Progress in Transcatheter Mitral Valve Replacement Transcatheter Mitral Valve Tendyne Device •...
Transcript of Progress in Transcatheter Mitral Valve Replacement Transcatheter Mitral Valve Tendyne Device •...
Progress in Transcatheter Mitral
Valve Replacement SOLACI 2017
Eduardo de Marchena, M.D., F.A.C.C., F.A.C.P., F.S.C.A.I.
Professor of Medicine & Surgery
Associate Dean for International Medicine
Program Director,
International Interventional Structural Heart Disease Fellowship
University of Miami Miller School of Medicine
Potential conflict of Interest
• Support for Educational Conference – Most Cardiovascular Corporations
• Active Sponsored Research Support – – Medtronic Other Conflicts:
1. Tendyne Medical Inc. - Co founder
2. Abbott Medical - Consultant
3. Intergene International LLC -Medical Advisory Board
4. Aegis Medical – Medical Advisory Board and stock holder
5. St. George Medical – consultant
6. Argo Medical – Investor/ Consultant
7. de Marchena Wellness - President
8. SwiftSynch – President
9. Vdyne – Advisory Board and investor
New Investigational Devices
******Not FDA or CE mark approved*******
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Mirabel M, et al. Eur Heart J 2007;28:1358-1365
No surgery in 49%
Not all patients are good surgical candidates
396 patients in Europe with symptomatic severe MR (53% degenerative)
0
20
40
60
80
100
120
140
160Decision not tooperate
Decision tooperate
P<0.0001
63% 59% 67% 42%
15%
<50 50-60 60-70 70-80 >80
Stone ,G TVT2012
Prevalance of MR in US
de Marchena E, Badiye A, Robalino G, Junttila J, Atapattu S, Nakamura M,
De Canniere D, Salerno TJ Card Surg 2011;26:385-392
Carpentier’s functional classification.
Type I, normal leaflet motion;
Type II, increased leaflet motion (leaflet
prolapse);
Type IIIa restricted leaflet motion during
diastole and systole;
Type IIIb restricted leaflet motion predominantly
during systole.*
Mitral Valve Replacement
A Long Road
Anatomic Challenges
Pouch, A et al. Circulation
Mitral Valve Sizing
FMR/IMR Subjects
3D TEE
AP 33 - 40 mm
CC 40 - 44 mm
Topilsky, JAHA 2013; Khabbaz, ATS 2013; Kovalova, Echocardiography 2011
Mitral Annulus in the context of TMVI
Projected area
Leipsic J TVT 2014
Transcatheter Mitral Valve Implantation
(TMVI) Devices
Maisano EHJ 2015
CardiAQ Twelve Medtronic
Neovasc - Tiara
TMVR Candidates
Tendyne
Edwards Mitral Direct flow
Tendyne Valve
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
• Large Effective Orifice Area (>3.0cm2)
• Transapical access, valve tethered to apex
• Adjustable tension provides valve stability
• Apical Pad assists in access closure
• Valve fully retrievable and repositionable
David WM Muller, MBBS, MD, TCT 2016
Animation Tendyne Valve
Site: Hospital Italiano;
Asuncion, Paraguay
Date: February & August, 2013
Team:
• Cardiac Surgery
• Georg Ludder
• Lucian Lozonski
• Adrian Ebner
• Santiago Gallo
• Interventional Cardiology
• Eduardo de Marchena
• Echocardiography
• Eduardo Alvarez
• James Berry
• Anesthesia
• Enrique Silva
• Technical assistant
• Dan Mans
• Bob Vidlund
• Zack Tegels
• Michael Evans
• Christian Marin y Kall
• Jeff Franco
Acute First in Man
Lutter G, Lozonshi Marin Y Kall C,… de Marchena E. J Am Coll Cardiol Intv. 2014;7(9):1077-1078
Tendyne Patient Number 1
• 57 y.o. man NYFC III from Myxomatous mitral valvular disease
• Echocardiographic findings • MR grade 4+ • Vena Contracta 8.0 mm • LA size 6.46 cm • Regurgitation fraction 35.4% • LV diastolic 51 mm; Systolic 35 mm • LVEF 59% • Carpentier class II with posterior leaflet prolapse
• STS mortality 7.1% and Mortality Morbidity 54.1%; Euroscore II - 8.8%. • Prolapse of posterior leaflet
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Lutter G, Lozonshi Marin Y Kall C,… de Marchena E. J Am Coll Cardiol Intv. 2014;7(9):1077-1078
Baseline TEE patient 1
Lutter G, Lozonshi L,… de Marchena E. J Am Coll Cardiol Intv. 2014;7(9):1077-1078
