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

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

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

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

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

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

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

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

No stroke Embolic protection device

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

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

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

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.

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

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.

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

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

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

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:

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

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 50-100 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

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

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

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:

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

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

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