transcatheter mitral innovations, part ii

Transcatheter Mitral Innovations, Part II

Michael Mack, M.D. Baylor Scott & White Health

Conflict of Interest Disclosure

• Co-PI of the COAPT Trial of MitraClip sponsored by Abbott Vascular

• Uncompensated

2

Transcatheter Mitral Valve: Device Landscape 2015 Edge-to-edge

• MitraClip* • MitraFlex

Direct annuloplasty and basal

ventriculoplasty • Mitralign Bident* • GDS Accucinch*

• Valtech Cardioband* • Quantum Cor (RF) • Micardia enCor

Other approaches • MitraSpacer*

• St. Jude leaflet plication* • Cardiac Implant perc ring

• NeoChord* • Babic chords

• Valtech Vchordal • Middle Peak Medical

• Mardil BACE • Mitralis

• Millipede

Coronary sinus annuloplasty

• Cardiac Dimensions Carillon* • Cerclage annuloplasty

MV replacement • CardiAQ* • Neovasc *

• Edwards Fortis* • Micro Interventional • Valtech Cardiovalve

• ValveXchange • Lutter Valve • Medtronic • Tendyne* • MitrAssist • MValve

*In patients

>30 Devices ! 8 Invented by Surgeons !!

TMV Repair

Edge to Edge MitraClip

Artificial Chords

Neochord Annuloplasty

Cardioband

4

MitraClip

Mitral Regurgitation


Functional (Secondary)

Degenerative (Primary)

Primary MR

Courtesy Gorav Ailawadi

MitraClip® Placement

Courtesy Gorav Ailawadi

MitraClip® Procedure

2 Mitraclips Courtesy Gorav Ailawadi

MitraClip Clip Delivery System Approved October 24, 2013

Indication for Use: The MitraClip Clip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.

Who Is High Risk ? • STS Risk Score >8-10 • Porcelain aorta • Hostile chest: Cobalt/mantle radiation, previous

sternectomy • Severe COPD (Prohibitive PFTs: FEV1< 0.8L) • Pulmonary Hypertension • Liver disease / cirrhosis • RIMA or LIMA across midline: • Frailty / Debility / Immobility • Severe Mitral Annular Calcification

Recommendations for Chronic Primary MR

Nishimura, RA et al. 2014 AHA/ACC Valvular Heart Disease Guideline

ACC LBCT –March, 2015

Outcomes of the Initial Experience with Commercial Transcatheter Mitral Valve

Repair in the United States

Paul Sorajja, MD, Saibal Kar, MD, D. Scott Lim, MD, Vinod Thourani, MD, Michael Mack, MD, David R. Holmes, Jr., MD, Wesley A. Pederson, MD, Gorav

Ailawadi, MD


Functional (Secondary)

Degenerative (Primary)

Secondary MR Disease of the Left Ventricle NOT the Mitral Valve

Normal LV Dilated LV tethering one or both leaflets

Secondary MR

MitraClip for Secondary MR

TTE 30 Days Post Procedure

~420 patients enrolled at up to 75 US sites

Randomize 1:1

Clinical and TTE follow-up: 1, 6, 12, 18, 24, 36, 48, 60 months

Control group Standard of care

N=210

Not appropriate for mitral valve surgery (local heart team) Specific anatomical criteria

MitraClip N=210

Significant FMR (≥3+ by core lab)

COAPT: Trial design

PIs: Michael Mack and Gregg W. Stone Sponsor: Abbott Vascular

Enrollment February 2015

Sites-72 Patients-

182

© 2014 Abbott. All rights reserved. AP2939842-OUS Rev. H (12/2014)

21 Information contained herein intended for use outside of the U.S. only.

*Data as of 01/31/2015. Source: Abbott Vascular

Study Population N*

EVEREST I (Feasibility) Feasibility patients 55

EVEREST II (Pivotal) Pre-randomized patients 60

EVEREST II (Pivotal) Non-randomized patients (High Risk Study)

78

EVEREST II (Pivotal) Randomized patients (2:1 Clip to Surgery)

279 184 Clip

95 Surgery

REALISM (Continued Access) Non-randomized patients 899

Compassionate/Emergency Use Non-randomized patients 66

ACCESS Europe Phase I Non-randomized patients 567

ACCESS Europe Phase II Non-randomized patients 286

Commercial Use Commercial patients 17,655

Total 19,850 +95 surgery

Worldwide Experience



Commercial MitraClip Implant Experience

– Treating Centers: 463 – Patients1: 18,508 – Implant Rate1: 96% – Etiology2

• Functional MR 65% • Degenerative MR 22% • Mixed 13%

Data as of 01/31/2015. Source: Abbott Vascular.

