1. Structural Heart Live Cases
Supported by:
Abbott Vascular Inc
Cook Inc
Terumo Inc

2. Disclosures Samin K. Sharma, MD, FACC
Speaker’s Bureau – Boston Scientific Corp., Abbott Vascular Inc., ABIOMED, CSI
Annapoorna S. Kini, MD, FACC
Nothing to disclose
Partho Sen-Gupta, MD, FACC
Nothing to disclose for today’s presentation
Vivek Rajagopal, MD, FACC
Speaker/proctor for Abbott, Edward, Medtronic, BSc

3. May 9th 2017 Structural Heart Live #17: GM, 85 yr. M
Presentation: Worsening dyspnea on exertion NYHA class III
PMH: Hypertension, Hyperlipidemia, HFpEF, AF on Coumadin, CABGx3 (2000), PCI (2017), Asthma and CKD
Medications: Clopidogrel, Warfarin, Furosemide, Ranolazine Atorvastatin, Losartan, Ranitidine, ISMN, Montelukast
TTE/TEE (04/07/17): Severe MR-A2 Prolapse and Restricted
P2, EF 55%
EKG (03/13/17): Rate controlled AF with narrow QRS
Cath (03/01/17): (OSH): Severe II V CAD. Patent LIMA-LAD,
SVG-D1 and stenosed SVG-rPDA. s/p PCI to SVG-rPDA

4. May 9th 2017 Structural Heart Live #17
Contd….
STS risk mortality: %
EuroScore II risk: %
Logistic Euroscore mortality: %
Course: Patient is determined to be high for surgical MVR due to age, surgical re-op and co-morbidities
Plan Today: Patient is planned for edge-to-edge MV repair with MitraClip
SLIDE TO BE EDITED BY JK

5. MitraClip Device

6. MitraClip Device

7. MitraClip NT System Steering
Clip Delivery Handle
Steerable Sleeve Handle
Guide Handle
Posterior L M
+/- Knob
Stabilizer
Anterior M L
Guide Handle – Anterior/Posterior, +/- Knob
Sleeve Handle – Medial/Lateral, Anterior/Posterior Knobs
Clip Delivery Handle – Clip Positioning, Grasping and Deployment
Stabilizer – Medial/Lateral

8. MitraClip: Clip Delivery Handle

9. Anatomic Eligibility Criteria for MitraClip
Echo Criteria

10. P2 Restriction, A2 Pseudo-prolapse
Calcification

11. A2 / P2 Leaflet Length
1.77 mm
2.95 mm

12. Severe MR at A2, P2 M L

13. 3D TEE
A2 Prolapse
P2 Restriction

14. Trans-septal Views LA LA SVC AV IVC RA Bicaval View AV Short-Axis View
Posterior LA LA
Inferior
SVC
Anterior AV
IVC
Superior RA
Bicaval View
AV Short-Axis View
Ideally >4 cm RV LV
4-Chamber View

15. Issues Related To The Case
Update on MitraClip studies and TMVR

16. Etiology of Mitral Regurgitation (MR)
Normal Degenerative MR Degenerative MR Functional MR
- Prolapse Flail Ischemic vs.
non-ischemic
- Due to dilated LV, mitral annulus or regional disruption of LV, MV apparatus

17. General Principles of Therapy for MR Etiology
Primary MR
No Medical Therapy
(Diuretics palliative)
Surgery for symptoms
or LV dysfunction
(Repair > Replacement)
Consider prophylactic repair for low risk with long term survival
Secondary MR
Medical
Therapy first
(BB,ACE/ARB, Aldactone, Diuretics)
CRT
Surgery only in highly selected pts with CHF
(Class 3/4 symptomatic and acceptable surgical risk)

18. Not All Patients Are Good Surgical Candidates
396 Patients in Europe with Symptomatic Severe MR
(53% degenerative)
No Surgery in 49%
Decision not to operate
Decision to operate
p=<0.0001 N
Mirabel et al., E Heart J 2007;28:1358

19. EVEREST II Randomized Clinical Trial
Surgical and Percutaneous Therapy for
Mitral Regurgitation
Mitral Valve Surgery Repair/Replacement
Catheter Based Mitral Valve Repair
MitraClip System or

20. MitraClip Deployment Technique

21. MitraClip System: US Clinical Trial Experience
EVEREST I
Feasibility Study
EVEREST II RCT
MitraClip vs Surgery
Continued Access: Surgical
Candidates
Surgical Candidates N= N=272
184 clip
95 surgery
High Risk Cohort
N=351
High Risk
Single-
Arm
Continued Access: Surgical
Candidates
N= N=273
High Surgical Risk
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012

22. EVEREST II (Endovascular Valve Edge-to -Edge Repair) Study
Primary Endpoints Per Protocol Cohort
SAFETY
Major Adverse Events
30 days
EFFECTIVENESS
Clinical Success Rate*
12 months
87.8
PNI =0.0012 %
72.4
57.0 %
Psup <0.0001
9.6
Device group (n=136)
Control group (n=79)
Device group (n=136)
Control group (n=79)
*Freedom from the combined outcome of death, MV surgery or re-operation for MV dysfunction, MR >2+ at 12 Month
Feldman T et al, ACC 2010

23. Feldman et al. NEJM 2011:364;678

24. EVEREST II Trial: Severity of MR and Heart Failure
Symptoms Post-Treatment
Echocardiographic Severity
of MR
NYHA Functional Class
Feldman et al., J Am Coll Cardiol 2015;66:2844

25. EVEREST II Trial: 5-Year Clinical Outcomes –
Percutaneous Repair and Surgery for Mitral Regurgitation
Landmark Analysis of Freedom from Death, MV Surgery or Reoperation Beyond 6 Months
Freedom from Death, MV Surgery or Reoperation
Feldman et al., J Am Coll Cardiol 2015;66:2844

26. TMVR in prohibitive surgical risk patients is associated with safety and good clinical outcomes, including decreases in re-hospitalization, functional improvements, and favorable ventricular remodeling, at 1 year.

