|Mr Michael Gough and Rosie Beale, Leeds General Infirmary, UK, have presented data comparing endovenous laser treatment (EVLT), a minimally invasive out-patient technique to the current standard of surgery for varicose veins in a randomised controlled trial in patients with saphenofemoral and long saphenous vein incompetence (>90% occlusion).
Gough told Vascular News that the advantages of EVLT are that it avoids the need for general anaesthetic, leaves no scars, carries a lower risk of complications, has a faster recovery time and is potentially less expensive - both directly and indirectly. Assessment of patient suitability for EVLT requires ultrasound confirmation of the sites of venous incompetence. Not all patients with varicose veins caused by saphenofemoral/ saphenopopliteal incompetence are suitable for EVLT. Although uncommon, a very tortuous greater or super saphenous vein may be a relative contra-indication owing to difficulties in advancing the guide-wire. Nevertheless, around 71% of patient with primary varicose veins are suitable for EVLT. Beale presented results of the study so far, covering 96 limbs in 81 patients: 41 female, 40 male, with a median age of 49 years. All subjects had similar classifications of disease and maximum long saphenous vein diameters.
Patients received one of EVLT-1 (810nm diode laser, 12 watts pulsed laser), EVLT-2 (14 watts continuous laser) or surgery to treat their varicose veins. Prior to treatment their veins were assessed using the Aberdeen Varicose Vein Score - AVVS and duplex ultrasound. Subjects kept an analgesic diary for one week following treatment and also recorded analogue pain scores. Six weeks post treatment they received sclerotherapy, followed by another AVVS and duplex ultrasound session at three months. The principal outcome measures were abolition of saphenofemoral/long saphenous vein incompetence and symptomatic improvement (as measured by the AVVS).
Ultrasound findings for the saphenofemoral junction at three months showed that all 21 limbs that underwent EVLT-2 had competent veins, said Beale. This compared to around 98% of the 26 that received surgery and 81% of the 34 that had EVLT-2. In the long saphenous vein the findings were more alike, with both laser treatments succeeding in more than 90% of limbs, while surgery's success rate was around 88%. All groups experienced a significant improvement in AVVS: EVLT-1 went from 13.17 pre-treatment down to 5.61 post-treatment; EVLT-2 went from 11.55 to 3.94; and surgery, from 14.31 to 5.80, but there were no inter-group differences, Beale added. While analgesia use and pain scores were similar across the three groups, there was one area where both types of laser treatment scored highly: return to normal activity and work. Patients, on average, went back to work a mere four days after receiving laser treatment, while patients recovering from surgery took an average of 14 days to return to normal activity and a total of 17 days to return to work.
However, in a third of cases, laser treatment is not enough on its own. Thirty-seven percent of cases required delayed sclerotherapy (1-2 treatments) to achieve satisfactory cosmesis. "Sclerotherapy has to be built into treatment for EVLT," Beale commented. In terms of complications, eight (12%) of the subjects who received EVLT developed phlebitis, while two (3.8%) had nerve injury. In surgery, two (6.7%) subjects had wound problems while four (15%) developed nerve injury and one developed acute respiratory distress.
"In summary," said Beale, "EVLT shows a comparable abolition of long saphenous vein reflux and symptom control in all groups. There is a shorter recovery time following EVLT." Gough added, "EVLT-1 and -2 had similar results and so either can be used. We have opted for EVLT-1 as it is easier and more accurate to administer the correct laser dose... Longer term follow- up is obviously needed to prove conclusively that EVLT is as good (it will probably be better) as surgery." He concluded: "The randomised trial is still ongoing although it is unlikely that many more patients will be recruited - most patients prefer EVLT to surgery and are thus not very willing to be randomised. We will stop at 120 patients, which we have already reached but some are still awaiting their follow-up."