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JFR 2007
LA FILTRATION CAVE Bilan et Nouveautés
Fabrice-Guy BARRAL
Jean-Paul BEREGI
Saint-Etienne – Lille / FRANCE
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Plan
1. Les Différents filtres disponibles2. Les indications3. Les nouvelles indications / PREPIC 24. En Pratique
� Procédure� Cas Particuliers� Retrait� Quelques cas cliniques
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LES FILTRES CAVES ACTUELLEMENT DISPONIBLES
A - Les filtres définitifs :
1 - le Greenfield (Boston Scientific)� le plus ancien (>100 000)
� voies jugulaire et fémorale� 2 versions :
* en acier sur guide
. 12 F. 6 branches en acier
. 4 crochets vers le haut. 2 crochets vers le bas
* en titane
. 12 F. 16 branches en titane
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LES FILTRES CAVES ACTUELLEMENTDISPONIBLES
2 - le LGM Vena Tech (Braun)
� le plus stable
� 2 versions* LGM
. 12 F. Voie jugulaire et fémorale. 6 branches en phynox réunies en cône. pattes latérales portant 4 crochets* Vena Tech LP
. 7 F. Voie jugulaire, fémorale, brachiale, sous clavière
. 8 branches en phynox repliées
. Jusqu ’à 35 mm de calibre
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LES FILTRES CAVES ACTUELLEMENTDISPONIBLES
3 - le SIMON NITINOL (Bard)
. Le plus intelligent
. 9 F
. Voie jugulaire, fémorale, sous clavière, brachiale
. Nitinol : nickel + titane : thermo-formable
. Une ombrelle à 7 pétales et 6 branches avec crochets
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LES FILTRES CAVES ACTUELLEMENTDISPONIBLES
4 - le BIRD NEST (Cook). Le plus long, le plus compliqué, mais le plus large (40 mm). 14 F
. Voie jugulaire, fémorale
. 4 fils en acier inoxydable (artefacts) de 25 cm de long, attachés sur
2 étais en V se fixant dans la paroi par des crochets.
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LES FILTRES CAVES ACTUELLEMENTDISPONIBLES
5 - le TRAPEASE (Cordis)
. Le plus récent
. 6 F
. Voie jugulaire, fémorale, brachiale
. 2 paniers symétriques en nitinol
. avec 6 pétales réunis par 6 branches et
un crochet à chaque extrémité.
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LES FILTRES CAVES ACTUELLEMENTDISPONIBLES
B - Les filtres temporaires :
1 - ANTHEOR (Boston scientific) / Arrêt commercialisation
. 7 F
. Voie jugulaire, brachiale
. 10 jours maximun
. Kit de thrombolyse en option
2 - TEMPO FILTER II (Braun). 6 F
. Voie jugulaire
. Courte durée : 3 mois (version II ?)
. Solidaire à la peau
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LES FILTRES CAVES ACTUELLEMENTDISPONIBLES
c - Les filtres optionnels :
1 - ALN
. 7 F
. Voie jugulaire, fémorale, brachiale (++)
. Acier inoxydable
. Conique, 3 pattes de centrage et 6 pattes de fixation, de longueursinégales, avec crochets à angle droit
. Retrait par voie jugulaire avec une pince-panier à 8 branches
. 2 kits de retrait (9F) droit et angulé
. Retrait facile, jusqu ’à 25 mois
•
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LES FILTRES CAVES ACTUELLEMENTDISPONIBLES
2 - GUNTHER TULIP (Cook). 8,5 F. Voie fémorale, jugulaire
. Elgiloy
. Conique à 4 pattes portant 1 pétale et 1 crochet
. Un crochet à l ’extrémité céphalique pour le retrait par lasso.
