Disclosure Statement of Financial Interest Saibal Kar, MD, FACC

Transcription

1 MitraClip Therapy Saibal Kar, MD, FACC, FAHA, FSCAI Director of Interventional Cardiac Research Program Director, Interventional Cardiology Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA

2 Disclosure Statement of Financial Interest Saibal Kar, MD, FACC Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Company Affiliation/Financial Relationship Grant/Research Support Abbott Vascular,Boston Scientific, St Jude Medical, Circulite, Coherex, Gore, Biotronics Consulting Fees/Honoraria Abbott Vascular, Boston Scientific, St Jude Medical, Gore Other Financial Benefit Coherex, Biosensors International

3 Mitral Regurgitation Common valvular heart disease problem Left untreated leads to a slow and expensive death Repair rather than replacment is preferable

4 Mitral Regurgitation (MR) leaflets, chords, papillary muscle Functional MR: Leaflets appear normal, MR due to abnormal LV geometry Valve makes the Ventricle Sick Ventricle makes the Valve Sick Mechanical Solution: Open Surgical /Transcatheter repair/replacement Medical treatment for LV dysfunction Mechanical reduction of MR? Primary Disorder of the Mitral Valve Apparatus (annulus,

5 Treatment of MR (an unmet need) 50% of patients with significant MV disease are not referred to surgery Age Left ventricular dysfunction Other co-morbidities Mirabel M et al. Eur Heart J 2007;28(11):

6 Standard of Care Percutaneous Mitral Approaches Leaflet repair MitraClip ( Abbott Vascular ) Leaflet folding( St Jude Medical) Coronary sinus annuloplasty Cardiac Dimensions Carillon Direct annuloplasty Emerging options Mitralign Suture-Based Plication Guided Delivery Anchor-Cinch Plication Quantum Cor Cardioband (Valtec Cardio, Or Yehuda, Israel) Chordal replacement NeoChord, V-Chordal(Valtec) MitraFlex Transcatheter Mitral Valve Replacement

7 Standard of Care Percutaneous Mitral Approaches Leaflet repair MitraClip ( Abbott Vascular ) Leaflet folding( St Jude Medical) Coronary sinus annuloplasty Cardiac Dimensions Carillon Direct annuloplasty Mitralign Suture-Based Plication Guided Delivery Anchor-Cinch Plication Quantum Cor Cardioband (Valtec Cardio, Or Yehuda, Israel) Chordal replacement NeoChord, V-Chordal(Valtec) MitraFlex Transcatheter Mitral Valve Replacement

8 MitraClip Concept Technical aspects Case selection Longterm data

9 Concept: Edge to Edge repair (Alfieri stitch) Simple solution for a complex problem Selected patients of degenerative and functional MR Not effective in rheumatic MR

10 MitraClip Concept Technical aspects Case selection Longterm data

11 MitraClip

12 Transseptal puncture is the critical step of MitraClip Procedure Too close to MV Too posterior from MV Correct TS for MitraClip; cm away from MV

13 Transseptal puncture during MitraClip Procedure Appropriate location determines the success of the procedure Short axis: Posterior Bicaval view: Superior 4 chamber view: Distance From Puncture to point of coaptation 4 to 4.5 cm

14

15 Grasping of Leaflets

16 Creation of double orifice valve

17 MitraClip Concepts Coaptation of Leaflets Reduces MR Creates tissue bridge Limits dilatation of annulus Septal-lateral (A-P) dimension Supports durability of repair Restrains LV wall Limits LV dilatation

18 Attributes of the procedure Only technology applicable for selected patients with degenerative and functional MR Percutaneous venous rather than atrial procedure - Less vascular complications - Lower stroke risk Procedure is intuitive - Echo guided transseptal procedure Repositionable and removable

