Recommended Reporting Standards for Endovenous Ablation for the Treatment of Venous Insufficiency: Joint Statement of the American Venous Forum and the Society of Interventional Radiology

Additional Anatomic and Physiologic Characterization of Venous Disease 

Potential candidates for EVA include patients with reflux in an incompetent GSV or small saphenous vein (SSV) or in a major tributary branch of the GSV or SSV such as the anterior thigh circumflex vein, posterior thigh circumflex vein, or anterior accessory GSV. Therefore, the presence of reflux in these veins is important to document using duplex ultrasound imaging, as pertaining to the CEAP A5 nonsaphenous category. Use of the nomenclature recommended by the International Union of Phlebology, the International Federation of Associations of Anatomists, and the Federative International Committee on Anatomical Terminology is expected (21, 22).

Variations to standard venous anatomy, when observed on the ultra-sound examination, should be reported. These include tortuosity of the target vein, duplications, atresia, the presence of anatomic venous variants, or variable termination of the SSV. The diameter of the GSV and SSV, ≤2 cm of the junction with the deep vein (common femoral or popliteal) and target vein (if not the GSV or SSV) should be measured. The patient position and site of treatment should be specified.

Although a combination of a directed physical examination and duplex ultrasound imaging (CEAP level II examination) is usually sufficient to characterize the anatomic and physiologic extent of lower extremity venous disease (23), diagnosis of chronic venous disorders can also be supported by direct or indirect physiologic tests (24, 25). When these tests are obtained, the results should be reported. Similarly, when a CEAP level III examination is performed using computed tomography or magnetic resonance imaging, the reason for their use should be specified, the results should be reported, and the specific criteria used for diagnosis of venous abnormalities should be indicated.

Terminology and Definitions 

Definitions of clinical signs and symptoms should comply with definitions presented in the revised CEAP classification (10).

Use of the nomenclature recommended by the International Union of Phlebology, the International Federation of Associations of Anato-mists, and the Federative International Committee on Anatomical Terminology is expected (21, 22). Specific recommendations include the terms great saphenous vein or GSV (instead of long saphenous vein, greater saphenous vein, or internal saphenous vein) and small saphenous vein or SSV (instead of short saphenous vein, lesser saphenous vein, or external saphenous vein).

The ultrasound criteria used to define reflux should be indicated; in current practice, most vascular laboratories consider the presence of venous flow reversal for >0.5 to 1.0 seconds with proximal compression, Valsalva maneuver, or distal compression and release to represent pathologic reflux (23, 26).

Pretreatment Preparation 

The aspects of pretreatment preparation that may influence EVA treatment outcomes are important to describe. This includes methods used to increase the distension of the lower extremity veins, such as pretreatment ambulation, patient positioning maneuvers, temperature adjustments to the procedure room, use of tourniquets, or pharmacologic maneuvers such as the administration of vasodilators. The method of marking and mapping the target vein(s) are also important to indicate.

Method of Vein Access, Intraprocedural Imaging, and Anesthesia 

The method of venous entry—percutaneous, surgical cutdown, or venotomy—should be stated. Imaging guidance for venous access, administration of anesthetic injections, and monitoring of other aspects of the procedure that is provided by ultrasound guidance, fluoroscopic guidance, or a combination should be reported. The type of access system (eg, micropuncture system vs larger needle) is important to report. The precise location of the percutaneous access site(s) is important to indicate as well as the reason for selection of this point (eg, absence of reflux, potential access difficulties below a certain point, and multiple large tributaries). Tumescent anesthesia is usually administered using a dilute local anesthetic to provide local anesthesia, protect surrounding tissues (including adjacent nerves and overlying skin) from the thermal injury, and mechanically collapse the vein to decrease the distance between the catheter-based heat source and the vein walls and thereby enable nonthrombotic ablation of the vein (3). The concentration, volume, and method of administration (ie, hand-injection or mechanical device) of local anesthetic drugs should therefore be described. The use of fluoroscopy or venography must be reported.

Method of Endovenous Ablation 

For thermal ablation techniques, the type of energy (endovenous laser or radiofrequency) along with the manufacturer of the device should be reported. The energy level (power in watts), time of energy deployment (seconds), mode of delivery (pulsed or continuous mode), and total amount of energy emitted must be reported. If a pulsed mode is used during endovenous laser ablation, the duration and frequency of the pulse should be noted.

For radiofrequency, temperature of the catheter–vein interface, size of the catheter (6F, 8F), catheter and generator model, rate of catheter pull-back in cm/min, and total treatment time should be reported.

