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- Flow Diversion- Multidevice Experience

Hans Henkes

Clinic for Neuroradiology Neurocenter, Klinikum Stuttgart, Germany

Polenov’s Readings, Sankt Petersburg, April 14th 2016

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- Flow Diversion- One center, Two devices

Hans Henkes

Clinic for Neuroradiology Neurocenter, Klinikum Stuttgart, Germany

25 minutes presentation

10 statements

5 minutes discussion

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Sample period: 9/2009 – 3/2016

920 FD procedures in 695 patients with 789 aneurysms or other targets 546 p64(+) procedures 310 PED(+) procedures 49 p64 + PED procedures 15 failed attempts

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472 saccular aneurysms 334p64 123PED 7p64+PED 8f.a. 248 fusiform aneurysms 131p64 89PED 24p64+PED 4f.a. 107 dissections 46p64 55PED 6p64+PED 0f.a. (+19 CCF, +63 acute artery occlusions, 10 thrombus fixation)

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Procedures

Retrospective analysis (per procedure) Total number of procedures

546 310 49 no complication* 486(89%) 261(84%) 37(75%)

any complication* 60(11%) 49(16%) 12(25%)

*of potential clinical relevance

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Safety

3 1 2 mo y y % Complete 56 76 84 Minor remnant 19 11 12 Failure 25 14 5

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Follow-up: saccular @

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PTA for ISS: 26 patients

Retreatment: performed or planned 97

mRS worsening: 21 / 695 patients (3.0%)

FD thrombosis: 25 / 695 patients (3.6%)

25 / 920 procedures (2.7%):

13 asymptomatic, 10 symptomatic (3 mRS), 2 fatal

12/298 (2.3%) PED; 10/ 433(0.9%) p64

Mortality: 32/695 patients (4.6%)

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10

Cessation of antiaggregation...

Issues

5.5.2010 9.3.2012

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Issues

Patient stopped ASA and Clopidogrel without reason

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Cessation of antiaggregation...

Issues

20.3.2014 9.10.2014

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Issues

Cessation of antiaggregation...

5.12.2014 pre LIF 5.12.2014 post LIF

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Cessation of antiaggregation...

Issues

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Issues

Vascular surgeon stopped

ASA and Clopidogrel

for minor reasons

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Unorthodox measures

“Flow Diversion” is not a generic term, it is a

concept which can be executed with different

tools, including a variety of flow diverters

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#1 FD Concept

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#1 FD Concept

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#1 FD Concept

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#1 FD Concept

The usual suspects are Pipeline (Flex, Shield) (Medtronic)

SILK (+) (Balt Extrusion) Surpass (Stryker)

p64 (phenox)

FRED (Microvention)

and others to come; understand the differences

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#2

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#2 Most popular

Only FDA Approved FD

Most widely published

Largest clinical experience

73% complete occlusion at 6 months in PUFS

Solid theory behind it

Seeking FDA approval

Usage requires effort

75% complete occlusion at 6 months

Double layer concept

Seeking FDA approval

Easy to use

73% complete occlusion at 6 months

Controlled detachment

CE mark

Easy to use

79% complete occlusion at 9 months

Oldest FD on the market

CE mark

Easy to use

83% complete occlusion at last F/U – Canadian Registry

48 strand NiTi FD

CE mark

“Poor visibility”

No published data

PED

Surpass

FRED

p64

Derivo

SILK

Select the right target for FD - side-wall aneurysms are most suitable

- repair of arterial dissections

- blister aneurysms

- collateralls, filling an aneurysm

- a few bifurcation aneurysms

- direct CCFs (became rare)

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#3

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Premium indication for FD are

sidewall aneurysm

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sidewall aneurysm

8/2014

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sidewall aneurysm

11/2014 5/2015

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Another indication for FD

bifurcation aneurysm with blister

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bifurcation aneurysm

2/2014

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bifurcation aneurysm

4/2014

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bifurcation aneurysm

4/2014 coil occlusion of the superior sac

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bifurcation aneurysm

5/2014 pre p64

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bifurcation aneurysm

5/2014 post p64 3/12

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bifurcation aneurysm

5/2014 pre p64

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bifurcation aneurysm

8/2014 F/U#1

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bifurcation aneurysm

2/2015 F/U#2

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Another indications for FD

dissections and collaterals

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Collateral

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Dissection

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Dissection

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Collateral

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Another indication for FD

direct CCF

Direct CCF

Direct CCF

Direct CCF

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Another indication for FD

bifurcation aneurysm with slip stream FD effect

(the aneurysm is under the effect of but not covered by the FD)

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Slipstream

4/2014

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Slipstream

4/2014

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Slipstream

4/2015

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With the available devices all patients need dual platelet

function inhibition prior to and after FD

Efficacy of the medication has to be tested and corrected if

necessary

#4 Response testing

Hyperresponse

60 year old female patient

right MCA aneurysm, incidental, surgery

BA / right SCA aneurysm, incidental, FD

acute right subdural hematoma

Hyperresponse

Hyperresponse

Hyperresponse

Hyperresponse

02.06.2016 Prof. Dr. Vorname Nachname Themennennung

Seite 55

7.2.2015 excessive platelet inhibition with 50 mg ASA PO and ½ 75 mg Plavix PO daily, now ½ 75 mg Plavix every other day

