TRANSCATHETER MITRAL VALVE IMPLANTATION FOR SEVERE MITRAL REGURGITATION: THE TENDYNE GLOBAL FEASIBILITY TRIAL 1 YEAR OUTCOMES David WM Muller, MBBS,

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Presentation transcript:

TRANSCATHETER MITRAL VALVE IMPLANTATION FOR SEVERE MITRAL REGURGITATION: THE TENDYNE GLOBAL FEASIBILITY TRIAL 1 YEAR OUTCOMES David WM Muller, MBBS, MD St Vincent’s Hospital, Sydney On behalf of the Tendyne GFS Investigators

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 Grant/Research Support Consulting Fees/Honoraria Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Tendyne, Medtronic Medtronic, Abbott, Boston Scientific, 4Tech, Cephea N/A

Tendyne Transcatheter Mitral Valve Tendyne Device Components: Valve: porcine pericardium Frames: outer and inner, self-expanding Delivery: Through the apex of the left ventricle Beating heart procedure Held in position by a thether attached to a pad Pad lies outside the apex, assists in closure Advantages: No need for heart lung bypass Allows treatment of surgically ineligible patients Valve fully retrievable and repositionable

Tendyne TMVR GFS Investigators Global Feasibility Study (n=30) St Vincent’s Hospital, Sydney Abbott Northwestern, Minneapolis Prince Charles Hosp, Brisbane Baylor Heart and Vascular, Dallas Oslo University Hospital, Oslo Evanston Hospital, Chicago Cleveland Clinic, Cleveland Medstar Hospital, Washington DC November 2014 – March 2016

Tendyne Global Feasibility Study Objective Evaluate the safety and performance of the Tendyne Mitral Valve System Key Outcome Measures Mitral regurgitation LV function and dimensions by echocardiogram Device function by echocardiogram Major Adverse Events NYHA Classification 6 Minute Hall Walk Test Quality of Life (KCCQ)

Tendyne Global Feasibility Study Inclusion criteria: Severe symptomatic mitral valve regurgitation of primary (leaflet degeneration) or secondary (damaged ventricle) etiology Poor candidate for cardiac surgery as determined by the Heart team (including Cardiologist and Cardiac Surgeon) Exclusion criteria: Severe mitral valve calcification Large heart and/or mitral annulus Poor heart function, high pulmonary pressure Previous aortic or mitral valve surgery Heart anatomically too small for the device by CT imaging

Tendyne GFS: Demographics (n=30) Age at Baseline Mean+SD 75.6+9.2 years Range 55.1-91.4 years Male Gender 25/30 (83.3%) Secondary mitral regurgitation 27/30 (90%) Impaired heart function (EF<50%) 17/29 (58.6%) Severe (grade 4) regurgitation 27/29 (93.1%) Muller DW et al JACC 2017;69:381-391

Tendyne TMVR: 1yr outcomes Valve not successfully implanted 2 (6.7%) Death (all cause) 5 (16.7%) CVA/TIA 0 (0%) Re-hospitalisation Heart failure 3 (10.0%) MV surgery Valve performance (n=28) Malposition/hemolysis 1 (3.6%) Leaflet thrombosis Mitral regurgitation >mild

Tendyne TMVR: 1yr outcomes Baseline 1 year No mitral regurgitation 0/30 (0%) 21/22 (96%) Functional class 1-2 (mild symptoms) 19/20 (95%) Heart function (LVEF) 46.7% 38.4% Heart size (LVEDVI) 83.0mls/m2 76.4mls/m2 Quality of Life (KCCQ)* 50.5 75.8 * >10pt improvement in 64%

Tendyne TMVR: Conclusions (n=30) Safe and effective procedure: Retrievable, repositionable device Predictable deployment, well tolerated No procedural deaths or strokes Encouraging mid-term clinical and echo results: Low one year mortality (16.7%) Durable relief of MR (no MR in 95%) Improvements in functional class and quality of life