Presentation on theme: "Percutaneous Mitral Repair with the MitraClip® Device for Functional Mitral Regurgitation: Acute Success, One year Durability and Reverse Remodeling."— Presentation transcript:
1 Percutaneous Mitral Repair with the MitraClip® Device for Functional Mitral Regurgitation: Acute Success, One year Durability and Reverse Remodeling in the Initial EVEREST Cohort James Hermiller, MD, FACC, FSCAI The Care Group, LLC St Vincent Heart Center of Indiana Indianapolis, IN
2 EVEREST Investigators Contributing AuthorsSaibal Kar, MD Cedars Sinai Medical Center, Los Angeles, CAPeter Fail, MD Cardiovascular Institute of the South, Houma, LAMichael Rinaldi, MD Sanger Clinic, Charlotte, NCTanvir Bajwa St. Luke’s Medical Center, Milwaukee, WIRichard Smalling Memorial Herrmann Hospital, Houston, TXJohn Lasala Washington University Medical Center, St Louis, MOScott Lim University of Virginia Medical Center, CharlottesvilleRobert Kipperman Oklahoma Heart Hospital, Oklahoma City, OKHoward Herrmann, MD University of Pennsylvania, Philadelphia, PAPatrick L Whitlow, MD The Cleveland Clinic, Cleveland, OHElyse Foster, MD Univ. of California at San Francisco, San Francisco, CADonald D Glower, MD Duke University, Durham, NCTed Feldman, MD Evanston Northwestern Hospital, Evanston, ILOn behalf of theEVEREST InvestigatorsTanvir Bajwa,; Richard Smalling,; John Lasala,; Scott Lim,, VA; Robert Kipperman,;
3 EVEREST Principal Investigators and Affiliation Ted Feldman, EVEREST I PI, EVEREST II PI Evanston Northwestern Hospital, Evanston, ILPatrick L Whitlow The Cleveland Clinic, Cleveland, OHHal Wasserman/Bill Gray Columbia University, New York, NY; Danville, CTMichael Rinaldi Sanger Clinic, Charlotte, NCHoward Herrmann University of Pennsylvania, Philadelphia, PARichard W Smalling Houston Health Sciences Center, Houston, TXBill Gray/Mark Reisman Swedish Medical center, Seattle, WAPeter Block/Ziyad Ghazzal Emory University Hospital, Atlanta, GAPaul Kramer Shawnee Mission Medical Center, Shawnee Mission, KSSteven Bailey Univ of Texas Health Sciences Center, San Antonio, TXAndrew C Eisenhauer Brigham and Women Hospital, Boston, MSSaibal Kar Cedars Sinai Medical Center, Los Angeles, CAJames Hermiller The Care Group, Indianapolis, INTanvir Bajwa St. Luke’s Medical Center, Milwaukee, WIVish Bhoopalam Nebraska Heart Institute, Lincoln, NEAndrew Berke St. Francis Hospital, Long Island, NYTim Byrne Banner Good Samaritan Medical Center, Phoenix, AZJohn Carroll University of Colorado, Denver, COPeter Fail Terrebonne General Medical Center, Houma, LAEric Fretz Victoria Heart Institute Foundation, Victoria BC, CanadaPaul Grayburn Baylor University Medical Center, Dallas, TXKenny Kent Washington Hospital Center, Washington DCRobert Kipperman Oklahoma Heart Hospital, Okalahoma City, OKJohn Lasala Washington University Medical Center, St. Louis, MOD. Scott Lim University of Virginia, Charlottesville, VAReginald Low University of California at Davis, Sacramento, CAJames Maddux/Mark Sanz St. Patrick's Hospital & Health Science Center, Missoula, MTMichael O'Donnell St. Joseph’s Mercy Hospital, Ypsilanti, MIWesley Pedersen Minneapolis Heart Institute, Minneapolis, MNStephen R Ramee Ochsner Clinic Foundation, New Orleans, LAEric Horlick Toronto General Hospital, Toronto, ON, CanadaJames Slater NYU Medical Center, New York, NYAndrew Wang Duke University, Durham, NCBrian Whisenant Latter Day Saints Hospital, Salt Lake City, UTChiu Wong Cornell–Weill Medical Center, New York, NYElyse Foster, Echocardiographic Core Laboratory University of California at San Francisco, San Francisco, CADonald D Glower, EVEREST II Co-PI (Surgery) Duke University, Durham, NCEVEREST I & IIEVEREST II ONLY
4 Disclosures All authors receive research support from Evalve Investigational Device:Limited by Federal (or United States) Law to Investigational Use
5 Background & PurposeOf the 250,000 patients in the United States developing significant mitral regurgitation (MR) each year, up to 60% have functional MRIsolated leaflet repair for functional mitral regurgitation (FMR) has not been well characterizedThe purpose of this study is to evaluate the safety and efficacy of isolated leaflet repair using the MitraClip device in patients with FMR
6 Edge to Edge & MitraClip Concepts Facilitates proper leaflet coaptationDegenerative - Anchor flail and prolapsed leafletsFunctional - Coapt tethered leafletsReduces LV volume overload by reducing MRCreates tissue bridgeMay limit dilatation of annulusSeptal-lateral (A-P) dimensionSupports durability of repairRestrains LV wallLimits LV dilatationPorcine model, 6M
7 MethodsSurgical candidates with FMR were treated with the MitraClip device as part of the EVEREST protocols.FMR was defined as the presence of MR without demonstrated echocardiographic structural valve defects as assessed by TEE.TTE performed to assess MR severity and LV function and dimensions at baseline and at 12 months.American Society of Echocardiography criteria were used for systematic Core Laboratory assessment of MR severity and LV function.
