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A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

CFCI 2012 Paris – 17 Novembre 2012 E.Grandmaire

2

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Oui, j’ai des liens et conflits d’intérêts à

déclarer …

3

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Mitral Regurgitation

4

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Mitral Regurgitation Etiologies

Source: Enriquez-Sarano, M et al. Lancet. 2009;373:1382-94.

Causes

• Degenerative MR

– Also known as primary or organic MR

– Usually caused by an anatomic defect of one or more structures comprising the mitral valve apparatus—the annulus, the leaflets, the chordae tendineae, and the papillary muscles.

• Functional MR

– Also known as secondary MR

– Results from left ventricular (LV) dysfunction and dilation, which causes otherwise normal valve components to fail and results in MR.

Normal Prolapse Flail Functional MR

5

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Vue échographique d’une fuite Mitrale

6

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Options de Traitement

6 Feldman, T. EVEREST II RCT, ACC 2011, NPL03771-D.

7

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Concept: Percutaneous Mitral Valve Repair

• Dr. Fred St. Goar, interventional cardiologist had patient successfully treated with edge-to-edge surgery

• Conceived several ideas for percutaneous valve repair

• Founded Evalve 1999 to develop devices to treat valvular disease

• Double-orifice suture technique developed by Prof. Ottavio Alfieri

• First published results in 1998 illustrated proven benefit

• Suggested procedure best suited for minimally invasive approach

8

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

La procédure Mitraclip

9

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

La Procédure Mitraclip

10

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

MitraClip Procedure

11

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Multidisciplinary Team

12

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Typical cathlab set-up

13

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Equipment

14

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

System

15

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

System Components

16

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

System Accessories

Stabilizer

Lift

Support Plate

17

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Patient Positioning

80 cm

18

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Procedure Items

19

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

20

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Post-procedure Considerations

21

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Etapes de la Procédure

22

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

MitraClip Procedure Driven by Echocardiography

23

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Trans-septal and Steering

24

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Perpendicularity and crossing the valve

25

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Leaflet grasping and deployment

26

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Creation of a double-orifice via vertical coaptation of leaflets

View from Left Atria View from Left Ventricle

27

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

Données Cliniques & Expérience Mondiale + de 6000 patients traités

28

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

MitraClip Therapy Broad Spectrum of Experience

73%

27%29%

71%

23%

77%

EVEREST II (Randomized Controlled Trial)

EVEREST (High Risk Cohort^)

ACCESS EU (Europe)

• 178 patients

• Device time – 156 minutes

• Implant rate – 89%

• 211 patients

• Device time – 128 minutes

• Implant rate – 95%

= DMR = FMR

• 567 patients

• Device time – 118 minutes

• Implant rate – 99%

^ Enrolled by February 28, 2010

Data on file Abbott Vascular, April 12, 2011

Maisano, F. TCT 2011, ACCESS 6-month results

29

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

EVEREST High Surgical Risk Cohort

*As of April 12, 2011

^Enrolled by February 28, 2010

EVEREST II

High Surgical Risk Study^

N=78

REALISM

High Surgical Risk Study^

N=294

EVEREST High Surgical Risk Cohort

With 1 Year Follow-up^

N=211

EVEREST

High Surgical Risk Cohort

N=372*

1 Year

N=133

1 Year

N=78

Demographics and Co-morbidities

High Risk Cohort (N=211)

Age (years) 76 ± 10

≥ 75 years, (%) 57

Predicted Mortality †, (%) 15

Prior Cardiac Surgery, (%) 58

History Myocardial Infarction, (%) 49

Prior Stroke, (%) 14

COPD/Chronic Lung Disease, (%) 30

Moderate to Severe Renal Failure, (%) 31

History Atrial Fibrillation, (%) 64

Diabetes Mellitus, (%) 40

Ejection Fraction < 30%, (%) 9

LV ESD (mm) 4.2

NYHA Class III or IV, (%) 86

Etiology—Functional MR, (%) 71

†Based on STS ≥ 12% or an assigned mortality 12% for

pre-specified co-morbidities

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© 2012 Abbott. All rights reserved.

