1. Proximal Embolic Protection Devices CRT 2013
Washington, DC, USA, Feb 23-26, 2013
12min
Proximal
Embolic Protection
Devices
Horst Sievert, Ilona Hofmann,
Laura Vaskelyte, Stefan Bertog, Wolf Stelter, Simon Lam, Sameer Gafoor
CardioVascular Center Frankfurt - CVC,
Frankfurt, Germany .

2. Horst Sievert, MD Consulting:
AccessClosure, Inc., AGA Medical Corporation, Ardian, Inc., Arstasis, Inc., Atritech Atrium Medical Corporation, Avinger, Inc., Bard Peripheral Vascular, Inc., Boston Scientific Corporation, Bridgepoint, CardioKinetix Inc., CardioMEMS, Inc., Coherex, Inc., Contego, CSI, EndoCross, Endotex Interventional Systems, Epitek, Evalve, Inc. and ev3, Inc.

3. Horst Sievert, MD Consulting:
FlowCardia, Inc., Gore, Guidant, Lumen Biomedical,
Inc., HLT, Kensey Nash Corporation, Kyoto Medical, Lifetech,
Lutonix, Inc., Medinol, Medtronic, Inc., NDCNMT Medical, Inc.,
OAS, Occlutech Osprey Medical, Inc., Ovalis, Inc., Pathway
Medical Technologies, Inc., PendraCare International B.V., Pfm
Medical, Inc., Rox Medical, Recor, Sadra Medical, Sorin
Biomedica Cardio S.R.L.,and Spectranetics Corporation, Trireme, Trivascular and Viacor, Inc.

4. Horst Sievert, MD
Honoraria: Veryan, Ardian, Inc., Atritech, Atrium Medical Corporation, Boston Scientific Corporation, CardioKinetix Inc.,
CardioMEMS, Inc., Coherex, Inc., Contego, Epitek, Evalve, Inc.,
Guidant,Gore,Kyoto Medical, Lutonix, Inc., Medinol, Medtronic, Inc., Pfm Medical, Inc., and Spectranetics Corporation.

5. Horst Sievert, MD
Honoraria: Viacor, Inc., HLT, Lifetech, Recor, Trivascular, Veryan, CVRx, GDS and InSeal Medical.

6. Creates multiple paths for blood to supply the brain
Circle of Willis
Creates multiple paths for blood to supply the brain
Principle is used for proximal embolic protection
Block the CCA
Open the Guide Cath

7. The external carotid artery also has to be occluded to avoid backflow
Occlusion of the external carotid artery
The external carotid artery also has to be occluded to avoid backflow
Angioplasty Balloon
The Arteria and Moma devices are very similar. They prevent distal embolization by establishing a retrograde flow in the internal carotid artery. First the balloon is inflated in the common carotid artery. To avoid blood flow from the external carotid artery, the external carotid artery is is occluded with a seperate balloon mounted on a wire which is introduced through the lumen of the guiding catheter.
Occlusion of the common carotid artery

8. Advantages of Proximal Occlusion Devices
Protection before crossing
Wire of your choice
No distal landing zone required
No distal spasm, dissection
Angiography possible during occlusion
Small particles are kept back

9. Any data?
Yes!

10. Microemboli Counts During Different Phases of CAS
Schmidt A, et al; JACC 2004; 44:1966-9

11. MOMA vs Filter Filter MOMA
MES Counts During Carotid Stenting Phases
Single center randomized study of MO.MA vs Filters to assess microembolization with TCD in high risk lipid plaques
Carotid Vessel Evaluation by CTA and Doppler Ultrasound
Filter
MOMA
Montorsi et al. JACC 2011

12. DWMRI Subgroup MO.MA Filter # new lesions 7 38 # pts with new lesions
14.2%
42.8% T2
DWI
ADC
Montorsi et al. JACC 2011

13. PROFI Study p < 0.001 62 consecutive patients
Prospective, randomized
p < 0.001
Bijiklic K et al., J Am Coll Cardiol 2012 Jan 19. [Epub ahead of print]

14. CREST (Accunet Filter) 30 Day Results: Stroke%
P<0.01
Driven by minor strokes,
no difference regarding major stroke
Brott et International Stroke Conference 2010

15. Prospective controlled registries with proximal occlusion have 30-day death/stroke rates < 3.0 %

16. CVC Frankfurt Carotid stenting with proximal protection
120 consecutive patients
Major stroke: zero
Minor stroke: zero

17. How to do it?

18. Gore Flow Reversal System
Balloon Sheath
Balloon Wire
External Filter
Balloon Sheath
Balloon Wire
External Filter
Not FDA approved

19. Endovascular Clamping MO.MA
External carotid balloon
Common carotid balloon
Aspiration of Debris with Syringe

20. "That's too complex for me!"