Hyperresponse

02.06.2016 Prof. Dr. Vorname Nachname Themennennung

Seite 56

6.5.2015 adequate platelet inhibition with 50 mg ASA PO and ½ 75 mg Plavix PO daily

Hyperresponse

53 year old male patient

MRI 16.10.2014: large aneurysm of the proximal basilar artery, partially thrombosed, mass effect

15.04.2015: VP shunt prior to the endovascular treatment

MRI 17.04.2015: aneurysm enlarged

Hyporesponse

Treatment on 17.04.2015

Anesthesia, medication: premedication with 1x 500 mg ASA IV und 1x 180 mg Brilique PO on the day of treatment; general anesthesia; medication: 3000 U Heparin IV, 500 mg ASA IV, 0.5 g Trapanal IV, 7.9 ml Integrilin IV (2 mg/ml); 2 ml Integrilin IA (2 mg/m); 40 mg Fortecortin IV

Hyporesponse

Treatment on 17.04.2015

Coils: 1x Morpheus 3D 10/30; 4x HydroCoil 10/20

Stent: 1x Enterprise2 4/39 mm (basilar artery / rt VA V4)

Flow diverter: 2x p64 4/24 mm (basilar artery / rt VA V4)

Hyporesponse

10/2014

10/2014

10/2014

10/2014

04/2015

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Treatment

pre, 17.4.2015

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Treatment

post, 17.4.2015

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Follow-up

ceMRA, 20.4.2015

Case Report

Post-medication

Medication since 18.04.2014: 1) 100 mg ASA PO daily forever (1-0-0) 2) 2x 90 mg Brilique (1-0-1) PO daily for 1 year 3) 2x 3000 U MonoEmbolex s.c. daily for 3weeks

4) 3x 4 mg Fortecortin daily for 3 days, tapering 5) 1x 400 mg Ibuprofen PO daily for 3 weeks (0-0-1) 6) gastric protection (e.g., Ranitidin, Pantozol) during steroid therapy 7) all other medication as before

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Multiplate

17.4.15 post loading 18.4.15 post Tx 24.4.15 post Ibuprofen

ADP

ASPI

TRAP

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pre aTE

pre aTE, 24.4.2015

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post aTE

post aTE, 24.4.2015

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MRI post aTE

Eur J Clin Pharmacol. 2013 Mar;69(3):365-71 Interference of NSAIDs with the thrombocyte inhibitory effect of aspirin: a placebo-controlled, ex vivo, serial placebo-controlled serial crossover study.

Meek IL, Vonkeman HE, Kasemier J, Movig KL, van de Laar, MA

RESULTS: Ibuprofen and naproxen inhibit ASA's antithrombocyte effect below the nonresponse threshold..

CONCLUSIONS: COX-1 affinity determines the interaction between NSAIDs and ASA on thrombocyte adhesion and aggregation. Ibuprofen and naproxen, … taken 2 h before ASA, significantly inhibit ASA's antithrombocyte effect.

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Hyporesponse on antiplatelet medication may result in thrombosis of the FD.

Hyperresponse is the cause of severe hemorrhagic

complications (e.g., SDH, ICH) and can prevent aneurysm

obliteration

#4 Response testing

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FD are iStents expect the preservation of side

branches, even after the aneurysm is obliterated

#5 Side branches

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Side branches

12/2014

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Side branches

4/2015

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Adding coils (just 1 or 2) enhances the efficacy of flow diversion in saccular aneurysms

#6 Additional coils

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Additional coils

pre 5/2014

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Additional coils

post 5/2014

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Additional coils

F/U 8/2014

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FD can be a viable option for aneurysms recurrent after (repeated) coil occlusion

#7 FD for recurrent @

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FD for recurrent @

pre recoiling 12/2011

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FD for recurrent @

post recoiling 12/2011

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FD for recurrent @

pre recoiling 6/2012

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FD for recurrent @

post recoiling 6/2012

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FD for recurrent @

pre recoiling 10/2012

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FD for recurrent @

post recoiling 10/2012

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FD for recurrent @

pre recoiling & FD 11/2012

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FD for recurrent @

post recoiling & FD 11/2012

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FD for recurrent @

post recoiling & FD 11/2012

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FD for recurrent @

F/U 1/2013

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FD for recurrent @

F/U & pre FD #2 1/2013

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FD for recurrent @

F/U & post FD #2 1/2013

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FD for recurrent @

F/U 3/2014

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FD for recurrent @

F/U 10/2014

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FD for recurrent @

F/U 10/2014

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Telescoping two identical FD may enhance the hemodynamic effect, combining two different

FD does it more reliably

#8 combine different FD

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Combine different FD

2 FD, matching braids, braids of same braiding angle

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Combine different FD

2 FD, non-matching braids, braids of same braiding angle

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Combine different FD

2 FD, non-matching braids, braids of different braiding angle

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1x 4 mm FRED, 1x 4 mm p64 24.9.2013

Combine different FD

103 1/2014 10/2014

Combine different FD

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In-stent stenosis is mostly benign and transient

#9 In-stent stenosis

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In-stent stenosis

blister @ seen intra OP 4/13

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In-stent stenosis

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In-stent stenosis

post p64 4/13

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In-stent stenosis

F/U 7/13

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In-stent stenosis

F/U 6/15

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Beware of FD

you might become addicted

#10 Warning

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Conclusion

While treating aneurysms, flexibility is the key…