1. Embolic Protection Devices for Stroke Prevention during TAVI
CRT 2012
Washington DC, February 6, 2012
Embolic Protection Devices for Stroke Prevention during TAVI
Eberhard Grube MD, FACC, FSCAI
Universitatsklinikum Bonn, Bonn, Germany
Hospital Alemão Oswaldo Cruz, São Paulo, Brazil
Stanford University, Palo Alto, California, USA

2. Financial Disclosure
Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Physician Name Company/Relationship
Eberhard Grube, MD Medtronic, CoreValve: C, SB, AB, OF
Sadra Medical: E, C, SB, AB
Direct Flow: C, SB, AB
Mitralign: AB, SB, E
Boston Scientific: C, SB, AB
Biosensors: E, SB, C, AB
Cordis: AB
Abbott Vascular: AB
Capella: SB, C, AB
Valtech: E, SB,
Claret: SB
Key
G – Grant and or Research Support E – Equity Interests S – Salary, AB – Advisory Board
C – Consulting fees, Honoraria R – Royalty Income I – Intellectual Property Rights
SB – Speaker’s Bureau O – Ownership OF – Other Financial Benefits‘ 1

3. Neurologic events are probably widely undereported in registries.
Stroke after TAVI
Neurologic events are probably widely undereported in registries.
A detailed collaboration with the neurology service is a critical part of program building to standardize the evaluation after an event

4. Source for Emboli in TAVI Aortic Valve Degenerations3

5. Source for Emboli in TAVI Aortic Atheroma
268 of 3404 CABG patients (8%) had
atheroma (>/= 5 mm) defined by epi-aortic US
15.3% of group had intra-operative stroke
Stern et al. American Heart Journal Oct
1Protruding aortic arch atheromas: risk of stroke during heart surgery with and without aortic arch endarterectomy. Stern et al. American Heart Journal Oct
2Atheromas of the thoracic aorta: clinical and therapeutic update. Tunick et al. J. Am. Coll. Of Card. March 2000
3Atheromatous disease of the thoracic aorta and systemic embolism. Clinical picture and therapeutic challenge. Sheikhzadeh et al. Z Cardiol. Jan. 2004 4 4

6. Stroke by Procedure Stroke Rate Reference Isolated CABG 1.4-3.8% PCI
Review Article, Current Concepts of Perioperative Stroke, Selim N Engl J Med 2007:
PCI
0.38%
Stroke Complicating Percutaneous Coronary Interventions
Incidence, Predictors, and Prognostic Implications Fuchs Circulation2002;106
Isolated Valve %
Double Valve
9.7%
CABG + Valve
7.4%
More complex CABG and AVR/MVR procedures may benefit. 5 5 5 5

7. 84% SILENT STROKE following TAVI
J. Am. Coll. Cardiol. 2010;55; ; originally published online Feb 23, 2010;
Rolf Fimmers, Georg Nickenig, and Daniel Thomas
Werner, Christoph Hammerstingl, Hans H. Schild, Jörg O. Schwab, Fritz Mellert,
Alexander Ghanem, Andreas Müller, Claas P. Nähle, Justine Kocurek, Nikos
Resonance Imaging
Implantation: A Prospective Pilot Study With Diffusion-Weighted Magnetic
Risk and Fate of Cerebral Embolism After Transfemoral Aortic Valve
This information is current as of April 6, 2011
located on the World Wide Web at:
The online version of this article, along with updated information and services, is
Downloaded from content.onlinejacc.org by on April 6, 2011
Bonn

8. Cerebral Ischemia After TAVI Kahlert PK et al
Cerebral Ischemia After TAVI Kahlert PK et al. Circulation 2010;121:
New Lesions
Lesion Volume %
mm3 7

9. Overview on Current Publications on TAVI
Year of publication
Type of TAVI
Study Design
Device
Total patients
Age
Logistic EuroScore
Procedural success
Procedural mortality
30 day mortality
30 day stroke
Lichtenstein et al.
2006 TA
Single center
Edwards 7
80±7 35
100 - 14
Cribier et al. TF 36
~27 75
7.4
22.2
3.7
Webb et al. 18
26.2±13.1
77.8
11.1
Grube et al.
TF/TS
CoreValve 25 11 84 20 12
Walther et al.
2007
Multi center 59 27
93.2
13.6
3.4 50
82±7 28 86 2 4
Multi center (2)
82±6
21.7±12.6 88 6 10
Svensson et al.
2008 40
35.5 90
22.5
17.5
Piazza et al.
646
81±7
23.1±13.8 97
1.5 8
1.9
136
10.8
2.9
82±5
27.6±12.2 94
2009
TF/TA
168
28.6
94.1
1.2
11.3
4.2
Himbert et al.
82±8
26±13
93.3
Osten et al. 46
25.3 91
2.2
6.5
Thielmann et al. 39
81±5
44.2±12.6
2.6
17.9
Bleiziffer et al.
TF/TA/TS
Edwards/CoreValve
203
22±14
11.2
Buellesfeld et al.
2010
23.8±15.4
90.5
11.9*
Thomas et al.
Multi center (34)
1038
25.7 (TF)/29.1 (TA)
93.8
8.5
2.5
Rodés-Cabau et al.
Multi center (6)
339
1.7
10.4
2.3
Petronio et al.
Multi center (13)
514 83
20.1
98.6
0.8
5.4
1.8
Tchetche et al. 45
81.8±4.2
25.2±8.4
97.8
4.4
*in-hospital

