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Ii foamer device presentation site 2015
1. Enric Roche MD , PHD
IS IT POSSIBLE TO IMPROVE TESSARI´S METHOD ?
ENRIC ROCHE, MD PhD.
Director CLINICA VASCULAR BARCELONA
Chief Vascular service HOSPITAL UNIVERSITARI SAGRAT COR & HOSPITAL GENERAL DE CATALUNYA
RAMON PONS, QD
Director INSTITUT QUÍMICA AVANÇADA , CONSEJO SUPERIOR DE INVESTIGACIONES CIENTÍFICAS
ANTONI PUIG, MD
CLINICA VASCULAR BARCELONA
2. Enric Roche MD , PHD
I declare I haven´t any conflict of interest
related to this presentation.
3. Enric Roche MD , PHD
Several strategies to ablate Major and minor saphenas
TO STRIP
BURN
ELECTRIFY
BOIL
STICK
EMBOLIZE
In your office,
Which % of Major/Minor saphenas are involved ?
4. Enric Roche MD , PHD
Main concerns…
Foam sclerotherapy has great variability
about syringes material, three way stopcock, type of gas, ratio sclerosant /gas, fabrication system, injection
system, strategy , temperature, patient position,
Safety is important
Physiological gases are safer than air, specially when a large volume of foam is used
Cabrera J, Patología Vascular. 1995; Wright D, Phlebology 2006; Morrison N. J Vasc Surg, 2008, Beckitt T,, Beckitt T,
Eur J Vasc Endovasc Surg 2011., Hesse G, Phlebology 2012,
Versatility is a plus
Easy to obtain a 1-2% stable foam …How many cases could be treated with high concentrations sclerosants ?
What about foams less concentrated ( < 0,5% …)
6. Enric Roche MD , PHD
OBJECTIVE:
To demonstrate the feasibility of a new system of standardized
foam fabrication and its superiority in front of Tessari´s method in
terms of stability and versatility.
MATERIAL AND METHOD
TESSARI´S METHOD
-0,5% POLIDOCANOL Foam with AIR
- 2% POL Foam with AIR
- 2% POL Foam with O2/CO2 (50%/50%)
FROTHER
-0,5% POLIDOCANOL Foam with AIR
- 2% POL Foam with AIR
- 2% POL Foam with O2/CO2 (50%/50%)
7. Enric Roche MD , PHD
Tessari´s method:
Two 10 cc (BD Brand – latex free ) with A three-way stopcock key ( B/ Braun) . A default 1/3 ratio was decided using
3 cc of POL / 9 cc of AIR or O2/CO2. ( O2/CO2 Experiments container was filled with gas bottle)
After 20 passes
Small amount In a slide for
measurements
Syringe left in a stand position
for half-life calculation
MATERIAL AND METHOD
Foam measurements :
Diameter of bubbles & Total foam volume
A single layer of bubbles covered by a coverslip. Zeiss microscopy with a 2,5x with a Canon
Power Shot 90S was used to take pictures. ( final magnification was 2428x1821 μm2 ) .
Program used: ImageJ. Threshold particles analysis ( Size 150Infinity, Circularity 0,75-1)
Half –time life calculation:
Was defined as Time necessary to get the half amount of sclerosant ( 1,5 ml) in a liquid
state. (Total volume of sclerosant : 3 ml)
Every 30 seconds was obtained a picture of the syringes in vertically placed position with a
camera ( in a fixed position ) on a dark background.
8. Enric Roche MD , PHD
PURESPUME or FROTHER system:
Because the ratio liquid /gas is unknow is necesary to calculate
previosly the sclerosant volume.
Weight the syringe with 10 cc of foam / without foam in a precision
scale
3 ml of POL was frothed during 2 minutes
( 15sec-300rpm, 15 sec-700rpm,90 sec-1600 rpm)
( O2/CO2 Experiments container was filled with gas bottle)
After 2 min. in a slide
A sample was deposited In a slide for
measurements
A stand position for half-life calculation
MATERIAL AND METHOD
9. Enric Roche MD , PHD
RESULTS
Frother system foam 2% POL AIR
Frother system foam 2% POL O2/CO2
Tessari´s foam 2% POL AIR
Tessari´s foam 2% POL O2/CO2
10. Enric Roche MD , PHD
RESULTS 1. FOAM MEASUREMENTS
- Diameter of bubbles
- Total foam volume
% POL
FROTHER SYSTEM TESSARI
AIR O2/CO2 AIR O2/CO2
Diameter ED- σ Diameter ED-σ
0,5 %
134±33μm 109±21μm 38±17μm 25±15μm
2 %
104±22μm 74±22μm 65+/-20μm 51±20μm 40±20μm 40±15 μm
IC = 95%POL= Polidocanol
ED= Estandar deviation
11. Enric Roche MD , PHD
RESULTS 1. FOAM MEASUREMENTS
% POL
FROTHER SYSTEM TESSARI
AIR O2/CO2 AIR O2/CO2
Diameter ED- σ Diameter ED-σ
0,5 %
134±33μm 109±21μm 38±17μm 25±15μm
2 %
104±22μm 74±22μm 65+/-20μm 51±20μm 40±20μm 40±15 μm
IC = 95%POL= Polidocanol
ED= Estandar deviation
- Diameter of bubbles
- Total foam volume
12. Enric Roche MD , PHD
RESULTS
FROTHER SYSTEM 2% AIR
Diameter range of FROTHER SYSTEM is lower than TESSARI’S FOAM
TESSARI´S 2% AIR
Bubble Range: 25-150 µm Bubble Range: 25-245 µm
13. Enric Roche MD , PHD
RESULTS
2. FOAM STABILITY: Half-time life
% POL FROTHER SYSTEM TESSARI´S FOAM
AIR
minutes
ratio O2/CO2
minutes
AIR
minutes
O2/CO2
minutes
0,5%
6,5±3m
0,093
1/9
1,1±0,5m
2% 10,6±3m 0,089
1/10
2,2± 0,5m
2,0±0,5m
1,0±05m
IC = 95%
Statistical differences
POL= Polidocanol
Ratio: Proportion of sclerosant/gas
14. Enric Roche MD , PHD
RESULTS
2. FOAM STABILITY: Ratio sclerosant /gas
% POL FROTHER SYSTEM TESSARI´S FOAM
AIR O2/CO2 AIR or O2/CO2
0,5% 0,093 - 1/9 0,25 - 1/3
2% 0,089 - 1/10 0,14 - 1/6 0,25 -1/3
IC = 95%
Statistical differencesPOL= Polidocanol
Ratio: Proportion of sclerosant/gas
15. Enric Roche MD , PHD
RESULTS 2. FOAM STABILITY: Half-time life
FROTHER SYSTEM foam 2%
AIR
Tessari´s foam 2%
AIR
16. Enric Roche MD , PHD
CONCLUSIONS
2. Tessari´s foam is more heterogeneous : although there are a very little
bubbles
3. In our experiment frother´s foam is more stable than Tessari´s foam.
(five times more stable compared to Tessari´s method when using air and twice when using a
mixture of O2/CO2 )
4. 2% concentration of Polidocanol foam is more stable than 0,5% POL.
1. This system has demonstrated that it is useful in manufacturing foam
with air as well as with a gas mixture of O2/CO2.
17. Enric Roche MD , PHD
Comments
Our Tessari´s foam could be different than others foams
The standardization of parameters can be useful in offices where
sclerotherapy is a common practice
Versatility is interesting in the office
Some Improvements have been necessary in order to request
Health Authorities Approval