27. Worldwide Experience Using the MitraClip
Study
Population N
EVEREST I (Feasibility)
Feasibility patients 55
EVEREST II (Pivotal)
Pre-randomized patients 60
Non-randomized patients (High risk Study) 78
Randomized patients
(2:1 Clip to Surgery)
184 Clip
95 Surgery
REALISM (Contd Access)
Non-randomized patients
899
Compassionate/ Use 66
ACCESS Europe Phase I
567
ACCESS Europe Phase II
286
Commercial Use
Commercial patients
>40,000
Total
>41,000

29. Adverse Clinical Events at Follow-Up
of 9 Months
D’ascenzo et al., Am J Cardiol 2015;116:325

30. Change of Functional and Echocardiographic Data at Follow-Up
D’ascenzo et al., Am J Cardiol 2015;116:325

31. Acute Procedure Success Rate MitraClip(s) implanted & MR ≤2+
2004
2015

33. COAPT Trial: Key Inclusion Criteria
Functional MR ≥3+
Symptomatic (NYHA Class ≥ II)
STS mortality risk is ≥ 8% OR heart team prohibitive risk
CHF hospitalization of BNP >300 in last year
On maximum tolerated OMT with BiV is indicated

34. COAPT Trial: Primary Endpoints
Primary Effectiveness (min 1-year follow-up all pts)
Recurrent heart failure hospitalizations
Superiority hypothesis (Andersen-Gill)
Primary Safety (1 year)
Composite of all-cause death, stroke, worsening kidney function, or LVAD or cardiac transplant
Non-inferiority hypothesis

35. RESHAPE-HF: Trial design

36. MitraClip Procedure Indications
FDA Approval
MitraClip is approved for patients with symptomatic primary MR that are poor surgical candidates as designated by the Heart Team
ACC/AHA Guidelines
MitraClip may be considered for prohibitive risk patients with primary MR and severe symptoms (Class IIb)

37. Evidence base Therapy for MR
Degenerative
Functional
Low Surgical Risk
Surgical MVR
? Surgical MVR ??
High Surgical Risk
Commercial MitraClip- registry
MitraClip
Global Practice-registries
COAPT/ Reshape trials

38. Transcatheter Mitral Valve Replacement (TMVR)
Abbott Tendyne Neovasc Tiara
TA TA
TS and TA access approaches
All self-expanding
All in the FIM or Phase 1 trials
Edwards CardiAQ
TA and TS

39. Clip Deployment

40. Deployment: multi-safety check steps
Use echo imaging throughout deployment steps to ensure both leaflets are still attached between each steps
Inter-commissural view (60°) x-plan with LVOT (140°)
• Establish “Final Arm Angle”: Test the lock mechanism
• Fully close the Arm Positioner (White knob)
Increase the 2 drips
• Remove the “Gripper Cap”, the “O” ring and unwrap the two ends of the Gripper Line
• “Floss” the Gripper line to ensure it is removable

41. Remove the “Lock Lever Cap”, the “O” ring and unwrap the two ends.
“Floss” the Lock Line to confirm it is removable.
Remove the Lock Line.
Establish Final Arm Angle:
Confirming the lock mechanism was not damaged while removing the “Lock Line”
• Keep the “Arm Positioner” to Neutral (White knob)
Remove the “Release Pin”
Turn the “Arm Positioner” counter-clockwise to fully expose the “Groove”
• Turn the “Actuator Knob” counter-clockwise : 8 times
Release the “DC Fastener” then retract the “Actuator Knob”
Retract the DC Handle to safely have the “Pin” away from tissue

42. Final Deployment
Confirm both leaflets are still nicely attached inside the Clip
Remove the “Gripper Line”
System removal:
Release all system curves
Retract the “Pin” into the Guide

43. Final Procedural Assessment
Final gradient after deployment
Hemodynamic:
LA pressure
V wave
MR grade

44. Take Home Messages for MitraClip Percutaneous Approaches for Ischemic/Functional MR in 2017+
MitraClip therapy is now FDA approved for symptomatic patients with severe MR of degenerative etiology (DMR) who are poor surgical candidates
For patients with symptomatic FMR in high surgical risk pts MitraClip is available through COAPT randomized trial
MitraClip implantation registry studies in FMR have shown acceptable results in high surgical risk pts; to reduce LV cavity size, MR volume, CHF class and re-hospitalization

45. Correct answer: C Question # 1
Following are the true statement regarding outcomes of MitraClip in the EVEREST Trial except:
MitraClip is safer then surgery at 30 days
MitraClip is inferior to surgery in effectiveness
Majority of MitraClip pts had severe residual MR
MitraClip was well tolerated with equal symptomatic relief
Correct answer: C

46. Correct answer: C Question # 2
What was the incidence of residual mod-severe MR in the MitraClip group in the EVEREST Ii trial;
<5%
6-10%
10-20%
>20%
Correct answer: C

47. Correct answer: C Question # 3
Following are the primary effectiveness endpoints at 1 year of COAPT Trial of FMR:
A. Mortality
B. CVA
C. Re-hospitalization
D. MI
Correct answer: C