JOURNAL OF VASCULAR SURGERY

Volume 53, Number 16S

instrument, such as the SF-36, and one of the diseasespecific QOL instruments (eg, VEINES, CIVIQ, Aberdeen) should both be used for this purpose.

Cosmetic results. Assessment of recurrent or residual varicose veins continues to be a challenge, and there are significant differences between physician assessments and patient-reported results. Patient satisfaction is directly related to the disappearance of the treated unsightly varicose veins. Photographing the treated areas is encouraged to assess late results on varicose vein recurrence and the status of skin changes. The Recurrent Varicose Veins After Surgery (REVAS) classification125 is a descriptive evaluation of recurrent and residual varicosities based on the physician’s assessment, and we suggest its use, although further modification of the assessment is warranted.

Surrogate outcomes

Surrogate outcomes assess specific technical questions about a particular therapy. Surrogate outcomes may include patency of the ablated saphenous or perforating vein, patency of a venous stent, or hemodynamic results after interventions. These should be used with care when evaluating the clinical benefit of an intervention.124

Anatomic success. Patency of an ablated vein and the length of the patent or obstructed segment of the vein, as confirmed with duplex scanning, should be reported when assessing anatomic success. Postprocedural duplex scanning 1 month, at 1 year, at 1 to 3 years, and 3 years is important to define periprocedural, early, midterm, and late failures. Timing of the study is important because saphenous patency after ablation on a periprocedural duplex image ( 3 days) indicates technical failure, whereas late patency after early occlusion suggests recanalization. The type of recurrence on late duplex scanning should also be documented, because recanalization of a previously occluded axial vein should be distinguished from neovascularization, which implies the presence of multiple small tortuous connections between the saphenous stump or the femoral vein and a residual saphenous vein or its tributaries.124

Hemodynamic success. The presence or absence of recurrent reflux in treated incompetent veins should be documented by duplex scanning, because this represents technical failure or success of the procedure.126 Changes in venous hemodynamics of the limb can also be documented by changes in plethysmographic findings before and after therapy; hemodynamic results frequently correlate with clinical outcome.95,127

Safety

The safety of any procedure used for treatment of varicose veins or more advanced CVD needs to be established, and the procedurally related early adverse effects ( 30 days) and late complications should be documented. Table V defines minor and major complications for reporting purposes.124

Gloviczki et al 17S

Table V. Definition of complications

Minor complications

No therapy, no consequence

Nominal therapy, no consequence; includes overnight admission for observation only

Major complications

Requires therapy, minor hospitalization ( 48 h)

Requires major therapy, unplanned increase in level of care, prolonged hospitalization ( 48 h)

Permanent adverse sequelae Death

Adapted from Kundu et al.124 Used with permission.

TREATMENT

Indications

Most patients who seek treatment for varicose veins have symptoms of aching, throbbing, feeling of a heavy leg, fatigue, cramps, pruritus, restless leg, ankle swelling, and tenderness or pain along bulging varicose veins. Some will have history of thrombophlebitis or bleeding from superficial varicose veins or have signs of more advanced CVD, such as edema, skin changes, including lipodermatosclerosis, eczema, pigmentation, atrophie blanche, corona phlebectatica, and healed or active ulceration. Less frequently, the veins are of cosmetic concern only.

Medical treatment

Venoactive drugs have been available for treatment of symptoms of varicose veins and more advanced forms of CVD for decades, and they have also been used to decrease ankle swelling and accelerate ulcer healing.128 Many compounds have been tried with varying success, but the most promising drugs include saponins, such as the horse chestnut seed extract (aescin)129; gamma-benzopyrenes (flavonoids), such as rutosides, diosmin, and hesperidin; the micronized purified flavonoid fraction (MPFF),130 and other plant extracts such as French maritime pine bark extract. Synthetic products include calcium dobesilate, naftazone, and benzarone.131

The principle for the use of venoactive drugs has been to improve venous tone and capillary permeability, although a precise mechanism of action of most of these drugs is unknown. Flavonoids appear to affect leukocytes and the endothelium by modifying the degree of inflammation and reducing edema.56

A recent Cochrane review of 110 publications selected 44 well-documented studies for analysis.132 The metaanalysis found that there appeared to be an effect on edema and on restless leg syndrome. Diosmin, hesperidin, and MPFF have been the most effective venoactive drugs. Calcium dobesilate reduced cramps and restless legs. Diosmin and hesperidin helped healing of trophic skin changes and were useful in treatment of cramps and swelling. Rutosides decreased venous edema. This meta-analysis, however, concluded that there is insufficient evidence to support the global use of venoactive drugs in the treatment of CVD.132