FMR 65%

DMR 22%

Mixed 13%

Etiology2

1. First-time procedures only. Includes commercial patients, ACCESS I and ACCESS II patients 2. Etiology not inclusive of U.S. cases as of 04/14/2014



MitraClip Therapy Current Global Adoption

Treating Centers 472

Patients (clinical and commercial) 19,850

Patients1 (commercial) 18,508

Implant Rate1 96%

Functional MR 65%

Degenerative MR2 22%

Mixed 13%

1. First-time procedures only. Includes commercial patients, ACCESS I and ACCESS II patients 2. Etiology not inclusive of U.S. cases as of 04/14/2014



Global MitraClip Procedures

Data on file at Abbott Vascular as of 01/31/2015

Transapical Off-Pump Neochord implantation

NeoChord Procedure

First in Man 2009 TACT Trial 2009-2012

30 patients CE Mark Dec 2012 TACT Surveillance Registry 2013

133 patients

NeoChord Experience

TACT Trial

TACT trial 30-days results

02468

10121416

Patients 1 - 15 Patients 16 - 30*

Fail PrimaryEndpointSuccess at 30days

33%

78%

Treated patients, N = 60 Successful neochordae implantation (n)

Median (IQR) n (%)

60 (100%)

Neochord implanted (n) - 3 - 4 - 5 - 6 - 7

4 (3-4) 21 (35%) 26 (43%) 10 (17%)

2 (3%) 1 (2%)

Operative time (minutes) 130 (110-150)

Neochord International Independent Registry

Mitral Regurgitation at follow-up

Neochord International Independent Registry

0

10

20

30

40

50

60

70

PreOp Discharge 1 M 3 M

4+ 3+ 2+ 1+ 0

Early Outcomes (N=30)

Effectiveness

• MR ≤ 2+ in 1 month follow up (N=27) 89%

• MR ≤ 2+ in 6 month follow up (N=16) 88%

• Accumulative implantation time >270 months

Procedure

• Implants successfully deployed on annulus (30/30)

• Intra-procedure MR reduction ≥1 degree (28/30)

• Average reduction of septolateral diameter 20%

Safety

• Procedural mortality 0/30

• 30 days Mortality (according to VARC) 1/30

• No Device Related Major Adverse Events as adjudicated by independent committee

38

Reduction in Septo Lateral Dimension (N=30)

39

0.00

5.00

10.00

15.00

20.00

25.00

30.00

35.00

40.00

Baseline Post procedure

A-P

Dim

ensi

on [m

m] *P<0.01

36 ± 4 (28-50)

29 ±6 (17-43)

20% average reduction in A-P

MR Grade at Endpoints

41

0

20

40

60

80

100

Baseline Discharge 1 month 6 months

3-4+

3-4+ 3-4+

2+

2+ 2+

0-1+ 0-1+

N=30 N=28 N=27

93% MR ≤ 2+ at Discharge

N=16

88% MR ≤ 2+ at 6 Month

0-1+

2+ 3-4+

89% MR ≤ 2+ at 1 Month

Functional Improvement at 6 Months

42

150

250

350

0

15

30

45

60

0

20

40

60

80

100

Baseline 6 months Baseline 6 Months Baseline 6 Months N = 15 N = 13 N = 15

Met

ers W

alke

d

6MWT P=0.1

MLWHF *P<0.05

80% N

YHA I/II

NYHA Class

259

340 41

18

II

III

IV

II

III

I

Summary

• Transcatheter mitral valve repair is progressing • MitraClip experience is ~20,00 patients • COAPT trial will inform the whole field • TMVR (Replacement) is imminent

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transcatheter mitral innovations, part ii

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