1. The Method of Embolic Protection has Important Implications in CAS Outcomes
Gary M. Ansel, MD, FACC, SCAI
Riverside Methodist Hospital
Columbus, Ohio

2. Gary M. Ansel, MD Honoraria: Consulting Fees: Cardiometrics
W.L. Gore and Associates,Inc./Embolitech
Consulting Fees:
Cardiometrics
Covidien/Ev3
Flexible Stenting Solutions
Nellix, Inc.

3. Vascular Think Tank/Becher VSG Vatrix Medical Best Doctors
Consulting Fees:
Nexeon
Ostial Solutions
SimSuite
Vascular Think Tank/Becher VSG
Vatrix Medical
Best Doctors
Vascular Performance Products

4. Royalty:
Veryan/Novate
Ownership Interest (stock, stock options, or other ownership interests):
Embolitech

5. My presentation will include off label discussions: Stents

6. I’m not going to debate this to win!!
No More Absolutes About Carotid Disease It is hurting our patients and Medicine in General

7. Everyone is talking absolutes and in doing so taking away physician decisions and patient options

8. The Lure of Carotids is Like “ The Carotid RING”

9. We Realize CMS wants to CONTROL the Carotid Ring
but not just this Ring, all Rings

10. Others also want to deny patient choice and want the “ring” of power

11. We know the government does not have a Hippocratic oath but what about US!

12. Richard Cambria and SVS
Signing on the the AHA carotid position statement and at the same time writing a negative position for SVS?
Maybe now we know why it took so long to get their own board!

13. Even The Neurologists Like Tom Brott and Anne Abbott Cannot Resist the Power of the Carotid Ring and Resort to Data Decption

14. So what about this topic
So what about this topic? I respect Horst but I have a strange feeling that the “carotid RING” may effect him too.

15. There are those of us that take care of patients long term

16. Embolic Protection Devices (EPD) Bottom LIne
There is no level 1 support documenting superiority of one EPD over another
Both proximal and distal protection have a role and physicians can be educated when which may best serve the patient’s procedure

17. Distal embolic protection Proximal embolic protection

18. Distal Protection Upside Intuitive Maintain flow (excl. bln)
Perfusion
Visibility
Low Profiles
Downside
Pass lesion unprotected
Suitable landing zone
Wall apposition (excl bln)
Tight lesions
Tortuosity
System stability
Pores allow some embolization (excl bln)

19. Proximal Flow Protection
Upside
Near total protection
Wire freedom
Not effected by ICA anatomy
No landing zone
No need to straighten tortuosity
Severe stenoses
? Choice for high risk lesion
Downside
Larger profile (9-fr)
Intolerance (3-8%)
New mechanism to learn
May be ECA dependent

20. Old confusing statements
Room to Improve
Lower profile
Wall apposition
Pore size
Foot plate
Wire independence
Wire transitions

21. Typical Distal EPD Anatomic Struggles
Distal tortuosity
Short landing zone
Acute angle

22. EMPiRE (WL Gore): MAE by Subgroup (Stroke, Death, MI)

23. Results 1° Endpoint 75y 30d Results (ITT & Full Population)
30d Results by Symptoms and Age (ITT)
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75y 23 23

24. Comparison of TCD counts
Wire
Stent
Balloon
Total
MES counts (filter)
25 +/- 22
73 +/- 49
70 +/- 31
196 +/- 84
MES counts (MO.MA)
1.8 +/- 3.2
11 +/- 19
12 +/- 21
57 +/- 41
(p < ).

25. Recent DEP devices have excellent results

26. Outcomes of DEP CAS Trials Over Time
CAS results have improved over time due to:
1) more experience; (2) better patient selection ; (3) technology
Year: 2000
Year: 2008
(Enrollment: ) CREST – 5.7%
(Enrollment: ) CREST – 1.1% 26

27. Proximal Intolerance

28. Effect different neuroprotection systems on microembolization
Distal EPD (filter wire) vs Proximal protection (MO.MA)
N = 42
Transcranial doppler
Single center
nonrandomized
Schmidt et al. J Am Coll Cardiol;2004 Nov 16;44(10):1966-9

29. Stroke 2011;42:675

30. Why you can’t compare registries
Besides from the well known reasons…
Not randomized
Different timings
Learning curve effect
More aggressive on pts selection with experience
Different patient population (symptoms, age, morphology)
Different inclusion and exclusion criteria
Different operators experience
Difference in end point definition
Difference in end point calculation and reporting

31. Riverside Methodist Hospital: Single Center “Octogenarian” Outcomes in Controlled Trials over a 10-year period

32. RMH Octogenarians 1998 - 2008 > 90% combo IC and NIR
All patients from formal trials
All patients with formal independent Neuro
4 IC operators, 2 NIR
Single center, non-peer reviewed at present

33. RMH Octogenarians N = 154 Symptomatic state = 17% EPD utilized = 83%
Single center, non-peer reviewed at present

34. RMH Octogenarians Results Peri-procedural (24 hours)
Major stroke = 0
Minor stroke = 1 (0.6%)
MI = 0
Death = 0
30 - Day new events*
Major stroke = 0
Minor stroke = 0
*(93% f/u)
Single center, non-peer reviewed at present

35. Summary: No one best way Treat the patient

37. High Volume Center Multicenter Registry
Octogenarias (83.2 ｱ 2.8 yrs) M
Male (63.2%)
Independent Neuro evaluation
Asymptomatic in two-thirds (68.2%)
Characteristics
coronary artery disease (74.4%)
hypertension (87.8%)
dyslipidemia (71.1%)
Diabetic (30.1%)
Tobacco use (56.5%)
Publication pending

38. Results (EPD) utilized in 78.7%*
The 30-day incidence of stroke and death was 2.8% (11/389)
* Lack of EPD was secondary to cases done prior to EPD availability