1. Role of Device Therapy in FMR: Challenges and Opportunities
Ori Ben-Yehuda, MD, FACC
Clinical Trials Center
Cardiovascular Research Foundation &
Columbia University

2. I have no relevant financial relationships
ORI BEN-YEHUDA, MD
I have no relevant financial relationships

3. FMR: More complicated than AS

4. Spectrum of Mitral Regurgitation
Mitral valve
Left Atrium
Chordae Tendnae
Functional Mitral Regurgitation (FMR)
Left ventricle
Papillary muscles
Degenerative Mitral Regurgitation (DMR)
LV Dysfunction Dilated Annulus
(Non-ischemic or ischemic dilated cardiomyopathy)
LA Dysfunction
Dilated Annulus (Chronic atrial fibrillation, hypertension)
Etiologies:
Advanced Barlow’s Disease
Fibroelastic deficiency
Leaflet prolapse due to:
Leaflet deformities or lesions
Ruptured/ elongated chordae
Papillary muscle rupture
Etiologies
Loss of leaflet coapation due to:
annular enlargement
Papillary muscle displacement causing leaflet tethering/tenting
Benjamin MM et al. Curr Cardiol Rep 2014;16:517

5. Functional MR: Role of Tethering
Levine et al. Curr Cardiol Rep 2002;4:125-9

6. CTSN: MR Recurrence with Repair
N Engl J Med 2016; 374:

8. Transcatheter Valve Implanation
(Piazza. PCR London Valve)

10. The Challenges with TMVR for FMR
LV Dysfunction
Advanced stage of disease- very high risk
Are we selecting patients that are too advanced?
Complex anatomy- D shaped annulus
Risk of PVL
Sizing
Low flow compared with Aortic Valve- risk of thrombosis
LVOT Obstruction
Conduction system issues, coronary risk

11. Transcatheter Mitral Valve Repair: Many Options
Leaflet repair
MitraClip
Pascal
Percutaneous Annuloplasty
Coronary sinus annuloplasty
Carillon
Direct annuloplasty
Cardioband
Mitralign
Millipede
MVRx
Basal ventriculoplasty
GDS
Chordal replacement
NeoChord
Harpoon

13. EVEREST II: 5 year results

14. EVEREST II: MR Recurrence but good functional outcome
Mitral Regurgitation
NYHA Class
Feldman T et al. JACC 2015

15. Carillion Cardiac Dimension
Indirect annuloplasty with nitinol device anchored into the coronary sinus to reduce annulus dimensions
Transgiugular approach
500 pts treated for commercial use
66 pts implanted in trial
FMR
Safe 0% device related) mo
1 grade of MR reduction
1 NYHA Class improvement (from III to II)

16. Valtech Cardioband
Direct annuloplasty with supra annular fixation of a band with anchors
Transseptal approach
~100 pts treated
FMR 4%
Effective
significant reduction of septo lateral dimension average up to 30%
significant MR reduction < 2 in
Sustained mo
MR < 2, 91%
NYHA I/II, 70%

17. Cardioband Study Demographics (N=54)
No. (%) or Mean
Variable
71 ± 8
Age (years)
Male 41
Female 13
Gender
7 (1-33)
Euroscore II (%) 82
Baseline NYHA Class of III or IV (%) 33 21
Ischemic
Non Ischemic
61 ± 6
LVEDD (mm) AvgSD
33 ± 11
EF (%) AvgSD
18 (32%)
11 (20%)
41 (74%)
13(23%)
Prev CABG
COPD
Moderate to Severe Renal Failure
Severe Pulmonary Hypertension
Afib

18. Reported Major Safety Events at 30 Days
30 Day Events*
Patients Experiencing Event, # (%)
All Patients N=54
Death
2 (3.7%)
Hemorrhagic Stroke**
1 (1.9%)
Need for elective Mitral Operation**
Ischemic attack
Major Bleeding Complications
Renal Failure
Myocardial Infarction
0 (0%)
Respiratory Failure
Cardiac Tamponade
* VARC Guidelines (European Heart Journal, 2012, 33: )
** Part of the Death case

19. Annuloplasty: Significant Reduction in Septo Lateral (A-P) Dimension
30% average reduction in A-P
*P<0.01
37±4
(29-46)
26±4
(18-35)

20. 30% average reduction in A-P
Annular Reconstruction by Significant Reduction in Septo Lateral (A-P) Dimension
30% average reduction in A-P
*P<0.01
37±4
(29-46)
26±4
(18-35)

21. Septo-Lateral (A-P) Dimension (mm) over time

22. 91% patients with MR≤2+ At 12 Months By Core Lab*
at Discharge
84% MR ≤ 2+
at 1 Month
91% MR ≤ 2+
at 6 Months
90% MR ≤ 2+
at 12 Months
*Dr. Paul Grayburn – Baylor University

23. Annuloplasty: Significant Reduction in Septo Lateral (A-P) Dimension
30% average reduction in A-P
*P<0.01
37±4
(29-46)
26±4
(18-35)

24. Cardioband: Functional Improvement at 12 Months
6MWT
P<0.05
MLHFQ
P<0.01
NYHA Class
P<0.01
343 41 II I
68% NYHA I/II
Meters Walked
MLHFQ Score
% of population II
272 20
III
III
Baseline
12 Months
Baseline
12 Months
N = 15
N = 20
N = 23

25. The complementary role of transcatheter techniques
annuloplasty
mitraclip
replacement
Stand-alone Annuloplasty: early treatment FMR
Stand-alone Mitraclip: FMR with asymmetric tethering (IMR)
Combined Annuloplasty and MitraClip: Advanced FMR
MV Replacement: Advanced FMR
(Adapted from F Maisano)

26. Future Directions and Dilemmas
COAPT- enrollment increasing
Will it create a new standard
Need more efficient trials
COAPT light?
Achievable but clinically relevant endpoints
MR reduction not enough
Heart Failure Hospitalizations, Exercise Capacity, QoL, Actigraphy
Repair vs. Replacement
Patient selection