Results of treatment of the edematous

Transcription

1 -- International Journal of Cosmetic Medicine & Surgery Results of treatment of the edematous fibrosclerotic panniculopathy grades in 50 patients with the Novashape device for selective fat uitracavitation DR JUAN PEDRO LAPUENTE FERNANDEZ Bachelor in Medicine and Surgery. Bachelor in Physiotherapy. Medical Director of the Phisia Center in Zaragoza. Medical Director of the Institute of Physical Medicine and Aesthetic Medicine Summary The purpose of the following trial is to verify the level of efficacy of the treatment of the edematous fibrosclerotic panniculopathy grades 11and III with the technique of dynamic resonance cavitation applied by the Novashape device. Fifty patients (46 women and 4 men) were treated with a protocol covering 6 weekly sessions lasting 50 minutes each. Treatment is administered to the abdomen and peritrochanter areas in women and the abdomen exclusively in men. The statistical analysis of the results shows a statistically significant reduction of the fat mass measured by impedance and the fat thickness measured by ultrasound. In addition, there were statistically significant reductions in the perimetric and volumetric measures. Physical and physiological basis For years there has been a search for a way to selectively destroy the fat cells avoiding surgery. Although in the surface, fat aspiration is a minimally invasive surgery, the truth says otherwise, as it is a highly destructive surgery performed through a very small hole. All the researches performed have been based on the use of ultrasound and, specifically, the attempt to selectively generate one of the direct effects, known as.cavitation" in the fat tissue. Nonetheless, to this date nobody had found the efficient frequency to achieve this cavitation effect at the expected depth and also, only affecting the fat tissue. All the ultrasound devices emit at a low frequency, as it depends exclusively on the nature and processing of the piezoelectric material used to manufacture the transducer. Typically, the ultrasound waves propagate in two forms: transversal or longitudinal. In the second, the wave propagates in the same direction in the zones of compression and depression. In the transversal form, the waves propagate in direction: orthogonal (in straight angles) to the direction of the zones of compression and depression. The traditional ultrasound devices emit waves propagating in both directions. In this sense, Novashape is not a conventional device, as it is able to emit ultrasound within a frequency band and it is not a concrete frequency. Also, it emits waves exclusively in longitudinal direction, generating, constantly and in a single direction, the compression-depression phenomena, although the compression phenomena, due to the emission frequency, predominate over those of depression. This is decisive to perform the cavitation exclusively in the fat tissue. Rememberthat the fat density is 0.92 x 103 kg/m~, leading to a transmission of the device waves at a rate of 1480 m/sec. (Table 1). Table 1 Muscle Dermis Blood Superficial fat Deep fat

2 Also, due to the lower acoustic impedance of the fat, the power that Novashape provides will be absorbed selectively by the fat tissue. The sound power that Novashape emits must be mainly absorbed by the fat tissue, because it is the retention capability of acoustic power of the medium exposed to radiation, which is mostly converted into heat due to the friction between particles. This effect is directly responsible for two physiological effects: Hyperemia in the capillary and pre-capillary zones by arterial vasodilation that, in part, can be attributed to the excitation of the vascular nervous plexus. Enhancement of the intercellular metabolism due to the increase in the permeability of the cell membrane..:. result, formation of free radicals and nitrites. Figure 1 waves within a liquid element. In fact, this phenomenon is due to the disintegration of the particlesof a liquid,with the liquid evaporating for the action of the pressures that the ultrasound beam exerts. The energy reaches such a concentration that may lead to the deaggregation of fixed or macromolecular cell complexes. The following sequence of images shows this; the liquefactionof the triglycerides contained in the adipocytes due to emulsification or the physical rupture of the molecules can be seen. The cavitation appears when pressure oscillations are introduced in the liquid. If the minimal pressure reaches the steam pressure of the liquid, the bubbles grow, collapsing with new elevations of the pressure. Under certain conditions, the collapse of the bubbles is implosive and the effects of the compression on their internal gases can cause peaks of temperatures and internal pressures of around 104 K and 103 atmospheres, respectively (Figures 1 and 2). The cavitation also exerts other two effects: Mechanical movement in the cell complexes inside to cells. This o IIU lvu~ UOIVI v IIII""IU~IUII ble The fat cells are destroyed sequentially. The first suffering the effects of the cavitation are the adipocytes whose wall have more tension, that it, the highest degree of "inflammation"for which the treatment may be very selective and efficient. The following figures offer the microscopic verification of the effect of the cavitation that Novashape device generated. phenomenon caused by the impact of sonic