21. Which one is more complex?
Filter
Access to CCA
Sheath
Filter  ICA
Pre-dilatation
Stent
Post-dilatation
Filter retrieval
Final angio
Prox Occlusion
Access to CCA
"Sheath"
Balloon  ECA
Pre-dilatation
Stent
Post-dilatation
Aspiration
Final angio

22. When do you feel save? Filter Prox Occlusion Access to CCA Sheath
Filter  ICA
Pre-dilatation
Stent
Post-dilatation
Filter retrieval
Final angio
Prox Occlusion
Access to CCA
"Sheath"
Balloon  ECA
Pre-dilatation
Stent
Post-dilatation
Aspiration
Final angio

23. Step by step
Angled hydrophilic wire to the distal external carotid artery followed by 5F diagnostic catheter
Stiff wire 300cm
Advance MOMA or Gore Flow Reversal into external carotid artery
External occlusion balloon:
MOMA: Bring into position and inflate
Gore: Insert external occlusion balloon into the ECA, pull back the guiding catheter, bring external occlusion balloon into position and inflate

24. Step by step Inflate common occlusion balloon
Make sure that balloons are occlusive and that there is no flow from other branches
Open stop-cock to start flow reversal
Cross lesion, predilate, stent, post-dilate
Aspirate at least 100 cc (slowly!)
Control angiogram
Deflate common occlusion balloon (under aspiration)
Deflate external occlusion balloon
Retrieve external occlusion balloon
Final angiogram

25. Case Example 71 yrs, male Right hemispheric stroke 2 weeks ago
Recurrent stroke 1 day ago
Concomitant diseases
Intermittent atrial fibrillation
Arterial hypertension
Coronary artery disease

26. MR Angio Proximal stenosis of the right ICA
Ostial lesion of the brachiocephalic trunk
Aortic arch type III

27. Ostial Stenosis of Brachiocephalic Trunk2

28. Intermittent Flow in the right ACA3

29. Tight bifurcation stenosis Thrombus in the ICA7

30. Filter: Prox occlusion
Too risky due to thrombus distal of the stenosis
Prox occlusion
How to occlude the ECA?
Do we have to occlude the ECA at all?
MOMA or Gore Flow Reversal? 7

31. Gore Flow Reversal guiding catheter
introduced over an Amplatz Extra Stiff wire into the distal CCA 8

32. Proximal occlusion balloon in the CCA is inflated
There is still flow from the ECA into the ICA !!
What else is bad?
What to do now? 11

33. Gore Guiding catheter positioned more proximal14

34. Gore Guiding catheter positioned more proximal
Occlusion balloon for the ECA 15

35. Both occlusion balloons are inflated …
… but something is still bad 16

36. Both occlusion balloons are inflated …
… persistent flow into the ICA !!
No protection!
What to do now? 16

37. Distal occlusion balloon repositioned
Complete protection 18

38. Carotid Wallstent 21

39. Carotid Wallstent
Post-dilatation 22

40. Angiogram under protection
Carotid Wallstent
Post-dilatation
Angiogram under protection 24

41. Final result 30

42. compared to distal filters?
Any disadvantages
compared to distal filters?
May be more difficult in
Contra-lateral occlusion (intolerance)
Isolated hemisphere (intolercance)
Patients with additional
external carotid artery stenoses (more difficult to occlude)
common carotid artery stenoses (landing zone for CCA balloon?
It is easy to make mistakes
No retrograde flow because the stopcock is closed
No aspiration before contrast injection
Operator panics because of patients intolerance
"all or nothing"
There is zero protection if the occlusion balloons are not stopping the flow

43. MOMA or Gore Flow Reversal?

44. MOMA Advantages Disadvantages One single unit (easier to handle)
8F version available
Disadvantages
No flow reversal, only blockage
Solution: open prox stopcock
The single-unit concept may have disadvantages
Occlusion of external carotid artery
Common carotid artery stenoses
Very angulated common carotid artery

45. Gore Flow Reversal Advantages Disadvantages
External occlusion balloon and guide catheter are separate
Occluded external carotid artery is not a problem
Free choice of landing zone in the common carotid artery
Flow reversal instead of only flow blockage
Disadvantages
Comes in multiple parts which have to be mounted together
Much more expensive

46. Trouble Shooting Flow via side branches Intolerance:
Reposition occlusion balloons
Gore: 2nd occlusion balloon for large side branch
Additional aspiration may overcome flow from side branches
Intolerance:
Do not panic, do not deflate the balloons!
Do it stepwise (aspirate and deflate between the steps of the procedure)
Difficulties to remove the external occlusion balloon
Don't pull strongly! Gently re-inflate and deflate

48. Thank You! 31