Management Of C4c6 Patients

For some authors,15,16 only patients who have chronic changes in the skin and subcutaneous tissues of the lower leg deserve to be referred to clinically as chronic venous insufficiency (CVI). This definition, also generally accepted, is used in this chapter, but in the updated CEAP1 C3 patients have been included in CVI.

CVI is an expression of severity in chronic venous disease, therefore management guidelines for CVI patients need to be stated both in terms of investigations and treatment.

Investigations

Besides clinical examination all C4-C6 patients must be investigated on level II as defined in the revision of the CEAP,1 which means mandatory DCS. In most cases, that allows documentation for the advanced CEAP classification. In other words, the physical signs, absence or presence of

*Axial reflux was defined as reflux in the Great Saphenous vein above and below the knee or in the femoral vein to the popliteal vein below the knee.

symptoms, etiology, and anatomic and physiopathologic abnormalities are all clearly identified. It is essential to know in every anatomical system—superficial, deep, and perforator—what veins are obstructed or refluxing and what etiology is identified: primary, secondary, congenital, or traumatic.

In patients with CVI we recommend complementing the CEAP classification by using the venous severity scoring system17—we know that in patients with C4-C6, the three scoring systems, venous clinical severity score (VCSS), venous segmental disease score (VSDS), and the venous disability score (VDS) are particularly useful. To fulfill the VSDS, complementary investigations are needed occasionally, such as venography, venous helical CT scan, magnetic resonance imaging, and so on, according to the venous disease type.

Quantifying the global CVI severity investigations such as ambulatory venous pressure (AVP) and APG may be useful.

Treatment Methods of Treatment

The various treatment methods will not be described in this chapter because they are detailed in others. They can basically be divided into two groups: conservative and invasive. The first includes compression, drugs, and physiotherapy; the second includes sclerotherapy, open surgery, and endovascular surgery. The main difference between the two is very important to keep in mind. Conservative treatment usually is prescribed regardless of the etiology, the anatomical and physiopathological anomaly.

On the contrary invasive treatments selectively take into account etiology, anatomic lesions, and physiopathologic disorders. Superficial venous reflux can be treated by sclero-therapy, open surgery, and endovascular surgery knowing that the different techniques can be combined.

For treating perforator insufficiency, three techniques are available: sclerotherapy, ligation by open surgery, and sub-fascial endoscopic perforator surgery (SEPS).

Deep venous surgery is supposed to treat obstruction or reflux. In primary etiology obstruction is not frequent and reflux common. For treating primary deep reflux, valvulo-plasty or valve transfer are the most common methods used.

Treatment Results

Since the information concerning the outcome of the various treatments is provided elsewhere in this volume, we will focus on patients C4-C6 with PVI.

Surprisingly very few studies give precise information both on the clinical class and etiology in this situation except for patient C5-C6. Only controlled randomized trials (RCTs) with few exceptions will be analyzed.

Compression

C4a (eczema, pigmentation). There are no RCTs. C4b (lipodermatosclerosis, atrophie blanche). One RCT18 has shown that stockings improve lipodermatosclerosis but C4b etiology is not detailed in this study. C5-C6 (healed ulcer, active ulcer). Many RCTs comparing different bandages are available but the results according to the etiology are not documented.

In two studies compression is compared to surgery.

In the first19 75 venous leg ulcers (VLU): 51 of primary etiology (47 isolated superficial venous insufficiency and 14 with a combination of superficial and deep vein reflux), 13 posthrombotic, and one congenital were randomized between minimally invasive surgical hemodynamic correction of reflux (CHIVA is the French acronym for this method) and compression. Healing was shorter in the CHIVA group (P < 0.02). At a mean follow-up of three years, the recurrence rate was lower in the CHIVA group (P < 0.05) and investigation parameters such as quality of life (QoL) were improved in the operated group. Because primary and secondary etiology were not evaluated separately, the extent of the reflux was not documented, and the number of patients was small.

