Recovery after ultrasound-guided foam sclerotherapy compared with conventional surgery for varicose veins

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1 Original article Recovery after ultrasound-guided foam sclerotherapy compared with conventional surgery for varicose veins K. A. L. Darvall, G. R. Bate, D. J. Adam and A. W. Bradbury Department of Vascular Surgery, Birmingham University, Heart of England NHS Trust, Birmingham, UK Correspondence to: Dr K. A. L. Darvall, Department of Vascular Surgery, Birmingham University, Flat 5, Netherwood House, Solihull Hospital, Lode Lane, Solihull B91 2JL, UK ( Background: The advantages of minimally invasive alternatives such as ultrasound-guided foam sclerotherapy (UGFS) over conventional surgery for the treatment of varicose veins include lower morbidity and faster recovery times. The aim was to compare morbidity, analgesia use, and time to return to driving and work following UGFS with those reported after conventional surgery for varicose veins. Methods: Patients who had UGFS or surgery for varicose veins were sent a questionnaire 4 weeks after treatment. Results: A total of 332 (84 9 per cent) of 391 patients who had UGFS and 53 (56 per cent) of 94 who had surgery returned a questionnaire. The groups were similar in terms of age, sex, and the proportion who had treatment of bilateral or recurrent veins. Patients who had surgery were more likely to have significantbruising (44 versus 7 2 per cent; P < 0 001) and pain (17 versus 5 5 per cent; P = 0 001). After UGFS, 43 2 per cent of patients returned to work within 24 h compared with none who had surgery (P < 0 001). Patients who had UGFS were more likely to return to driving within 4 days (P = 0 014). Conclusion: UGFS was associated with less pain and analgesia requirement, time off work and quicker return to driving. Paper accepted 12 June 2009 Published online in Wiley InterScience ( DOI: /bjs.6754 Introduction Surgical treatment of varicose veins improves physical symptoms, generic and disease-specific health-related quality of life, and venous haemodynamics 1 5. However, it is also widely accepted that such surgery can be associated with a significant incidence of complications, morbidity, and delayed return to normal activities and work Apart from being unpleasant for some patients and a rich source of medicolegal activity 14,15, adverse outcomes after varicose vein surgery can have a significant financial impact in this predominantly young and economically active patient population. New endovenous thermal ablation techniques, such as radiofrequency ablation (RFA) and endovenous laser ablation (EVLA), may have advantages over traditional surgery that include less morbidity and a quicker return to normal activities 7, The situation with regard to ultrasound-guided foam sclerotherapy (UGFS) for varicose veins is less well defined. The aim of this study was to determine early morbidity, analgesia use, and time taken to return to driving and work following UGFS, and to compare these findings with those in a contemporaneous series of similar patients undergoing conventional varicose vein surgery. Methods Local ethics committee approval was obtained for this nonrandomized observational study and patients gave written informed consent. Patients and pretreatment assessment Questionnaires were posted to 391 consecutive patients who had UGFS between April 2005 and April 2007, and 94 consecutive patients who had conventional superficial venous surgery between October 2007 and March All patients were treated in the same hospital (Heart of Copyright 2009 British Journal of Surgery Society Ltd British Journal of Surgery 2009; 96:

2 Recovery after foam sclerotherapy compared with conventional surgery for varicose veins 1263 England NHS Foundation Trust) but under the care of separate surgical teams. All patients were referred by their general practitioners to National Health Service outpatient clinics, and were assessed in a consultant-led vascular outpatient clinic. Patients were examined and the severity of venous disease determined according to the clinical, (a)etiological, anatomical, pathophysiological (CEAP) clinical classification. All patients underwent venous duplex imaging in outpatient clinics to determine sites of deep and superficial venous reflux. Patients were examined standing with their weight on the contralateral limb, with the leg to be examined slightly bent with the heel on the floor to relax the calf muscle while maintaining stability. A Sonosite Micromaxx (Sonosite, Hitchin, UK) fitted with a 10-MHz transducer was used for imaging. The proximal and distal superficial femoral vein, above- and below-knee popliteal vein, saphenofemoral junction (SFJ) and saphenopopliteal junction (SPJ), and the whole length of the great saphenous vein (GSV) and small saphenous vein (SSV) were insonated. All veins were assessed for patency and compressibility. Venous flow was induced with a manual calf squeeze and reflux was defined as reversed flow longer than 0 5 s. Foam treatment All UGFS treatments were performed on outpatients in a treatment room, and each took less than 30 min. Patients with bilateral varicose veins had only one leg treated at a time (worst leg first); the second leg was treated at least 4 weeks later. Immediately before treatment the incompetent truncal veins and