Valve at annulus
Pre and Post Ventriculogram Patient 1
Transcardiac Echo of LV outflow post implantation Patient 1
3d short axis of valve
Lutter G, Lozonshi L,… de Marchena E. J Am Coll Cardiol Intv. 2014;7(9):1077-1078
David WM Muller, MBBS, MD, TCT 2016
David WM Muller, MBBS, MD, TCT 2016
Tendyne TMVI Trials
Compassionate Use (n=8)
• 3 sites
Global Feasibility Study (n=30)
• 8 sites, Australia, US and Norway
CE Mark Study/Expanded Feasibility Study (n=110)
• Up to 25 centers (10 US)
• Up to 40 US patients
Total experience to date:
• >50 cases, longest follow-up 2yrs
Tendyne TMVI 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
Muller et al JACC In press
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 )
David WM Muller, MBBS, MD, TCT 2016
Tendyne GFS: Demographics
Co-morbidities N=30
Diabetes (all T2DM) 11 (36.7%)
Chronic lung disease/COPD 10 (33.3%)
Chronic kidney disease (eGFR<60) 17 (56.7%)
Prior CVA 2 (6.7%)
Prior thoracotomy
CABG 14 (46.7%)
Prior valve intervention/surgery 0 (0.0%)
Arrhythmia
Atrial fibrillation 17 (56.7%)
ICD/BiV PPM in situ 15 (50.0%)
David WM Muller, MBBS, MD, TCT 2016
Tendyne GFS: Patient Overview (n=30)
Baseline Mitral Valve pathology
Primary MR 3 (10%)
Secondary MR 23 (76.7%)
Mixed pathology 4 (13.3%)
Baseline LV function N=29
LVEF <30% 3 (10.3%)
LVEF 30-50% 14 (48.3%)
LVEF>50% 12 (41.4%)
David WM Muller, MBBS, MD, TCT 2016
GFS: Acute Outcomes
Outcome N=30
Death (all cause) 0 (0%)
CVA 0 (0%)
Major bleeding
Transfusion 3 (10%)
Device-related
Device embolization 0 (0%)
Cardiac perforation 0 (0%)
Paravalvular leak 1 (3.3%)
Device Retrieval
LVOT obstruction 1 (3.3%)
Did not properly seat - access issue 1 (3.3%)
David WM Muller, MBBS, MD, TCT 2016
Tendyne TMVI: D30 Outcomes
Outcome N=30
Death (all cause) 1 (3.3%)
Cardiac 0 (0%)
Non-cardiac 1 (3.3%)
CVA 0 (0%)
MV surgery 0 (0%)
Re-hospitalisation
Heart failure 4 (13.8%)
LVAD/transplant 0 (0%)
Other (ileus) 1 (3.3%)
Device-related
Hemolysis, transfusion 1 (3.3%)
Leaflet thrombosis 1 (3.3%)
David WM Muller, MBBS, MD, TCT 2016
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Baseline 30 days
Grade IV
Grade III
Grade II
Grade I
None
MR severity post-TMVI (n=30)
3.3
6.9
93.1
90.0
6.7* *No device in situ (n=2)
David WM Muller, MBBS, MD, TCT 2016
Functional capacity post-TMVI (n=30)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Baseline Day 30
NYHA Class
Class IV
Class III
Class II
Class I
7.1
46.7
53.3
25.0
50.0
17.9
p=0.03
David WM Muller, MBBS, MD, TCT 2016
Tendyne TMVI: D30 QOL Outcome
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10
20
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50
60
70
Baseline 30days
KCCQ score
p=0.0018
50.2
64.6
David WM Muller, MBBS, MD, TCT 2016
Baseline Day 30
90.1
72.1
p=0.0012
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40
60
80
100
120
140
160
180
LV End-Diastolic Volume Index (mls/m2)
LV Volume post-TMVI (n=30)
David WM Muller, MBBS, MD, TCT 2016
Baseline Day 30
48.4 43.1
p=0.18
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1 2
LV End-Systolic Volume Index (mls/m2)
LV Volume post-TMVI (n=30)
David WM Muller, MBBS, MD, TCT 2016
Baseline Day 30
47.1 41.3
p=0.043
LV Function post-TMVI (n=30)
0
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30
40
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60
70
1 2
LV Ejection Fraction (%)
David WM Muller, MBBS, MD, TCT 2016
Day 30 CT: systole
Circumferential apposition of atrial skirt
Seated well at annulus/atrioventricular junction
Tether perpendicular to plane of annulus
The Trans-catheter Mitral Valve Replacement era has begun!
• Early phase mayor questions:
– Case selection
– New designs to minimize LVOT obstruction
– Proper planning and imaging for technique
– Thrombosis and long term anticoagulation
– Can Transapical approach be replaced by antegrade approaches
– Longevity of valve
Thank You