Ten-year follow-up of a randomised controlled trial (RCT) has shown no clear long-term advantage of endovenous laser ablation (EVLA) with a 980nm wavelength and bare-tip fibre over high ligation and stripping of the great saphenous vein (GSV) under local tumescent anaesthesia.
Writing in the May 2022 edition of the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL), Céline A M Eggen (Skin and Vein Clinic Oosterwal, Alkmaar, The Netherlands) et al explain that this was a single-centre, prospective RCT with a follow-up time of 10 years.
The researchers note that patients with GSV incompetence were randomised to undergo saphenofemoral ligation and stripping or EVLA under tumescent anaesthesia. The primary outcome, they detail, was recurrence of groin-related varicose veins seen on duplex ultrasound imaging and clinical examination. Secondary outcomes were changes or improvement in CEAP (Clinical-Etiology-Anatomy-Pathophysiology) class, venous symptoms, cosmetic results, quality of life, reinterventions, and complications.
Between June 2007 and December 2008, Eggen and colleagues included 122 patients (130 limbs) in the study; of these, 68 limbs were treated with ligation and stripping and 62 limbs with EVLA.
The authors report in JVS-VL that 10-year estimated freedom from groin recurrence as seen on duplex ultrasound imaging was higher in the ligation and stripping group (73% vs. 44% in the EVLA group; p=0.002), and that they saw the same trend for clinically evident recurrence (77% vs. 58%, respectively; p=0.034).
In terms of reinterventions, Eggen et al reveal that nine (17%) were deemed necessary in the ligation and stripping group vs. 18 (36%) in the EVLA group (p=0.059). They specify that all reinterventions in the ligation and stripping group consisted of foam sclerotherapy, and that reinterventions in the EVLA group included foam sclerotherapy (n=5), crossectomy (n=2), and endovenous procedure (n=11).
Furthermore, they outline that there were no significant differences in quality of life and relief of venous symptoms between the two groups.
Finally, the authors relay that cosmetic appearance improved, with a better cosmetic rating in the ligation and stripping group compared with the EVLA group (p=0.026) and that one patient in the ligation and stripping group had a persisting neurosensory deficit remaining at 10 years.
The follow-up time of 10 years is a “major strength” of this study, the authors remark in the discussion of their findings, adding that this study is the first with a 10-year follow-up comparing ligation and stripping with EVLA, to their knowledge. Another strength of the study, they note, is its randomised controlled prospective design.
Eggen and colleagues also recognised some limitations of their study, including the fact that it was performed right after the introduction of EVLA in their clinic. This, they elaborate, meant that the device used and performance technique were still in their infancy, in contrast with the ligation and stripping procedure, which the surgeons had performed routinely for many years.
They also note that, after 10 years, 21% of patients were lost to follow-up, and that the statistical power of the study was not met, because further inclusion was halted because of post-treatment pain after EVLA in the one-year interim analysis. Therefore, the authors advise that “these results must be interpreted with caution”.
In their conclusion Eggen et al stress that the significantly higher rate of recurrences after EVLA will remain a matter of further investigation, considering its minimal invasive character, the current experience, and better endovenous treatment modalities.