Optimize MitraClip Success in FMR and DMR Paul A. Grayburn, MD - - PowerPoint PPT Presentation

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Jun 08, 2023 33 likes •234 views

Patient/Anatomy Selection to Optimize MitraClip Success in FMR and DMR Paul A. Grayburn, MD Baylor University Medical Center Dallas, TX Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had 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

rganization(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, Teva Consulting Fees/Honoraria: Abbott Vascular Tendyne, ValTech, Neochord Major Stock Shareholder/Equity:None Royalty Income: None Ownership/Founder: None Intellectual Property Rights: None Other 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 Therapy

Worldwide Commercial Implant Experience Etiology Implant Rate: 97% > 30,000 Patients

FMR 64% DMR 22% Mixed 14%

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European Number of MitraClips Implanted 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 ≤2 DMR 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<0.001

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Anatomic Eligibility

Leaflet 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

<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