superficial varices were marked on the skin using duplex imaging. The patient then reclined in the supine position for cannulation of the GSV and/or anterior accessory saphenous vein (AASV), or prone for cannulation of the SSV. Peripheral intravenous catheters (Optiva TM ; Medex Medical, Rossendale, UK) were inserted under direct ultrasound guidance. According to the size and depth of the target vein, G cannulas (green, pink or blue) were used. Once all cannulas were secured, the leg was elevated (to empty the veins) for injection of the foam. All cannulas were flushed with normal saline to ensure that they were not dislodged during the changes in leg position. Sclerosant foam was prepared by a modified Tessari s method using two 2-ml syringes connected by a threeway tap and a 5-µm filter (B. Braun Medical, Sheffield, UK), and comprised 0 5 ml 3 per cent sodium tetradecyl sulphate (Fibrovein ; STD Pharmaceuticals, Hereford, UK) and 2 ml air. Foam was injected in 2-ml aliquots, and its distribution and resulting venous spasm observed by duplex imaging. At least 30 s was left between injecting each aliquot of foam. After each injection patients were asked to dorsiflex and plantarflex their ankle several times to clear any foam that might have entered the deep venous system. Volumes of foam used were 2 8 ml for the SSV and 4 12 ml for the GSV (with or without concomitant AASV treatment). When all the trunk and tributary veins and the varices were in spasm, and occluded with foam, the cannulas were removed and compression was applied with the leg still elevated. A roll of Velband (Johnson and Johnson Medical, Ascot, UK) was applied directly along the line of the previously marked saphenous trunk and superficial varices, and retained using Pehahaft cohesive bandage (Hartmann, Heidenheim, Germany). This regimen produced direct compression over the treated truncal veins. A thigh-length class II compression stocking (Credelast ; Credenhill, Ilkeston, UK) was applied over the bandage. The bandaging was left intact for 5 10 days, depending on the size of the veins, after which it was removed and the class II stocking worn alone for a further 3 weeks. Patients were told to take analgesia as required, to return to driving when they felt able to perform an emergency stop, and to return to work when they felt comfortable. It was suggested to patients who had had their right leg treated that they wait until the bandaging was removed to commence driving as it may prove difficult to perform an emergency stop. Surgical treatment All surgery was performed on inpatients, usually without an overnight stay, under general anaesthesia. Patients with bilateral varicose veins usually had both legs treated at the same time. Primary GSV incompetence was treated by saphenofemoral ligation, stripping of the GSV to knee level and multiple stab phlebectomies. Recurrent GSV varices were treated by re-exploration at the groin, and phlebectomies with stripping of any GSV remnant, as appropriate. SSV incompetence was treated by saphenopopliteal ligation (marked immediately before operation by duplex imaging), removal of the proximal 10 cm of SSV via the popliteal fossa incision, and phlebectomies. No surgeon performed stripping of the SSV. Limbs were bandaged after surgery with Velband and Elastocrepe (Smith and Nephew Healthcare, London, UK). Bandaging was replaced after 24 h with thigh-length antiembolism stockings (TED ; Kendall Healthcare Products, Mansfield, Massachusetts, USA), worn for a further 2 weeks. No specific restrictions were suggested to patients. They were advised to take analgesia as required,

3 1264 K. A. L. Darvall, G. R. Bate, D. J. Adam and A. W. Bradbury to return to driving when they felt able to perform an emergency stop, and to return to work when they felt comfortable. Questionnaires and outcome measures Questionnaires were sent to all patients 4 weeks after treatment. No reminders were sent. Patients were asked to grade the amount of pain, bruising, itching and lumpiness they had following foam injections or varicose vein surgery. Possible responses were an awful lot, a lot, quite a bit, a little or none. An awful lot and a lot were grouped together, as were a little and none. Patients were also asked: For how many days after your foam injections/varicose vein surgery did you take painkilling tablets?. Possible responses were none at all, same day only, 1 2 days, 2 4 days, 5 7 days, 7 14 days and more than 14 days. The final questions were: How long after your foam injections/varicose vein surgery did you return to work/driving?. Possible responses were: I don t go out to work/drive, same day, next day, 2 7 days, 7 14 days and more than 14 days. Statistical analysis Statistical analysis was performed using SPSS version 17.0 (SPSS, Chicago, Illinois, USA). The χ 2 test (with Yates correction where appropriate) was used to compare proportions between the two groups. Analysis of return to work and driving, and analgesia use was undertaken for the group as a whole, and then again after exclusion of patients who had bilateral surgery. Results The response rates were 84 9 per cent (332 patients, 418 legs) in the UGFS group and 56 per cent (53 patients, 70 legs) in the surgery group. There were no significant differences between the groups in terms of age, sex, proportion with bilateral or recurrent