Endovenous Laser Treatment of Saphenous Vein Reflux: Long-Term Results

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PURPOSE

To report long-term follow-up results of endovenous laser treatment for great saphenous vein (GSV) reflux caused by saphenofemoral junction (SFJ) incompetence.

MATERIALS AND METHODS

Four hundred ninety-nine GSVs in 423 subjects with varicose veins were treated over a 3-year period with 810-nm diode laser energy delivered percutaneously into the GSV via a 600-μ fiber. Tumescent anesthesia (100–200 mL of 0.2% lidocaine) was delivered perivenously under ultrasound (US) guidance. Patients were evaluated clinically and with duplex US at 1 week, 1 month, 3 months, 6 months, 1 year, and yearly thereafter to assess treatment efficacy and adverse reactions. Compression sclerotherapy was performed in nearly all patients at follow-up for treatment of associated tributary varicose veins and secondary telangiectasia.

RESULTS

Successful occlusion of the GSV, defined as absence of flow on color Doppler imaging, was noted in 490 of 499 GSVs (98.2%) after initial treatment. One hundred thirteen of 121 limbs (93.4%) followed for 2 years have remained closed, with the treated portions of the GSVs not visible on duplex imaging. Of note, all recurrences have occurred before 9 months, with the majority noted before 3 months. Bruising was noted in 24% of patients and tightness along the course of the treated vein was present in 90% of limbs. There have been no skin burns, paresthesias, or cases of deep vein thrombosis.

CONCLUSIONS

Long-term results available in 499 limbs treated with endovenous laser demonstrate a recurrence rate of less than 7% at 2-year follow-up. These results are comparable or superior to those reported for the other options available for treatment of GSV reflux, including surgery, US-guided sclerotherapy, and radiofrequency ablation. Endovenous laser appears to offer these benefits with lower rates of complication and avoidance of general anesthesia.

Section snippets

MATERIALS AND METHODS

This prospective, nonrandomized, consecutive-enrollment study included 423 patients who underwent endovenous laser treatment of incompetent GSV segments with 810-nm diode laser energy delivered intraluminally for treatment of primary varicose veins. The study protocol was approved by the Weill Medical College of Cornell University Institutional Review Board. All patients gave written informed consent before treatment.

RESULTS

Follow-up results ranging from 1 month to 39 months (mean, 17 months; SD, 11 months) were obtained in 499 of the 504 limbs treated with endovenous laser during the study period. Successful endovenous laser treatment, as defined earlier, was seen in 490 of 499 limbs (98%) at 1-month follow-up. Eight of nine GSVs requiring repeat endovenous laser were successfully closed with a second endovenous laser treatment. Continued closure of the treated GSV segments was noted at longitudinal follow-up at

DISCUSSION

Percutaneous methods for treating incompetent GSVs are not new. Duplex-guided sclerotherapy for treatment of GSV reflux has been attempted, but long-term studies have failed to prove durability comparable to surgery (15, 16, 17, 18, 19). Initial attempts at damaging vein walls by electrocoagulation involved creation of a thrombus within the vessel lumen, ultimately resulting in recanalization (20, 21, 22). Early methods of intraluminal delivery of high-frequency alternating-current

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    R.J.M. is a consultant to Diomed (Andover, MA), assisting in development of medical treatments and physician training. R.J.M. is coinventor and part owner of a patent on endovenous laser treatment of veins, for which he receives royalties. R.J.M. and Cornell Vascular have paid for all medical equipment used in procedures relating to this study. S.E.Z. is a paid consultant to Diomed, Inc. (Andover, MA), assisting in development of medical treatments. S.E.Z. is also paid to assist in physican training. S.E.Z. purchased all medical equipment he used in connection with this study. The other author has not identified a potential conflict of interest.

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