19 MitraClip Concept Technical aspects Case selection Longterm data

20 Case Selection: Suitable Anatomy Non rheumatic MR originating from a localized area of the valve Etiology: degenerative or functional Sufficient leaflet tissue for mechanical coaptation Valve anatomic exclusions Flail gap >10mm Flail width >15mm Calcified leaflet MVA 4 sq cm

21 Case Selection: Origin of the Jet Origin of the jet is from the central part of the valve Some cases of commissural MR have been tried Multiple jets should be avoided TEE: Transgastric view

22 Large flail segment minimal chordal support >15 mm Hinge point at annulus Poor secondary chord support

23 Flail P2 Good candidate for MitraClip 4 Chamber view Secondary chords are preserved Flail gap < 10 mm Bicommissural view Flail Width < 15 mm

24 TEE before and after 2 Clips Pre Procedure Post MitraClip

25 Case Selection: Anatomical suitability Functional MR Coaptation Length Coaptation Depth Coaptation length > 2mm

26 Case Selection: Functional MR Coaptation length < 2 mm Coaptation length >2 mm

27 Expanded indications of the MitraClip: Beyond the EVEREST criteria A1P1 or A3P3 flail or prolapse Failed surgical repair Ring annuloplasty, or snapping of artificial chord HOCM : Systolic anterior motion with MR End stage heart failure with MR Delay heart transplantation or VAD

28 Flail P2/P3 segment

29 MitraClip for a Flail P2/P3

30 71 yr old male with previous CABG underwent Mitral valve repair (artificial chords and surgical ring) Presents: Shortness of breath and loud systolic murmur 10 days after surgery Detached artificial chord

31 One clip > Trace MR Both patient and surgeon became less short of breath Patient discharged home next morning

32 Case Selection: Cases to Avoid Mitral Valve Orifice < 4 sq cm Barlows disease Multiple flail/prolapsing segments Very dilated annulus Post repair: cases were leaflet tissue was excised Calcified leaflet tips

33 MitraClip Concept Technical aspects Case selection Long-term data

34 MitraClip Therapy Worldwide Experience More than 17,000 patients have been treated - Nearly 2,000 patients have been enrolled in prospective clinical trials worldwide A majority are high risk for mitral valve (MV) surgery On October 24, 2013, FDA approved MitraClip for a limited indication for high risk primary MR

35 Background EVEREST II one year results MitraClip versus Surgery for MR Safer Less reduction of MR Equivalent Clinical benefits

36 EVEREST II 5 year data Kaplan-Meier Freedom From Mortality EVEREST II RCT MitraClip (N=178) 93.7% 92.3% 1 year Proportion of Patients Surviving MitraClip # At Risk Surgery # At Risk Surgery (N=80) 81.2% 79.0% 5 years Baseline 6 Months 12 Months 18 Months 2 Years 3 Years 4 Years 5 Years

37 EVEREST II 5 year data Kaplan-Meier Freedom From MV Surgery in MitraClip Group or Re-operation in Surgery Group Proportion of Patients Free From Surgery Surgery (N=80) MitraClip (N=178) 78.9% 97.4% 1 year MitraClip # At Risk Surgery # At Risk 74.3% 92.5% 5 years Baseline 6 Months 12 Months 18 Months 2 Years 3 Years 4 Years 5 Years EVEREST II RCT

38 EVEREST II 5 year data Mitral Regurgitation Grade MitraClip (N=178) MR 2+ at 1 and 5 Years p < p < % Surgery (N=80) MR 2+ at 1 and 5 Years p < % 0+ 99% p < % Baseline 1 Year N= Baseline 5 Years N= Baseline 1 Year N=66 N = survivors with paired data; p-values for descriptive purposes only Baseline 5 Years N=38

39 EVEREST II 5 year data NYHA Functional Class p < % I II p < % I 88% I I II I p < II 97% I p < Surgery (N=80) NYHA I/II at 1 and 5 Years I MitraClip (N=178) NYHA I/II at 1 and 5 Years I II III III II III II II IV II IV Baseline 1 Year N=151 III III Baseline 5 Years N=105 IV III Baseline 1 Year N=66 N = survivors with paired data; p-values for descriptive purposes only IV Baseline 5 Years N=40

