1. 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

2. 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

3. 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

4. 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

5. 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)

6. 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

7. Tendyne GFS: Demographics (n=30)
Age at Baseline
Mean+SD
years
Range
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:

8. 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

9. 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%

10. 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