In the second study,20 500 consecutive patients with VLU presenting superficial venous reflux and mixed superficial and deep reflux were randomized in two groups, either compression alone or in combination with superficial venous surgery. Deep venous reflux was assessed in three locations: common femoral or femoral veins, above knee popliteal vein, and below knee popliteal vein. When one or two of the three studied deep segments were refluxing, deep reflux was denominated segmental deep; when the three segments were involved it was classified as total deep.

Primary endpoints were 24-week healing rates and 12-month recurrence rates. Results were analyzed on an intention-to-treat basis. Overall healing rates were similar in both groups.

Results of subgroup analysis showed that the surgery and compression arm with isolated superficial reflux and mixed superficial and segmental deep reflux had lower 12-month recurrence rates (12% vs 26% and 9% vs 25%; P < 0.0001 and P = 0.04, respectively).

No significant difference in recurrence rate was seen in patients with mixed superficial reflux and total deep reflux (19% vs 31%; P = 0.42).

These results are in accordance with Adam's article.21 In a series of 39 VLU in which superficial and segmental deep reflux were combined, segmental deep reflux resolved in 19 of 39 (49%) limbs, and ulcer healing occurred in 30 of 39 (77%) limbs at 12 months after isolated superficial venous surgery.

Although these studies did not differentiate primary from secondary etiology, their results provide major information that will be very helpful for recommending indications for treatment PVI in C4-C6 patients.

Sclerotherapy

There are no RCTs comparing sclerotherapy versus other treatment in PVI C4-C6 patients.

Open Surgery

Superficial Venous Surgery

In the two RCTs studies previously reported surgery plus compression versus compression alone in C5-C6 patients, only superficial venous surgery was used. In the first one19 it was the CHIVA technique, that is, high ligation + disconnection of the tributaries from the saphenous trunk. In the second,20 the procedures were isolated saphenofemoral or saphenofemoral junction disconnection, or combination of junction disconnection, tributary stab avulsion, and saphe-nous trunk stripping (only for the great saphenous vein).

There are no RCTs for C4 patients comparing surgery to other treatment.

Perforator Surgery

Although SEPS largely has been used for treating C5-C6 patients whatever the etiology, there are no RCTs comparing results of superficial surgery versus superficial surgery + SEPS. In the North American Subfascial Endoscopic Surgery Perforator study22 (146 patients), SEPS was combined with superficial venous surgery in 103 patients (71%). Patients with primary valvular incompetence had one-year (limbs at risk 41) and two-year (limbs at risk 25) recurrence rates of 15% and 20%, respectively, compared to 47% after two years in those of secondary etiology.

Deep Venous Surgery

As obstruction is not very frequent in PVI, only reflux will be considered. There are no RCTs comparing either conservative treatment versus any kind of surgery including reconstructive surgery for correcting deep venous reflux. Outcomes of this surgery remain difficult to judge because PVI superficial, perforator, and deep reflux are frequently combined; when they are present and treated by surgery all of them are corrected.

Nevertheless in many series treated by deep venous reconstructive surgery conservative treatment or/and venous superficial surgery, perforator ligation had been used previously and were unsuccessful.

In the last large series reported,23 118 limbs with nonheal-ing ulcers (PVI C6) were treated by valvuloplasty. At two-year follow-up, 63.5% ulcers were healed.

In our series24 the ulcer recurrence free survival was 75% at five years (44 limbs) for PVI (C5-C6) and among the 24 limbs PVI (C4) no ulcer occurred after deep surgery.

Grossly deep valvuloplasty +/- previous or concomitant superficial venous surgery and perforator ligation is credited at five years with 70% good clinical (no ulcer recurrence) and hemodynamic results: competence of the valve(s) repaired.24

It is worth noting that in all series treated by valve repair, the deep reflux was an extended axial reflux graded 4 according to Kistner's classification.14

Endovenous Surgery

There is no outcome assessment concerning PVI C4-C6 patients.

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