. Limité à 10 jours (pas FDA)
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LES FILTRES CAVES ACTUELLEMENTDISPONIBLES
3 - OPTEASE (Cordis)
. 6 F
. Voie fémorale, jugulaire, brachiale
. 2 paniers symétriques en nitinol (C.Trapease)
. 1 crochet, retrait par lasso
. Limite à 12 jours
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4 - RECOVERY(RNF) (Bard). 7 F
. Voie fémorale
. 6 bras et 6 jambes en nitinol
. Retrait par voie jugulaire par pincepanier à 8 branches progressant sur un guide
LES FILTRES CAVES ACTUELLEMENTDISPONIBLES
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LES FILTRES CAVES EN PRE-COMMERCIALISATION
1. SAFEFLO : Rafael Medical
2. Celect filter : Cook
3. Option et Option LT : Rex Medical
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Un nouveau concept de filtre caveFiltre convertible
VenaTech Convertible / B Braun / Images from Courtesy of V Scott
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CONVERTIBLE FILTERWITH MECHANICAL HEAD
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Snare catheter
Approach of the Goose Neck Snare kit
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Capture of the head’s hook
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Descent of the Snare catheter
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Support of the Snare catheter on the filter’s head
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Withdrawal of the filter’s head by pulling on the Snare catheter
and opening of the convertible filter
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Veine cave de porc
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Veine cave de porc
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Filtres : Indications
• Filtre cave définitif• Filtre cave temporaire• Filtre cave optionnel
• Filtre cave convertible ?
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LES FILTRES CAVES DEFINITIFS : QUAND ?
•Malade avec une Embolie Pulmonaire et :
• Récidive malgré traitement anticoagulant bien conduit
• Contre-indication aux anti-coagulants
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LES FILTRES CAVES DEFINITIFS : QUAND ?
• Chez les patients très âgés• En cas de veine cave tortueuse• En cas de méga veine cave• En cas de mauvaise observance (surveillance)
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les filtres temporaires : quand ?
� Indications de courte durée* Période péri-opératoire* Fin de grossesse
�Indications “anatomiques* Compression de la veine cave
inférieure* Thrombose extensive* Dernier trimestre de la grossesse
� Gestes de thrombolyse
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les filtres temporaires : MAIS
� Doivent être retirés après 10 jours ou 3 mois(tempo filter II).
� Nécessitent un catheter intra-cave pour fixerle filtre, émergeant à la peau :
• Risque de sepsis et de thrombose• Assez inconfortable
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Filtre optionnel : quand ?
• Indications de filtre cave avec risque de récidive sur une durée limitée de 1 mois à6 mois voire 1 an ou davantage
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Main results of retrievable filter studies
Retrieval technical success (%)
Mean duration between placement and retrieval (days)
N° of filters removed and
placedFilter
Study
10016;range 3-4840 of 40OpteaseRosenthal et al., 2005 [28]
10011;range 5-1421 of 27OpteaseOliva et al., 2005 [27**]
99150;range 0-41914 of 107RecoveryGrande et al., 2005 [26**]
9319;range 11-4114 of 130VariousMorris et al., 2004 [28]
10072;range 30-12028 of 96ALNPancione & Mecozzi 2004 [22]
10022;range 11-9013 of 54ALNBarral et al., 2003 [21]
10063;range 49-1927 of 18ALNPieri et al., 2003 [20]
10053;range 5-13424 of 32RecoveryAsch, 2002 [25]
9714;range 3-3037 of 44Gunther TulipOffner et al., 2003 [17]
989;range 2-2552 of 91Gunther TulipMillward et al., 2001 [15]
8812;range 8-148 of 10Gunther TulipPonchon,1999 [16]
In Imberti et al, Current Opinion in Hematology 2006, 13:351-356
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Main results of retrievable filter studies
86.416 ;range 7-2532 of 37OpteaseMeier et al.,2006
100
100
11.1 ;range 2-14
51 ; range 6-352
23 of 41
55 of 220
Gunther Tulip
ALN
Hoppe et al.,2006
Mismetti et al 2007
84.68;range 2-1510 of 13Gunther Tulip OpteaseLam et al., 2004
96?24 of 53?Allen et al., 2005
94?66 of 127VariousRosenthal et al., 2006
100254.2 ;range 181-41913 of 13RecoveryBinkert et al.,2006
10018 of 35?Hoff et al., 2004
84 34;range 7-12616 of 53Gunther TulipTerhaar et al., 2004
Retrieval technical success (%)
Mean duration between placement and retrieval (days)
N° of filters removed and
placed
Filter
Study
10010 ;range 6-112 of 83Gunther TulipNeuerburg et al.,1997
From Pubmed (June 1985 – September 2006) - Mostly Traumatic Centers
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R.F. What do we should demonstrate ?� Their efficacy/complications?
