TRANSCATHETER MITRAL VALVE IMPLANTATION FOR SEVERE MITRAL - - PowerPoint PPT Presentation

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transcatheter mitral valve implantation for severe mitral
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TRANSCATHETER MITRAL VALVE IMPLANTATION FOR SEVERE MITRAL - - PowerPoint PPT Presentation

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

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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

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Disclosure Statement of Financial Interest

  • 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
  • N/A
  • N/A
  • N/A
  • N/A

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

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Tendyne Transcatheter Mitral Valve

Tendyne Device

  • Tri-leaflet porcine pericardial valve
  • Self-expanding nitinol double frame
  • D-shaped outer frame, anterior cuff
  • Large valve size matrix
  • Single inner valve size
  • Multiple outer frame sizes
  • Transapical access, valve tethered to apex
  • Adjustable tension provides valve

stability

  • Apical Pad assists in access closure
  • Valve fully retrievable and repositionable
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Tendyne TMVI: Final valve deployment 3D

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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

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Tendyne Global Feasibility Study

Objective

Evaluate the safety, performance and usability of the Tendyne Mitral Valve System

Key Outcome Measures

1. Mitral regurgitation* 2. LV function and dimensions by echocardiogram 3. Device function by echocardiogram 4. Major Adverse Events** 5. NYHA Classification 6. 6 Minute Hall Walk Test 7. Quality of Life (KCCQ)

* Echo Core Laboratory: Beth Israel Deaconness MC ** Clinical Events Committee

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Tendyne Global Feasibility Study

Inclusion criteria: 1. Severe mitral valve regurgitation of primary or secondary etiology 2. NYHA functional class II, III or ambulatory IV 3. Age >18yrs, able to provide informed consent 4. Poor candidate for cardiac surgery as determined by the Heart team (including Cardiologist and Cardiac Surgeon) Exclusion criteria: 1. Severe mitral annular or valvular calcification/stenosis, vegetation or mass 2. Largest annular dimension >45mm, LVEDD >70mm 3. LVEF<30%, severe TR/RV dysfunction/pulmonary HT 4. Prior aortic or mitral valve surgery 5. Small neo-LVOT (echo, CT modeling, 3D printing)

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Tendyne GFS: Demographics (n=30)

Age at Baseline Mean+SD 75.6+9.2 years Range 55.1-91.4 years Gender Male 25 (83.3%) Female 5 (16.7%) NYHA Functional Class II 14 (46.7%) III 16 (53.3%) IV 0 (0%) STS Score (range) 7.3+5.7 (2-16 )

Muller DW et al JACC 2017;69:381-391

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Tendyne GFS: Patient Overview (n=30)

Baseline Mitral Valve pathology Primary MR 3/30 (10%) Secondary MR 24/30 (80%) Mixed pathology 3/30 (10%) Baseline LV function N=29 LVEF <30% 3/29 (10.3%) LVEF 30-50% 14/29 (48.3%) LVEF>50% 12/29 (41.4%) Baseline MR severity Grade 3+ 2/29 (6.9%) Grade 4+ 27/29 (93.1%)

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GFS: Subject follow-up as of 23 May 2017

N=30 12 Month (n=22)

Death (n=5) Missed Visit (n=0) Visit Pending (n=0) Withdrew Consent (n=1) Implant not successful (n=2)

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Kaplan-Meier survival curve (n=30)

1.0 0.8 0.6 0.4 0.2 0.0 100 200 300

Days

All-cause mortality 0.83

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Tendyne TMVR: 1yr outcomes

Outcome N=30 Death (all cause) 5 (16.7%) Cardiac 4 (13.3%) Non-cardiac 1 (3.3%) CVA/TIA 0 (0%) Re-hospitalisation Heart failure 3 (10.0%) MV surgery 0 (0%) Valve performance (n=28) Malposition/PVL/hemolysis 1 (3.6%) Leaflet thrombosis 1 (3.6%)

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MR severity 1 year post-TMVR

Paired data

N: 19 19 19 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Baseline 1mth 12mths Grade 4 Grade 3 Grade 2 Grade 1 Grade 0

89.5 10.5 94.7 5.3 94.7 5.3

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LVEF post-TMVR

Paired analysis

p=NS N: 18 18 18 5 10 15 20 25 30 35 40 45 50 Baseline 1mth 12mths 46.7 38.4 42.0 p=NS LVEF (%)

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Functional capacity post-TMVR (n=30)

>1 class improvement in 60%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Baseline 1month 12months

NYHA Class

Class 4 Class 3 Class 2 Class 1

46.7 53.3 55.0 40.0 5.0 7.1 25.0 50.0 17.9 N: 30 28 20

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Quality of Life: KCCQ

20 40 60 80 100 120

baseline 30 day 12 months KCCQ

KCCQ in subjects with complete data at three timepoints (n=22)

* *

p<0.001 p<0.001

* vs baseline

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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%)
  • Low need for hospitalisation for heart failure (10%)
  • Substantial improvements in NYHA class, QOL

CE Mark Study / Expanded Global Feasibility Study enrolling