1. Panel Discussion:
What Should Be the Optimal Design for Percutaneous Aortic Valve Therapy?
Raoul Bonan, MD
Institut de Cardiologie de Montreal

2. Presenter Disclosure Information Raoul Bonan, MD
Scientific Advisory Board and/or Consultant
Medtronic Vascular
Clinical Research Agreements
Multiple Medical Device Clinical Investigations
Including CoreValve

3. TAVI wish list Ease of use Minimally invasive
Accurate deployment without support
Repositionable and retrievable
No para-valvular leak
No stroke
No or minimal conduction system disturbance
Multi sizes from 16 to 31 mm
Durability comparable to surgical valve

4. Ease of Use Low profile catheter system Flexible
Easily identify by X Rays and Echo
Achieving large AVA > 1.5 cm2

5. Minimally invasive Low profile catheter system
Versatility: Trans-Femoral, Axillary, Apical

6. Accurate deployment without support
Different part of the device easily identify
No or minimal aortic flow interruption
No need any support and pacing

7. Repositionable and Retrievable
During deployment
Axis
Para-valvular leak
Retrievable:
Size consideration
Specific anatomy

8. No para-valvular leak
Potential expansion to younger and healthier patients
Conformability to the annulus

9. No stroke
Embolic protection device

10. No or minimal conduction system disturbance
Balloon dilatation
Device:
Length
Stiffness
Level of implantation

11. Multi sizes from 16 to 31 mm
To accommodate from aortic valve stenosis to aortic valve regurgitation

12. Durability comparable to surgical valve
Actual bench data are equivalent
Expected equivalent long term quality

13. Material Selection Thickness Tensile Strength Pliability
Valve Design
Leaflet Geometry
Supra-annular Valve
Performance
Clinical Data
Bench Testing
In summary, CoreValve’s durability is the product of the proper material selection
matched with the right bioprosthetic valve design:
Porcine pericardium’s thin profile is well suited for transcatheter valve design and its strength far exceeds peak physiological pressures; it also is a pliable material that reduces stress by preventing the buckling and deforming seen in thicker tissue valves.
Additionally, CoreValve is designed to reduce stresses on valve leaflets through employing a high commissure and supra-annular valve location.
Since high leaflet stress contributes to valve tearing, delamination, and eventual
failure, CoreValve is uniquely designed and built for performance and durability.

14. Why a Team? Simple solution to a complex problem or
Complex solution to simple problem?
Multidisciplinary inputs, knowledge, competence and skills
Abolish “Turf” battle
Prepare the future

15. The TEAM “functional” multidisciplinary team .
- ≥ 2 interventional cardiologists.
- ≥ 2 cardiac surgeons.
- a dedicated cath-lab team
- a dedicated clinic with a nurse specialist
- dedicated imaging specialists.
- dedicated cardiac anesthetists.
- a (“elderly”) medicine specialist.

16. Knowledge /Competence
The TEAM
Before
During
After
Diagnostic
Skills
Immediate
Decision
Knowledge /Competence
Plan
Follow up
Backup plan
Closure / vascular
Communication

17. Information to patient, Family Inform consent Follow up
The Team Clinic
The Team
- Nurse specialist
- ≥ 2 interventional cardiologists
- ≥ 2 cardiac surgeons
The Set up
- specific office on a scheduled day
- concomitant visit with common decision
- evaluation and follow up
Multidisciplinary meeting
Once a week
Review data and confirm indication
Follow up
“Time”
Communication between the Team
Information to patient, Family
Inform consent Follow up

18. Diagnostic: Anatomic, Measures Before, During, After and Follow up
Imaging Modalities
Echocardiography (required)
TTE, TEE
Additional aortic root, AI, left ventricle, and mitral valve imaging
Angiography Imaging (required)
Coronary artery anatomy
Aortic root anatomy
Aortic arch anatomy
Abdominal aorta
Peripheral vasculature
CT Imaging (recommended)
Aortic root and arch anatomy
Abdominal aorta
Peripheral vascular anatomy
3D rendering
MRI
Purpose:
Which imaging modalities should be used to assess the suitability of a CoreValve candidate? Ideally, as many imaging modalities as possible should be used because the information obtained from each modality is complimentary and confirmatory.
As a minimum, two modalities should be used to assess a patient’s anatomical conditions. If there are any doubts or misgivings about the actual data – a third diagnostic modality should be used.
Diagnostic: Anatomic, Measures
Before, During, After and Follow up

19. Team Planning Day Before Procedure
Pre-evaluation of the procedure (IC, CS, CAnesth)
Review Risk Assessment and determine strategy accordingly
Confirm vascular access and procedural plan
Anesthesia local, general, assess airway intubation
Review anatomy (angulation, calcification, size, etc.)
Potential complications and treatments
Access site, choice of sheath (hemostasis, potential need for retrieval), closure, tortuosity, treatment of potential perforation …)
Reserve blood, bed, physiotherapy …
 Confirm availability of rescue equipment (snares, covered stents, closure balloons, etc.)
 Talk to patient and family
Obtain signed Inform Consent
Purpose:

20. Cath-Lab Equipment: the “Best” no compromise Personnel: “dedicated”
Hybrid room vs
Cath lab
Devices: “all”
Personnel: “dedicated”
Nurses
Cath lab tech
X rays tech
Echo tech
MDs

21. Desired skill set from Interventionalist
Experience with the different cath-lab procedures and devices (Aortic Valvuloplasty; this is the backbone of TAVI procedure. Cumulative experience of about BAVs will greatly increase operator comfort)
Working knowledge of TEE and CT
Knowledge of Peripheral Vascular Interventions/AAA procedures-large catheters, pre-closure techniques, covered stents, up and over technique etc

22. Desired skill set from the Surgeon
Experience with Percutaneous approaches
Endovascular skills:
Increases familiarity with wire skills and cath lab environment
Working knowledge of TEE and CT
Ability to play in the “sand-box” with the interventionalist

23. Team Cath-Lab Set up Communication Valve Preparation Table
Anesthesia
Monitors
Valve Preparation Table
Echo
Sterile Table
Other Back-up Equipment
Communication

24. Team Post Procedure surveillance
Hemodynamics
Heart Rhythm Disturbances
Bleeding Complications
Limb Ischemia
Deep Vein Thrombosis and Pulmonary Embolism
Neurological Complications
Renal Function
Infections
Gastrointestinal Complications
Purpose:

25. Team Follow up Evaluation pre-discharge: Follow up:
Clinical evaluation.
Heart rhythm disturbances, quality of vascular access and functional evaluation of the intervention
Follow up:
At the clinic
By the Team
Clinical and imaging evaluation

26. Conclusion Team work Time consuming
Total commitment and “respect” of the respective skills, knowledge and competence.
Training the Team together and improving communication.
Tailoring the future of the Structural Heart Intervention

27. CoreValve Bioprosthesis Design
Tissue mass distributed over greater height
More compressible
Smaller French size catheter
CoreValve Bioprosthesis Design
Suspension bridge concept L1 L2 L3
Static Frame
design =
Fixed post
equivalent
Even load (L) distribution
L1 = L2 = L3
Load absorbed equally by each point on leaflet commissures
NO frame flexing under load
Less tissue mass needed in post area