complications rate (%) permanent filters retrievable filters44/169 G.T.24/32 R.N.F.
pulmonary embolism 2 – 5 1%fatal pulmonary embolism 0,7 1%deaths linked to the placement of a filter 0,12complication of placement 4 – 11 0.2%veinous thrombosis at insertion point 2 – 28 1%migration of filter 3 – 69 3% (as)penetration of venous wall 9 – 24 1%obstruction of cava vein 6 – 30 3%veinous insufficiency 5 – 59 1%
large thrombi 10-22%
veinous thrombosis 1%trapped thrombus 9%
So:
� The R.F. have more or less the same complications as theP.F. (no randomization, questionable comparison …)
� They avoid the long term complications of caval filtration (long life expectation, young patients, pregnency, …)
� The complications of retrieval have to be better evaluated
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Should we expand the indications for retrievable
VCF’s ?
PREPIC 2
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Arguments for :
Vena cava filters have proven to be an effective adjunctive tool for
the prevention of PE
� The ICOPER Registry� No recurrent PE within 90-days
� IVC filters associated with a reduction in 90-days mortality
Kucher et al, Circulation, 2006
� Results of the PREPIC study
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BackgroundPREPIC
• PREPIC design: randomised trial in patients with proximal DVT (200 with permanent filter, 200 without filter)
• PREPIC results: the insertion of a vena cava filter showed:
a significant reduction in asymptomatic and
symptomatic PE at day 12
a significant increase in symptomatic recurrent
DVT at 2 years
• PREPIC long term follow-up: 8 years
No effect on overall mortality (day 12 and 2 years)
Decousus et al. N Engl J Med 1998
Prepic Study Group, Circulation 2005
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Cumulative rate of symptomatic PEPREPIC
PE : 24 pts vs 9 pts(fatal PE): 5 pts vs 2 pts
No filter:
15.1%
Year 1 2 3 4 5 6 7 8
Filter:
6.2%
HR=0.37 [0.17-0.79]
p = 0.008
2%
4%
6%
8%
10%
12%
14%
16%
Prepic Study Group, Circulation 2005
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Cumulative rate of recurrent DVT(DVT of the lower limbs and filter thrombosis)
PREPIC
Recurrent DVT: 41 pts vs 57 pts(filter thrombosis): 2 pts vs 26 pts
Year 1 2 3 4 5 6 7 8
Filter: 35.7%
No filter:
27.5%
HR=1.52 [1.02-2.27]p = 0.042
5%
10%
15%
20%
25%
30%
35%
40%
Prepic Study Group, Circulation 2005
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Conclusions (1)PREPIC
• Significant reduction in clinical PE in the filter group at 8 years� Permanent filters could be recommended in VTE
patients at permanent very high risk of PE and fatal PE:
� initial documented PE� cardiac or respiratory insufficiency� male gender� advanced age?� echocardiography data?� biological parameters ?. . .
[Douketis et al. JAMA 1998Heit et al. Clin Chest Med 2003Mismetti et al. J Thromb Haemost 2003 Suppl P1411, Ten Walde et al. J Thromb Haemost 2003 Suppl OC153 ]
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Conclusions (2)PREPIC
• Increased risk of clinical DVT recurrence in the filter group at 8 years
� Temporary (optional) filters should be preferred instead of permanent filters in potential temporary
filter indications
� Filters cannot be recommended in a general VTEpopulation
• No difference in terms of overall mortality
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• Arguments for :
Optional filters are almost always retrievable
� PubMed :Retrievable filters : 107 references from june 1985 to september 2006Optional filters : 17 referencesConvertible : 2 references
� With :Number of filters placed: 1324Number of filters removed: 517Retrieval technical success: 96%
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Arguments for :
RF have the same efficacy then definitive filters when left in situ
MISMETTI et al. Chest 2007
A prospective long-term study of 220 patients with a retrievable venacava filter for secondary prevention of venous thromboembolism.
