative incidence of recurrence. There are theoretical reasons why the recurrence rate might be lower with UGFS than with surgery. Neovascularization in the groin region is a major factor in recurrence16. Some suggest that this arises in response to the angiogenic stimulus inherent to the surgical procedure20,21. Another explanation is that it is the ablation of normal groin tributaries that might provoke neovascularization, and to retain them might avoid it22. Either way, endovenous interventions would, at least theoretically, avoid either of these stimuli. Another important area for comparison with surgery is cosmetic outcome. Initial anecdotal experience suggests that it takes longer with UGFS to reach a satisfactory appearance, and persistent skin staining and to a lesser extent nodularity can be of concern even when an aggressive policy of aspiration after sclerotherapy has been employed. However, others with longer follow-up report that, although this may last a year, it rarely persists11. In many other respects, differences between the two forms of treatment are self-evident in terms of cost, convenience, time off work, and the avoidance of an anaesthetic and surgical intervention. It is these aspects that may attract a number of patients who otherwise might not seek intervention. Another advantage is that it offers treatment for patients who are on the borderline for surgery on the basis of fitness or age. There are also those in whom the technical prospects of a surgical intervention may be daunting. Re-exploration of the saphenofemoral junction might be one example. Finally, there is the management of SSV incompetence where objective assessment shows the results of conventional surgery to be disappointing23. Cannulation of the GSV under ultrasound guidance was a new skill that took time to acquire. During the learning period, there were occasions when cannulation was either not attempted or failed. It was apparent that the trunk could nonetheless be filled via adjacent superficial varices; however, initial results suggested that this way was less effective than direct injection. Although the two groups of patients were not randomized, it seems likely that direct cannulation is better. Overall the procedure appears to be safe, as has been reported by others8–14,24. There were three episodes that may have resulted from embolism of foam. Interestingly, all these patients were being treated for recurrent veins and in retrospect may have been given inappropriately large amounts of foam. Most of the foam almost certainly rapidly spilled into the deep system via multiple perforator connections16. Although when treating a single system, such as primary GSV, moving the foam around by milking and leg elevation is effective, it may not be appropriate in recurrent varicose veins. It is essential to monitor where the foam is tracking with ultrasound imaging; since becoming aware of this, there have been no further embolic problems in 150 legs treated. Even when this does occur, symptoms seem to be transient without any lasting consequence24. Another area of concern is the possibility of deep vein thrombosis due to diffusion of foam into the deep system. Patients were not screened routinely, but no such events apparently occurred. Such a complication would seem to be rare, as has been the experience of others8–14,24. The technique and protocol of this study was used in the light of considerable experience gained from others (see Acknowledgements), from the literature and from personal practice. Clearly, there is no evidence that this is the optimal technique; there could be a wide variety of regimens in terms of sclerosant, concentration, volume and mode of administration25. Using this protocol, however, it is reasonable to conclude that UGFS in the short term is safe and effective in treating a fully representative spectrum of patients with varicose veins. Acknowledgements The authors would like to acknowledge the considerable advice and information received from Dr Stephen Tristram (Basingstoke) and Mr Philip Coleridge Smith (London). References 1 Schadeck M , Allaert F. [Ultrasonography during sclerotherapy.] Phlebologie 1991 ; 44 : 111 – 130 . Google Scholar PubMed OpenURL Placeholder Text WorldCat 2 Vin F . [Echo-sclerotherapy of the external saphenous vein.] Phlebologie 1991 ; 44 : 79 – 84 . Google Scholar PubMed OpenURL Placeholder Text WorldCat 3 Kantar A , Thibault P. Saphenofemoral incompetence treated by ultrasound-guided sclerotherapy . Dermatol Surg 1996 ; 22 : 648 – 652 . Google Scholar PubMed OpenURL Placeholder Text WorldCat 4 Orbach EJ . Sclerotherapy of varicose veins: utilization of an intravenous air block . 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European Consensus Meeting on Foam Sclerotherapy, April 4–6 2003, Tegernsee, Germany . Dermatol Surg 2004 ; 30 : 709 – 717 . Google Scholar Crossref Search ADS PubMed WorldCat Copyright © 2006 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) Copyright © 2006 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. TI - Ultrasound-guided foam sclerotherapy for the treatment of varicose veins JF - British Journal of Surgery DO - 10.1002/bjs.5423 DA - 2006-07-17 UR - https://www.deepdyve.com/lp/oxford-university-press/ultrasound-guided-foam-sclerotherapy-for-the-treatment-of-varicose-lhpz3zdRdj SP - 969 EP - 974 VL - 93 IS - 8 DP - DeepDyve ER -