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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

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

Carpentiers 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 Vincents 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

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 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