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EVEREST High Surgical Risk Cohort Clinically Significant Reduction of Mitral Regurgitation

31

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

EVEREST High Surgical Risk Cohort: Favorable Reverse LV

Remodeling

EVEREST High Surgical Risk Cohort Left Ventricular End Diastolic and Systolic Volumes

163

86

141

77

136

71

0

2 0

4 0

6 0

8 0

10 0

12 0

14 0

16 0

18 0

LVEDV LVES V

B aseline

1 Y ear

2 Y ear

177 121 39

All Patient Data 2 Yr Matched Data

177 121 39

164

86

141

77

0

2 0

4 0

6 0

8 0

10 0

12 0

14 0

16 0

18 0

LVEDV LVES V

174

81

139

69

136

71

LVEDV LVES V117 117 39 39

1 Yr Matched Data

p-values generated from paired t-test; matched data

p<0.0001

p<0.0001

p<0.0001

p=NS

p<0.0001

p=0.005

p=0.002

p=NS

ml ml

32

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

EVEREST High Surgical Risk Cohort: Significant Reduction In The Rate

Of Hospitalization For Heart Failure

33

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

EVEREST High Surgical Risk Cohort Summary

• Robust clinical evidence in a large cohort of high surgical risk patients

– Prospective, multi-center clinical trial

– Independent Core Lab assessed MR and LV measurement

• MitraClip device reduced MR and demonstrated significant clinical benefits

at 1 year follow up

– Reduction in LV volumes

– Improvement in NYHA Functional Class

– Reduction in the Rate Of Hospitalization for Heart Failure

High Surgical Risk Cohort

34

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

MitraClip Therapy in Real-world Settings ACCESS EU—MitraClip Patients Preliminary 6-month Results

*Data as of March 2012

ACCESS EU, 6-month results, ACC 2012

35

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

ACCESS-EU: etiology and safety

The majority of patients

treated have functional MR

and extensive co-morbidities

*Data as of March 2012

ACCESS EU, 6-month results, ACC 2012

36

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

ACCESS-EU: significant MR reduction

*Data as of March 2012

ACCESS EU, 6-month results, ACC 2012

37

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

ACCESS-EU: Significant NYHA improvement

*Data as of March 2012

ACCESS EU, 6-month results, ACC 2012

38

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

ACCESS-EU: improvement in 6 min walk test

*Data as of March 2012

ACCESS EU, 6-month results, ACC 2012

39

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)

MitraClip Therapy in Real-world Settings ACCESS EU Results

• The majority of patients have functional MR and extensive co-morbidities

• The MitraClip procedure provides

– Improvement in MR grade

– Significant clinical benefits through 6 months, including symptomatic and functional improvement in select patients with mitral regurgitation

ACCESS EU Analysis Cohort

*Data as of March 2012

ACCESS EU, 6-month results, ACC 2012

Abbott Vascular International BVBA

Park Lane, Culliganlaan 2B, B-1831 Diegem, Belgium, Tel: 32.2.714.14.11

Photo(s) on file at Abbott Vascular.

Product is subject to prior training requirement as per the Instruction for Use. This product is

intended for use by or under the direction of a physician. Prior to use, it is important to read

the package insert thoroughly for instructions for use, warnings and potential complications

associated with the use of this device. Information contained herein is for distribution for Europe,

Middle East and Africa ONLY. Please check with the regulatory status of the device before

distribution in areas where CE marking is not the regulation in force.

EVEREST, ACCESS and REALISM are Abbott Vascular Sponsored Studies.

All drawings are artist’s representions only and should not be considered as an engineering drawing or

photograph.

MitraClip is a trademark of the Abbott Group of Companies.

For more information, visit our website at abbottvascular.com

© 2012 Abbott. All rights reserved.

A introduction to the MitraClip therapy 9-EH-4-2606-01 08/2012 / TRN-EXT-03951 Rev. A (07/2012)