3 )' The images taken at the beginning and during treatment support the evaluation of the efficiency of the Novashape device, as well as its harmlessness with regard to possible damage to subjacent tissues (Figures 3-10). Figure 3. Human fat tissue of the abdominal zone before beginning the cavitation process , '. --.'~. ""\m-t'-'~t,,. Figure 4: Beginning of the bubble generation on one side of the fibrous septi and the large adipocytes. The sample was taken 20 seconds following the beginning of the cavitation treatment. urinary density increased 615 points 3 hours after the administration of treatment The emulsified fats willbe removed by lymphatic and venous via, as the cavitation causes physical changes and makes them water-soluble so finally they are excreted in the urine. In fact, in this trial, the mean implosions, begins the destruction of the fat cells (red arrow). Figure 5: Increase in the number and size of the bubbles, approximately40 seconds after beginningthe treatment.

4 "" ' ~'i ~~i,,,,..r>~ " Figure 6: One minute after beginning treatment, an exponential increase is seen in the number of bubbles and the formation of a serous liquid can be seen on the left upper angle of the image (blue arrow), resulting from the emulsification of the fat. Figure 9: The selectivity of the treatment can be seen with the contrast of the zones of adipocyte with blood capillaries totally intact. ~.r ~ ~..~ _. }. I; "!f< ( Figure 7: Two minutes after the initiation of the treatment, for confluence of a large number of Figure 10: Four minutes after beginning treatment, the emulsification and rupture of the triglycerides contained in the adipocytes exploded is highest.

5 Material and methods Fifty patients with edematous fibrosclerotic panniculopathygrades 11-11Iwere treated: 46 women (92%) and 4 men (8%) (Figure 11). of total fat volume of 3.46%, equal to a relative loss of 14% (Figure 13). During treatment, the patients continued with the usual diets without any type of regime, as shown in the mean variations, practically nil, of the lean mass and total water (Figure 14)....".. 1 "11 t.\ Figure 11: Sample The protocol covered 4 sessions of 40 minutes each with the Novashape system, one weekly session. All the patients were previously subject to segmented ortho polar multifrequency impedanciometry to evaluate the general and local fat volume, in abdomen and lower limbs in kg and in percentage. The volumes were also measured with perimeter measurements with accurate anatomical references adapted to each patient, as well as the ultrasound sections in the zones described, before and after treatment. Before treatment the ketonic bodies are controlled in urine, as well as urinary density, cholesterol, triglycerides, aminotransferase, glutamicpyruvate and gamma-glutamyl transpeptidase in samples of capillary blood. The same tests were repeated at the end of the session and 48 and 96 hours after. The results were statistically analyzed with descriptive statistics. Results When comparing the fat mass in kg, before and after treatment with segmented ortho polar multifrequency impedanciometry, a reduction of the total fat volume of 4.24 Kg was observed, of which 3.32 kg corresponded to the abdomen and 0.4 to each lower limb (Figure 12). The same comparison in percentages showed a loss '0 () :tl,... Mass Mass fat fat Mass fat klo.> ~.,./ " 1.,.'1... t Figure 12: Loss of fat volume in Kg measured by segmented ortho polar multifrequency impedanciometry..co.!,.,,2 3Hf... 3!i. D.n...,es..0 I 'I... _. 9"'.. ;IS; _1"08iob 20. "...11Io '4. 5 '0 3.46"i. 'i 0. ''"''''!,I"I" Figure 13: Loss ohat volume in percentage measured by segmented ortho polar multifrequency impedanciometry.

