BrijM ainim D,FA CC ClinicalP rofessorofm edicine. FloridaAtlanticU niversity,bocar aton,fl. R egionalm edicaldirectoroft ranscathetert herapies

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1 BrijM ainim D,FA CC ClinicalP rofessorofm edicine CharlesE.S chm idtco legeofm edicine FloridaAtlanticU niversity,bocar aton,fl R egionalm edicaldirectoroft ranscathetert herapies T enethealthcarecorporation EasternR egion-coastaldivision

2 Dis clos u re Statem entoffinancialinteres t BrijM ainim D,FACC 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 Grant/Research Support Consulting Fees/Honoraria Company Abbott Vascular Medtronic Abiomed SJM Siemens Atritech/Boston Scientific Keystone

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6 Prim a ry Se c ond a ry The Va lve The Ve ntric le Usua llym yxom a tous Isc he m ic ornot Sorajja, Paul, MD; Abbott Northwestern Hospital

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10 1. Includesclinicaland com m ercialproceduresasof30/11/2016.s ource:dataonfileata bbottvascular 1

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12 Slide courtesy: Hüseyin Ince, MD PhD

13 Flail gap is defined as the greatest distance between the ventricular side of the flail leaflet segment to the atrial side of the opposing leaflet edge This distance is measured perpendicular to the plane of the annulus in two views and the largest measurement is used The TEE views for measurement are the: 4 Chamber long axis (LAX) LVOT Measure Flail Gap during Systole

14 Flail width is defined as the width of flail leaflet segment as measured along the line of coaptation in the transgastric short axis view TEE View for measurement is transgastric SAX Measure during systole

15 This measurement can also be made along the line of coaptation in the intercommissural view

16 Vertical coaptation length is defined as the vertical length of leaflets that is in contact, orisavailablefor contact, during mid-systole in the atrial-to-ventricular direction. This measures the length of leaflet tissue available to be inserted into the arms of the MitraClip Device. The TEE view for measurement is the: 4 Chamber Simultaneous color and non-color views are helpful Color views of both the proximal convergence zone in the ventricle and regurgitant jet in the atrium confirm location of the regurgitant lesion. Non-color views are used to measure the coaptation length at the regurgitant lesion.

17 Evidence of calcification in the grasping area of the A2 and/or P2 scallops The Grasping Area is defined as the most distal 7mm of available leaflet tissue

18 Centers 757 Patients >35,000 Implant rate 97% Functional MR 64% Degenerative MR 22% Mixed* 14% Data source: Abbott Vascular

19 EVEREST II Randomized Controlled Trial (Endovascular Valve Edge-to-Edge REpair Study)

20 EVER ES T -EndovascularValveEdge-toEdgeR EpairS T udy The EVEREST II RCT was a prospective, multi-center trial designed to compare the safety and effectiveness of the MitraClip System with mitral valve surgery in the treatment of patients with significant ( 3+) mitral regurgitation Feldm ant,a CC 2014 W ashington

21 L ong-t erm M itraclipdevice Through 1 Year # (%) of patients 1 Year to 5 Years # (%) of patients Single Leaflet Device Attachment (SLDA) 10 (6.3%) 0 (0.0%) MV stenosis 1 (0.6%) 0 (0.0%) Device Embolization 0 (0.0%) 0 (0.0%) Based on N=158 who were implanted with 1 or 2 MitraClip devices Feldm ant,a CC 2014 W ashington

22 M itralr egurgitationgrade EverestIIR CT alltreated patients258

23 S tableim provem entn YHA FuntionalClass EverestIIR CT alltreated patients258

24 5-YearsFU inever ES T II 24 Feldm ant,a CC 2014 W ashington

25 M e ta Ana lysis 26 studiesincluding 38 21patient sw ho w eretreatedw ithm C Etiology.. The resul ts are com parable w ith open m itral valve repair ( omvr) but patients are m arkedly 25 older and have a higer risk profile..