For chemical ablation techniques, the concentration, type of sclerosant (including manufacturer), and volume of the sclerosing agent must be reported. If a foam solution is used, the foaming technique should be recorded.

The starting point, ending point, and total length of the ablated segment should be reported in a quantitative fashion (eg, from 1 cm below the saphenofemoral junction to 1 cm above the puncture site; total, 40 cm), and for GSV ablation in relation to groin tributaries (ie, below epigastric vein).

The type and timing of postprocedure care such as compression therapy should also be reported. The class and type of compression therapy and activity restrictions should be reported.

Adjunctive Procedures 

Adjunctive procedures such as sclerotherapy and stab phlebectomies are commonly used in patients undergoing EVA. Because of their influence on treatment outcomes, the use and timing of any adjunctive procedures used at the time of EVA or before the initial outcomes assessment should be described. Administration of sclerosant solution through the vascular sheath encasing the laser or radiofrequency probe should be reported. The type of sclerosant, concentration, volume, and foaming technique for foam sclero-therapy should be noted. It should also be clear whether adjunctive procedures were intended as part of the initial treatment approach.

Clinical Outcomes Studies 

These studies are designed to assess the clinical efficacy and to verify the safety of EVA procedures and are expected to quantify the impact of therapy on clinical outcomes that are meaningful to patients, such as:

EVA may succeed in achieving all, some, or none of these goals; similarly, EVA may alleviate all, some, or none of the presenting symptoms. It is therefore important for authors to define the primary clinical intent of the procedure and to adjudicate success or failure by this criterion. The primary clinical intent must be a clinical outcome of importance to patients (eg, relief of the dominant presenting symptom) rather than an anatomic/ imaging outcome (eg, ultrasound-proven occlusion of the target vein). Other end points of interest may also be reported, such as the continued need for compression stockings and anti-inflammatory medications after EVA and the need for additional endovenous or surgical procedures.

Because causation of clinical outcomes is generally implied as related to treatment, anatomic and imaging outcome at the same follow-up points must be reported.

Technology Assessment Studies 

These studies are designed to answer specific technical questions about a new treatment modality before embarking on full-scale clinical outcomes studies. For such studies, it is acceptable to report an anatomic or imaging outcome (eg, successful ultrasound-proven ablation of the target vein) as the primary outcome, but the authors must limit their conclusions accordingly and no mention of clinical efficacy may be made unless a clinical outcome was systematically evaluated. Because the specific goals of therapy will vary among patients, investigators should report outcomes in as many of the following relevant categories as possible.

Assessment of Treatment Effectiveness 

Assessment of Treatment Effectiveness 

Assessment of Treatment Effectiveness—Cosmesis 

Successful treatment of venous reflux commonly leads to complete disappearance or marked reduction in the size and visibility of varicose veins. This effect of therapy often enhances patient satisfaction and may lead to improvements in both body image and social functioning, which are comparable with those of cosmetically directed interventions in other body areas. Quantification of these effects in future EVA studies is expected. In general, the use of validated measures of body image, social functioning, and patient satisfaction, such as have been used for other forms of cosmetic intervention, is recommended rather than the use of “home-made” scales. However, because such measures have not yet been validated for use in varicose vein populations, recommendations for reporting in this area cannot be firmly made at this time. It is hoped that future versions of this document will be able to provide greater guidance in this regard.

The assessment of recurrent symptomatic or asymptomatic varicosities remains controversial. Use of a validated classification, such as Recurrent Varicose Veins after Surgery (32) should be encouraged. However, a clear and reliable way to discriminate between persistent (residual) veins, “true recurrences,” and varicose veins developed as a result of disease progress remains subject to future investigation.

Assessment of Treatment Effectiveness—Anatomic/Imaging End Points 

EVA is believed to lead to improved clinical outcomes by eliminating flow in the target vein, enabling reduction in venous hypertension. To properly determine whether treatment failures are due to inability of the technology being evaluated to ablate the vein, use of suboptimal treatment parameters, or other factors, it is therefore important to know if successful ablation of the vein was actually achieved. Because EVA may lead to complete ablation or varying degrees of partial ablation of the vein, it is also important to report the extent of successful ablation. The exact anatomic result that correlates with improved long-term clinical outcomes has not been scientifically demonstrated. At present, however, anatomic success should be defined as successful ablation of the target vein, as demonstrated by complete lack of flow or disappearance of vein by duplex ultrasound imaging in the entire treated segment.

