From Mitral Repair to Replacement Mayra Guerrero MD

From Mitral Repair to Replacement Mayra Guerrero, MD, FACC, FSCAI Director of Cardiac Structural Interventions North. Shore University Health. System CRT 2017 Washington, DC Feb 19, 2017 Evanston Hospital

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 • Research Grant Support, Proctor • Consultant • Speaker’s Bureau Company • Edwards Lifesciences • Tendyne Holdings/Abbott • Abiomed Off label use of products and investigational devices will be discussed in this presentation Evanston Hospital

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. Evanston Hospital

Evolution of Transcatheter Interventions 70’s Coronary Angioplasty 80’s Balloon Valvuloplasty 90’s Coronary Stents 2000’s Valve Replacement Evanston Hospital

Mitral Stenosis Timeline 1920 1 st succesful Surgical Mitral Commissurotomy 1902 Concept of mitral commisurotomy proposed Brunton First TMVR in MAC 2013 1982 Inoue Percutaneous Transvenous MV Commissurotomy (PTMC) 1950 -1960 Transatrial and Transventricular Closed MV commissurotomy 1994 PMBV Clinically approved in US 5

Percutaneous Transluminal Mitral Commissurotoomy Evanston Hospital

Evanston Hospital

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

Mechanism Abandoned Approved In Development Mobius Edwards Cardica Mitra. Flex Monarch Edwards PMTA Viacor Arto-MVRx Re. Cor (US) Direct Annuloplasty Cerclage Millipede Mitra. Span TASRA Micardia Encor Mitral Bridge Quantum. Cor (RF) Chordal Repair Harpoon Valtech Vchordal MISTRAL Mitralis Leaflet Repair Indirect Annuloplasty Neo. Chord Enhanced Coaptation LV Remodeling Myocor Coapsys Mitra. Spacer Middle Peak Mitr. Assisst Acorn Myocor Accucinch BACE Mardil Evanston Hospital

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

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

Outcomes of Approved Devices Reduction of MR (no elimination) Improvement of Symptoms 5 -year survival similar to surgery (Mitra. Clip) Low 30 -Day Mortality 7. 7% EVEREST II 5. 8% STS database 1. 9% TITAN 7. 8% CE study What else do they have in common ? 5% CE study Evanston Hospital

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 ? Evanston Hospital

Tendyne Feasibility Trial 30 high risk surgical patients Muller et al, J Am Coll Cardiol Dec 2016; S 0735 -1097(16)37122 -4. Evanston Hospital

Dvir CRT 2017 Evanston Hospital

Dvir CRT 2017 Evanston Hospital

The MITRAL Trial Mitral Implantation of TRAnscatheter va. Lves Inclusion Criteria Valve-in-Ring Native MV (MAC) Valve-in-Valve Calcific MS (MVA ≤ 1. 5 cm 2) Failing surgical ring Failing Bioprosthesis Severe MR + Mod MS Severe MR or MS NYHA II or greater Not surgical candidate “Goal 100% Transeptal access” www. clinicaltrials. gov Evanston Hospital

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

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 ? Evanston Hospital

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

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

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 Evanston Hospital

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