CLIP ΜΙΤΡΟΕΙ ΟΥΣ: ΠΟΥ ΒΡΙΣΚΟΜΑΣΤΕ;

Transcription

1 CLIP ΜΙΤΡΟΕΙ ΟΥΣ: ΠΟΥ ΒΡΙΣΚΟΜΑΣΤΕ; Επιµορφωτικά Σεµινάρια Ειδικευοµένων Καρδιολογίας 7 Απριλίου 2012 M Chrissoheris MD FACC THV Department HYGEIA Hospital

2 Degenerative MR (DMR) Usually refers to an anatomic defect of one or more structures comprising the mitral valve apparatus the annulus, the leaflets, the chordae tendineae, and the papillary muscles Spectrum of degenerative mitral disease Adams et al. EHJ (2010) 31, 1958

3 Functional/Degenerative MR: outcomes by treatment Surgeryfor functional MR is not well defined and when performed has a 30-day mortality risk of 4% to 17.8%(but as high as 42.9% in high risk pts) In comparison, the 30-day mortality in (by definition high risk) patients with functional MR treated The role with of surgeryis MitraClipwell is 1.1% defined to 4.7% with an operative mortality (goal is mitral valve repair)of 1.4%to 3.8% The operative mortality for MitraCliptreatment is 1% to 2.1%

4 Functional MR (FMR)in Ischemic (IHD) and Dilated (DCM) cardiomyopathy Result of left ventricular (LV) dysfunction and dilation, which causes otherwise normal valve components to fail and produce MR IHD DCM

5 Functional/Degenerative MR: outcomes by treatment Surgeryfor functional MR is not well defined and when performed has a 30-day mortality risk of 4% to 17.8%(but as high as 42.9% in high risk pts) In comparison, the 30-day mortality in (by definition high risk) patients with functional MR treated The role with of surgeryis MitraClipwell is 1.1% defined to 4.7% with an operative mortality (mitral valve repair or replacement)of 1.4%to 3.8% The operative mortality for MitraCliptreatment is 1% to 2.1%

6 Long-Term Survival of Patients with Functional MR Undergoing Surgical Annuloplasty Mean Survival 5-6 years Wu et al. J Am Coll Cardiol2005;45:381 7

7 A Closer Look at the MitraClip Device Implant made of cobalt chromium Polyester-covered to promote healing MRI Safe to 3 Tesla Real-time positioning during procedure Surgically removable when required 1 EH /2010

8 The MitraClip principle Surgery MitraClip

9 Mitraclip System Parts Overview 1 EH /2010

10 MitraClip Regulatory status MitraClip -CE mark approval March 4th, Currently the MitraClip is available for use in 15 European countries as well as in several other geographies (Australia, Asia, Middle-East and Canada). The U.S. Food and Drug Administration. Registration is still pending Australia Canada United States

11 Data as of 4/2011 Franzen TVT /2012 est > 5000

12 EVEREST II Randomized Clinical Trial Study Design 279 Patients enrolled at 37 sites Significant MR (3+-4+) Specific Anatomical Criteria Randomized 2:1 Device Group MitraClip System N=184 Control Group Surgical Repair or Replacement N=95 Echocardiography Core Lab and Clinical Follow-Up: Baseline, 30 days, 6 months, 1 year, 18 months, and annually through 5 years

13 EVEREST II RCT: Patient Flow Per Protocol Cohort: Analysis of Device Performance Randomized Cohort n=279 Device Group n=184 Treated n=178 Randomized, not treated Device, n=6 Control, n=15 Control Group n=95 Treated n=80 (86% MV repair) Acute Procedural Success Not Achieved n=41 (23%) n=25 (62%) underwent surgery Acute Procedural Success (APS) = MR 2+ at discharge Acute Procedural Success Achieved n= days n=136 99% Clinical Follow-up 30 days n=79 99% Clinical Follow-up 12 months n= % Clinical Follow-up 98% Echo Follow-up 12 months n=74 94% Clinical Follow-up 92% Echo Follow-up

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17 EII RCT: Safety & Effectiveness Endpoints Intention to Treat Cohort Safety Major Adverse Events 30 days Effectiveness Clinical Success Rate * 12 months Device Group, n= % Device Group, n= % Control Group, n=94 p SUP < p NI = Control Group, n= % 74.2% Met superiority hypothesis Pre-specified margin =2% Observed difference = 32.9% 97.5% LCB = 20.7% 17 LCB = lower confidence bound UCB = upper confidence bound Met non-inferiority hypothesis Pre-specified margin = 25% Observed difference = 7.3% 95% UCB = 17.8% * Freedom from the combined outcome of death, MV surgery or re-operation for MV dysfunction >90 days post Index procedure, MR >2+ at 12 months