10. TAVR Outcomes – VARC Meta-Analysis
17 Studies – 3519 Patients
Genereux et al JACC submitted

11. PARTNER Strokes

12. Timing of Neurological Events
AATS May, 2011 D. Craig Miller , M.D.
>53%
Periprocedural
AVR
TAVR
AVR
TAVR
AVR
TAVR
AVR
TAVR
AVR
TAVR
AVR
TAVR
AVR
TAVR
0-2
days
3-5
days
6-10
days
11-30
days
31-364
days
1-2
years
2-3
years
Bonn

13. What can we do to Reduce Stroke ?
New Embolic Devices
Anti platelet drug regiment, anti coagulant
Less invasive, smaller devices
Less pre-dilatation, careful positioning
Bonn

14. Embolic Protection SMT - Deflector
Clinical Phase
9F Transfemoral delivery
Claret Medical - Dual Filter (Montage)
6F Transradial or brachial delivery
Edwards/Embrella - Deflector

15. SMT – SHEF Device

16. Claret Dual Filter “Montage” (2nd Gen.)
Proximal Filter
Distal Filter 20

17. Clinical Data – FIM Study Outline
Pilot Study to evaluate safety and effectiveness of the Claret Medical filter
Multi-Center, prospective study
Sites: Germany (Elisabeth-Krankenhaus Hospital – Essen and Sigmund-Freud University Hospital – Bonn, Dante Pazzanese, São Paulo, Brazil)
Drs. Eberhard Grube, Christoph Naber, Georg Nickenig, Alex Abizaid
Primary Endpoint: Technical Success (Delivery and Retrieval)
Devices Used during TAVI:
Medtronic CoreValve 26 mm Aortic Valve
Medtronic CoreValve 29 mm Aortic Valve
Edwards Sapien 23 mm Aortic Valve
Edwards Sapien 26 mm Aortic Valve
Numed Valvuloplasty Balloon (various sizes)
TAVI Introduction Sites: Trans-Femoral and Left Subclavian

18. Embolic Material found in 95% of cases
Clinical Data – Patient Demographics
Number of Patients Treated
N=40
Access
(4) Radial / (36) Brachial
Patient Age (avg)
76-91 (82.8)
Female / Male
21/19
EuroSCORE
10-35
Valve Manufacture
38 – CoreValve (95%)
2– Edwards Sapien (5%)
Current Average Deployment Time
4 minutes
Brachiocephalic Filter Placement
38/40 (95%)
Left Carotid Filter Placement
37/40 (93%)
Embolic Material found in 95% of cases

19. Variety of Emboli Captured & Removed
Embolic Material

20. Variety of Emboli Captured & Removed
Embolic Material

21. Variety of Emboli Captured & Removed
7 mm
3.5 mm
7 mm
16 mm Diameter

22. Emboli Captured & Removed
7 mm
3.5 mm
7 mm
16 mm Diameter
Courtesy Thoraxcenter Rotterdam, Dr N. van Migelen

23. Embrella Embolic Deflector®
Porous membrane designed to deflect embolic debris
Nitinol® Frame & Shaft
Hydrophillic Coating with antithrombogenitc properties
3 Radiopaque Markers
Suture; Monofilament Nylon 28 28

24. Embrella: Study Centers
Site Number
Center
Principal Investigator
Number of Subjects Enrolled 01
St. Paul’s Hospital
Vancouver, BC
John Webb, M.D. 5 02
HELIOS Hospital Center
Siegburg, DE
Ralf Müller, M.D.
Ulrich Gerckens, M.D. 10 03
University Hospital
Hamburg, DE
Joachim Schofer, M.D.

25. Average Number of Lesions/Subject
6.0
4.69
3.2
Although statistical significance was not met, the data suggest a trend toward reduction in new lesions.
* Embrella subjects 1 BAV, 14 TF TAVI
**Ghanem et al, J Am Coll Cardiol 2010;55:1427–32 (TF TAVI)
***Astarci et al, Abstract presentation EACTS 2010 (TF TAVI) 31 31 31

26. Summary
Stoke due to embolized plaques from the arch or the diseased native valve remains an issue with variable reported incidences ( %)
Event range in reported studies is partially due to differences in endpoint definitions which is now taken care of by the joint VARC efforts
Various protection tools are currently in development with remarkable demonstration of usefulness and efficacy
We have to learn more about embolic risk predictors, dividing patients in low risk and high risk, who are likely to benefit from protective tools.
Until then......

27. Summary
Given prior surgical and present TAVI experiences with new cerebral lesions occuring in up to 84% of cases…
and given the highly embolic environment within the aortic arch and the valve…
TAVI procedures should be performed under cerebral protection in order to lower or even eliminate procedurally caused cerebral events!
The embolic material that we are liberating during the TAVI procedure cannot be beneficial to our patients. 33

28. Thank you!