� Prospective (and exhaustive) cohort study with18 months follow-up.
� 220 ALN filters� From april 1999 to june 2005� 55 retrievals
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28 (1-462) - Number of days between filter placement and first event, median(range)
13 (6.0) - Event associated with filter thrombosis, n (%)
2 Upper limb deep-vein thrombosis, n (%)
2 Distal deep-vein thrombosis, n (%)
29 Proximal deep-vein thrombosis, n (%)
33 (15.2) - DVT, n (%)
5 (2.3) - Pulmonary embolism, n (%)
37/217 (17.0) - At least one event, n (%) 2
Venous thromboembolic event
2 (0.9) - Other,1 n (%)
2 (0.9) - Infection, n (%)
3 (1.4) - Filter migration, n (%)
9 (4.2) - Puncture site hematoma, n (%)
12 (5.7) - Filter tilting, n (%)
25/212 (11.8) Immediate complication, n/N (%)
166 (34-478)Number of days of filter implantation, median (Q1-Q3)
Patients
Clinical events during filter implantation
1 : acute renal impairment
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Arguments against :
�Every retrievable filter placed has the potential to become a permanent filter (young patients, or with long life expectancy).
�Placing a RF is not a innocuous radiological procedure requiringcautiousness and expertise for every step (cannot be routinely recommended).
�Clinical studies are lacking.
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Arguments against :
Limits of Retrieval Filter
1. Specific complications :- Migrations need- Ruptures surgery ?- Tears of the IVC- Thrombogenicity
� IVC occlusion
2. Failure to removal :- Bad positioning - Endothelisation permanent- Large trapped thrombus implant- Difficult catching (tilting)
� Pub Med : 17 references� MAUDE
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• Secondary prophylaxis against PE :
Suggested filter placement in patients (grade 2 C) :
– with recurrent thromboembolism despite adequateanticoagulation
– with a contraindication or complication of anticoagulants– before thromboendarterectomy for Chronic Thrombo-
embolic Pulmonary Hypertension (CTEPH)
Buller HR et al, Chest 2004
Future prospects/New indications ?
Filter indications – Recommendations from
the 7th ACCP Conference
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Secondary prophylaxis against PE : no, except for pregnancy ?
2 nd preg.under LMWH
Hemorrhage during the placental stage
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Future prospects/New indications ?
Filter indications – Recommendations
from the 7th ACCP Conference
• Primary prophylaxis against PE :
Recommended against the use of filter as primary prophylaxis in trauma patients (grade 1C) and in spinal cord injury (grade 1 C)
• Secondary prophylaxis against PE :
Recommended against the routine use of filters in addition to anticoagulants (grade 1 A)
Geerts W et al. Chest 2004Buller HR et al. Chest 2004
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Future prospects / New indications ?
� Primary prophylaxis against PE (no VTE)
MAJOR or MULTIPLE TRAUMA
* 9 references in Pubmed : � Further Investigations are warranted
* ANTEVIL J.L. : J.Trauma – 2006.
* 5,042 vs 5.038 patients with/ whitout RF
* 21 % of successful removal� Major filter related complications were encountered
Low incidence of PE not altered by of the use of RF
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Future prospects / New indications ?
� Primary prophylaxis against PE (no VTE)
SPINAL CORD INJURY
From : * Maxwell RA (8,269 patients) J.Trauma,2002
* Rutherford RB Sem.Vasc.surg, 2005
Indications when :
- Long bone fractures- Detected DVT
- Progression of DVT- Contraindication to AC
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Future prospects / New indications ?
