1. A Review of All Available Self-Expanding Transcatheter Valve Clinical Results
Ganesh Manoharan
Consultant Cardiologist
Regional Cardiology Department
Royal Victoria Hospital
Belfast, UK

2. Disclosures
I am a consultant for: St. Jude Medical Medtronic CardioVascular GDS Inc

3. Self-Expanding TAVR Systems
Clinically approved (European CE Mark)
Transfemoral (+Other Access Route)
Transapical
Emerging Systems
Transfemoral

4. Transfemoral (+Other Access)

5. Medtronic CoreValve System
Trileaflet heart valve
Tissue valve sutured to frame
Single layer of porcine pericardium

6. CoreValve ® Full Range of Valve Sizes
26mm Valve
29mm Valve
31mm Valve
Annulus Size (mm)
AccuTrak® Stability Layer
7mm
15Fr Fr Fr
Over-the-wire compatible
18Fr delivery system for all
valve/annulus sizes and access routes
Annulus Size (mm)

7. Supra-Annular Valve Design
Flexible frame conforms to native annulus shape while maintaining bioprosthesis in a higher position
This decoupling of the valve from native annulus shape minimizes the impact of ellipticity at the valve level post deployment1
Data on file at Medtronic

8. CoreValve® Access Options
Direct Aortic
Subclavian
Transfemoral

9. Pacemaker Implantation Varies Between Studies
Procedural variability, anatomical
differences and clinical practice
variation impact pacemaker
implant rates:9,10
Depth of implant may induce conduction disturbances11
Valvuloplasty balloon size may impact conduction system11
Anatomical and patient-related factors may impact conduction disturbances12
Inter-hospital variability due to physician subjectivity, country-based healthcare norms and reimbursement strategies9
1. Medtronic Data on File. COR : 18 Fr Safety& Efficacy Study Re-Analysis, August 14, 2009.
2. Meredith IT. A Snapshot from the Ongoing Australia-New Zealand Medtronic CoreValve® Registry. Transcatheter Cardiovascular Therapeutics 2009, September 21-25, San Francisco, CA.
3. Avanzas P, Munoz-Garcia AJ, Segura J, et al. Percutaneous implantation of the CoreValve® self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain. Rev Esp Cardiol. 2010;63:
4. Eltchaninoff. French Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.
5. Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.
6. German Registry data on file. New pacemakers with Corevalve 240/565.
7. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.
8. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.
See Reference slide for sources 1-8
See Reference slide for sources 1-8
See Reference slide for sources 1-8
9. N. Piazza, “AV-Block and Pacemaker Requirements Associated with Medtronic CoreValve TAVI: Incidence, Outcomes and Treatment Strategies”, TCT 2009.
10. Latsios et al. Device Landing Zone” Calcification, Assessed by MSCT, as Predictive Factor for Pacemaker Implantation after TAVI. Catheter Cardiovasc Interv [Epub ahead of print].
11. N. Piazza, “AV-Block and Pacemaker Requirements Associated with Medtronic CoreValve TAVI: Incidence, Outcomes and Treatment Strategies”, TCT 2009.
12. N. Piazza, “Persistent Conduction Abnormalities and Requirments for Pacemaking 6 Months after TAVI”, PCR 2010. 9 9

10. Medtronic CoreValve® System Subclavian and Direct Aortic Approaches Summary of Clinical Experience
UC a_EE1P

11. Subclavian Access: CoreValve® System Procedure Success
Note: Procedure success definition varies among publications
1. Petronio AS. Italian Experience Subclavian vs. Transfemoral. Presented at TCT Laborde JC. TAVR Access Site Considerations. Presented at TVT Verkroost MWA. TAVI Using Left Subclavian Route. Presented at TCT Modine T. TAVI using Axillary/subclavian Access. J Thorac Cardiovasc Surg. 2011; 141(2).

12. Subclavian Access: CoreValve® System 30D Survival
1. Petronio AS. Italian Experience Subclavian vs. Transfemoral. Presented at TCT Gilard M. France 2 Registry. Presented at TCT Blackman D. UK Registry Comparison valve type and access approach. Presented at TCT Verkroost MWA. TAVI Using Left Subclavian Route. Presented at TCT Modine T. TAVI using Axillary/subclavian Access. J Thorac Cardiovasc Surg. 2011; 141(2).

