Safety Measures In Microfoam Sclerotherapy

The Closed-door Maneuver

The most feared complications of sclerotherapy are intraarterial injection and deep vein thrombosis. The use of color duplex ultrasonography helps to avoid intraarterial injection, and injection of the Great Saphenous at the thigh rules out a possible injection of the femoral artery. At other sites, the use of ultrasound-guided injection and the excellent reports on this issue have reduced the incidence of this complication, although the clinician must always be alert to this danger. Routine is a poor companion in sclerotherapy.

In the sclerotherapy of varicose trunk veins, deep vein thrombosis usually is produced by a coagulation disorder in the patient or by an error in the administration technique (see Figure 22.6). The most frequent site for this complication is in leg muscle veins. However, in our experience treating over 10,000 Great Saphenous veins with microfoam sclero-therapy, we have observed no occlusion of the common femoral vein. Its high flow dilutes the sclerosant and reduces the impact of failures of technique, such as the injection of high concentrations or excessive volumes of microfoam for the size of vessel treated. Nevertheless, at the start of our experience, when the technique was not fully developed, we performed slow injections, letting the microfoam pass through the Great Saphenous vein without taking advantage of the mechanical action of the pneumatic piston. At that time, we observed several thromboses in the common femoral caused by bubbles that floated on the blood with the patient in supine position. These passed to the femoral vein in "Indian file" still loaded with sclerosant, contacting its upper epithelial wall. The limited extent of this thrombosis and its subocclusive nature ensured its rapid lysis in the very few patients with this complication.

The potentially most controversial points in sclerotherapy of the saphenous reflux are perforating veins with direct connection to the DVS: femoral, popliteal, and medial gastrocnemius veins (see Figure 22.7).

The very common type of reinjection carries a high risk of extending the thrombosis of the varicose vein to a more

FIGURE 22.5 Patient after a few days of treatment with the compression device. The positional stability on thigh was good but the compression intensity was inadequate.
FIGURE 22.7 Perforating veins to the femoral vein carry an increased risk of deep venous thrombosis, and the insertion of the cannula must be carefully controlled to avoid their direct injection.
FIGURE 22.6 A partially occlusive thrombosis of common femoral vein caused by an error in technique.
FIGURE 22.8 Passage of microbubbles to the femoral vein during injection of saphenous vein. This situation requires careful duplex monitoring and clearance of the foam particles by foot flexion and extension.
Elimination Varicose Veins

FIGURE 22.9 Perforating veins to the popliteal fossa must be treated while there is compression at the connection point to minimize the volume of foam drained into the deep venous system. Varicose vein leading to medial gastrocnemius vein. Nothing prevents the injected sclerosant from exerting its action a little beyond the desired segment.

FIGURE 22.9 Perforating veins to the popliteal fossa must be treated while there is compression at the connection point to minimize the volume of foam drained into the deep venous system. Varicose vein leading to medial gastrocnemius vein. Nothing prevents the injected sclerosant from exerting its action a little beyond the desired segment.

FIGURE 22.10 Color duplex ultrasonography is used to confirm that dorsal flexion of the foot closes the intramuscular venous segment.

or less extensive segment of the gastrocnemius vein, which would result in thrombosis of the deep venous system, with the possibility of it spreading proximally to popliteal and superficial femoral veins.

We take two precautionary measures to avoid this undesirable action. The first is a dual measure: a reduction in the concentration of sclerosant and a strict limitation of the injected volume to the capacity of the vein to be treated (see Figure 22.8). Injections that exceed this volume and concentrations greater than 0.37% are errors of technique.

The second measure is to close the gastrocnemius vein during and after the injection by taking advantage of the muscle function. We first confirm by ultrasound that these muscle veins are completely closed when the patient is standing and that they remain so while the muscle contraction caused by this position persists, with complete closure of the lumen. In supine position, active dorsal flexion of the foot produces a similar result. If the patient tires, closure by the muscles can be achieved by passive flexion, using the hand of clinician or assistant to exert dorsal pressure on the foot (see Figure 22.9). Active, voluntary contraction of the muscles is more effective, although many patients do not have this ability and must be taught it.

