Duplex Ultrasound Outcomes following Ultrasound-guided Foam Sclerotherapy of Symptomatic Recurrent Great Saphenous Varicose Veins

Eur J Vasc Endovasc Surg (2011) 42, 107e114 Duplex Ultrasound Outcomes following Ultrasound-guided Foam Sclerotherapy of Symptomatic Recurrent Great Saphenous Varicose Veins K.A.L. Darvall a,b, *, G.R. Bate a, D.J. Adam a, S.H. Silverman b, A.W. Bradbury a a Birmingham University, Department of Vascular Surgery, Heart of England NHS Trust, Birmingham, UK b Department of Vascular Surgery, City Hospital, Birmingham, UK Submitted 18 November 2010; accepted 13 March 2011 Available online 6 April 2011 KEYWORDS Varicose veins; Chronic venous insufficiency; Sclerotherapy; Duplex ultrasound Abstract Objectives: To describe duplex ultrasound (DUS) outcomes 12 months following ultrasound-guided foam sclerotherapy (UGFS) of recurrent great saphenous varicose veins (GSVV). Methods: A consecutive series of UK National Health Service patients underwent serial DUS examinations following UGFS with 3% sodium tetradecyl sulphate for symptomatic recurrent GSVV. Results: 91 treated legs (CEAP C 2/3 58, C 4 21, C 5 8, C 6 4) belonging to 73 patients (24 male) of median age 58 (range 32e86) years were enrolled between November 2004 and May 2007. The median volume of foam used was 8 (range 4e14) ml. Above-knee (AK) and below-knee (BK) GSV reflux was present in 88 (97%) and 80 (88%) legs respectively prior to treatment. AK and BK-GSV reflux was completely eradicated by a single session of UGFS in 86 (98%) and 74 (93%) legs respectively; and by two sessions of UGFS in 88 (100%) and 77 (97%) legs respectively. In those legs where GSV reflux had been eradicated, recanalisation occurred in 7/78 (9%) AK and 8/68 (12%) BK-GSV segments after 12 months follow-up. Retreatment, where undertaken, with a single UGFS session effectively eradicated all GSV reflux in all cases of recanalisation. Discussion: AsinglesessionofUGFScaneradicaterefluxintheAKandBK-GSVinover93%of patients with symptomatic recurrent GSVV. Re-recurrence at 12 months is superior to that reported after redo GSV surgery, similar to that observed following other minimally-invasive techniques and, when it occurs, is effectively and simply treated by a single further session of UGFS. ª 2011 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. * Corresponding author. Birmingham University, Department of Vascular Surgery, Flat 5 Netherwood House, Solihull Hospital, Lode Lane, Solihull, West Midlands B91 2JL, UK. Tel./fax: þ44 0121 424 5086. E-mail address: katydarvall@btinternet.com (K.A.L. Darvall). 1078-5884/$36 ª 2011 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.ejvs.2011.03.010

