Percutaneous Therapy for Mitral Regurgitation: Current and Future Options: Could we do better today?

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1 Percutaneous Therapy for Mitral Regurgitation: Current and Future Options: Could we do better today? Peter S. Fail, MD, FACC, FACP, FSCAI Director of the Cardiac Catheterization Laboratories and Interventional Research Cardiovascular Institute of the South

2 Peter S. Fail, MD FACC, FACC, FSCAI Disclosure Statement of Financial Interest Grant Research Support Abbott Vascular Medtronic CardioKinetix Boston Scientific Stock CardioSolutions Off label use of products and investigational devices will be discussed in this presentation

3 Relative Sizes of Clinical Needs Primary vs Functional MR Expected WW Ann. Incidence Primary MR ~650,000 Functional MR ~2,570,000 ~2,570,000 Functional MR

4 Bulging Mechanisms Mitral Regurgitation Degenerative Functional Redundant / Broken Chordea Sick Valve Papillary muscle traction Sick Heart Increased tethering Flail or Degenerative Leaflets Decreased closing force MR MR Annular dilatation

5 Transcatheter MV Repair: Device Landscape 2015 Edge-to-edge MitraClip* MitraFlex irect annuloplasty and basal ventriculoplasty Mitralign Bident* GDS Accucinch* Valtech Cardioband* Quantum Cor (RF) Micardia encor *In patients Coronary sinus annuloplasty Cardiac Dimensions Carillon* Cerclage annuloplasty MV replacement CardiAQ* Neovasc * Edwards Fortis* Micro Interventional Valtech Cardiovalve ValveXchange Lutter Valve Medtronic Tendyne* MitrAssist MValve Other approaches MitraSpacer* St. Jude leaflet plication* Cardiac Implant perc ring NeoChord* Babic chords Valtech Vchordal Middle Peak Medical Mardil BACE Mitralis Millipede

6 Percutaneous Mitral Valve Therapies Evalve leaflet repair n >20,000 Annular & chamber remodleing Replacement icoapsys Vaicor Ample PS3 Monarc Cardiac Dimensions Mitralign

7 Catheter-Based Mitral Valve Repair MitraClip System Investigational Device only in the US; Not available for sale in the US

8 Surgical isolated edge-to-edge mitral repair without annuloplasty Clinical proof of principle for endovascular approach Freedom from re-operation and 2+ MR Maisano F, Vigano G, Blasio A, Columbo A, Calabrese C, Alfieri O Eurointervention 2: , 2006

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10 Grasping

11 Results from 2 clip Case Degenerative MR

12 Functional MR with Severe Cardiomyopathy Pre Following 1 Clip

13 Functional MR with Significant Cardiomyopathy Post CRT

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15 % Patients Mitral Regurgitation Severity All Treated Patients (N=258) MitraClip (N=178) 84% MR 2+ at 3 Years Surgery (N=80) 96% MR 2+ at 3 Years 100% 100% 80% 80% 0+ 60% % 3+ 40% 4+ 40% 20% 20% 15 0% Matched N = BL 1Y BL 2Y BL 3Y % BL 1Y BL 2Y BL 3Y

16 Kaplan-Meier Freedom from MV Surgery in MitraClip group or Re-operation in Surgery group All Treated Patients (N = 258) Surgery (N = 80) MitraClip (N = 178) 98.7% 97.2% 97.1% 96.3% 1 year 2 years 95.6% 95.5% 3 years Surgery Non-High Risk (N = 80) RCT MitraClip Non-High Risk (N = 178) MitraClip Non-High Risk (N = 178) RCT Surgery Non-High Risk (N = 80) Days Post Index Procedure TCT 2012

17 Kaplan-Meier Freedom From Mortality All Treated At Risk: Percutaneous FMR Percutaneous DMR Surgery FMR Surgery DMR 0 Days 1Y 2Y 3Y

18 Endovascular Valve Edge-to-Edge REpair STudy Subgroup Analyses for the Primary End Point at 12 Months Feldman T et al. N Engl J Med 2011;364:

19 C-19 Improved LV Dimensions at 1 Year Left Ventricular Internal Diastolic Diameter -0.2 cm p < Paired Analysis Left Ventricular Internal Systolic Diameter -0.1 cm p < N = 221 N = 210 HRR: p < 0.001, REALISM: p < HRR: p = 0.09, REALISM: p = 0.006

20 HRR: p = 0.02, REALISM: p < Significant Reduction in HF Hospitalization Rate 48% Reduction p < All Treated C-20

21 Lets take a closer look: Could have we done better?

22 MitraClip vs Surgery Learning Curve 2 clip limit +2 MR as an acceptable endpoint Making MR the end point and not the clinical response Surgeons were able to the best procedure to achieve MR Reduction

23 Learning Curve EVEREST Investigators Roll-in with 3 case then able to randomize??? Can you really understand a new procedure with 3 cases? Against surgeons the had a average to 15years experience at MVR

24 Learning Curve Procedural Time Device Time APS 6 Month Durability First 25 Last 25 European Journal of Heart Failure (2011) 13,

25 Learning Curve Time First Cohort Second Cohort Multiple Clips % European Journal of Heart Failure: 2011, 13;

26 2 Clip Limit (+2MR as an Acceptable endpoint)

27 2 Clip Limit After 2 Clips Did the insertion of the 3 rd clip improve this patients long term survival? After 3 Clips

28 Reduction in HF Hospitalization Rate by MR Reduction - - Is this Trial Effect? All Treated MR Grade 1+ or 2+ MR Grade 3+ or 4+ C-28 54% Reduction Exploratory analysis 1 Year Prior to MitraClip 1 Year Post Discharge 1 Year Prior to MitraClip 1 Year Post Discharge

29 Freedom from Death and MR >2+ or MR > 1+ at 1 Year C Freedom from death and MR > 2+ 1 Year Freedom from death and MR at 1 year Freedom from death and MR > % 29.5% Days Post Index Procedure

30 MR versus NYHA

31 Left Ventricular Volume Per Protocol Cohort

32 Left Ventricular Dimension Per Protocol Cohort

33 NYHA Functional Class Ask your patient what matters more to him/her. How he or she feels or what their MR is?

34 Think back to the PTCA vs CABG Trials Endpoints Death Angina MI Hospitalizations MI Angina Repeat angioplasty/cabg

35 Isolated procedure vs Multiple Procedures SURGERY (Control) prosthetic ring annuloplasty Full or partial leaflet resection chordal shortening Neo-chords leaflet mobilization papillary muscle reimplantation Alferei Stitch VS DEVICE 1 or 2 clip

36 Is this REALY expected to be equivalent

37 Despite the previous criticism, the MitraClip remains the first in-class device of many, many more to come. Those of us that have witnessed the results of those patients we have treated with the MitraClip have been nothing short of amazing Where are we today?

38 19,000 patients

39 MitraClip Approved for Degenerative MR High surgical risk as reported by 2 CT surgeons experienced in mitral valve surgery 2 Trials underway to look at Functional MR COAPT RESHAPE HF (EU)

40 Conclusion and Questions No lack of creativity and device iteration Thresholds remain difficult to determine for percutaneous treatment as well as assessment of the outcomes Will the threshold for success be the same for surgery Will percutaneous procedures have the ability to treat less severe patients what is the optimal time to alter the course of the natural history of the disease. Will there be optimally a hybridization of techniques and how will they be adequately tested.

41 THANK YOU