� Primary prophylaxis against PE (no VTE)
BARIATRIC SURGERY
FROM : * Sapala JA (5.554 patients) Obes.Surg.2003* Rectenwald JE Sem.Vasc.surg. 2005
INDICATIONS WHEN :- Venous stasis disease- Body mass index ≥ 60- Truncal obesity- Obesity hypoventilation syndrome/sleep apnea syndrome
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Future Prospects / new indications ?
� Filters could be useful in a selected PE population athigh risk of recurrent PE and/or recurrent fatal PE
Secondary prophylaxis against PE, in addition to anticoagulants:
– In a general population, up to 1.5 % of patients with PE versus only 0.5 % with DVT still die from fatal PE despiteanticoagulants, in a 3 month follow-up period
– More generally, PE patients are at higher risk of recurrentPE than DVT patients.
Douketis JD, JAMA 1998 Mismetti P et al, Chest 2005, in pressEichinger, Arch Intern Med 2004…
Buller H et al N Engl J Med 2003Buller H et al Ann Intern Med 2004Laporte S et al, Riete, ISTH 2005
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Future Prospects / New Indications ?
• Are we able to define this high risk PE population ?
• What kind of filters could be proposed in thissituation ?
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Future Prospects / new indications ?
- PE population with a high risk of recurrent PE and/or recurrent fatal PE can be defined as follows :
* Severe PE (Massive or sub-massive PE)* Age > 75 * Cardiac or respiratory insufficiency* Malignancy* Neurologic disease* Bilateral and proximal DVT…
Laporte S et al, Riete, ISTH 2005ICOPER, Lancet 2004Heit JH, Thromb Haemost 2001Mismetti P et al, Chest 2005, in press
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Future Prospects / new indications ?
� Randomized trials are needed to assess retrievablefilters in addition to anticoagulants in selected PE population
� Retrievable filters would be preferable
- 80 % of recurrent fatal PE occur in the first month
Laporte S et al, Riete, ISTH 2005ICOPER, Lancet 2004
Douketis JD, JAMA 1998
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Future Prospects / New Indications ?
� RF and secondary prophylaxis against PE, inaddition to AC ?
� PREPIC 1 � positive effect on PE before 3 months� negative effect on DVT after 6 months
� PREPIC II (on going)� Patients with symptomatic PE� Plus at least one other risk factor
� Retrievable filter versus no filter and retrieval at 3 months
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CONCLUSIONS
⌦ Les revues de la littérature : oui, mais
⌦ Trouver un équilibre entre :- Surestimer le risque- Surestimer le bénéfice
⌦ L’identification plus précise des patients « à très haut risque » malgré le traitement anti-coagulant curatif ou préventif n ’est pas terminée.
⌦ Les filtres optionnels ont un potentiel indéniable (paclitaxel ?)
⌦ Donc : de très enthousiastes perspectives de recherche
⌦ Le filtre « idéal » ?
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En PratiqueLES DIFFERENTES ETAPES
1 – Echo-doppler pour apprécier la perméabilité de la veine cave inférieure,de la veine fémorale et jugulaire.
2 – Seldinger :� Veine fémorale (droite – gauche)� Veine jugulaire (droite - gauche)� Veines brachiales (écho-doppler)
3 – Cavographie (Face + profil) :� pour apprécier le calibre de la veine cave inférieure� abouchement des veines rénales
4 – Pose du filtre
5 – Cavographie
6 – A.S.P. (24 h)
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LES DIFFERENTES ETAPES
1 – Echo-doppler pour apprécier la perméabilité de la veine cave inférieure,de la veine fémorale et jugulaire.
2 – Seldinger :� Veine fémorale (droite – gauche)� Veine jugulaire (droite - gauche)� Veines brachiales (écho-doppler)
3 – Cavographie (Face + profil) :� pour apprécier le calibre de la veine cave inférieure� abouchement des veines rénales
4 – Pose du filtre
5 – Cavographie
6 – A.S.P. (24 h)
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En PratiqueLes différentes étapes
1 – Echo-doppler pour apprécier la perméabilité de la veine cave inférieure,de la veine fémorale et jugulaire.
