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07. Introduction to the Phlebotherapy TRAP

Introduction to Three-dimensional Regenerative Ambulatory Phlebotherapy (TRAP)

Current treatments for varicose disease, the most common disease on earth, are not rational.  Varicose veins, venules and telangiectasias must not be excised, obliterated, ligated or burnt; they simply have to be treated.  Sclerotherapy, phlebectomy, saphenectomy, laser therapy, treatment with high-frequency current and functional ligature all damage the integrity of the venous circulation.  Moreover, they fail to achieve the patient's objectives: functional restoration of the circulation and the permanent disappearance of visible vessels. These traditional therapies –  sclerotherapy, phlebectomy, saphenectomy and laser therapy – act on the effect of the disease, not on its cause.  Removing or obliterating the effect without treating the anatomical cause of the varices cannot cure varicose disease.  Indeed, obliterating or removing dilated superficial veins, as the traditional methods do, simply means eliminating the “escape valve” of a haemodynamic hypertension that the traditional techniques are unable to cure.  Removing or obliterating this escape valve will merely generate further varicose veins and telangiectasias.  Obviously then, the patient is not cured.   In order to cure varicose veins, we must consider that varicose disease is caused by a congenital weakness of the venous wall, which involves all the veins of the perforating and superficial circulation. Thus, in order to cure varicose disease, the venous walls have to be treated.  This treatment must not be limited to a localised area.  A genuine cure for varicose disease must involve strengthening the walls of all the veins of the superficial and perforating circulation.  Only a three-dimensional treatment that extends to all the vessels of the superficial and perforating circulation in the three regions of the limb can be effective: visible vessels disappear from view; the legs no longer feel heavy; progression of the varicose disease is halted, and ulcers caused by stasis and haemodynamic hypertension heal within a few sessions.  In addition, all this is achieved without the complications caused by the traditional methods. TRAP is not a mechanistic treatment, but a biological one.  Mechanistic treatments are unsuited to biological matter. TRAP is based on simple, rational physiopathology and on a new concept.  A solution of sodium salicylate in a buffered hydroglycerine vehicle is used to regenerate the veins.  Sodium salicylate is an ancient and safe active principle.  This regenerative solution travels in the opposite direction to the formation of the varices.  The solution is injected into the dilated veins that are visible to the naked eye or through the new means of illumination and reflection and absorption that are now available, and into the capillary telangiectasias.  The solution spreads more easily through the most dilated vessels and exerts its therapeutic action on the endothelium of the non-visible perforating veins, which are the most frequent cause of varicose disease.  Indeed, dilation of the perforating veins is responsible for the formation both of the superficial varices that are visible to the naked eye and of those which are visible only by means of the new optical diagnostic techniques.  The walls of the “regenerated” veins are strengthened and their function is restored.  Regeneration means restoration of the structure and function.  Current phlebological treatments do not work because they do not address the true cause of varicose disease; they only treat the effect of the disease, while neglecting its anatomical cause, which is the dilation of some of the 200/300 perforating veins of the lower limb.  This dilation leads to valvular incontinence and haemodynamic hypertension in the superficial circulation.  Another reason why current phlebological treatments do not work is that they only treat small portions of the circulation. All the veins of the lower limbs are interconnected and the weakening of the vessel walls extends to the entire superficial, perforating and communicating circulation.  It therefore follows that the entire circulation must be treated.

Some concepts

• We do not treat the varices but the hemodynamic hypertension. 
• If we treat the haemodynamic hypertension, we also treat the increase in hydrostatic thrust (which causes stasis ulcers).
• The main causes of varicose disease are prolonged standing and congenital weakness of the walls of the superficial and perforating veins.
• TRAP treats the venous walls, thereby regenerating the veins of the superficial and perforating circulation.
• Regeneration means restoring the structure and function
• According to TRAP, ectatic veins must not be stripped out or obliterated, but simply treated.
• A large varix is not a local phenomenon; rather, it represents the point of greatest weakness of a three-dimensional system that extends to all three regions of the limb.
• It is obvious that stripping out or obliterating veins cannot cure varicose disease.
• The mechanistic approach, with all its haemodynamic studies, is clearly unsuited to the treatment of a complex biological apparatus which, precisely because it is biological, can easily be regenerated.  In this way, its native function is restored.
• A three-dimensional disease cannot be treated by two-dimensional methods
• The visible vessels are the gateways through which the regenerative solution reaches  the perforating and communicating veins
• The classical phlebological culture is not only unnecessary; in certain cases, it may hinder the proper execution of TRAP, owing to the errors that have been handed down from one generation to the next 
• Varicose disease must be looked at from the biological, not mechanistic, point of view
• The superficial veins disappear from view once we have corrected the incontinence of the perforating veins in all three of the regions into which the leg is divided.
• The saphenous vein is innocent. Many people are born without valves in the saphenous vein, and yet they do not develop varicose disease 
• The visible vessels are the gateways through which the regenerative solution reaches the perforating and communicating veins. 
• TRAP is able to cure venous disease of any severity
• TRAP is difficult to understand if one does not realize that there is no etiopathogenic difference between a large varix and a telangiectasia.
• Standing erect has caused the lower limbs to become a pump that is destined to work badly. For this pump to function properly, the veins absolutely must not be visible. Man can correct nature's imperfections

The technique

Three-dimensional Ambulatory Regenerative Phlebotherapy (TRAP) utilises a non-obliterative solution of 3% sodium salicylate in a buffered hydroglycerine vehicle. The solution is injected into all the “gateways” that are visible to the naked eye or by means of transillumination and the new optical means of near-infrared reflection and absorption.  These so-called gateways are reticular veins, truncal veins, perforating veins, venules and telangiectasias.  In practice, the regenerative solution flows in the opposite direction to that of the formation of varices and telangiectasias.  The operator must always bear in mind that even the smallest telangiectasia is the result of hemodynamic hypertension and, as such, must be injected.  

