fair-embolisation et agents liquidesjficv.com/usrfile/presentation/2019/s04-p04.pdf · new type of...
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Nouveaux agentsNouvelles destinations
Fair-Embolisation et agents liquides
Vincent VIDAL
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Nouveaux liquides
Tr a nsca theter emboliza t ion in a nima l models with GPX,
a novel water -bor ne polymer embolic.Joshua P. Jones, PhD; Jessica C. Karz; and Matthew S. Johnson, MD, FSIR
Swine Kidney and Liver Embolizations
• All procedures/evaluations were done by non-Fluidx personnel.
• A Boston Scientific Direxion HI-FLO microcatheter (0.027” ID)
was placed proximal to the target vasculature.
• GPX was injected (~0.3 mL) over 1 min. Embozene Microspheres
(40µm) were used as a control (deployed as per the IFU).
• Occlusion was assessed at 15 m and 14 d (see Table 1).
Diverse Use Scenarios
• GPX was deployed into coils at multiple sites including the rete
mirabile as well as the splenic, gastric, and renal arteries.
• In rabbits, elastase was used to create model aneurysms in the
subclavian artery. Embolization was performed using a balloon
and jailed catheter technique. Follow-up was performed at 28 d.
• These procedures explored the use of GPX with a variety of
catheters ranging from 0.017” ID (Medtronic Echelon 10) to
0.041” ID (Terumo Glidecath).
GPX (Fluidx Medical Technology, Salt Lake City, UT) is a
new type of transcatheter embolic: a water-based
coacervate which solidifies upon injection into the
vasculature. The agent is primarily comprised of two
oppositely charged polymers, with interactions
shielded by high concentrations of monovalent ions
(salt). Tantalum powder is added for radiopacity.
Solidification results from strengthened interactions
between the oppositely charged polymers in
response to decreasing salt concentration (Figure 1).
This produces a cohesive viscoelastic gel that can be
delivered with control and precision without adhering
to catheters. Here, the performance of the GPX
embolic was evaluated in procedures out to 14 days
in a porcine model and 1 month in a rabbit model.
GPX was used alone and in combination with other
agents to simulate a variety of clinical scenarios.
Purpose
Materials & Methods
Results
ConclusionsAFA Flow Scale
Grade Definition
AFA
Grade
0
No antegrade flow within the treatment site.
AFA
Grade
1
Contrast passes into the treatment site but “hangs
up” and fails to opacify the entire distal vascular
bed.
AFA
Grade
2
Antegrade filling of contrast with complete filling of
the artery and its major and minor branches after
more than two cardiac cycles. Alternatively,
delayed contrast washout in the target site territory
may occur, compared with comparable areas of
distal vascular bed not perfused by the target site.
AFA
Grade
3
Antegrade flow of contrast with complete filling of
the vessel and its major and minor branches within
two cardiac cycles. Contrast also clears from the
arterial segment within two cardiac cycles.
Post Injection(0.9% Saline)
Coacervate
(6-9% Saline)
Figure 1: GPX solidifies after delivery in response to decreasing salt concentration.
Table 1: The AFA Flow Scale was used to grade occlusion at 15 minutes and 14 days.
Swine Kidney and Liver Embolization
• GPX distally penetrated into small arteries
without fragmentation, resulting in
immediate occlusion.
• All treatment sites [n=20] showed no flow
(AFA grade 0) at the acute follow-up,
compared with an average of 0.7 (+/-0.6)
for microspheres [n=4].
• In the survival arm, all sites remained fully
occluded (AFA=0) at 14 days [n=7].
Microspheres had an average AFA score of
2.3 (+/- 1.2) [n=4].
• At necropsy, GPX remained cohesive and
was well distributed in the target tissue.
Penetration was seen into small arterioles.
Initial angiogram
15 minutes post 14 days post
Faxitron of GPX
GPX placement
Figure 2: Porcine kidney embolization using GPX at 14 days.