6 satisfied; 7% rather satisfied and 10% unsatisfied (Figure 18) % Antes '-I 30 35]. Despu6s % % 10 I. 15 -" o Muy Satisfechos Poco 1\ 5 satlsfechos satisfechos sati! 0 MM TBW Figure 14: The patients in the sample have continued with the daily diet during the trial Figure 15: Reduction of the abdominal and lower limbs perimeter so Abdomen The perimeter of abdomen and the zones treated in the lower limbs, measured in constant anatomical situations and with clear anatomical references, suffered an average reduction of 12 cm and 5 cm, respectively (Figure 15). The abdominal volume suffered an average reduction of cm3, equal to 9.27% (Figure 16). The volume in the lower limbs was reduced to an average of cm2, which represents a reduction of 11.29% (Figure 17). The mean level of satisfaction, evaluated with an anonymous survey at the end of treatment, was optimal: 72% of the patients indicated that they were very satisfied; 21% _ 6~~~duction ~~ I , VOLUMEN of the abdominal I I I -11,29% I ,7 ' Figure 17: Reduction of the volume in the lower limbs. Figure 18: Levels of satisfaction with the treatment. An*-. Despues Hrdlda

7 4294, , " ,8 VOWMEN -398,21 cc Antes. Despues The levels of blood triglycerides were 90 mg/dl before treatment. Immediatelyafter completing it, they rose to 160 mg/dl, which means an elevation of 77.7%. Forty-hours after completing treatment, the levels continued increasing until 180 mg/dl to normalize 96 hours after finishing treatment with levels of 105 mg/dl. In patients also showing hypertriglyceridemia(mean levels 255 mg/dl) the elevation was not so important: they increasedto no more than 295 mg/dl, normalized in the first record obtained 48 hours after. The mean levels of total cholesterol did not now significant changes. The mean levels of liver transaminaseswere 15.9 Uti at the beginning of the treatment and 17.7 UII at the end, representing an elevation of 11.3%. Forty-eight hours the completion of treatment the levels normalized. The mean levels of gammaglutamyl transpeptidase did not now significant changes. The mean urinary density was 1010 at the beginning of treatment and 1025 at its completion. After 48 hours the density was 1030 and returned to normal values 96 hours after completing treatment. The ketonic bodies did not show significant mean changes in urine, but a slight elevation in the first 48 hours in patients with hypertriglyceridemia(mean 255/mg/dL). Discussion The elevation in the blood triglycerides registered following treatment with Novashape is important enough to show its efficacy in the destruction of the adipocytes. Also, this is not proportional to the volume of tissue destroyed, because the ultracavitation per se achieved with Novashape, due to the wavelength emitted, fractures the triglyceride molecules and generates amorphous carbohydrate compounds that may be excreted without problems by via guided by the water-solubility of the tissue..-- L Case 1: before Case 2: before Case 1: after Case 2: after The treatment technique used also induces tritrophic changes in the treated tissue, thus reducing the edema and the fibrosis, as the ultrasound exams performed clearly show. In spite that the mean values obtained indicate that good results were achieved, it should be emphasized that the dynamic resonant cavitation is very effective when the fat is poorly compacted, but less efficient with higher density and fibrosis, although good results are still obtained. In this regard, is more reasonable to treat patients with this type of characteristics with the protocol designed by J. Victor Garcia and Maurizio Ceccarelli. Before treatment they infiltrate hypotonic serum, a measure with which the results should be more evident. HCMS&S Bibliography '" Agarwal V, Jana A K, Das G and Das P K, Taylor bubbles in liquid filled annuli: Some new observations. Phys. Fluids 19, (2007) '" Ajaev V. Effect of nanoscale bubbles on viscous flow and rupture in thin liquid films. Phys. Fluids 18, (2006) '" Akhatov I, Lindau 0, Topolnikov, A, Mettin R, Vakhitova, Nand Lauterborn W. Collapse and rebound of a laserinduced cavitation bubble. Phys. Fluids 13 (10), (2001) '" Asakura Y, Nishida T, Matsuoka T and Koda S. Effects of ultrasonic frequency and liquid height on sono chemical efficiency of large-scale sonochemical reactors. Ultrason. Sonochem., in press (2007) '" Berthelot M, Sur quelques phenomenes de dilatation forcee des liquides. Ann Chim Phys 30 (3) (1850)

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