2 – Seldinger :� Veine fémorale (droite – gauche)� Veine jugulaire (droite - gauche)� Veines brachiales (écho-doppler)
3 – Cavographie (Face + profil) :� pour apprécier le calibre de la veine cave inférieure� abouchement des veines rénales
4 – Pose du filtre
5 – Cavographie
6 – A.S.P. (24 h)
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LES DIFFERENTES ETAPES
1 – Echo-doppler pour apprécier la perméabilité de la veine cave inférieure,de la veine fémorale et jugulaire.
2 – Seldinger :� Veine fémorale (droite – gauche)� Veine jugulaire (droite - gauche)� Veines brachiales (écho-doppler)
3 – Cavographie (Face + profil) :� pour apprécier le calibre de la veine cave inférieure� abouchement des veines rénales
4 – Pose du filtre
5 – Cavographie
6 – A.S.P. (24 h)
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En PratiqueLes Cas particuliers
1 – patient très fragile� Mise en place du filtre au lit du patient sous guidage
échographique
2 – Contre indication au produit de contraste� Guidage échographique� Salle de vasculaire
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En pratiqueLa technique de retrait
1 - Filtres temporaires :- Echo-doppler- Contrôle scopique
2 – Filtres optionnels :- Echo-doppler- Salle angiographie
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Technique de retrait
� Voie d’abord jugulaire ou fémorale
� Cavographie
� Retrait
� Cavographie
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Technique de pose et de retrait (film)
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Cas Clinique 1Mme S.A.Mme S.A. : 27 ans
ATCD :ATCD : RCH récente� Anémie (transfusions)� Corticoïdes� T.V.P. M.I.D.
H.M. :H.M. : Défenestration 12/02/2003
Choc hémorragiqueFractures du BassinFractures ouvertes - Pied gauche }
- Tibia Gauche }Fractures côtes � Hémothorax � drain
�Filtre ALN 12/02/2003
Evolution :� Colectomie totale� Plusieurs arthrodèses
– 4 février 2005
� Retrait Filtre ALN 08/02/2005
Chirurgie
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Cas Clinique 2
Mme D.G. : 78 ans
ATCD : � HTA
• DNID
• Hypercholestérolémie• 1999 : ADK sigmoïde
• 2002 : PTH
• 2003 : EP
H.M. : → 09/2004 : PT genou droit
� 1er filtre ALN� 01/2005 : ABLATION FILTRE ALN
→ 2ème EP
→ 03/2007 : Chirurgie éventration
� 2ème filtre ALN
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Cas Clinique 3
Mr M.L. : 42 ans
ATCD : 18/02/2007 : Accident de tennis
� Thrombose VFS → Veine iliaque externe� pas EP (petit embole périphérique sur scinti)
� HBPM � AVK
H.A. : 02/03/2007 : TDM – TAP
Thrombus jusqu’aux veines rénalesINR < 2
� Tempo filtre IIRetiré 48 heures
HBPM
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Cas Clinique 4
Me M.D. : 27 ansH.M. : � Post-partum (2ème P)
� pas EP
� HBPM
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Cas Clinique 5 : FC sus rénal
Mme L.V. : 25 ans
H.M. : � TVP fémorale G � Héparine� EP droite
� 38 SA + 5 jours� Indication de déclenchement
� Filtre cave temporaire
� 24/05/2006 : 2 TF II� 26/05/2006 : Filtre ALN par voie humérale� 06/06/2006 : Retrait filtre
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Cas Clinique 6 : FC sus rénal
Mme DS A. : 22 ans
ATCD : - 2006 : � Endométrite post IVG� TVP hypogastrique
� HBPM
- 2ème grossesse sous HBPM
H.M. : - 23/02/2007 � Hémorragie de la délivrance
� Thrombus VRD
� Filtre temporaire� TF II : Echec� Filtre cave ALN
� HBPM
- 29/05/2007 : Retrait filtre cave
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