Comment to: Six-year follow-up of endovenous laser ablation for great saphenous vein incompetence by Spreafico G, Piccioli A, Bernardi E, Giraldi E, Pavei P, Borgoni R, Ferrini M, Baccaglini U. J Vasc Surg 2013;1:20-5.

Stefano Ricci and Fedor Lurie

Abstract

A prospective cohort study to assess the efficacy of endovenous laser ablation (EVLA) for treatment of great saphenous vein (GSV) insufficiency over a 6-year follow-up period was conducted at the Multidisciplinary Centre of Outpatient Surgery - University Hospital, Padua (Italy). Patients were recruited between January 2003 and July 2004, and the follow-up phase lasted until July 2010.
Two hundred and four patients underwent EVLA procedure at the outpatient surgery unit. A 980-nm diode laser and tumescent echo color doppler (ECD) guided perivenous anesthesia were used. The most prominent varices were treated with stab-vein avulsion immediately after the EVLA procedure. All patients had to wear 35-mm Hg elastic compression stockings for 24 h daily during the first week after EVLA, and then switch to second-class graduated elastic compression stockings for 4 weeks more. Patients were scheduled for clinical and ECD assessments at 3, 7, 30, and 90 days after EVLA; and thereafter once a year, for 6 years. The main outcome of the study was the incidence of clinical (e.g., lack of improvement or worsening of leg symptoms) and ECD-confirmed (e.g., finding of measurable venous reflux in the treated segment) EVLA failures (ECEFs) during the planned 6-year follow-up period.
The ECEFs were categorized as type 1 (venous reflux limited to the junction and/or the residual saphenous stump, for a maximum length of 5 cm from the junction, without reflux in its collaterals); type 2 (reflux also in a collateral vein without clinically evident recurrent varices ); or type 3 (same as 2 with clinically evident recurrent varices, either symptomatic or asymptomatic). One hundred and twenty four patients (60.8%) underwent stab-vein avulsion as well; and 65 patients (32.8%) with residual varicose veins received sclerotherapy within 12 weeks from the procedure. Fourteen (6.8%) out of 204 patients were lost for follow up. No deep vein thrombosis was detected during the follow-up period.
After 6 years, 168 (88.4%) patients reported a symptomatic improvement; of them, 87 patients had no residual symptoms, and 81 experienced a significant reduction of their leg complaints. Fourteen patients complained of persistent symptoms, six reported unsatisfactory aesthetic results, and two patients had worsened skin alterations. Of these 22 patients, only two had an ECEF as well.
Patients with a competent saphenous junction and a persistently occluded saphenous trunk were 70.0% (133/190); therefore, 57 (30.0%) had an ECEF. Of them, 20 patients had a type 1 ECEF, 18 had a type 2 ECEF [three of which were at the anterior accessory saphenous vein (ASSV)], and 19 had a type 3 ECEF (12 of which were at the ASSV). An atypical junction or one with a diameter ≥8 mm and a mean trunk diameter ≥8 mm, were highly significantly associated with ECEF.
Expected EVLA results, either from a clinical or technical (ECD) perspective, were obtained in 88.4% and 70.0% patients, respectively, and persisted throughout the 6-year follow-up period. All failures were observed within the first 2 years from EVLA.
The unexpectedly high (57/190; 30.0%) rate of ECEF is possibly due to the systematic application of the Valsalva maneuver during ECD; this probably accounts for the high rate of type 1 ECEF. It is likely that most of the technical failures observed will soon be eliminated thanks to the use of adequate linear endovenous energy density (LEED) (at least 70 joules/cm), which was not in use in the period studied, and to the latest implements now available.

Invited commentary by Fedor Lurie

The reflux in the remaining proximal segment of the great saphenous vein (GSV) occurs more frequently than previously thought, and progresses mostly during the first year, and exclusively within 2 years after treatment.
The relationships between clinical outcomes and the ultrasound findings after thermal ablation of the GSV are rather complex. Only two of the 22 patients with clinical failure also had endovenous laser ablation failure confirmed by duplex ultrasound. Conversely, only half of the patients with progressive reflux developed symptoms. How much of this failure is due to the non-venous nature of patients’ symptoms remains unknown. Interestingly, the majority of clinically relevant recurrences was associated with reflux in the previously competent anterior accessory saphenous vein (AASV).
Authors used a prophylactic dose of low-molecular-weight heparin in 44 patients. Surprisingly, the only two cases of endovenous heat-induced thrombosis (EHIT) (both type 2) occurred in patients who received this prophylaxis.

Comment by Stefano Ricci

My compliments to the Authors for their compelling and well developed study showing long-term results of EVLA treatment.
Interestingly, final data (although filtered through specific variables and anatomical conditions) appear proximal to the results obtained with most other techniques in use for treating great saphenous vein (GSV) incompetence, though being less expensive. This is in contrast with some 100% good results claimed when EVLA was firstly adopted.
The caliber of the GSV, either at the junction or at the trunk, seems to affect the outcome; for this reason, it is a pity that Authors did not report detailed data concerning GSV calibers, especially in ECEF cases.
As regards the anterior accessory saphenous vein (AASV), it seems that out of 37 cases of failure (ECEF 2+3), 15 patients (i.e. nearly 50%) had AASV involved, although these veins were competent at the pre-operative echo color Doppler (ECD) evaluation. In fact, if laser action at the junction involves the competent terminal valve of AASV, it is likely that this vein, if supported by a sufficient antegrade flow, will re-canalize at the junction, though without a more specific terminal valve competence. Probably, when an AASV is found pre-operatively, the laser action should avoid the entire confluence of the superficial inguinal veins region to save the AASV valve. The same could be possible in presence of a Giacomini vein.

Authors' reply (G. Spreafico and P. Pavei)

The first comment by S. Ricci deals with EVLA efficacy. This paper reports data of our early experience with EVLA, between 2003-2004, and results are therefore to be considered as a sort of historical benchmark.
Now, ten years later, thanks to higher delivered energy and new devices, i.e. 1470 nm LASER and radial fibers, re-canalized trunks are very rare, reflux on the AASV is decreased to 3.7% and isolated reflux of the junction or of the stump is about 4.9%. These are unpublished data on 174 consecutive patients recruited between 2008-2009, who underwent EVLA procedure by 1470 nm LASER and radial fiber with a mean 3 years follow up.
These results are definitely better with a percentage of good technical results of 88.4%, essentially comparable with the good clinical outcomes obtained in the published study and verified with the same very careful ECD exam.
Unfortunately, to my knowledge, in literature there are not similar available long term prospective studies about the other therapeutic options to face with. The mean caliper of the treated trunks of the 190 patients who completed the 6 years follow up, measured with the patient standing, was 7.1 mm (DS 1.2, range 6-12) and the mean caliper measured 2 cm below the sapheno-femoral junction was 8.8 mm (DS 2.3, range 6-16).
The multiple logistic regression analysis showed that diameters of the saphenous trunk or 2 cm below the junction major than 8 mm, were statistically significative risk factors for ECEF.
As regard the anterior accessory saphenous vein (AASV–ASSV is a misprint), I totally agree with S. Ricci and it should always be tested.
When the patients of the study were treated, we used to place the tip of the fiber 2 cm below the junction or below a big competent saphenous branch.

[TOP]