40 EVEREST II 5 year data Septal Lateral Annular Dimensions MitraClip (N=178) Systolic SLAD at 1 and 5 Years p = ns Baseline 1 Year N=124 Baseline 5 Years N=83 p < 0.05 p = ns Baseline 1 Year N=124 Baseline 5 Years N=83 Mean SLADsyst (cm) Mean SLADdiast (cm) p = ns MitraClip (N=178) Diastolic SLAD at 1 and 5 Years N = survivors with paired data; p-values for descriptive purposes only

41 EVEREST II RCT 5 Year data Summary The EVEREST II RCT is the longest prospective follow-up of two therapies for treating MR Clinical benefits provided by MitraClip and MV surgery are durable through 5 years Beyond 6 months, the rate of MV surgery is low in the MitraClip group

42 MitraClip for High-Risk Patients Glower D, Kar S et al. J Am Coll Cardiol 2014; 64:172-81

43 MitraClip for High Risk surgical patients No of patients ( pooled data) Mean predicted surgical mortality by STS calculator Functional MR Previous open heart surgery 351 pts 11% 70% 60%

44 High Risk Cohort Major Adverse Events at 30 days Death Myocardial Infarction Stroke 4.8% 1.1% 2.6%

45 Kaplan Meier Survival Curve All Patients 95% 77%

46 Paired MR Grade at Baseline and Follow-Up in 223 Patients with 12 Month Echo Data

47 High Risk Cohort NYHA Functional Class at Baseline & Follow-Up

48 High Risk Cohort Hospitalizations for Heart Failure HF Hospitalization Rate Per Patient Year % reduction p< Year Prior to MitraClip 1 Year Post Discharge

49 MitraClip for high risk patients Summary Safe Effective Makes them feel better Keeps patients out of hospital

50 Current status: MitraClip Commercially available in Europe, Australia, and some countries in Asia FDA approved the MitraClip for patients with primary disorder of the mitral valve apparatus(degenerative) who are at prohibitve risk for surgery on Oct 24, 2013

51 AHA/ACC Guideline 2014 Circulation Mar 3]

52 ESC Guideline 2012 The guideline recommends the MitraClip therapy as class IIb indication for both degenerative and functional MR

53 What about Functional MR

54 Treatment of FMR Medical treatment is the mainstay The role of surgery is controversial Often high risk since patients have low EF Symptomatic improvement High recurrence No mortality benefit No census whether repair is better than replacement

55 MV surgery for FMR: Rings More Rings than Surgeons Dr McCarthy has three rings in his name Note the various size, shape, configuration, materials Courtesy of D. Craig Miller, MD

56 MitraClip for Functional MR EVEREST trial, and non randomized data from Registries in Europe Safe MR reduction Clinical Improvement Favorable LV remodeling No randomized studies in this subgroup to demonstrate survival benefit

57 Future Studies for MitraClip for FMR COAPT Trial ( US and Canada) RESHAPE trial (Europe)

58 Trial design 420 patients enrolled at up to 75 US sites Significant FMR ( 3+ by core lab) Extremely high risk for mitral valve surgery Specific valve anatomic criteria Randomize 1:1 MitraClip N=210 Control group Standard of care N=210 Clinical and TTE follow-up: 1, 6, 12, 18, 24, 36, 48, 60 months

59 Conclusion MitraClip is the only transcatheter treatment option for selected patients with significant mitral regurgitation in US Safe, effective and there is evidence of durability Approved by the FDA for high risk primary(degenerative) MR Role of Mitraclip in FMR is being evaluated in the COAPT study Case selection is critical to the success of procedure [

60 We have added life to year in most and years to life in some