We routinely use dorsal flexion during the injection of any varicose leg vein, checking its effectiveness on ultrasound. If it is not effective, another technique is used (see Figure 22.10).

We also use these novel "closed door" maneuvers during the sclerosis of low perforating veins as a complementary

Foam Sclerosant
FIGURE 22.11 Voluminous and complex varicose veins before and after treatment.

measure to the exertion of pressure on the perforating vein itself with finger or ultrasound probe. We must be 100% sure that the sclerosant does not reach the deep venous system in an uncontrolled manner. This combination of safety measures that we have gradually developed and applied in our daily practice has led to a progressive reduction in any complications of this nature.

In our long experience, we have had 22 cases of deep venous thrombosis of leg muscle veins in more than 10,000 patients. In 10 patients, a coagulation disorder was the cause. After the use of these maneuvers we have not observed DVT of muscular veins.

The efficacy of sclerotherapy with microfoam is now beyond doubt. It achieves the elimination of all varicose veins in all patients, with no limitations on the extent, size, site, or morphology of the vessels that can be treated by this method.

The effective safety measures that we have introduced make it the therapeutic approach of choice when the anatomical and functional removal of large and complex pathological varices is indicated (see Figure 22.11).

LONG-TERM EVOLUTION— STABILITY OF OUTCOMES

Our final objective is to make these optimal outcomes stable over the long-term. The Achilles' heel of surgery is the high recurrence rate of varicose veins.18,19 This is a major limitation of the surgical approach along with the aggressive nature of surgery and its incomplete outcomes.

TABLE 22.1 Compression Requirements of Large Superficial Varicose Veins

Selective

Controllable (with capacity to occlude the vein) Stable pressure values and position on leg

TABLE 22.2 Measures to Insure Efficacy and Safety

Previous proximal sclerosis Appropriate concentration of sclerosant Precise injected volume Closed-door maneuver

Selective compression of dilated superficial varicose veins

TABLE 22.3 Treatment Strategy

1° Elimination of existing varicose veins

2° Elimination of varicose heritage

One-year active follow-up equals stable outcomes

TABLE 22.4 Future Perspectives

Pharmaceutical grade microfoam Standard technique

We must warn you that varicose veins often can reappear in legs that were treated only a few months earlier, even when all varicose veins were successfully removed. These recurrences seem to be caused by the development of varicose veins that were not visible at the time of treatment but were nevertheless part of the varicose heritage of the patient. These incompetent veins take the place of those that are removed, maintaining hemodynamic continuity to the end-vessels in leg muscles and ensuring their progression.

Besides sclerotherapy with microfoam, we know of no therapeutic procedure that can remove all types of varicose veins. However, the disappearance of all varicose veins from a given area does not mean that total success has been achieved. Final victory can be claimed only when we can be reasonably sure that we have also eliminated all veins that may constitute a source of recurrence. To this end, an exhaustive color duplex ultrasound study is made at the second treatment session (at 3 to 5 months) and we treat all varicose veins revealed in the leg. Newly formed varicose veins are also identified and treated during follow-up sessions at six, nine, and 12 months. This active follow-up approach achieves the progressive, systematic, and complete removal of varicose veins that could produce a recurrence and whose suppression is the key to long-term stability of outcomes. These goals cannot be attained by surgery or endoluminal techniques when used alone.

Varicose disease is considered an essentially progressive condition. Nevertheless, application of the correct treatment can markedly reduce the recurrence rate.

Our current working objectives are to continue to improve the technique, accelerating the treatment and making it more comfortable for the patient. The type of compression applied is of critical importance for comfort. Since we have observed no benefits from the application of a strong compression, we use high-quality stockings that exert moderate compression. These Mediven®plus stockings have been well accepted by patients.

The availability of a micronized, homogeneous, and reproducible foam of pharmaceutical grade is crucial, because it would allow us to develop a standard treatment protocol, allowing outcomes obtained by different groups to be compared.

References

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14. Wollmann JC. The history of sclerosing foams, Dermatologic Surgery. 2004. 30: 694-703.

15. Breu FX, Guggenbichler S. European consensus meeting on foam sclerotherapy, April, 4-6, 2003, Tegernsee, Germany, Dermatol Surg. 2004. 30: 709-717.

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