108 K.A.L. Darvall et al. Introduction Residual and/or recurrent great saphenous vein (GSV) reflux is disappointingly common after superficial venous surgery (SVS). For many years, authors have reported that around 20% of patients undergoing SVS for great saphenous varicose veins (GSVV) have been operated previously for GSVV in the same leg. 1,2 In our current ultrasound-guided foam sclerotherapy (UGFS) practice we find that figure to be 21% suggesting that there has been little improvement in surgical outcomes in recent times. Recurrence after GSVV surgery may be due to 1. Residual varicose veins (VV) often because of failure to adequately strip a refluxing above-knee (AK) and below-knee (BK) GSV at the first operation, 3 2. True recurrence, often referred to as neovascularisation. This can occur at the previously dissected saphenofemoral junction (SFJ) or stripping track, or 3. Progression of disease, for example the development of new reflux in the anterior accessory saphenous vein in the thigh. All three pathologies often co-exist in the same patient and can be difficult to distinguish. Redo GSVV surgery typically comprises re-exploration of the SFJ, stripping of the AK-GSV and multiple phlebectomies. Such surgery can be technically demanding and associated with a higher incidence of significant complications and rerecurrence than first time GSVV surgery. 4,5 Furthermore, reflux in the BK-GSV, a well-recognised cause of recurrence resulting from a reluctance to strip the BK-GSV for fear of causing saphenous nerve injury at the first operation, 6 is similarly difficult to treat with further surgery. Although the role of endovenous laser ablation (EVLA), radiofrequency ablation (RFA) and UGFS in treating primary GSVV is well established, their effectiveness in recurrent GSVV is less well defined. 7e15 The aim of the present study, therefore, is to describe duplex ultrasound (DUS) outcomes 12 months following UGFS of recurrent GSVV. Methods Patients Local ethics committee approval and written informed consent were obtained. Consecutive UK National Health Service (NHS) patients referred to AWB and DJA by their general practitioners between November 2004 and May 2007 because of symptomatic recurrent GSVV were studied. Recurrence was defined as previous surgery to the GSV in the same leg on at least one previous occasion. Specifically, all patients had undergone attempted SFJ ligation and multiple phlebectomies, with or without attempted stripping of the GSV; in most cases this was to the level of the knee only. To be considered suitable for UGFS patients had to have symptomatic (CEAP C 2e6 ) 16 venous disease (i.e. treatment was not offered for cosmetic indications) and significant (>0.5 s) reflux in a segment of residual AK and/or BK-GSV on DUS. Vein size was not a consideration in patient selection. Patients with absent pedal pulses or an ankle brachial pressure index <0.9 were excluded as were those with post-thrombotic deep venous disease. Pre-treatment assessment DUS was performed, as previously described, 7 at the initial clinic attendance in order to identify sites of superficial, deep and communicating venous reflux. UGFS treatment Our method of UGFS treatment has been described in detail previously and is thus summarised here. 7 All treatments took less than 30 min and were performed as office procedures in a treatment room. The superficial varices and incompetent truncal veins were marked on the skin using duplex imaging with the patient standing, and then, with the patient supine, cannulae were inserted into the truncal veins under direct ultrasonographic guidance. Sclerosant foam, prepared by a modified Tessari s method using two 2 ml syringes connected by a three-way tap and a 5 micron filter (B Braun Medical, Sheffield, UK), and comprising 0.5 ml of 3% sodium tetradecyl sulphate (STS) (Fibrovein Ò ; STD Pharmaceuticals, Hereford, UK) and 2 ml of air, was then injected with the leg held in an elevated position. Aliquots of foam were injected until all target veins were observed to be in spasm and full of foam on DUS. With the leg still elevated, compression bandaging was applied and a thigh-length class II compression stocking (Credelast Ò ; Credenhill, Ilkeston, UK) providing 23e32 mmhg at the ankle applied over the bandage. This was left intact for five to ten days, depending on the size of the veins, after which it was removed and the class II stocking worn alone for the remainder of the first month. All patients were provided with a 24 h help-line number to call at any time following treatment in case of any concerns. Outcome measures and follow-up The aim of treatment was to relieve the symptoms of venous hypertension. The chosen primary end-point was, therefore, complete eradication of superficial venous reflux in the trunk and major tributaries of the GSV. All patients were seen at 1, 6 and 12 months after treatment in a dedicated nurse-led (GRB) research clinic. Patients were also asked at their first post-treatment visit whether they had had any problems following treatment. Specifically they were asked about visual disturbance, headache, and possible nerve problems in the treated leg. Phlebitis and skin pigmentation were not recorded. Repeat DUS was performed at each follow-up visit as per the pre-treatment duplex. In addition, occlusion of the treated saphenous trunk was determined by a lack of compressibility and the absence of any flow. Complete occlusion was defined as occlusion over the entire length of the GSV. Recanalisation was defined as the presence of flow in either an antegrade or retrograde direction in a previously