Initial angiogram
Coil placement Minimal occlusion
With GPX: total occlusion
Necropsy minutes post-injection: GPX did not fragment and
displayed distal penetration
Figure 3: Diverse uses of GPX. Top: With coil. Right: Acute necropsy. Bottom: Swine rete mirabile (left) and aneurysm model (right).
Initial angiogram
GPX
embolization
No balloon adhesion after
embolization of rabbit aneurysm
Diverse Use Scenarios
• When injected proximal to coils in
branches of the iliac, splenic, and
renal arteries, GPX formed a
cohesive embolus that did not
travel distal to the coils (Fig. 3).
• In an acute procedure, GPX
demonstrated deep penetration
into the rete mirabile, resulting in
rapid complete occlusion with no
signs of crossing into venous
circulation (Fig. 3).
• GPX totally occluded model wide-
neck aneurysms at both acute
and 1 month evaluations with no
signs of catheter or balloon
adhesion. Explanted tissue
appeared grossly normal (Fig. 3).
• When used as a stand-alone embolic, GPX
demonstrated good distal penetration, filling down to
the arterioles, and generating a stable occlusion.
• In the porcine kidney model, kidney lobes embolized
with GPX had less flow at the acute and long term
follow-up than those performed with Embozene
Microspheres (40 µm).
• When used in tandem with coils, the cohesiveness of
GPX allows it to form a proximal, complete occlusion
without distal migration in different vessel/flow
situations.
• GPX is a flow directed embolic agent that appears to
have utility in a variety of embolization scenarios.
Onyx, Squid, Phil, Easyx and others
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GPX
• Polymeres à charge opposées + Tantalum
• Retenus par une barrière d’ions monovalents
• Diminution de la concentration
Post Injection(0.9% Saline)
Coacervate
(6-9% Saline)
Figure 1: GPX solidifies after delivery in response to decreasing salt concentration.
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Initial angiogram
15 minutes post 14 days post
GPX placement
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Initial angiogram
Coil placement Minimal occlusion
With GPX: total occlusion
Necropsy minutes post-injection: GPX did not fragment and
displayed distal penetration
Figure 3: Diverse uses of GPX. Top: With coil. Right: Acute necropsy. Bottom: Swine rete mirabile (left) and aneurysm model (right).
Initial angiogram
GPX embolization
No balloon adhesion after embolization of rabbit aneurysm
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Nouveaux liquides
Onyx, Squid, Phil, Easyx and others
• GPX
• Polymeres + solvant
• Radio-opacité
• Viscosité
• Rupture technogique …
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The Fair-Embo Concept
Faisabilité in vivo de l’embolisation artérielle
avec des fils de sutures
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Radiologie Interventionnell
e
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PRIX
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DISPONIBILITEDISTRIBUTION
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• Promouvoir :
• RI dans les pays émergents
• Développement d’un agent d’embolisation :
• Efficace
• Disponible
• Peu couteux
The Fair-Embo Concept
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Matériels & méthodes : Ex VIVO
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Matériels & méthodes : Ex VIVO
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Materiels & méthodes : In VIVO
• AIGU : (n = 1)
• Sécurité (hors cible)
• Succès technique• mesenterique, splenique, pharyngée, rénale
• Suture non-absorbable (SNA):• MersuturesT M 6, Ethicon (polyethylene terephthalate)
• diamètre 0.8 and 0.899 mm, préparé en fragments de 1 à 3 cm
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• Chronique (n = 3) :
• efficacité et tolerance (moyen terme)• Artère polaire rénale inférieure :
• Droite : SNA
• Gauche : SA Vicryl, polyglactin 910: Ethicon.
• Suivi 3 mois.
• Suture taille 1 • diametre USP
• 0.4 / 0.5 mm, fragments de 1 cm (3 mg)
Materiels & méthodes : In VIVO
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Protocole
CT- Scanner
Angiographie
Histological study
J-1 J0 M1 M3
X X X X
X X
X
Materiels & méthodes : In VIVO
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• AIGU: • Securité
• Succès technique
Résultats : In VIVO
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• AIGU:
• Polyethylene terephthalate • 6 USP (0.8–0.9 mm) 4 Fr (0.97 mm)
• Variation possible 1 à 3 cm voir plus
• Occlusion rapide avec 2 à 4 fragments (9.3 ± 3.4 cm).