Reporting the length of patent GSV below the saphenofemoral junction after ablation, as measured on the post-procedure ultrasound scan, provides important information on the relation between the treatment starting point and the point of achieved ablation. This can be different for different modalities. There also may be a difference in long-term outcome in patients who have no patent GSV or a 1-cm stump compared with a patient with a 5-cm length of patent GSV.

If complete ablation has not been achieved, the anatomic extent of the open segment, presence or absence of reflux, and time of flow reappearance must be reported. Early failures (≤3 days from procedure) may indicate technical failures, whereas late failures can be result of recanalization.

In some patients, successful ablation of a target refluxing vein results in a reduction in size of other initially refluxing veins, with subsequent restoration of unidirectional flow. For this reason, it may be useful to report the presence or absence of reflux in other ultrasound-evaluable major lower extremity veins as well.

Although more studies are needed to more completely validate its utility, the Venous Segmental Disease Score (VSDS, Table 3) enables this information to be represented on a continuous scale with subsequent calculation of an overall “reflux score” (11, 28, 30).

Table 3. Venous Segmental Disease Score

	Reflux	Score	Obstruction	Score
	Small saphenous	½
	Great saphenous	1	Great saphenous (only if thrombosed from groin to below knee)	1
	Perforators, thigh	½
	Perforators, calf	1
	Calf veins, multiple	2	Calf veins, multiple	1
	Posterior tibial vein alone	1
	Popliteal vein	2	Popliteal vein	2
	Femoral vein	1	Femoral vein	1
	Profunda femoris vein	1	Profunda femoris vein	1
	Common femoral vein and above	1	Common femoral	2
	Iliac vein	1	Inferior vena cava	1
	Maximum reflux score	10	Maximum obstruction score	10

Uniform points for clinical and duplex ultrasound follow-up are highly desirable. The most common being within the first 3 days, at 1 month, 1 year after treatment, and annually thereafter. The performance of an early postprocedure ultrasound scan at some point ≤1 month after treatment is essential and must be reported. For assessment of short-term (<1 year), mid-term (1 to 3 years), or long-term (>3 years) outcomes, duplex results at the longest follow-up should also be reported.

Assessment of Treatment Effectiveness—Terminology and Definitions 

Reports of long-term results should use uniform terminology:

Assessment of Treatment Efficacy—Recommendations 

Authors must explicitly state whether the study is a technology assessment study or a clinical outcomes study.

For clinical outcomes studies, authors must report the proportion of patients for whom the primary clinical intent of EVA is symptom relief, venous ulcer healing, prevention of progression of chronic venous insufficiency, and improvement in cosmesis. Authors must adjudicate the overall clinical success or failure of EVA according to whether the primary clinical intent of the procedure was achieved and must report the proportion of patients in which this occurred.

Anatomic and imaging outcomes (eg, successful ultrasound-proven target vein ablation) may be used as the primary outcome for technology assessment studies but not for clinical outcomes studies. Additional reporting of the proportions of patients in whom symptom relief, ulcer healing, regression of chronic venous insufficiency, or cosmetic improvement was achieved, or a combination of these is highly recommended.

Assessment of Treatment Safety 

Performance of EVA may be associated with a number of early and late complications. Any invasive therapy can produce an infectious complication, and those that require conscious sedation carry risks of cardiorespira-tory compromise. If venography is used to guide therapy, allergic reactions or renal failure, defined as a ≥20% increase in serum creatinine level, may occur (33). Deep vein thrombosis (DVT) or pulmonary embolism, or both, occur with rare frequency in patients treated with EVA and must be reported along with anatomical location and extent of the thrombus (34). Other complications may include skin burns, paresthesias or other nerve injuries, and superficial thrombophlebitis in the treated vein or in a tributary (35).

All adverse events occurring during or ≤30 days after the EVA plus adjunctive procedures must be considered procedure-related. The SIR classification system for grading minor or major complications (Table 4) can be used when reporting results.

Table 4. Definition of Complications

	Minor complications
	No therapy, no consequence
	Nominal therapy, no consequence; includes overnight admission for observation only
	Major complications
	Require therapy, minor hospitalization (<48 hours)
	Require major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours)
	Permanent adverse sequelae
	Death

Assessment of Resource Utilization 

A rigorous analysis of EVA costs should include the cost of all procedures, devices, medications, and the inpatient treatment required; the cost of use of the procedure suite used; the costs of immediate and long-term complications and recovery time; and the costs of long-term monitoring and treatment (36, 37, 38).