Patient/Anatomy Selection to Optimize MitraClip Success in ...€¦ · mitral valve surgery and a...
Transcript of Patient/Anatomy Selection to Optimize MitraClip Success in ...€¦ · mitral valve surgery and a...
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Paul A. Grayburn, MD
Baylor University Medical Center
Dallas, TX
Patient/Anatomy Selection to Optimize MitraClip Success in
FMR and DMR
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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
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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.”
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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)
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MitraClip TherapyWorldwide Commercial Implant Experience
Etiology
Implant Rate: 97%
> 30,000 Patients
FMR 64%DMR 22%
Mixed 14%
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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.
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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%
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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
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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
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Early Anatomic Exclusions for MitraClip
Grayburn et al, Am J Cardiol 2011
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Multivariate Analysis of Demographic and Clinical Predictors of 3-4 + MR
after MitraClip
4 + MR at Baseline
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Lack of Secondary Chordal Support
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Severe Mitral Annular Calcification
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Not Enough Room for MitraClip
3D Area 2.90 cm2
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Post-Inflammatory MR
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Non-Anatomic Imaging Considerations
• Severe TR and right heart failure
• Severely depressed LVEF (≤20%)
• Infective endocarditis
• Life-threatening conditions that preclude
longevity/QOL
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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