varicose veins, symptoms or extent of superficial venous reflux treated (Table 1). In the surgical group, four legs had primary SPJ ligation and phlebectomies; four legs had primary combined SFL and SPJ ligation, GSV stripping and phlebectomies; four legs had groin exploration for recurrence and phlebectomies without GSV stripping; and 58 legs had SFJ ligation, GSV stripping and phlebectomies (nine recurrent). In the foam group, 341 had GSV treatment (90 recurrent) with additional AASV treatment Table 1 Demographic details of patients with varicose veins treated by foam sclerotherapy or surgery UGFS Surgery P No. of patients No. of legs Age (years)* 58 (46 66) 53 (42 64) Male sex 111 (33 4) 20 (38) Bilateral 87 (26 2) 17 (32) Recurrent varicose veins 109 (26 1) 13 (19) Great saphenous vein 363 (86 8) 66 (94) CEAP C2 or C3 296 (70 8) 57 (81) *Values are median (interquartile range); values in parentheses are percentages of patients or legs. UGFS, ultrasound-guided foam sclerotherapy; CEAP, clinical, (a)etiological, anatomical, pathophysiological; χ 2 test unless indicated otherwise; Mann Whitney U test. in 22; 55 had SSV treatment (ten recurrent); and 22 had both GSV and SSV treatment (nine recurrent). Complications One symptomatic popliteal vein thrombosis was detected 4 days after UGFS, localized to the area of the SPJ. This was treated with warfarin for 6 months, at which point the patient was asymptomatic but had mild popliteal vein reflux. Three patients complained of visual disturbance following foam injections, consisting of blurred vision that lasted for less than 10 min. There were no other complications or adverse effects and, in particular, no other neurological symptoms or symptoms of nerve injury in the treated leg. Complications after surgery were not recorded separately. Questionnaire results Significant bruising (44 per cent after surgery versus 7 2 per cent after UGFS; P < 0 001) and pain (17 versus 5 5 per cent; P = 0 001) (Fig. 1) were significantly more common after surgery. There was no difference in terms of itching (10 versus 8 4 per cent) or lumpiness (9 versus 7 4 per cent). After UGFS, 70 8 per cent of patients required no analgesia compared with 24 per cent after surgery (P < 0 001). After 1 week only 4 1 per cent were still using analgesia compared with 30 per cent after surgery (P < 0 001). These differences persisted when patients undergoing bilateral surgery were excluded from the analysis (Fig. 2). After UGFS, 47 7 per cent of patients resumed driving within 4 days compared with 25 per cent after surgery (P = 0 014). After sclerotherapy, 43 2 per cent of patients returned to work within 24 h, but none after surgery

4 Recovery after foam sclerotherapy compared with conventional surgery for varicose veins 1265 % of patients UGFS A little, or none Quite a bit A lot, or an awful lot Surgery Fig. 1 Pain reported after ultrasound-guided foam sclerotherapy (UGFS) (n = 418) or surgery (n = 70) for varicose veins. In the UGFS group 5 5 per cent of patients reported a lot, or an awful lot, of pain compared with 17 per cent in the surgery group (P = 0 001, χ 2 test) % of patients > 7 days 2 7 days First 24 h None at all UGFS Surgery (all) Surgery (unilateral) Fig. 2 Duration of analgesia needed after ultrasound-guided foam sclerotherapy (UGFS) (n = 418), all surgery (n = 53) and unilateral surgery (n = 36) for varicose veins (P < 0 001). Respective proportions after 1 week were 77 4 and 23 per cent (P < 0 001) (Fig. 3). These differences in resuming driving and returning to work persisted when patients undergoing bilateral surgery were excluded from the analysis. % of patients > 2 weeks 1 2 weeks 2 7 days Within 24 h UGFS Surgery (all) Surgery (unilateral) Fig. 3 Time taken to return to work after ultrasound-guided foam sclerotherapy (UGFS) (n = 234), all surgery (n = 35) and unilateral surgery (n = 23) for varicose veins Discussion Compared with conventional varicose vein surgery, UGFS was associated with significantly less pain and analgesia requirement, and time off work and driving. Foam sclerotherapy was well tolerated, with only one clinical deep vein thrombosis and three instances of self-limiting blurred vision after treatment. A weakness of the study is that the two groups were not randomized. Two surgeons in this vascular unit used UGFS as the preferred treatment for varicose veins, whereas other colleagues continued to employ conventional surgery. All patients in the present study were referred from general practitioners through a common UK National Health Service referral pool. The hospital management system allocated patients to each vascular surgeon in accordance with their capacity to offer treatment. Therefore, there was little or no clinical or surgeon selection bias, which explains why, despite the lack of formal randomization, the UGFS and surgery groups were so similar. Another limitation of the present study was the discrepancy in size of the UGFS and surgery cohorts, although this was unlikely to have resulted in any systematic bias. Assessment of severity of bruising and pain was subjective, and performed by the patient. This could have been improved by objective assessment of bruising in a follow-up clinic using a validated pain score, but the patient s assessment of their postoperative recovery remains the most important outcome measure.

