Transcript CATCH : Mechanical Thrombus Retriever

Neuroradiology by
BALT Extrusion
CATCH :
Mechanical Thrombus Retriever
What is a Stroke ?
Stroke is a sudden interruption in the blood supply of
the brain
ISCHEMIC STROKE
85%
The blockage is caused by an
abrupt blockage of arteries
leading to the brain
Atheroscleroti
c plaque
HEMORRHAGIC STROKE
15%
The stroke is caused by bleeding into
brain tissue when a blood vessel or an
aneurysm bursts
blood
clot
With 20.000.000 cases per year,
strokes are the 3rd cause of death in developed
countries and a major cause of disability
An ischemic stroke has to be managed very quickly after
the crisis by fibrinolysis therapy and/or embolectomy
Intravenous fibrinolysis therapy
A anti platelets is injected through patient
vascular system to dissolve the clot
H0 to H+3
H+3
Brain
attack
For fibrinolysis contraindicated patients
H+3 to H+8
Mechanical Thrombo Embolectomy
The clot is mechanically removed thanks to a mechanical
thrombus retriever with intravascular access
Due to the short time limit, less than 3% patients get an intravenous fibrinolysis therapy
Up to now, mechanical thrombus retrievers were not
very efficient…
LASSOO
(BALT Extrusion, Boston Sc., …)
• initially designed for coil retrieval
• high risk of clot fragmentation
MERCITM (Concentric Medical)
• « corkscrew » system
• Less than 50% success rate
IN-TIMETM (Boston Scientific)
• Dormia system
• too stiff for intracranial use
…so fibrinolytic therapy remained the most secure treatment
BALT designed the CATCH, a new system based on the
technology developed for the LEO intracranial stent
a 16-wire self-expandable basket
allowing for a clot retrieval
with a reduced risk of fragmentation
CATCH thrombus retrieval system combines good
navigation and excellent visualization
2,4F braided catheter
VASCO+21
CATCH
coupled to a
pusher
Ø4mm
4 ORX markers for CATCH
opening visualization
18mm
1 distal ORX marker
Pusher’s ORX marker
THROMBO-EMBOLECTOMY GUIDELINES
WITH THE CATCH DEVICE
PER MEDICATION: heparin bolus intravenous injection (50 Ul/kg) at the beginning
1st CATCH procedure
CATCH procedure is detailed here
after
TIMI grade flow ≥ 2
If you carefully follow CATCH
instructions for use as
described hereafter, the same
CATCH system can be used for
these 5 procedures
In situ fibrinolysis
through VASCO+21
20mg rtPA*
TIMI grade flow ≥ 2
2nd, possibly 3rd
CATCH procedure
TIMI grade flow ≥ 2
Complementary
in situ fibrinolysis
through VASCO+21
max. 0,9mg/kg rtPA*
TIMI grade flow ≥ 2
*only if in situ fibrinolysis procedure is recognized by local
health authorities and if patient has no contraindication to
fibrinolysis
4th, possibly 5th
CATCH procedure
CATCH system has to used according
following procedure
CATCH procedure
Positioning &
deployment
Clot & CATCH
retrieval
CATCH
resheathing
If needed*
*If TIMI ≥ 2 after the first CATCH procedure, the system
can be resheathed to be used for another procedure, and
so on up to 5 procedures
CATCH Procedure (1/2)
Positioning and deployment
Positioning &
deployment
Clot & CATCH
retrieval
CATCH
resheathing
Use a 8F guiding catheter (ENVOY8F for example)
or a CORAIL8F+ or a long introducer (IVA6F80)
VASCO+21
Microguidewire
ORX CATCH
Run the VASCO+21 catheter through the
thrombus and position it at least at 2 cm
downstream from the thrombus
After removing the microguidewire, introduce the
CATCH into VASCO+21 and push it until it
reaches the tip of the catheter
ORX Pusher
ORX VASCO
Deploy the CATCH downstream out of the
VASCO+21
from the thrombus by pulling the catheter
The radiopaque marker of the pusher should be
at least 1cm from that of the VASCO+21
Do not push the CATCH out of the catheter: its tip may damage the artery
Using a CORAIL8F will allow to inflate the balloon to facilitate clot retrieval
CATCH Procedure (2/2)
Clot and CATCH retrieval
Positioning &
deployment
Clot &
CATCH
retrieval
CATCH
resheathing
If you use a CORAIL8F, inflate the balloon
Slightly pull back, with pauses, the assembly
CATCH+Catheter to move the thrombus down
to the guiding catheter,
Do not try to pull back the CATCH into the VASCO+21 catheter
When approaching the guiding catheter, turn
off its perfusion.
