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

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 financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship inancial Relationship 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 All Fellows Course 2016 faculty disclosures are listed on the CRF Events App.

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 Therapy Worldwide Commercial Implant Experience Etiology > 30,000 Patients Mixed 14% FMR 64% DMR 22% Implant Rate: 97%

European Number of MitraClips Implanted and Implant Rate 95.9% Implant Rate (N=8,951) 100% 4% 4% 5% 7% 80% 0 MitraClip 53% 58% 53% 60% 60% Patients 1 MitraClip 2 MitraClips 40% ≥ 3 MitraClips 38% 35% 20% 32% 34% Note: Unknown etiology (N=25), not shown 4% 5% 4% 4% 0% All Patients FMR DMR Mixed Etiology (N=8,951) (N=6,000) (N=1,950) (N=976) R. S. von Bardeleben at TCT 2013. Data as of 09/30/2013.

U.S. vs. Other Registries In-hospital MR ≤2 Age (yrs) DMR death • STS/ACC TVT (US)...……. 83 86% 93% 2.3% • SENTINEL (EU)….……….. 74 28% 95% 2.9% • ACCESS (EU)….……...…. 74 23% 91% • TRAMI (DE)………..……… 75 29% 95% 2.9% • MitraSwiss (CH)................ 77 38% 85% 4.0% • France (FR)……................ 73 23% 88% 3.3% • GRASP (IT)……..….…….… 72 24% 100% • Netherlands (NL)………… 73 18% 93% • MARS (Asia)……………… 71 46% 94% 4.2% • EVEREST I……………….. 71 79% 74% 0.9% • EVEREST II RCT…...….… 67 51% 77% 1.1% • EVEREST II HRS……...... 76 30% 86% 2.6%

Change in Mitral Regurgitation Clip implantation occurred in 94% 100% 93% MR ≤ 2 80% Grade 2 60% Grade 4 40% 63.7% MR≤1 Grade 1 20% p<0.001 Grade 3 0% Baseline Post-implant Mitral Regurgitation Grade

Anatomic Eligibility Leaflet mal-coaptation resulting in MR • Sufficient leaflet tissue for mechanical coaptation • Non-rheumatic/endocarditic valve morphology <2mm >11mm • Protocol anatomic exclusions – Flail gap >10mm – Flail width >15mm – LVIDs > 55mm (now 60 mm) >10mm – Coaptation depth >11mm – Coaptation length < 2mm >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 cm 2

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