SURGICAL AND TRANSCATHETER MITRAL VALVE REPLACEMENT VS. REPAIR: COMPETITION OR SYNERGY

Transcription

1 SURGICAL AND TRANSCATHETER MITRAL VALVE REPLACEMENT VS. REPAIR: COMPETITION OR SYNERGY Michael J. Reardon, M.D. Professor of Cardiothoracic Surgery Allison Family Distinguish Chair of Cardiovascular Research Houston Methodist DeBakey Heart & Vascular

2 DISCLOSURES Executive committee Intrepid EFS and Apollo IDE trials

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4 General Population Olmsted County

5 General population Olmsred county 1/8 over 75 have moderate to severe mitral valve disease

6 MR MORTALITY Studies with predominantly moderate MR had a 3%

7 Should we worry about MR? YES What do we do about it is the question.

8 Primary MR Secondary

9 NON ISCHEMIC 2 0 MR

10 ISCHEMIC 2 0 MR

11 Primary degenerative MR is a disease of the valve and we strive to fix this before the ventricle deteriorates Secondary or functional MR is a disease of the ventricle and it is already too late to prevent deterioration

12 There is substantial evidence that correcting degenerative MR improves QoL and extends survival There is little evidence that correcting FMR improves Qol or extends survival

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14 CHALLENGES Aortic Valve Mitral Valve Simple Complex

15 CHALLENGES Anyanwu A, Adams DH, TMVR The next revolution? JACC

16 THE MITRAL VALVE MULTIPLE STRUCTURAL CHALLENGES Anterior annulus Anterior leaflet Commissure Commissure Posterior leaflet Posterior annulus Chordae Papillary muscle Papillary muscle Left Ventricular free wall

17 The Mitral Valve Complex is Complex! It s not round nor D shaped it s asymmetric It s not flat it s saddle-shaped (3D) Its annulus is not rigid it s dynamic It s not passive it contracts, reducing valve area during systole It s a high pressure closure valve, not a high pressure opening valve It has 24+ chords; it calcifies with age (MAC) It s relatively easy to block aortic outflow It s easier to form thrombus on than the

18 Primary MR

19 PRIMARY MR

20 THERE IS AN UN MET NEED IN MITRAL VALVE TREATMENT FOR PRIMARY MR?

21 MITRAL SURGERY IN THE US

22 EUROPE

23 CLEVELAND CLINIC 1,095 PATIENTS WITH SEVERE MR AND CHF 577 (53%) MEDICAL RX 226 (21%) DMR

24 MV REPAIR TECHNIQUES FOR PROLAPSE

25 REPAIR TECHNIQUES Edge to edge Annuloplasty Chords

26 CATHETER-BASED MITRAL VALVE REPAIR MITRACLIP SYSTEM Clip toward MV Leaflets grasped Clip across MV N Engl J Med 2011;364:

27 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. N Engl J Med 2011;364:

28 FREEDOM FROM MORTALITY & REINTERVENTION DMR MitraClip DMR Surgery DMR Clip: 97.7% [92.7%, 99.3%] DMR Surg: 91.8% [81.3%, 96.5%] FMR Clip: 83.2% [69.1%, 91.3%] FMR Surg: 93.8% [63.2%, 99.1%] At 1 year FMR Surgery FMR MitraClip Kaplan-Meier estimate # At Risk RCT Device FMR RCT Device DMR RCT Surgery FMR RCT Surgery DMR Baseli ne 12 Month s 24 Month s 36 Month s 48 Month s 60 Month s DMR Clip: 89.4% [77.7%, 95.2%] DMR Surg: 85.9% [60.1%, 95.6%] FMR Clip: 59.7% [31.6%, 79.4%] FMR Surg: 55.0% [27.2%, 76.0%] At 5 years EVEREST II RCT

29 CARDIOBAND Surgery Cardioband

30 CARDIOBAND 1 Transseptal Puncture 2 System Insertion 3 Implant Deployment 4 Implant Size Adjustment

31 Cardioband 92% patients with MR 2+ At 24 Months By Core Lab* 87% MR 2+ at 30 Days 92% MR 2+ at 6 Months 93% MR 2+ at 12 Months 92% MR 2+ at 24 Months *Dr. Paul Grayburn Baylor University

32 TRANSCATHETER NEOCHORDAL REPAIR NeoChord Edwards Harpoon ChordArt

33 GRASPING OF PROLAPSING LEAFLET

34 RETRACTION OF DEVICE AND HITCH KNOT

35 FIXATION ON LV APEX

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37 WHAT DO WE KNOW? PRIMARY MR Surgery MV repair relieves symptoms, returns life span to normal and has less up front risk than MVR Transcatheter repair Repairs MR less well than surgery, safer than surgery, appears to relieve symptoms well

38 SECONDARY MR

39 SECONDARY MR

40 SECONDARY MR

41 SECONDARY MR

42 SECONDARY MR

43 SECONDARY MR

44 SECONDARY MR Higher up front mortality for MVR More heart failure and readmissions in repair group but; For those that worked better LV remodeling

45 CATHETER-BASED MITRAL VALVE REPAIR MITRACLIP SYSTEM Clip toward MV Leaflets grasped Clip across MV N Engl J Med 2011;364:

46 CARDIOBAND 1 Transseptal Puncture 2 System Insertion 3 Implant Deployment 4 Implant Size Adjustment

47 Cardioband 92% patients with MR 2+ At 24 Months By Core Lab* 87% MR 2+ at 30 Days 92% MR 2+ at 6 Months 93% MR 2+ at 12 Months 92% MR 2+ at 24 Months *Dr. Paul Grayburn Baylor University

48 WHAT DO WE KNOW? SECONDARY MR Surgery Repair inconsistent at best, MVR has a higher risk, lack of long term benefit Transcatheter repair Good safety profile, safe, long term outcomes?

49 TMVR?

50 VALVE IN VALVE/RING

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52 TMVR CLINICAL EXPERIENCE Intrepid Tendyne CardiA Q Neovasc Caisson Highlife M3 System CardioVa lve Overall Human Experie nce ~5 Pivotal IDE Status APOLLO Trial, approved and enrolling IDE approve d, enrollme nt to begin in US EFS Status Ongoing Ongoing Ongoin g Ongoing Ongoing - Ongoing - OUS Implan t Status Ongoing Ongoing Ongoin g Ongoing Ongoing Ongoing Unknown Ongoing

53 VALVE FEATURES

54 INTREPID DIFFERENTIATED DUAL STENT DESIGN Conformable Outer Stent engages the annulus providing fixation & sealing while isolating the inner stent from the dynamic anatomy Circular Inner Stent houses a 27 mm tricuspid bovine pericardium valve (EOA = 2.4cm2) Flexible Brim aids imaging during delivery One valve size significantly reduces development & manufacturing complexity/cost One implant platform regardless of delivery approach: trans-apical or trans-septal

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56 TENDYNE

57 TENDYNE 30 Day Outcome s

58 CARDIAQ

59 NEOVASC TIARRA

60 CAISSON

61 CAISSON

62 HIGHLIFE

63 SAPIEN M 3

64 SAPIEN M 3 30 Day Outcomes

65 4C

66 TMVR VS. REPAIR Repair vs. Replacement Competitive or Complementary?

67 Thank You