8 Methods: Key Eligibility Criteria Age 18 years or olderModerate to severe (3+) or severe (4+) MRSymptomaticAsymptomatic with LVEF < 60% or LVESD > 40mmACC/AHA Guidelines, Circ. 114;450,2006MR originates from A2-P2 mal-coaptationCandidate for mitral valve surgeryTransseptal deemed feasibleKey ExclusionsEF < 25% or LVESD > 55 mmRenal insufficiencyEndocarditis, rheumatic heart disease
9 Methods: Anatomic Eligibility TEE evidence of FMR:Absence of Degenerative valve diseasePresence of leaflet “tethering”Not exceeding 10mmSufficient leaflet tissue available for mechanical coaptation> 2mm “vertical” leaflet tissue availableAbsence of severe LV dysfunctionExcluding LVID-s > 55mm or EF <25%Ischemic or non-ischemic etiologyExclusions<2mm>11mm
10 EVEREST Preliminary FMR Cohort Subset of patients with FMR treated in the EVEREST I Feasibility Study or as roll-ins in the EVEREST II Study.Excludes EVEREST II Randomized patients or EVEREST II High Risk Registry patients.StudyPopulationnEVEREST I(Feasibility)FMR patients8EVEREST II(Pivotal)Non-randomized FMR patients(excludes high risk patients)15Total23Analysis per EVEREST II definitions
12 EVEREST Initial FMR Cohort Clinical Features EVEREST OverallN = 107Median Age (range)≥ age 6575 (50 – 88)74%71 (26 – 88)62%Male gender52%Diabetes mellitus48%21%Hypertension96%69%COPD22%12%History CHF87%56%Prior Cardiac Surgery43%19%Atrial Fibrillation26%29%Median EF50%NYHA III or IV83%46%LVID Systole (cm)4.3 ± 0.73.5 ± 0.8
13 EVEREST Initial FMR Cohort Patients with 30 Day Major Adverse Events (N = 23) Freedom from Major Adverse Events87%Death – Unrelated to ClipStroke (>72 hours)Myocardial InfarctionRe-operation for failed surgeryNon-elective Cardiac Surgery (Pericardial Effusion)1Renal failureDeep wound infectionVentilation > 48 hrsGI complication requiring surgerySepticemiaBleeding requiring transfusion ≥ 2 units2
14 EVEREST Initial FMR Cohort Efficacy Results through Discharge N = 23 * Acute Procedural Success (APS): Defined as placement of one or more Clipsresulting in discharge MR severity of 2+ or less, as determined by Core Lab.
17 EVEREST Initial FMR Cohort NYHA Class, APS Patients EVEREST Initial FMR Cohort NYHA Class, APS Patients* (matched data, n = 12)75% (9/12) Improved17% (2/12) No Change8% (1/12) Worsened w/o MR > 1+* Excludes patients that went to MV surgery post-Clip prior to 12-months or have not reached 12-month follow-up
18 EVEREST Initial FMR Cohort Reverse LV Remodeling APS Patients EVEREST Initial FMR Cohort Reverse LV Remodeling APS Patients* (matched data, n = 12)p = 0.006p = 0.12p < 0.04p < 0.03DiastolicSystolic* Excludes patients that went to MVsurgery post-Clip prior to 12-months orhave not reached 12-month follow-up
19 EVEREST Initial FMR Cohort Ejection Fraction APS Patients EVEREST Initial FMR Cohort Ejection Fraction APS Patients* (available matched data, n = 12)p = NSPercent (%)± 9± 11EF: 50 ± 9% at baseline and 48 ± 11% at 12-months* Excludes patients that went to MV surgery post-Clip prior to 12-months or have not reached 12-months
20 EVEREST Initial FMR Cohort: Surgery Following Clip Procedure N = 23 SURGERY FREE19/23Median Follow-up369 DaysSurgery After Clip Implanted (n = 3)2 Repairs1 ReplacementSurgery After No Clip (n = 1)1 ReplacementNo Partial Clip DetachmentsNo Clip Embolizations
21 EVEREST Initial FMR Cohort Conclusions Percutaneous mitral repair with the MitraClip: Effective in reducing MR with a low MAE rateSignificant reverse LV remodeling at 1-yearClinical improvement with 58% of patients NYHA Class I at 1-year79% freedom from death, surgery for valve dysfunction and MR > 2+ at 1-yearMitraClip facilitates leaflet coaptation reducing MR in functional patients
22 Study LimitationsSmall number of patientsNon randomized registry populationInitial experience – early in learning curveOnly 12/19 with acute procedural success have 1 year follow up (clinical and echo)
23 EVEREST II Randomized Trial Enrollment still openRandomized sample size: ~280 patientsAdditional information available at:
24 EVEREST Investigational Study Sites Prospective, Multi-centerSafety and EffectivenessRandomized vs. Surgery
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