My Choice For Percutaneous Mitral Valve Replacement. Jose Luis Navia, MD.

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1 My Choice For Percutaneous Mitral Valve Replacement Jose Luis Navia, MD.

2 Disclosure Edwards Lifescienses St. Jude Medical MAQUET NaviGate Consultant, Investigator Consultant, Investigator Consultant, Investigator Scientific Board Commitee

3 % of Population Baby-Boomers now > 60 U.S. Population over Age to Year

4 Mitral Valve Disease and AFib % Age

5 Mitral Disease is Split into Two Distinct Patients Populations Degenerative (DMR) Functional (FMR) Definition: The mitral valve has a physical deformity in need of repair due to congenital or rheumatic disease Dilated heart stretches open the mitral valve causing it to leak or regurgitate Prevalence: Over 2 Million Worldwide Over 5 Million Worldwide

6 Surgical Platforms for Mitral Valve Repair/Replacement Small Incisions Right Thoracotomy Robotics Median Sternotomy

7 Deaths (%/year) Survival (%) Mitral valve repair for posterior leaflet prolapse compared with expected survival of an age- and sex- matched US population Years Ann Thorac Surg 2010; Johnston

8 Surgical Studies Indicate MV Repair is the Treatment of Choice for FMR Short term Survival Long term Survival Patients in the MVR group had 2.5 times lower short term risk of death Patients in the MVR group had a 35% lower long term risk of death Vassileva C. M. et al.; Eur J Cardiothorac Surg 2011;39:

9 Mitral Valve Repair/Replacement Through One of these Surgical Platforms is Effective in Every Form of Degenerative or FMR.

10 Why Percutaneous Mitral Valve Therapy?

11 Reasons for Percutaneous Mitral Valve Therapy Patients with Mitral Valve Regurgitation present a large clinical unmet need for therapeutic advances, specially high risk patients unsuitable for open heart surgery. Large Underserved Patient Population Tremendous Opportunity for Growth

12 The field of percutaneous mitral valve therapy has progressed at much slower pace than anticipated clinical introduction. Different Causes of the Mitral Disease. Complexity of Valvular Anatomy. Challenge Imaging Technology. Devices, Delivery Issues.

13 What PMVR Must Do: Delivery the device Transseptal, transatrial or transapical. Deploy the implant in Proper Position. Securely Anchor the implant. Ensure proper hemodynamics. Avoid LVOT obstruction. Avoid conduction system issues. Preserve Subvalvular apparatus. Have No PVL / Residual MR. 4 keys: Delivery, Fixation, Residual MR, SAM

14 Percutaneous MVR Technologies

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16 Fixation Mechanisms

17 Delivery Access Routes

18 Principle Device CardiAQ Valve Perhaps Procedure: the most advanced replacement program. * 30F femoral Self-positioning vein access chordae-sparing Transseptal replacement approach. valve is a two level construct consisting * Nitinol prongs a tissue in the valve valve inside superstructure a self-expanding nitinol grab the frame. mitral annulus, relies on axial clamping rather than radial force. * Device is positioned largely in the LA.

19 CardiAQ TMVR System Multiple access routes Transfemoral successful FIH June 2012 Transapical successful FIH May 2014 Controlled deployment Multi-stage deployment Accurate positioning Self-positioning within native valve annulus Intra/supra annular placement to preserve LV contractility and maximize LVOT area Secure anchoring Preserves native chordae and leaflets Anchoring without radial force

20 CardiAQ Final Release

21 Post-procedural imaging

22 Early clinical experience with CardiaQ

23 US Approval IDE Approval received April 9 th, patients Early Feasibility Study for 10TF and 10TA Primary Endpoint:30 day MAE(Mitral VARC Def.) Secondary: Procedures success, MR reduction. High Risk Surgical Candidates are included. Up to 5 Centers, currently 2 Cedars-Sinai, Los Angeles, CA: Dr. Trento University of Pennsylvania, PA: Dr. Szeto

24 Tiara Valve Device * The Tiara valve ( Neovasc, Inc., Canada) comprises a self-expanding stent and biological tissue leaflets fixed within the frame. * The valve orifice is D-shape to match the natural shape of the MV, and prevent impingement of the LVOT. * Minimally invasive off-pump mitral valved stent implantation via transapical approach under TEE guidance. * Limitations: Anchoring challenges, and Paravalvular leaks.