UGFS of Recurrent GSV Varicose Veins 109 occluded AK and/or BK-GSV. Recanalisation was considered complete if over 50% of the length of vein had recanalised. Where recanalisation was found, the presence or absence of recurrent reflux was determined. Patients with residual reflux or recanalisation at any follow-up appointment were offered further treatment by repeating foam sclerotherapy with 3% STS as outlined above. Results Patients and treatments Patient characteristics are shown in Table 1. In 88 legs there was reflux in the AK-GSV, of which 77 also exhibited reflux in the BK-GSV; isolated BK-GSV reflux was observed in only 3 legs. Despite a previous SFJ dissection as evidenced by a previous scar, in 27 legs there was an apparently intact and incompetent SFJ refluxing into an incompetent residual AK- GSV. In 34 legs the SFJ appeared to have been (at least partially) ligated and there was collateral reflux into an incompetent residual AK-GSV through tributaries and/or neovascularisation. In the remaining 30 legs the SFJ has been satisfactory ligated and the proximal (usually 5e10 cm) Table 1 Patient and disease characteristics and patterns of recurrence. Parameter 73 patients (91 legs) Age in years e median (range) 58 (32e86) Sex M 24 (33) F 49 (67) CEAP clinical grade C 2 54 (59) C 3 4 (4.5) C 4 21 (23) C 5 8 (9) C 6 4 (4.5) Etiology Primary (E P ) 91 (100) Secondary (E S ) 0 (0) Anatomical patterns of venous reflux Superficial and deep (A SD ) 5 (5.5) Superficial only (A S ) 86 (94.5) Recurrent GSV 77 (84.5) above and below-knee Recurrent GSV above-knee only 11 (12) Recurrent GSV below-knee only 3 (3.5) Pathophysiological classification Reflux (P R ) 91 (100) Obstruction (P O ) 0 (0) Pattern of recurrence Incompetent SFJ into GSV 27 (30) Neovascularization into 34 (37) proximal thigh GSV Isolated GSV remnant reflux 30 (33) AK-GSV removed but there was reflux in the AK and/or BK-GSV trunk below this point as a result of perforator incompetence. One, two, and three cannulae were used to introduce the foam in 36, 43, and 12 treatments respectively. The median volume of 3% STS foam used at each treatment was 8 (range 4e14) ml. There was no clinical or DUS evidence of DVT or PE, no visual disturbance, or any other complication or side effects. Treatment of the AK-GSV Complete eradication of AK-GSV reflux was achieved in all 88 legs; 86/88 (98%) legs after one treatment and in a further two legs after a second (course of primary treatment) (Fig. 1). Recanalisation was observed in 0/79 (0%) scanned legs at 6 months and 7/78 (9%) scanned legs at 12 months (Fig. 1). Nine and ten legs were not scanned at 6 and 12 months respectively because the patients defaulted from follow-up. At 12 months this AK-GSV recanalisation was partial (<50% length) with reflux in four legs, and complete (>50%) with reflux in three legs. Of these seven legs, four underwent one session of repeat UGFS which resulted in successful complete eradication of AK-GSV reflux, and three were content with the clinical result and declined further treatment. Treatment of the BK-GSV Complete eradication of reflux in the BK-GSV was achieved in 77/80 (96.5%) legs; 74 (93%) legs after one, and in a further three (3.5%) legs after a second, treatment session (course of primary treatment) (Fig. 2). In three legs (3.5%), complete eradication of reflux in the BK-GSV was not achieved after a single treatment session but these patients, despite residual reflux in the BK- GSV, were content with the clinical result and declined further treatment sessions. In the 77 legs in whom the primary course of UGFS achieved complete eradication of the reflux in the BK-GSV, recanalisation was observed in 1/69 (1.5%) scanned legs at 6 months and 8/68 (12%) scanned legs at 12 months (Fig. 2). Eight and 12 legs were not scanned at 6 and 12 months respectively. At 6 months this BK-GSV recanalisation was complete (>50%) with reflux in the single leg, but the patient was content with the clinical result and declined further treatment. At 12 months this BK-GSV recanalisation was partial (<50%) with reflux in three legs, and complete with reflux in five legs. Of these eight legs, three underwent one session of repeat UGFS which resulted in successful complete eradication of BK-GSV reflux, and for the remaining five legs the patient was content with the clinical result and declined further treatment. Treatment of the entire GSV Complete eradication of reflux in the entire (AK and BK) GSV was achieved in 84/91 (92%) legs after one, and in

110 K.A.L. Darvall et al. Figure 1 Eradication of reflux and recanalisation in the above-knee great saphenous vein (AK-GSV). a further 4/91 (4.5%) legs after two treatment sessions (course of primary treatment) (Fig. 3). In three legs (3.5%), complete eradication of GSV reflux was not achieved by one treatment session but these patients, despite residual GSV reflux, were content with the clinical result and declined further treatment sessions. In the 88 legs in whom the primary course of UGFS achieved complete eradication of GSV reflux, recanalisation was observed in 1/79 (1.5%) legs at 6 months and 9/77 (12%) legs at 12 months (Fig. 3). Nine and 11 legs were not scanned at 6 and 12 months respectively. At 6 months, the single patient was content with the clinical result and declined further treatment. At 12 months, four underwent one session of repeat UGFS which resulted in successful complete eradication of GSV reflux, and for the remaining five legs the patient was content with the clinical result and declined further treatment.

UGFS of Recurrent GSV Varicose Veins 111 Figure 2 Eradication of reflux and recanalisation in the below-knee great saphenous vein (BK-GSV). Discussion Many observers have reported disappointing results with redo surgery for residual and recurrent GSVV; and most surgeons would probably prefer not to do such surgery if an effective alternative could be found. 4,5 Intuitively, therefore, it is in the treatment or recurrent VV that one might imagine that the new endovenous techniques would have their greatest appeal to patients and surgeons alike. But, somewhat surprisingly, data on the effectiveness of EVLA, RFA and UGFS for recurrent GSVV are relatively limited when compared to primary disease. 7e15

