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Nouveaux agentsNouvelles destinations

Fair-Embolisation et agents liquides

Vincent VIDAL

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

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.

Initial angiogram

15 minutes post 14 days post

GPX placement

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

Nouveaux liquides

Onyx, Squid, Phil, Easyx and others

• GPX

• Polymeres + solvant

• Radio-opacité

• Viscosité

• Rupture technogique …

The Fair-Embo Concept

Faisabilité in vivo de l’embolisation artérielle

avec des fils de sutures

Radiologie Interventionnell

e

PRIX

DISPONIBILITEDISTRIBUTION

• Promouvoir :

• RI dans les pays émergents

• Développement d’un agent d’embolisation :

• Efficace

• Disponible

• Peu couteux

The Fair-Embo Concept

13

Matériels & méthodes : Ex VIVO

14

Matériels & méthodes : Ex VIVO

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

• 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

Protocole

CT- Scanner

Angiographie

Histological study

J-1 J0 M1 M3

X X X X

X X

X

Materiels & méthodes : In VIVO

• AIGU: • Securité

• Succès technique

Résultats : In VIVO

• 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

• 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

• Angiographie à 3 mois

SNA SA

J0 M3 J0 M3

n°1

n°2

n°3

Résultats : In VIVO

• Scanner à 1 et 3 mois :

• Pas de complications (abces, urinome).

Résultats : In VIVO

• 3 mois,

• Atrophie polaire inférieure

• SNA

• Matériel non fragmenté retrouvé dans tous les reins droits, rien à gauche (SA) !

Résultats : In VIVO

• 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

PUBLICATION CVIR April 2019

DISCUSSION

DISCUSSION

DISCUSSION

• Avantages

• Low cost

• Disponibilité universelle

• Facile d’utilisation (taille, flushable)

• Toxicité (implantation)

• Désavantages

• Linéaire (accrochage, torpille gélatine)

• Non radio-opaque (particules et gelatine)

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

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

DISCUSSION

• Agents d’embolisation:

• Dispositifs médicaux implantables (DMIs) :

• Circuit légal et pharmaceutique

• Problématique :

• Pas LOW COAST mais AVAILABLE

FAIR-EMBO PROJECT

• Particules non sphériques:• tumeurs Bénignes (fibromes Afrique) et Malignes

• Embolisation blanche

33

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

L. FindeissSIR

A. GangiCIRSE

A. DiopWestern

Africa

Y. AraiAPSCVIR

F. CarnevaleSthA IR

C. BigotAmbassadeur de

France

FONDATION : AMU (Amidex)

36

• 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

38

CONCLUSION

• Embolization avec SA et SNA

•Faisable

•Sécuritaire

•Efficace