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UGFS results in higher residual reflux at 12-month

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A clinical trial comparing open surgery and endovenous laser ablation (EVLA), ultrasound-guided foam sclerotherapy (UGFS) (with phlebectomies) on quality of life and the occlusion rate of the great saphenous vein (GSV) 12 months after surgery, has found that UGFS resulted in equivalent improvement in quality of life but significantly higher residual GSV reflux at 12-month follow-up.

The study, ‘Randomized clinical trial comparing surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy for the treatment of great saphenous varicose veins’, by the Finnish Venous Study Collaborators and published in the British Journal of Surgery, included 214 patients: 65 had surgery, 73 had EVLA and 76 had UGFS.

Patients included at the trial had symptomatic, uncomplicated varicose veins (Clinical Etiologic Anatomic Pathophysiologic (CEAP) class C2–C4) were examined at baseline, one month and one year. Before discharge and at one week, patients reported a pain score on a visual analogue scale. Preoperative and one-year assessments included duplex ultrasound imaging and the Aberdeen Varicose Vein Severity Score (AVVSS).

The inclusion criteria were unilateral symptomatic, uncomplicated varicose veins (CEAP clinical classification C2–C4), duplex ultrasound-verified reflux in the GSV, mean diameter of the GSV in the thigh 5-10 mm, and age 20-70 years. Duplex ultrasound imaging was done in standing position, and reflux was measured after pneumatic compression of the calf. Incompetence was defined as a reflux of more than 0.5s.

Outcomes

All 214 patients attended the one-month follow-up, and 206 (96·3 per cent) the one-year follow-up: 61 of 65 after surgery, all 73 patients who had EVLA and 72 of 76 who had UGFS. There were no significant differences in the basic demographics, CEAP clinical classification, AVVSS or GSV dimensions at baseline between the study groups.

The mean duration of treatment was 95 (19) (range 62–155) min in the surgery group and 83 (17) (range 50–139) min in the EVLA group (p<0.001). Twenty-six patients (34 per cent) in the UGFS group received two treatments; no patient required a third treatment. The sclerosants employed for the first treatment were: STS 3 per cent (64 patients), STS 1 per cent (6), polidocanol 3 per cent (4) and polidocanol 1 per cent (2). The mean volume of foam used in the GSV was 4.7(1.6) (range 2.0-9.0) ml. Some 33 per cent also had foam injected into varicose tributaries: mean volume 4·6 (range 2.0-12.0) ml. In the second treatment session, the mean volume of foam used in the GSV was 3.8 (2.0–10.0) ml.

At one year, the GSV was completely occluded or absent in 59 (97 per cent) of 61 patients after surgery, 71 (97 per cent) of 73 after EVLA and 37 (51 per cent) of 72 after UGFS. The GSV was partially occluded in two patients (3 per cent), none (0 per cent) and 21 patients (29 per cent) in the respective groups. The difference between UGFS and the two other treatments was significant (p<0·001). No patient in the surgery group and only two (3 per cent) in the EVLA group had a patent GSV after one year, compared with 14 (19 per cent) in the UGFS group.

Of the two patients with a patent GSV in the EVLA group at one year, one had a tiny but patent GSV with no reflux and the other had asymptomatic reflux in a very narrow GSV. On duplex imaging at one year, reflux was seen in the below-knee GSV in 13, 16 and 33 per cent of patients in the surgery, EVLA and UGFS groups respectively (p=0.008 for UGFS versus other two procedures). Reflux in another unnamed thigh vein was present in 8, 10 and 12 per cent respectively (p=0.471 between groups). When GSV patency rates were analysed according to size of the GSV before treatment, there was a clear correlation between larger diameter and GSV patency, but only in the UGFS group (Figure 1).

Figure 1: Patency of the great saphenous vein (GSV) at various diameters on duplex ultrasound imaging 1 year after a) surgery, b) endovenous laser ablation (EVLA) or c) ultrasound-guided foam sclerotherapy (UGFS)

At baseline, there were no significant differences in median AVVSS between the groups. At one year, median AVVSS was significantly improved in all groups and there were no significant differences between the groups.

Pain after treatment was significantly reduced (lower VAS score) after UGFS in comparison with the surgery and EVLA groups, both at the time of discharge, and after one week.

“Reflux in the GSV was extremely rare at 1 year after surgical stripping or EVLA; however, after UGFS, reflux was seen in half of the patients, and the GSV was patent and refluxing in one of five. Despite these differences, disease-specific quality of life was significantly better in all groups at 1 year compared with preoperative values, with no significant differences between the interventions,” the authors write, “…Although recurrent/residual GSV reflux was seen in every other patient treated with UGFS, quality of life remained better than before surgery. One-year follow-up may be too early to show the consequences of recurrent reflux.”

The Finnish Venous Study Collaborators were: VP Suominen (Tampere University Hospital), P Vikatmaa, P Aho, M Lepäntalo, K Halmesmäki, S Laukontaus, EM Weselius, S Vuorisalo (Helsinki University Hospital).

The article was edited from the original article, under the Creative Commons license.

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