Emerging Mitral Technologies Where Are We Now? MICHAEL MACK, MD BAYLOR SCOTT & WHITE HEALTH DALLAS, TX

Emerging Mitral Technologies Where Are We Now? MICHAEL MACK, MD BAYLOR SCOTT & WHITE HEALTH DALLAS, TX

Conflict of Interest Disclosure Abbott Vascular- Co PI COAPT Trial Medtronic- Executive Committee APOLLO Trial Edwards Lifesciences- Co-PI PARTNER 3 Trial

SAVR & TAVR Volumes in US 60000 50000 48231 48355 46000 48434 40000 37988 41490 30000 24908 AVR +/-CABG TAVR 20000 16106 10000 0 2014 2015 2016 2017Est Source: STS and ACC database as of January 23, 2018

Transcatheter MV Repair: Device Landscape 2018 Edge-to-edge MitraClip*** MitraFlex Coronary sinus annuloplasty Cardiac Dimensions Carillon** Cerclage annuloplasty Direct annuloplasty and basal ventriculoplasty Mitralign TAMR** Valtech Cardioband** GDS Accucinch* Millipede IRIS* MVRx ARTO* Mardil BACE* Mitraspan* Valcare Amend* Micardia encor Cardiac Implants RDS QuantumCor (RF) MV replacement MV replacement (cont) Edwards CardiAQ* MitralHeal Edwards Fortis* HT Consultant Saturn Neovasc Tiara* Lutter valve Abbott Tendyne* Transcatheter Technologies Tresillo Medtronic Intrepid* Venus HighLife* Verso MValve* Transmural Systems Caison* Other approaches NCSI NaviGate NeoChord DS 1000** St. Jude Harpoon neochords* Micro Interventional Babic chords* Valtech CardioValve Middle Peak Medical* ValveXchange St. Jude leaflet plication* MitrAssist Cardiosolutions Mitra-Spacer* Braile Quattuor Valtech Vchordal Cephea Mitralix Direct Flow Sinomed Accufit

Mitral Regurgitation Secondary Primary Type IIIb Type II

Transcatheter Mitral Valve Therapy PRIMARY MR Repair MitraClip Pascal Neochord Harpoon Adjunctive Annuloplasty Replacement (TMVR) SECONDARY MR Repair MitraClip Pascal Annuloplasty Direct Indirect Replacement (TMVR)

Mitral Regurgitation Secondary Primary Type IIIb Type II

MitraClip Approved in US for High Surgical Risk Degenerative (Primary) MR Only

MitraClip Therapy - Global Adoption Treating Centers 800 Patients (clinical & commercial) Over 50,000 Implant Rate 97% Functional MR 64% Degenerative MR 22% Mixed 14%

5000 4500 MitraClip Patients TVT Registry 4305 4720 4000 3500 3000 2500 2676 2000 1500 1159 1000 500 0 2014 2015 2016 2017 Source: STS/ACC TVT Registry Database as of January 23, 2018 6 Months

MitraClip In Hospital Mortality 5.00% 4.50% 4.00% 3.50% 3.00% 2.50% 2.00% 1.50% 1.00% 0.50% 0.00% 2.50% 2.20% 2.30% 2015 R4Q 2016 R4Q 2017 R4Q Source: STS/ACC TVT Registry Outcomes Report as of Oct 17, 2017

Mitral Interventions Edwards PASCAL Repair System PA S C AL ddles pacer lasps fieri FIM Ongoing

Mitral Interventions Edwards PASCAL Repair System

Mitral Interventions NEOCHORD Delivery Instrument Needle Leaflet Capture Verification Monitor Suture Cartridge

Mitral Interventions NEOCHORD Transapical access Off pump (beating heart) Echo guided Free leaflet edge, chordal implants MV repair CE Approved; U.S. Pivotal RCT Ongoing

Harpoon Artificial Cords

JACC Jan 2018

Mitral Regurgitation Secondary Primary Type IIIb Type II

Mitral Interventions Annulus MV Repair Systems Direct Annuloplasty Mitralign Valtech Cardioband Valcare AMEND Cardiac Implants Millipede Indirect Annuloplasty Carillon (coronary sinus approach) Mitral Cerclage MVRx

Cardioband

Millipede Complete Semi-rigid AV Valve Ring; Adjustable and Repositionable #1 Placement #2 Annular Attachment #3 Annular Reduction

Millipede Surgical Human Implants FIM Pending

Transcatheter MV Replacement More than 30 in development! Potential advantages (vs. repair) 1. Applicable to primary and secondary MR, regardless of anatomy or pathology 2. Ease of implantation (?) 3. Reliable elimination of MR 4. Greater durability?

New TMVR Systems First in Human Timelines

Early Feasibility Studies in US TMVR

Currently in Trials in US Tendyne CardiaQ Caisson Intrepid

Tendyne TMVR A global registry of 30 patients with symptomatic severe MR; Tendyne TMVR with procedural and 30-day outcomes Muller DWM et al. J Am Coll Cardiol 2016

JACC Jan 2018

Mitral Valve Disease Major Unanswered Questions Does MR need to be completely corrected? Can primary MR be corrected sufficiently by a transcatheter approach? Does correction of secondary MR improve survival or quality of life? Which is preferable for secondary MR- repair or replacement?

#8 New TMVR Systems

Fusion Imaging

Transcatheter Valve Therapy TAVR Mitral Tricuspid

Summary None of This is Ever As Easy As It Looks!