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“Soon, I Will Remodel Your Valve” Evolving Interventional Therapies for Treatment of Mitral Regurgitation Duane Pinto, MD MPH Beth Israel Deaconess Medical Center Harvard Medical School Harvard Medical School MR Etiology Normal Degenerative MR —Prolapse Degenerative MR —Flail Functional MR Ischemic vs nonischemic Harvard Medical School Edge to Edge (Evalve) Human S/P surgical Alfieri Circulation 2002;106:e173 Evalve clip repair in porcine heart (6 mos post repair) Circulation 2003;108(Supp IV):493 Harvard Medical School The MitraClip System Clip Delivery System MitraClip Device (Clip) MitraClip System Arm Steerable Guide Handle Delivery Catheter Handle Gripper Steerable Guide, Steerable Sleeve, and Delivery Catheter Stabilizer MitraClip Device (Clip) Harvard Medical School MitraClip Features • Venous puncture • Standard Percutaneous Left Atrial Access • Versatile Positioning Capabilities o Adaptability to varying patient anatomy • Precise MitraClip Placement Control o Re-positioning capability • Allows multiple tissue releases and grasps • Allows optimal MR reduction • Provides option to not deploy Clip Harvard Medical School Echo Related Valve Anatomy Use of common anatomically based vocabulary reinforces clear communication MEDIAL 60 POSTERIOR FOSSA P3 30 A3 AO P2 A2 A1 P1 30 ANTERIOR LAA LATERAL Worldwide Experience Study Population N* EVEREST I (Feasibility) Feasibility patients 55 EVEREST II (Pivotal) Pre-randomized patients 60 EVEREST II (Pivotal) Non-randomized patients (High Risk Study) 78 EVEREST II (Pivotal) Randomized patients (2:1 Clip to Surgery) REALISM (Continued Access) Non-randomized patients 899 Compassionate/Emergency Use Non-randomized patients 66 ACCESS Europe Phase I Non-randomized patients 567 ACCESS Europe Phase II Non-randomized patients 286 Commercial Use Commercial patients Total *Data as of 2/28/2014 Source: Abbott Vascular 279 184 Clip 95 Surgery 10,754 12,949 +95 surgery Harvard Medical School Commercial MitraClip Implant Experience – – – – – Treating Centers: 305 Patients1: 11,607 Implant Rate1: 96% Acute MR reduction1,2: 99% Etiology • Functional MR • Degenerative MR • Mixed Etiology 67% 21% 12% First-time procedures only Includes commercial patients, ACCESS I and ACCESS II patients Successful implants only Data as of 2/28/2014 Source: Abbott Vascular Harvard Medical School Long-Term Durability of Clinical Success 5-Year Outcomes in Patients Who Were Alive and Free From MR 3+/4+ and MV Surgery (or Re-Operation) at Year EVEREST II RCT Clinical Success Groups MitraClip (N=97) Surgery (N=64) Freedom From Death at Years 87% 90% Freedom From MV Surgery (or Re-operation) at Years 94% 95% MR ≤ 2+ at Years 86% 97% MR ≤ 1+ at Years 47% 92% 47%  6% 40%  3% Mean Change in LVEDV From Baseline to Years -27 ml -45 ml Mean Change in Diastolic SLAD From Baseline to Years 0.0 cm -0.4 cm Outcome NYHA Class III/IV (%) Baseline  Years Harvard Medical School MR Etiology Normal Degenerative MR —Prolapse Degenerative MR —Flail Functional MR Ischemic vs nonischemic Harvard Medical School Edge-to-edge (2) • eValve • Edwards Mobius Coronary sinus annuloplasty (3) • Edwards Monarc • Cardiac Dimensions Carillon • Viacor PTMA Indirect annuloplasty (3) • Ample PS3 • Myocor i-Coapsys • St Jude AAR Direct annuloplasty (5) • Mitralign • Guided Delivery Systems • QuantumCor, Cordis DPA • MiCardia, Mitral Solutions Device Landscape: Percutaneous MV Repair Harvard Medical School The Coronary Sinus Approach to Mitral Regurgitation A L P …cinch the valve Harvard Medical School Coronary Sinus Approach CARILLON – – – – Reduces annulus by traction Varying degrees of tension to system Effect on FMR can be assessed during