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29 EVEREST II conclusions -EVEREST II: A RCT in patients with DMR and (less) FMR who are candidates for surgery -Done early with little or no operator experience + Mitraclip reduces significantly MR and LV volumes and results in meaningful clinical benefits through 2 years When Mitraclip is compared to surgery Mitraclip provides increased safety Surgery provides more complete MR reduction Mitraclip provides improved functional status Mitraclip is a therapeutic option for select patients with MR

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35 EVEREST II HRS and EVEREST II RCT comparisons HRS n=78 EVEREST II n=184 Age (y) 76.7 ± ±12.8 Functional (%) Surgical risk (%) 18.2 ± 8 No device implant (n) 4 3 MR reduction 2 (%) Surgery when failure (%) 0 62

36 Impact of the learning curve on outcomes after percutaneous mitral valve repair with MitraClip in the first 75 consecutive patients 1st 2nd 3rd p value Time (min) <0.005 Safety events (n) <0.001 APS (%) m success (%) APS: acute procedural success defined as clip implanted and MR 2 at discharge Scillinger et al, Eur J Heart Fail 2011;13:

37 MitraClip: suggested current state of use (2012) High risk patients: A less invasive treatment is always preferred over a more invasive treatment by doctors and patients alike provided that it is almost equally effective High risk patients undergoing MV surgery have a life expectancy of ~6 years (average) If a patient needs 6 months to go over an valve surgery, this time equals 10% of his remaining life!

38 MitraClip: suggested current state of use (2012) Inoperable patients: Both FMR and DMR if anatomic criteria met and STRONG clinical indication present FMR: By definition high risk patients with «normal»mv and no proved surgical benefit (unless concominant surgical revascularization required). MitraClip therapy sounds attractive However, before we generalize Mitraclip treatment in FMR we urgently need an RCT of MitraClip vs. standard medical treatment

39 The MitraClip effect on MR in our first 9 patients Type of MR Baseline MR severity Post Clip MR severity Patient 1 F Patient 2 M Patient 3 F Patient 4 D Patient 5 D Patient 6 F Patient 7 F 4+ Not deployed Patient 8 D Patient 9 F Average - 3.8± ±0.3

40 Degenerative / Organic MR 83 year-old female NYHA-III dyspnea, despite optimal HF therapy EF 65% MR 4+ due to P2 prolapse (fibroelastic deficiency, ruptured chord) Pulmonary HTN (spap 80 mmhg) Chronic Atrial Fibrillation

41 MVQ analysis: P2 prolapse with area of mal-coaptation in the A2-P2 segment

42 X-plane mode: Simultaneously project 2 orthogonal views LVOT 2ch 2C LVOT 42

43 X-Plane with Color Flow Doppler

44 Steerable Guide Catheter in Left Atrium

45 Clip Delivery System in Left Atrium

46 Mitra Clip Alignment Above Valve at Center of MR jet

47 LVOT view during grasping of the mitral valve leaflets

48 Leaflet Insertion Check pre- Deployment ME 4 Chamber View LVOT Long Axis View Commissural View

49 Post Mitra Clip: Assessment for MS Planimetry of two orifices combined:2.4cm 2 Mean Transmitral Gradient: 1mmHg

50 LVOT view post Mitra Clip: Trace MR

51 Double Orifice Mitral Valve post Mitra Clip Deployment

52 30-Days Follow up: Functional Class now NYHA I Reports significant improvement MR trace

53 Functional MR 66 year-old male Dilated cardiomyopathy NYHA-III dyspnea despite optimal HF therapy EF 25-30%, dilated LV (70mm End-Diastole) MR 3+ functional ERO 31mm 2 EuroScore 21.2%

54 Mitra Clip Alignment to MR jet

55 Post Grasping: MR reduced 1+

56 Post Mitra Clip:Assessment for MS Mean Transmitral Gradient 3mmHg Combined planimetry:1.82cm 2

57 Final TMVR result: MR 1+

58 Follow up at 30 days Reports clinical improvement with relative increased exercise tolerance Echocardiography with 1+ MR

59 Ischemic MR 66 year-old male CABG in 2010 Ischemic Cardiomyopathy EF 35% Severe MR due to posterior leaflet tethering NYHA III Multiple heart failure admissions EuroScore 29.5%

60 Clip Deployment and Initial Acute Results

61 Deployment of 2 nd Clip Residual MR 1-2+

62 Deployment of 3 rd Clip

63 Case 3: Final Result Mean Transmitral Gradient 3mmHg Combined planimetry: 2.4cm 2

64 Conclusions Transcatheter mitral valve repair is feasible and effective in reducing severe mitral regurgiation New therapeutic option for heart failure patients at high or prohibitive surgical risk Clinical studies in heart failure patients needed to evaluate potential survival benefit in addition to quality of life improvement

65 May 11-13, 2012

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67 Siegel et al, JACC 2011;57:

68 Pre Post Siegel et al, JACC 2011;57:

69 Whitlow et al, JACC 2012;59:130 9