Résultats : In VIVO
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• CHRONIQUE: • Rein Dt: SNA, polyethylene terephthalate
• 1 cm USP 1 : 21.3± 5.6 fragments (0.064 g± 0.017, n = 3).
• Rein Gch: SA, polyglactin 910• 1 cm USP 1 : 17.7 ± 4.6 fragments (0.053 g ± 0.014, n = 3).
Résultats : In VIVO
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• Angiographie à 3 mois
SNA SA
J0 M3 J0 M3
n°1
n°2
n°3
Résultats : In VIVO
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• Scanner à 1 et 3 mois :
• Pas de complications (abces, urinome).
Résultats : In VIVO
• 3 mois,
• Atrophie polaire inférieure
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• SNA
• Matériel non fragmenté retrouvé dans tous les reins droits, rien à gauche (SA) !
Résultats : In VIVO
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• SA totalement résorbé à 3 mois
• Pas d’infiltration perivasculaire. • no significant difference of tissue fibroplasia, edema, neovascularization,
hemorrhage, necrosis, or polymorph nuclear cells, lymphocytes, plasma cells, macrophages and giant cells observed in all the sections.
Résultats : In VIVO
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PUBLICATION CVIR April 2019
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DISCUSSION
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DISCUSSION
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DISCUSSION
• Avantages
• Low cost
• Disponibilité universelle
• Facile d’utilisation (taille, flushable)
• Toxicité (implantation)
• Désavantages
• Linéaire (accrochage, torpille gélatine)
• Non radio-opaque (particules et gelatine)
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DISCUSSION
Suture la plus absorbable du marché :
• (Vicryl, polyglactin 910)
• resorption rates of:
• 25% at 14 days, 50% at 21 days, 75% at 30 days
• 100% at 42 days (peut etre plus court en endovasculaire).
Suture la moins chère du marché :
• MersuturesTM (polyethylene terephthalate)
• non résorbable
• Embolisation définitiveConsidering tissue suturing and according manufacturer information
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DISCUSSION
• Impact pour les patients ?• Hémorragie des premières 24 h après délivrance,
polytraumas … représente une mortalité trés élevée dans les pays émergents
• FAIR-Embolisation :
• Réalisé avec un ampli et du matériel très simple
• Aiguille
• Cathéter 4-5 Fr
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DISCUSSION
• Agents d’embolisation:
• Dispositifs médicaux implantables (DMIs) :
• Circuit légal et pharmaceutique
• Problématique :
• Pas LOW COAST mais AVAILABLE
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FAIR-EMBO PROJECT
• Particules non sphériques:• tumeurs Bénignes (fibromes Afrique) et Malignes
• Embolisation blanche
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FAIR-EMBO PROJECT
• Taille des micro-particules :
• Panel 8 personnes avec analyse microscopique
• Rhéometrie :
• Pr Gilles SOULEZ - CHUM
• Granulométrie, dispersion … suspension (polyamide)
• Effets tissulaires :
• Année recherche : Dr M. Di Bisceglie
• Sénégal : Dr A.N DIOP
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L. FindeissSIR
A. GangiCIRSE
A. DiopWestern
Africa
Y. AraiAPSCVIR
F. CarnevaleSthA IR
C. BigotAmbassadeur de
France
FONDATION : AMU (Amidex)
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• Effort international
• Multiples leadership
• Chaque projet destination
• Promouvoir : RI en général
• Ex : Pr DIOP - Dakar• école de l’embolisation pour Afrique de l’Ouest
• Data de la communauté FairEmbo• Crédits OMS
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CONCLUSION
• Embolization avec SA et SNA
•Faisable
•Sécuritaire
•Efficace