112 K.A.L. Darvall et al. Figure 3 Eradication of reflux and recanalisation in the entire great saphenous vein (GSV). Fassiadis et al. reported on the use of RFA in 18 legs with recurrent GSV. 17 Fifteen legs had neovascularisation connecting with a residual GSV, two had an incompetent thigh perforator, and one had a refluxing anterior thigh branch reconnecting with the GSV. They found occlusion of all 18 GSV at one month; and in 16/16 followed up to 12 months. One-third had temporary sensory disturbances. All returned to daily activities within three days. Hinchcliffe et al. randomised 16 patients with bilateral recurrent GSVV to have one leg treated with RFA and the other with SVS comprising a lateral approach to the SFJ and GSV strip to the knee. 9 All limbs had previously been

UGFS of Recurrent GSV Varicose Veins 113 treated with SFJ ligation and had an incompetent SFJ and reflux in the GSV on DUS. Prior to randomisation they found that 70% of patients had a persistent and incompetent GSV suitable for treatment with RFA. GSV were considered unsuitable if excessively tortuous, or <3 or >12 mm in diameter. The patients were followed up to 12 months and they found complete occlusion in 13/16 GSV treated with RFA, and complete GSV stripping in 14/16 legs treated with SVS. RFA was significantly quicker to perform and associated with less pain and bruising. van Groenendael et al. retrospectively compared outcomes in 149 patients who underwent SVS and 67 patients who underwent EVLA for recurrent GSVV. 18 All limbs had a recurrent SFJ and had reflux in a part of the GSV. In the surgically-treated group 87% had had previous GSV stripping, and in the EVLA group 57% had had stripping. All had had previous SFJ disconnection. All treatments were deemed successful immediately after treatment and in the 46 (69%) legs scanned 8 weeks after EVLA, all treated veins remained occluded. At a median follow-up of 13.5 months 26% of surgery patients had clinical recurrence (although a definition for this is not given in the paper and repeat DUS was not performed), compared with 12% in the EVLA group at a median follow-up of 15 months. After adjusting for length of follow-up this difference was not statistically significant. They also found less post-treatment pain in the surgical group, but more analgesia usage. Wound infection occurred in 8% of the surgical group. They conclude that if anatomically suitable EVLA is a good treatment alternative for recurrent GSVV, however, they also point out that only 31% of patients with recurrent GSVV were suitable for EVLA. Various reasons were given for unsuitability: 37% tortuosity of the GSV, 8% GSV diameter <4 mm, 4% presence of thrombophlebitis, 51% other reasons including veins too branched or superficial and too many connections with the deep venous system. Four groups have looked at UGFS for recurrent GSVV. Kakkos et al. presented immediate results of 45 legs with recurrent GSVV treated with UGFS (3% STS foam). 19 Twentyeight had groin reflux, five perforator vein, and the remainder had isolated GSV remnant reflux. A single injection of 6 ml was adequate in 58% of legs; 11% needed three or more treatment sessions. However, complete elimination of reflux at the end of treatment was only achieved in 39/45 (87%) legs. Follow-up was only for 3 weeks. Darke et al. treated 18 legs with recurrent GSVV with UGFS (3% polidocanol foam). 20 All had persistent or reconstituted GSV trunks in continuity with superficial varicosities and usually with the femoral vein in the groin. Legs were assessed clinically and with DUS after 6 weeks. Ten legs had complete occlusion after one treatment; a further five had complete occlusion after two treatments. The three remaining legs had partial occlusion (either GSV still open but varicosities all closed, or less than complete GSV occlusion but patient satisfied) after one, two or three treatments. Coleridge Smith reported his experience with using UGFS (mostly 3% STS foam) for 267 recurrent GSVV in 2006. 21 Further information about the type of recurrence was not given. One hundred and six legs (40%) were reviewed at least 6 months (mean 11 months) following treatment. The GSV was occluded in 98/106 (92%); better than the 86% occlusion rate seen in primary GSV. O Hare et al. reviewed 32 legs 6 months after UGFS (3% STS foam) for recurrent VV. 22 They found occlusion of treated veins on DUS at 6 months in 23/32 (72%) and 28/32 (88%) were satisfied with the results of treatment. Unfortunately, this represented less than 50% of their treated cohort and they gave no further information regarding the type of recurrence treated. They also included some patients treated for SSV rather than GSV recurrence. In conclusion, the present paper adds further evidence that UGFS is a safe and clinically effective treatment for recurrent GSVV. A primary course of UGFS, comprising one and infrequently two treatment sessions, leads to complete eradication of GSV reflux in virtually 100% of cases. Recanalisation at 12 months is superior to that reported after surgery and similar to that observed following other minimally-invasive techniques. Recanalisation is easily and successfully treated with a further single UGFS treatment. Conflict of Interest/Funding None. References 1 Bradbury AW, Stonebridge PA, Ruckley CV, Beggs I. Recurrent varicose veins: correlation between pre-operative clinical and hand-held Doppler ultrasonographic examination and anatomical findings at surgery. 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