Paul A. Grayburn, MD

Baylor University Medical Center

Dallas, TX

Patient/Anatomy Selection to Optimize MitraClip Success in

FMR and DMR

Disclosure Statement of Financial Interest

Within the past 12 months, I or my spouse/partner have had a

financial interest/arrangement or affiliation with the

organization(s) listed below.

Affiliation/Financial Relationship

inancial Relationship

All Fellows Course 2016 faculty disclosures are listed on the CRF Events App.

Grant/Research Support: Abbott Vascular, Tendyne, Medtronic, Boston Scientific, Edwardsl Lifesciences, TevaConsulting Fees/Honoraria: Abbott Vascular Tendyne, ValTech, NeochordMajor Stock Shareholder/Equity:NoneRoyalty Income: NoneOwnership/Founder: NoneIntellectual Property Rights: NoneOther Financial Benefit: Echo Core Lab – NeoChord, Valtech

MitraClip Clip Delivery System FDA 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.”

Primary vs Secondary MR

• Primary (organic) MR– Abnormal leaflets, most commonly MVP

– “Valve makes the heart sick”

– Surgical valve repair is gold standard

• Secondary (functional)– Leaflets are normal or nearly so

– MR is caused by LV dilation/dysfunction

– It is not clear if MR repair is beneficial or not

– Surgery is Class IIB LOE C (except during CABG)

MitraClip TherapyWorldwide Commercial Implant Experience

Etiology

Implant Rate: 97%

> 30,000 Patients

FMR 64%DMR 22%

Mixed 14%

European Number of MitraClipsImplanted and Implant Rate

4% 4% 5%

32%38% 35%

60%53%

53%

4% 5% 7%

4%

34%

58%

4%

0%

20%

40%

60%

80%

100%

All Patients FMR DMR Mixed Etiology

Patients

0 MitraClip

1 MitraClip

2 MitraClips

≥ 3 MitraClips

(N=8,951) (N=6,000) (N=1,950) (N=976)

95.9% Implant Rate(N=8,951)

Note: Unknown

etiology (N=25),

not shown

R. S. von Bardeleben at TCT 2013. Data as of 09/30/2013.

U.S. vs. Other Registries

• STS/ACC TVT (US)...…….

• SENTINEL (EU)….………..

• ACCESS (EU)….……...….

• TRAMI (DE)………..………

• MitraSwiss (CH)................

• France (FR)……................

• GRASP (IT)……..….…….…

• Netherlands (NL)…………

• MARS (Asia)………………

93%

95%

91%

95%

85%

88%

100%

93%

94%

MR ≤2DMR

In-hospital

death

2.3%

2.9%

2.9%

4.0%

3.3%

4.2%

Age (yrs)

83

74

74

75

77

73

72

73

71

86%

28%

23%

29%

38%

23%

24%

18%

46%

• EVEREST I………………..

• EVEREST II RCT…...….…

• EVEREST II HRS……......

71

67

76

74%

77%

86%

0.9%

1.1%

2.6%

79%

51%

30%

Change in Mitral Regurgitation

Clip implantation occurred in 94%

0%

20%

40%

60%

80%

100%

Baseline Post-implant

Grade 4

Grade 3

Grade 2

Grade 1

Mitral Regurgitation Grade

93% MR ≤2

63.7% MR≤1

p

Anatomic EligibilityLeaflet mal-coaptation resulting in MR

• Sufficient leaflet tissue for mechanical coaptation

• Non-rheumatic/endocarditic valve morphology

• Protocol anatomic exclusions– Flail gap >10mm

– Flail width >15mm

– LVIDs > 55mm (now 60 mm)

– Coaptation depth >11mm

– Coaptation length < 2mm

11mm

>10mm

>15mm

Early Anatomic Exclusions for MitraClip

Grayburn et al, Am J Cardiol 2011

Multivariate Analysis of Demographic and Clinical Predictors of 3-4 + MR

after MitraClip

4 + MR at Baseline

Lack of Secondary Chordal Support

Severe Mitral Annular Calcification

Not Enough Room for MitraClip

3D Area 2.90 cm2

Post-Inflammatory MR

Non-Anatomic Imaging Considerations

• Severe TR and right heart failure

• Severely depressed LVEF (≤20%)

• Infective endocarditis

• Life-threatening conditions that preclude

longevity/QOL

Summary

• MitraClip is a robust technology

• High success rate and good safety profile in a wide range of pathology (DMR and FMR)

• Main issue is who NOT to do

– Difficult grasp, especially for new sites

– Risk of mitral stenosis

– Other conditions that preclude clinical benefit