From Mitral Repair to Replacement Mayra Guerrero, MD, FACC, FSCAI Director of Cardiac Structural Interventions NorthShore University HealthSystem CRT 2017 Washington, DC Feb 19, 2017

Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Research Grant Support, Proctor Consultant Speaker’s Bureau Edwards Lifesciences Tendyne Holdings/Abbott Abiomed Off label use of products and investigational devices will be discussed in this presentation

First Transcatheter Valvular Interventions Pulmonic Valve Valvotomy Tricuspic Valve Valvotomy Rubio-Alvarez V, Limon-Lason R, Soni, J. Arch Inst Cardiol Mex 1953 April;23(2):183-92. Rubio-Alvarez V, Limon-Lason R. Arch Inst Cardiol Mex 1955 Jan-Feb;25(1):57-69.

Evolution of Transcatheter Interventions Balloon Valvuloplasty Coronary Angioplasty 80’s Balloon Valvuloplasty 90’s Coronary Stents 2000’s Valve Replacement

Mitral Stenosis Timeline First TMVR in MAC 2013 1920 1st succesful Surgical Mitral Commissurotomy 1982 Inoue Percutaneous Transvenous MV Commissurotomy (PTMC) 1950-1960 Transatrial and Transventricular Closed MV commissurotomy 1902 Concept of mitral commisurotomy proposed Brunton 1994 PMBV Clinically approved in US

Percutaneous Transluminal Mitral Commissurotoomy

NHLBI PMBV Registry n=738 NHLBI Registry participants. Circulation 1992;85:2014-2024

Indirect Annuloplasty Monarch Edwards PMTA Viacor Arto-MVRx Mechanism Abandoned Approved In Development Leaflet Repair Mobius Edwards Cardica MitraFlex Indirect Annuloplasty Monarch Edwards PMTA Viacor Arto-MVRx Direct Annuloplasty ReCor (US) Cerclage Millipede MitraSpan TASRA Micardia Encor Mitral Bridge QuantumCor (RF) Chordal Repair NeoChord Harpoon Valtech Vchordal MISTRAL Mitralis Enhanced Coaptation Myocor Coapsys MitraSpacer Middle Peak MitrAssisst LV Remodeling Acorn Myocor Accucinch BACE Mardil

5-year Results of EVEREST II Primary MR Survival 30 Day mortality 6% Feldman et al, JACC 2015;66:2844-54.

High Surgical Risk Patients 5-year Results of EVEREST II Primary MR Survival Feldman et al, JACC 2015;66:2844-54.

Outcomes of Approved Devices Reduction of MR (no elimination) Improvement of Symptoms 5-year survival similar to surgery (MitraClip) Low 30-Day Mortality 7.7% EVEREST II 5.8% STS database 1.9% TITAN 7.8% CE study 5% CE study What else do they have in common ?

Operator’s experience ? Early Outcomes of Transcather MV Replacement Better MR Reduction (almost eliminates MR) But High 30-Day Mortality Patient Selection ? Valve Design ? Operator’s experience ? Access route ? All of the above ?

Tendyne Feasibility Trial 30 high risk surgical patients Muller et al, J Am Coll Cardiol Dec 2016;S0735-1097(16)37122-4.

Dvir CRT 2017

Dvir CRT 2017

Mitral Implantation of TRAnscatheter vaLves The MITRAL Trial Mitral Implantation of TRAnscatheter vaLves Inclusion Criteria Native MV (MAC) Valve-in-Ring Valve-in-Valve Calcific MS (MVA ≤1.5 cm2) Severe MR + Mod MS NYHA II or greater Not surgical candidate Failing surgical ring Severe MR or MS NYHA II or greater Not surgical candidate Failing Bioprosthesis Severe MR or MS NYHA II or greater Not surgical candidate “Goal 100% Transeptal access” www.clinicaltrials.gov

Is not what you say… it’s how you say it !

Is not what we do to the MV… it’s how we do it ! What if you could obtain TMV replacement results with the same safety of TMV Repair? “Transeptal Transcatheter MV Replacement” Is this what we need ?

Operator Requirements for a Smooth Transition TAVR experience would help, team approach concept Percutaneous mitral commissurotomy/BMV experience MitraClip experience Transcatheter Mitral Valve-in-Valve experience Transcatheter Mitral Valve-in-Ring experience

Institutional Requirements for a Smooth Transition Heart team approach Excellent quality cardiac imaging expert TAVR experience Percutaneous mitral commissurotomy/BMV experience MitraClip experience Mitral Valve-in-Valve and Valve-in Ring experience

Conclusions Repair to Replacement is a natural transition This transition will take time Operators and Institutions with transcatheter mitral repair experience will have advantage We must resist temptation to perform procedures outside clinical trials Enrollment in clinical trials will be crucial for this field to mature

Thank You mguerrero@northshore.org mayraguerrero@me.com