Get out the assembly CATCH+Catheter
through the guiding catheter
Suck the guiding catheter inner lumen (blood
and clot), with a syringe 20ml minimum
Turn on the guiding catheter perfusion
Clean carefully the CATCH
in a physiological serum or sterile water bowl and/or under a syringe jet
CATCH system can be re-used up to 5 times
if the resheathing procedure is strictly
respected
Positioning &
deployment
Clot &
CATCH
retrieval
CATCH
resheathing
Before resheathing the CATCH, carefully check if its basket is not
damaged
A HUB PACKED WITH THE CATCH ENABLES IT RESHEATHING
Trying to resheath the CATCH without the hub will destroy the basket
A hub is packed with the CATCH
to allow its correct resheathing
1
CATCH
VASCO+21
2
Resheathing hub
3
4
Pusher
Basket
Positioning &
deployment
Clot &
CATCH
retrieval
CATCH
resheathing
Take the basket + pusher
out of the VASCO+21 by
its distal tip
Insert the proximal part of the pusher inside the
proximal hole of the resheathing hub
Introducing
sheath
Insert the distal part of the introducing sheath
on the proximal part of the pusher
1
2
Introducing sheath
3
Resheathing hub
Gently pull on the
pusher until the basket
passes through the hub
inside the sheath
CATCH
4
Cases already done show a high success rate
for the CATCH system
EXAMPLES OF CASES
CASE
#1
Occlusion of the medium cerebral artery
(Pr René Chapot, Limoges - France)
CASE
#2
Occlusion of the basilar artery
(Pr René Chapot, Limoges - France)
CASE
#3
Occlusion of the medium and anterior cerebral arteries
(Pr Schroth and Dr Remonda, Bern - Switzerland)
CASE #1 : Occlusion of the medium cerebral artery
(Pr René Chapot, Limoges - France)
BEFORE
CATHETER POSITIONING
CATCH POSITIONING
Vasco+21
CATCH
microguidewire
Vasco+21
CASE #1 : Occlusion of the medium cerebral artery
(Pr René Chapot, Limoges - France)
CLOT RETRIEVAL
CATCH
Vasco+21
AFTER
RETRIEVED CLOT
CASE #2 : Occlusion of the basilar artery
(Pr René Chapot, Limoges - France)
BEFORE
CATCH POSITIONING
CATCH OPENNING
CATCH
CATCH
Vasco+21
CASE #2 : Occlusion of the basilar artery
(Pr René Chapot, Limoges - France)
CLOT RETRIEVAL
AFTER
RETRIEVED CLOT
CASE #3 : Occlusion of the medium
and anterior cerebral arteries
(Pr Schroth and Dr Remonda, Bern - Switzerland)
BEFORE
CATCH POSITIONING
CATCH
Vasco+21
CASE #3 : Occlusion of the medium and
anterior cerebral arteries
(Pr Schroth and Dr Remonda, Bern - Switzerland)
AFTER FIRST USE (Anterior Cerebral)
CLOT RETRIEVED
Frequently Asked Questions
Which guiding catheter do we use with a CATCH ?
Minimum guiding catheter diameter is 6Fbut the more the diameter is high, the less there is clot fragmentation risks during the retrieval. We
would advise a 8F guiding catheter. CORAIL8F is particularly indicated since the balloon inflation allows a very efficient thrombo-aspiration
in addition to mechanical retrieval.
Is one CATCH use sufficient to unblock an artery ?
In some cases, one use allow to completely retrieve the clot however, it is often necessary to go through several times, up to five times. This
can be done with the same device, if the CATCH is well resheathed according to the detailed resheathing procedure and is washed
according to IFU.
How do we have to wash the CATCH between two uses ?
You should shake the CATCH basket in a physiological serum bath. If some pieces remain in the basket, it is possible to use the pressure of
a syringe jet to get rid of them.
Do you have or Can you use fibrinolysis during CATCH use ?
Yes. Within the European multicentric study we are presently conducting, the protocol holds that, if the artery is not completely unblocked
after the CATCH first use, 20m rtPA should be locally injected with the microcatheter. After the third use, if the artery is not still completely
unblocked, a complementary rtPA local injection can be done with a total maximum of 0,9mg/kg rtPA.
In which arteries can the CATCH be used ?
CATCH can be used in any intracranial artery which diameter is at least 2mm.
For peripheral and venous sinus use, we developed another reference, CATCH9, with a bigger diameter from 5 to 10mm.
What is the CATCH success rate ?
We do not have yet any statistics. However, users’ feedbacks make us think that it will be far higher than MERCI success rate. Two
multicentric studies are under way to get a more precise estimation of this device success rate. Our first feedbacks, with experienced users
following the procedure described here above, give around 80% success rate.
Thank you!
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