Post on 02-May-2019
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*******
4
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
22
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
0
10
20
30
40
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
0
20
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
0
10
20
30
40
50
60
70
80
90
100
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
10
20
30
40
50
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