5 1266 K. A. L. Darvall, G. R. Bate, D. J. Adam and A. W. Bradbury The differences between UGFS and surgery reported here were not only statistically significant but also highly clinically meaningful, with less pain and quicker return to normal activity. When the patients in this study were treated, endovenous thermal ablation techniques were not available in this hospital. These newer methods may have some of the advantages of UGFS. Previous reports suggest that the incidence of bruising after RFA and EVLA, while significantly less than after surgery, is still higher than the 7 2 per cent rate after UGFS in the present study 7,16,17,20,21. The levels of pain and analgesia use reported here after surgery were similar to those described by others In contrast, pain and analgesia use after UGFS were much lower than after surgery, and possibly less than reported after EVLA, and similar to that reported after RFA by others 7,16,17,19,21,25,26. In the present study, return to work and driving was significantly quicker after UGFS than after surgery and appeared similar to, or better than, that reported after other minimally invasive treatments. The median time to return to work after conventional surgery has been reported as between 8 and 21 days 9,27. In one study, 10 per cent of patients took from 6 to 12 weeks to return to work 23. Patients who had experienced minor complications, such as wound infection or haematoma, took even longer 9.No study has looked specifically at return to driving, but return to normal activities took a median of 8 (range 5 20) days after standard GSV surgery 27. Bilateral surgery had no effect on return to work and physical activity 24, a finding supported by the present study. It has been suggested that, for the procedure to be cost effective, patients undergoing RFA must return to work 3 2 days earlier than those having conventional surgery 25. Reported median time to return to work after RFA ranges from 1 4 to 6 5 days 7,21,25 ; 81 per cent returned to normal activities within 1 day of RFA compared with 47 per cent of patients who had conventional surgery 21. One study found return to work and normal activities to be similar after EVLA and conventional surgery 17, whereas another reported an almost immediate return to normal activity after EVLA 18. Ravi and colleagues 28 noted that 95 per cent of patients undergoing EVLA resumed normal activity 2 days later. In a recent randomized trial, patients who had EVLA returned to work after a median of 4 days, compared with 17 days after standard surgery; it took a median of 2 days after EVLA and 7 days after surgery to return to normal activities 19.In a comparative trial, patients returned to normal activities a median of 2 days after UGFS, compared with 13 days after surgery 29. This questionnaire study showed that, when compared with conventional varicose vein surgery, UGFS was associated with significantly less pain and analgesia use, and time off work and driving. Ideally these observations should be confirmed in a controlled study. Acknowledgements The authors thank Mr M. X. Gannon, Mr J. M. Scriven and Mr A. B. M. Wilmink for allowing access to their patients undergoing surgery. The authors declare no conflict of interest. References 1 Smith JJ, Garratt AM, Guest M, Greenhalgh RM, Davies AH. Evaluating and improving health-related quality of life in patients with varicose veins. JVascSurg1999; 30: MacKenzie RK, Paisley A, Allan PL, Lee AJ, Ruckley CV, Bradbury AW. The effect of long saphenous vein stripping on quality of life. JVascSurg2002; 35: MacKenzie RK, Lee AJ, Paisley A, Burns P, Allan PL, Ruckley CV et al. Patient, operative, and surgeon factors that influence the effect of superficial venous surgery on disease-specific quality of life. 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