25 Anatomically shaped (Dshaped) Nitinol based, self-expanding frame Bovine pericardium leaflets Full Atrial skirt Ventricular anchors to fix the valve onto fibrous trigone and posterior annulus Captures the anterior and posterior leaflets

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27 Tiara Valve Early clinical experience Status

28 Tiara- I Early Feasibility Study International Multicenter Registry: total 30 patients (15 NA and 15 EU); 6-8 centers Inclusion Criteria: Severe MR by Echo NYHA FC III/IV CHF Primary or secondary MR Etiology High Risk for MV surgery; STS 8% Fulfills anatomic inclusion criteria (echo+ct) Pis: Anson Cheung,MD, and Martin Leon,MD Enrollment:2 patients.

29 Tendyne Lutter Transapical Mitral Implantation Self-expanding tri-leaflet porcine pericardium bioprosthesis Features: Left ventricular apical tether Requires no rapid pacing or CPB support Leaflet indifferent Multiple sizes Simple, controlled deployment Fully retrievable and repositionable

30 Baseline and Post-Valve Fluoro Baseline Grade 4+ MR Tendyne Valve No MR

31 Post-Valve Fluoro - Echo

32 Conclusions from Acute First-in Human Cases 3 successful human implants Feasibility of trans-apical mitral valve replacement Excellent immediate results demonstrated Lessons learned for betterment of Tendyne chronic program

33 Future Clinical Plans First-in Man Chronic Implant Feasibility 2-3 Continents, with US Up to 20 Patients Approved Expanded Clinical Use To be determined following FIM study CE Mark and US initiatives in preliminary stages

34 The FORTIS Valve (Edwards Lifescience) Self-expanding 3 parts Bovine pericardial tissue Anti-calcification Designed to minimize PV leak Unique anchoring Adaptable to multiple etiologies and pathologies Transapical approach

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37 Post-Valve Implant Echo Images

38 Early clinical experience with FORTIS

39 FORTIS Continued FIM Experience >20 Patients treated worldwide, predominantly compassionate use MR<1+ in 100% of patients DMR less commonly treated FMR most commonly treated Heart Teams in 5 countries trained OUS: Multi-center, prospective limited study started August US: Early feasibility trial approved.

40 Medtronic TMVR Program Self expanding Nitinol Fixation with the native mitral apparatus Preserves native mitral apparatus Cylindrical, trileaflet pericardial valve Large, flexible inflow Minimal extension into LV Recapturable Chronic animal studies

41 NaviGate: Transcatheter Mitral Valved Stent Mitral Valved Stent Delivery Systems Echo images of valve Explant atrial view 5 days implant Trans-Apical Mitral VaIve Implant

42 Summary Percutaneous Mitral Valve Therapy has the potential to be larger than TAVR for inoperable high risk patients. Due to the complexity of the disease, and MV anatomy, there will be more than one valve solution. Now at least 4 MV devices are in early clinical, and patient selection is critical Percutaneous Repair Devices address part of the problem, disappointing early results in clinical feasibility trials. PMVR has the potential to eliminate MR with a single shot device, is becoming an attractive alternative treatment for HR FMR patients, but challenge : Delivery, Fixation, Residual MR, SAM

43 Is PMVR Here, Now.. or is Here and Not Now?

44 It is Not Quite Here, But Stayed Tuned, is Coming Soon!

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47 NaviGate Mitral Valve NiTinol Stent-frame with a 21 mm height truncated-cone shape (Inflow=30mm/Outflow=40mm) Chemically Preserved Xenogeneic Pericardium Annular winglets anchoring structures of annulus and mitral valve leaflet Delivery system 30F profile distal capsule and 18F catheter shaft Four degrees of motion at tip with 135 Articulation Controlled Valve Release Transatrial, transseptal and transapical delivery available