How much solution should be injected? About 50 ml. The regenerative solution should act upon the largest possible endothelial surface.  Thus, if the plunger of the syringe does not encounter resistance, a maximum of 10 ml of solution may be injected during each single injection.  By contrast, if resistance is felt, a small amount of solution will be injected. The solution enters the circulation of the superficial vessels and travels in depth through the most dilated vessels, strengthening their walls and reducing their calibre until continence is restored.  If the plunger of the syringe encounters little resistance, the quantity of solution injected must be sufficient to act upon the walls of the non-visible veins and the perforating and communicating veins and to reach the deep veins. If there is a large varix in a region of lower limb, this region must be treated after the other regions. You must consider the escape valves!  Elastic compression is very important in order to stabilize the result.

Discussion

In a complex circulation, such as that of the lower limbs, what better approach could there be than to administer treatment through the superficial vessels, so that it can spread in pyramid fashion throughout the miopragic circulation, thereby regenerating it? Naturally, this therapy must not only be three-dimensional; it must also be extended to the entire limb: i.e. to the superficial, perforating and communicating circulation in all three regions. If treatment is limited to an area where the veins are visible to the naked eye and does not involve the whole circulation, it will be inefficacious.  If hemodynamic hypertension is not eliminated in all three regions of the limb, the result will not be stable over time. All three regions are interconnected. The instability of a treatment that is limited to one area stems from the fact that the untreated hypertension in the other regions prevents the proper regeneration of the portion of the circulation that has been treated.

The lack of effectiveness of sclerotherapy and phlebectomy lies not only in the fact that they act on the effect and not on the anatomical cause of the disease, but also in the fact that they act upon a limited portion of the circulation and that this portion remains subject to the pressure exerted by the untreated regions.  Then again, we cannot obliterate or strip out all the veins; what we can do is treat them.  For these anatomical and hemodynamic reasons, Three-dimensional Regenerative Ambulatory Phlebotherapy treats one limb at a time; normally, the limb with the most evident disease is treated first.  The reason for this is that it is advisable to achieve valvular continence in the shortest possible time.  Indeed, no more than five weeks should elapse between one treatment session and the next. Furthermore, when the limb that displays the most evident disease is treated first, the result can, if necessary, be perfected when treatment of the contralateral limb is started. 

What does the regenerative solution do when it comes into contact with the endothelium? First, it causes a lesion of the venous wall; this is a perfectly calibrated lesion which stimulates endogenous currents.  This phase is followed by inflammation, which is a key event in the regenerative process.  The inflammatory cells, neutrophils and M1 macrophages already present in the ectatic venous wall are activated and very soon cleanse the tissue of necrotic cells.  By contrast, the M2 macrophages produce anti-inflammatory cytokines and activate the stem-cell component.  Sodium salicylate strongly inhibits COX-2 synthesis, thereby eliciting a potent stimulatory action on the stem cells and strengthening the connective framework; this latter action has recently been demonstrated. 

Conclusion

Now that we have seen some of the key concepts of TRAP, it is time to look at the treatment itself and the tricks of the trade which enable success to be achieved.  What does achieving success mean?  It means eliminating the sensation of heavy legs and healing any ulcers that may be present within a few sessions.  All the visible vessels must disappear from view, without complications and without too much discomfort for the patient; moreover, the result must be stable over time.  First of all, it must always be borne in mind that TRAP is a method of regenerating the venous walls; it is able to treat any pathology.  Moreover, TRAP is also able to prevent the onset of varicose disease – and prevention is always better than cure. When treating mild disease, TRAP plays both a curative and a preventive role. We must remember that we are using a sclerosing solution diluted to a non-obliterative concentration: a 3% solution of sodium salicylate which does not give rise to post-sclerotherapy pigmentation or ulcers. 

In sum, TRAP treats varicose disease in a holistic manner. In our view, focusing on the individual vein or varix is limiting. Indeed, we do not aim to treat the varices themselves, but to eliminate the haemodynamic hypertension in the limb; this is done by treating the walls of the veins of the superficial, perforating and communicating circulation. A large “escape valve” should not be injected during the first treatment sessions; it should be injected when the hypertension of the circulation has already been alleviated and the varix is less tense. Varicose disease should be regarded as a “disease”, or rather a dysfunction that is present in 100% of people. The lower limbs contain 80% of the blood in the body. As we get older, the capacity of the venous circulation increases, the velocity of circulation slows down and the lateral thrust is increased. The blood that stagnates reduces the oxygenation and trophism of our organs at a time of life when we have the greatest need. By reducing the capacity of the circulation, TRAP restores proper venous return. 

Reducing venous hypertension also has an impact on the arterial microcirculation, thereby eliciting beneficial effects on the circulation of the blood in the entire organism. Naturally, this benefit is also local. For example, even diabetic ulcers heal rapidly, though they require more treatment sessions than ulcers due to hydrostatic thrust, which can be cured in two sessions.

Capurro S. (2014): Introduction to the course of Phlebotherapy (TRAP).CRPUB Medical Video Journal. Phlebotherapy section. http://www.crpub.org