13. Direct Aortic Access: CoreValve® System Dataset
A standard dataset was circulated to 19 centres who were believed to have carried out 3 or more cases in their individual centre.
A total of 115 cases had been performed in these 19 centres prior to 31/12/11
To date, a completed dataset has been returned from 12 of these centres

14. Results (N=93) 30 day Mortality In-hospital Stroke
9/93 (9.7%)
In-hospital Stroke
3/93 (3.2%)
Thoracic Aortic Dissection
0/93 (0%)
Life Threatening Bleed (VARC)
4/93 (4.3%)
Major Vascular Injury (VARC)
Conversion to Full Sternotomy
New Permanent Pacemaker
16/93 (17.2%)

15. CoreValve® US Pivotal Trial Study Design1-3
Extreme Risk Cohort
High Risk Cohort
CoreValve
Observational
CoreValve Single Arm
SAVR
Iliofemoral Access?
Up to 100
Randomization 1:1
395a
395
790
487 No
Alternative Access
Medtronic CoreValve US Pivotal Trial
Up to 45 Sites
Estimated Enrollment: 1497
Yes
Up to 587
aIncludes patients with iliofemoral and alternative access.
SAVR=surgical aortic valve replacement.
1. Medtronic CoreValve® U.S. Pivotal Trial. US National Institutes of Health Web site. Accessed 6/30/11.
2. Medtronic CoreValve® U.S. Pivotal Trial (Extreme Risk Patients). Version 7.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2011.
3. Medtronic CoreValve® U.S. Pivotal Trial (High Risk Patients). Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2011.
References:
Medtronic CoreValve® U.S. Pivotal Trial. US National Institutes of Health Web site. Accessed 6/30/11.
2. Medtronic CoreValve® U.S. Pivotal Trial (Extreme Risk Patients). Version 7.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2011.

16. Transapical System Approved for Clinical Use in Europe (CE Mark)

17. Jena Valve Ensures Coronary Flow -low profile
Maintains haemodynamics during deployment
Feeler guided anatomical positioning
Active fixation
-Unique Jena Clip
Partially retrievable and repositionable

18. Jena Valve Described as a 2nd generation TAVR device
Potential advantages:
Feeler guided anatomical positioning
Clip fixation on native leaflet
Device retrievability
CE mark in September 2011

19. Clinical Research Programme
FIH
CE Mark Study
Post-market
Proof of concept
Germany (Leipzig)
12 patients enrolled
(July April 2010)
Demonstrate safety and efficacy
Germany (7 centres)
73 pts(Nov2010-July2011)
FU ongoing
Primary endpoint: 30D mortality
Evaluation in real world
European centres
Approx 150 pts

20. Enrolled N=73 Withdrwan N=6 Procedure Initiated N=67 30 day FU N=66
Withdrawn=1

24. Symetis Acurate TA System

25. t

26. t

27. t

28. t

29. t

30. Emerging Technologies with Clinical Data

31. Heart Leaflet Technology

32. Direct Flow Medical Valve

33. Medtronic Engager Valve
Bovine pericardial valve
3 support arms for fixation at the valve leaflets
Nitinol frame for sealing in the LVOT

34. Sadra-BSC Lotus Valve Locking mechanism Bovine pericardium
Nitinol frame
Adaptive seal
Radial expansion with axial compression

35. Overview: SJM Portico 23mm Valve
St Jude Medical Portico Valve
Overview: SJM Portico 23mm Valve
General
18F (TF) Nitinol self expanding valve designed to be:
Fully re-sheathable*
Repositionable* (antegrade and retrograde) at the implant site
Retrieveable*
Bovine and porcine pericardial valve with Linx™ anti-calcification technology**
For annulus range: 19 – 21 mm
Cuff tissue and stent geometry designed to minimize PV leak
Implanted transfemorally without need for rapid pacing
* Until fully deployed
** There is no clinical data currently available that evaluates the long-term impact of anti-calcification tissue treatment in humans.

36. Access N Procedure success Complication Results Current Status
Device
Access N
Procedure success
Complication
Results
Current Status
Heart Leaflet Technology TF 9
N=5
X4 Tamponade
Death=3
Devise redesign: animal planned
Direct Flow Medical (22F) 31
N=20
X9 not done
X2 surgical conversion
Death = 2
71% survive at 2 yrs
18F system under evaluation
Medtronic Engager TA 10
N=10
X2PPM
Mortality=1(at FU)
Pivotal study to start
Sadra-BSC Lotus (18F) 12 NA
Reprise I (S&E) and Reprise II (CE Mark) to start
St Jude Portico (18F)
None at 30D
European CE Mark study started Dec 2011

37. Conclusions
TAVR landscape with self expanding technologies is expanding
Standardisation of event reporting (VARC) will allow more transparent comparisons to be made
Technological iterations will further enhance the safety and efficacy of this technique
Long term durability and outcome awaited