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Mitral Valve Repair: State of the Field - Where Are We Going from Here? Ted Feldman, M.D., MSCAI FACC FESC Evanston Hospital Cardiovascular Research Technologies 2015 February 21st-24th Washington, DC. Ted Feldman MD, MSCAI FACC FESC Disclosure Information The following relationships exist: Grant support: Abbott, BSC, Edwards, WL Gore Consultant: Abbott, BSC, Coherex, Edwards, JenaValve, Diiachi Sankyo-Lilly, WL Gore Off label use of products and investigational devices will be discussed in this presentation Treated Patients >19,000 Carillon >300 >60 MitraClip >40 >25 TRAMI MitraClip Experience n=828 German TRAnscatheter Mitral valve Interventions Registry Age 76.0 (71.0-81.0) STS 6.0 (3.5-11.0) Functional MR 515/734 (70%) Procedure time (minutes) 103.2 ± 54.1 Fluoroscopy time (minutes) 29.1± 57.1 Fully successful procedure 682/818 (83.4%) Death 18/825 (2.2%) Intraprocedural death 1/825 (0.1%) Stroke 7/784 (0.9%) Clip embolisation 0 Early partial leaflet detachment 16/784 (2%) Severe complications in-hospital 106/828 (12.8%) -major bleeding requiring transfusion 58/783 (7.4%) -pericardial tamponade 15/783(1.9%) -injury of inter-atrial septum 1/828 (0.1%) Catheter Cardiovasc Interv. 2015 Jan 19. doi: 10.1002/ccd.25838. [Epub ahead of print] TMVR in prohibitive surgical risk patients is associated with safety and good clinical outcomes, including decreases in rehospitalization, functional improvements, and favorable ventricular remodeling, at 1 year. J Am Coll Cardiol 2014;64:182–92 Left Ventricular Volumes Left Ventricular End Diastolic Volume 180 Mean = -17.9 ml 97.5% UCB = -13.5 ml p<0.0001 Mean Volume (ml) 160 Left Ventricular End Systolic Volume 85 140 80 120 75 160.5 142.6 100 65 60 60 1 Year Paired data (N=203) 87.0 70 80 Baseline Mean = -8.1 ml 97.5% UCB = -4.8 ml p<0.0001 90 78.9 Baseline 1 Year Paired data (N=202) Hospitalizations For Heart Failure 1.00 0.80 0.67 73% Reduction p < 0.0001 0.60 0.40 0.18 0.20 0.00 1 Year Prior to MitraClip N = 127 1 Year Post Discharge N = 120 MitraClip Clip Delivery System 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. DMR Case Example • • • • • • 87M Multiple hospitalizations for CHF EF 70-75% NYHA Class III PASP 50mmHg STS – Repair 7.5% – Replace 11% Pre vs Post 2 Clips The EVEREST II Randomized Clinical Trial: 5 Year Outcomes By MR Etiology CONCLUSIONS Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery, the procedure was associated with superior safety and similar improvements in clinical outcomes. Septal Lateral Annular Dimensions EVEREST II RCT All Treated Patients - MitraClip Group (N=178) Diastolic SLAD 5 5 4 4 3.4 3.3 3 2 1 0 Baseline 5 Years Mean SLADdiast (cm) Mean SLADsyst (cm) Systolic SLAD 3.9 3.9 Baseline 5 Years 3 2 1 0 Freedom From Mortality & Reintervention DMR MitraClip DMR Surgery DMR Clip: DMR Surg: FMR Clip: FMR Surg: FMR Surgery Baseline 12 Months 24 Months 36 Months 48 Months 60 Months RCT Device FMR 48 39 33 31 26 9 RCT Device DMR 130 119 110 102 93 49 RCT Surgery FMR 18 15 13 11 9 8 RCT Surgery DMR 62 55 52 46 43 16 # At Risk Kaplan-Meier estimate FMR MitraClip 97.7% [92.7%, 99.3%] 91.8% [81.3%, 96.5%] 83.2% [69.1%, 91.3%] 93.8% [63.2%, 99.1%] At 1 year DMR Clip: DMR Surg: FMR Clip: FMR Surg: 89.4% [77.7%, 95.2%] 85.9% [60.1%, 95.6%] 59.7% [31.6%, 79.4%] 55.0% [27.2%, 76.0%] At 5 years EVEREST II RCT Therapy for MR Degenerative Functional Low Surgical Risk Surgical Mitral Repair ? High Surgical Risk Commercial MitraClip COAPT Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk ~430 patients enrolled at up to 75 US sites Significant FMR ≥3+ core lab; EF<50%; CHF hospitalization or BNP>300 High risk for mitral valve surgery- Local Heart Team Specific valve anatomic criteria Randomize 1:1 MitraClip Control group Standard of care Safety: Composite death, stroke, worsening renal function, LVAD implant, heart transplant at 12 months Effectiveness: Recurrent heart failure hospitalizations Protocol conditionally approved by FDA July 26, 2012 Outcomes of Unoperated Patients With Severe Symptomatic MR and Heart Failure Unoperated patients had lower EF(27 ±15% vs. 42±17%, p < 0.0001) and higher STS score compared with operated patients (median [interquartile range]: 5.8 [2.8 to 11.5] vs. 4.0 [2.1 to 7.4], p < 0.001. JACC 63:185-186, 2014 COAPT Inclusion • Symptomatic functional MR (≥3+) – Cardiomyopathy ischemic or non-ischemic • LVEF ≥20% and ≤50% • HF hospitalization ≤12 months and/or a corrected BNP ≥300 pg/ml or NT-proBNP ≥1500 pg/ml ≤90 days • TTE on optimal therapy ≥30 days after: – any change in GDMT – revascularization and/or implant of CRT Version 5.1 November 11, 2013 STS 18.2±8.4% J Am Coll Cardiol 2014;64:172–81 MitraClip Status • • • • • 19,148 total implants 420 global sites in 35 countries 1200 US commercial implants 110 commercial US sites 73 active COAPT sites – 170 patients randomized Abbott Vascular updated Dec 31st 2014 Percutaneous Mitral Repair Devices Already gone Still developing • • • • • • • • • • • • PTMA Monarc Mobuis leaflet repair Recor RF annular remodeling • Coapsys Leaflet repair CS annuloplasty Direct annuloplasty Cerclage Mitral spacer Midle Peak Chordal replacement Valve replacement Coronary Sinus- Indirect Annuloplasty CARILLON Mitral Contour System Trans Femoral Cardioband DIRECT ANNULOPLASTY Mitralign Procedure Steps Wire Delivery Pledget Delivery Plication & Lock Suture bicuspidization of the tricuspid valve vs ring annuloplasty for functional tricuspid regurgitation Midterm results of 237 consecutive patients Suture bicuspidization is performed by placement of a 2-0 pledget-supported mattress suture from the antero-posterior to the posteroseptal commissures along the posterior annulus. J Thorac Cardiovasc Surg 2007;133:117-126 Mitral Replacement Technologies • • • • • • • CardiaAQ Neovasc TIARA Tendyne Edwards FORTIS Endovalve M-Valve Medtronic • • • • • • • • Valtech Lutter MitrAssist Caisson MitraSeal Twelve HighLife Others…. Mitral Repair vs Replacement for Severe Ischemic MR The composite end point included death, stroke, subsequent mitral-valve (MV) surgery, hospitalization for heart failure, and an increase in the New York Heart Association class of 1 or more. Acker M et al NEJM 370:23, 2014 The MITRAL Trial Mitral Implantation of TRAnscatheter vaLves in native mitral stenosis Principal Investigator Mayra Guerrero, MD The safety and feasibility of the SAPIEN XT TM Transcatheter Heart Valve with NovaFlex and Ascendra delivery systems in patients with symptomatic severe calcific mitral stenosis who are not candidates for mitral valve Surgery – Cedars-Sinai Medical Center (Co- Principal Investigators: Saibal Kar, MD; Rajendra Makkar, MD) – Columbia University (Co-Principal investigators: Susheel Kodali, MD; Martin Leon, MD) – Evanston Hospital (Co- Principal Investigators: Mayra Guerrero, MD; Ted Feldman, MD) – Henry Ford Hospital (Principal investigator: William O’Neill, MD) – Massachusetts General Hospital (Principal Investigator: Igor Palacios, MD) – Mayo Clinic (Principal Investigator: Charanjit RIhal, MD)