implantation Implant can be recaptured if placement is not as desired (e.g LCX compression) Distal anchor Proximal anchor Harvard Medical School Mitralign Direct Annuloplasty System Before and after implant: Atrial view • Direct reduction of the annular SL dimension based on posterior leaflet surgical plication • Small (1 cm, 20%) plication of the posterior annulus reduces ischemic MR, with durable surgical results Tibayan et al Ciculation 2003;108:II-128-133 Aybek et al JTCS 2006; Nagy et al Scand Cardio J 2000 Harvard Medical School Percutaneous Mitral Valve Replacement: Role in DMR and FMR may be different • In DMR, there is something physically wrong with the valve apparatus • With the exception of MitraClip, percutaneous repair technologies apply less to DMR • Also the use of MitraClip in DMR, may limit future ability to place a percutaneous replacement valve, complicating the choice of therapy • Therefore, percutaneous replacement may become a viable option earlier in DMR patients Status of Emerging Replacement Systems (all but one are pre-clinical) Status of Emerging Replacement Systems CardiaQ • NiTi, self-expanding • Trileaflet, symmetric • sets of 12 anchors • Transcatheter venous, transseptal • Percutaneous FIM Gen1 in 2012 (1 patient) • Percutaneous FIM Gen2 planned for 2013 • The only percutaneous replacement technology to perform a human case Successful First-in-Human procedure in June 2012 CardiaQ - Acute In Vivo Results Status of Emerging Replacement Systems Neovasc •NiTi, self-expanding •Trileaflet, D-shaped •3 ventricular tabs •Transapical access •150d animals completed •FIM target late ‘13 or early ‘14 Status of Emerging Replacement Systems Medtronic • NiTi, self-expanding • Trileaflet, D-shaped • ventricular arms • Transatrial access • Acute animals • FIM not yet planned Status of Emerging Replacement Systems Tendyne •NiTi, self-expanding •Neochords with apical tethering •Transapical •30d animals completed •FIM planned for late ‘13 Status of Emerging Replacement Systems Valtech • NiTi, self-expanding • Trileaflet • Transapical with hope for transfemoral • 30d animals completed • FIM not yet planned Status of Emerging Replacement Systems Many others in development • Edwards • Endovalve • Mitralix • Mehr • Caisson • Others Conclusions • Percutaneous Mitral Solutions will have a role in DMR, FMR • May treat at an earlier stage in DMR, but will compare to surgery • May treat at a later stage in FMR, once repair options have been exhausted • Mitral replacement poses a much greater technical challenge when compared to TAVR • We look forward to future developments [...]... Delivery Systems • QuantumCor, Cordis DPA • MiCardia, Mitral Solutions Device Landscape: Percutaneous MV Repair Harvard Medical School The Coronary Sinus Approach to Mitral Regurgitation A L P …cinch the valve Harvard Medical School Coronary Sinus Approach CARILLON – – – – Reduces annulus by traction Varying degrees of tension to system Effect on FMR can be assessed during implantation Implant can be recaptured...Trial design 430 patients enrolled at up to 75 US sites Significant FMR (≥3+ by core lab) Symptomatic heart failure subjects who are treated per standard of care Determined by the site’s local heart team as not appropriate for mitral valve surgery Specific valve anatomic... surgical plication • Small (1 cm, 20%) plication of the posterior annulus reduces ischemic MR, with durable surgical results Tibayan et al Ciculation 2003;108:II-128-133 Aybek et al JTCS 2006; Nagy et al Scand Cardio J 2000 Harvard Medical School Percutaneous Mitral Valve Replacement: Role in DMR and FMR may be different • In DMR, there is something physically wrong with the valve apparatus • With the exception