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27 Summary There was no difference in the degree of reverse remodeling and mortality No difference in MACCE, overall SAEs, and QOL

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29 Summary No difference at 1 year: in the degree of reverse remodeling in mortality in MACCE, hospital readmission, or QOL CABG + MV repair associated with more: neurologic events increased cross clamp and cardiopulmonary bypass time longer ICU and hospital LOS At 1 year, higher degree of moderate and severe MR in the CABG alone group The trial did not demonstrate a clinically meaningful advantage to the routine addition of MVR to CABG

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31 5 trials randomizing ~1656 patients with heart failure and secondary (functional) MR to MitraClip vs. GDMT or MV Surgery As of Oct. 24th, 2016, ~876 ~876 patients have been randomized: - COAPT 482/610 (79%) - MITRA MITRA--FR 231/288 (80%) - RESHAPE RESHAPE--HF HF /380 (35%) - MATTERHORN 31/210 (15%) - EVOLVE EVOLVE--HF 0/168 (0%)

32 ~610 patients enrolled at up to 100 sites Symptomatic HF treated with maximally tolerated guideline directed medical therapy Significant FMR ( 3+ by echo core lab); Not appropriate for MV surgery as determined by site s local heart team Valve anatomy eligible for MitraClip treatment Up to 3 roll-in procedures per site for investigators without prior MitraClip experience or no MitraClip procedures in the prior 12 months Randomize 1:1 Control group Standard of care N~305 MitraClip N~305 Clinical and TTE follow-up: Baseline, treatment, 1-week (phone), 1, 6, 12, 18, 24, 36, 48, 60 months Primary endpoint: Hospitalization for heart failure within 2 years Principal Investigators: Gregg Stone, Michael Mack Heart Failure Co-Principal Investigators: William Abraham, JoAnn Lindenfeld Sponsor: Abbott Vascular

33 Death Heart Failure Hospitalization % % Months after treatment Patients at risk: Death HF Hospitalization

34 At30 Days M R 2+: 0.0% (0/42) At1 Year 78.6% (33/42) 0.0% (0/24) p< % p= % 2.4% 80% % % 60% 40% Baseline N= % % 58.3% 60% 40% 20% % % 30 Days % 45.2% 0% % P atients % P atients 80% 20% 83.3% (20/24) % % Baseline N=24 1 Year 8.3% 8.3%

35 At30 Days ClassI/II: 30.6% (15/49) At1 Year 57.1% (28/49) 27.8% (10/36) 28/49 = 57.1% improved at least 1 class 21/36 = 58.3% improved at least 1 class p=0.008 % P atients 80% I II 100% 2.0% 28.6% I III III 36.7% IV N=49 30 Days 6.1% II 40% III 19.4% 0% Baseline 13.9% II 55.6% III 27.8% IV 2.8% 52.8% 20% IV I 27.8% 60% 22.4% 0% Baseline 36.7% 46.9% 20% IV 20.4% 80% II 60% 40% p=0.004 % P atients 100% 69.4% (25/36) N=36 1 Year

36 KCCQ S core KCCQ S core ± N=48 30 Days ± 23.6 Baseline Δ = % CI (14.6, 30.9) p< Δ = % CI (12.1, 29.2) p< ± ± 20.9 Baseline N=35 1 Year

37 Population N Randomized Primary EP Cardioband Carillon Symptomatic HF and FMR Ischemic or non-ischemic cardiomyopathy; optimized and stable medical HF regimen Symptomatic HF and FMR Ischemic or non-ischemic cardiomyopathy; optimized and stable medical HF regimen ~400 ~400 2:1 2:1 1 year: Prevalence of MR 2+ and 1-year efficacy: Clinical endpoints and regurgitant volume hierarchical comparison of all-cause mortality, # of HF hospitalizations, 6 minute walk test and KCCQ 1-year safety: Device-related major adverse events Preliminary pending FDA approval

38 Among patients with degenerative MR with a flail leaflet, referred to mitral surgery, MV repair was associated with lower operative mortality, better long-term survival and fewer valve-related complications compared to MV replacement. Lazam et al. Circulation 2016

39 The surgical experience: mitral repair vs. mitral replacement Lazam et al. Circulation 2016

40 S urgery already show ed betterresultsfor m itralrepair.w hy should percutaneous treatm entbedifferent?

41 Future ofm itra ClipProce d ure

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