1. Percutaneous Mitral Devices will Change the indications for Mitral Valve Procedures (Con.)
Niv Ad, MD
Chief, Cardiac Surgery
Inova Heart and Vascular Institute
Washington DC Metropolitan Area

2. Mitral Valve Repair: “The Surgical Viewpoint” Or, “A surgeon viewpoint”..

3. Financial Discolosures
NO DISCLOSURES

4. MV repair
What can we do in surgery today?

5. Degenerative MR
Adams et al. Ann ThoracSurg 2006;82: 5

6. An intraoperative picture which reveals femoral venous and arterial canulas, the 4cm long 4th intercostal space thoracotomy and the video camera system.

7. Why do we need an alternative to surgical repair?
Less invasive
lower risk procedure compared to surgery in high risk patients
Unmet need

8. Euro Heart Survey Symptomatic MR
Isolated MR
n=877
No Severe MR
n=347
Severe MR
n=540
No Symptoms
n=103
Symptoms
n=437
Intervention
n=211 (48%)
No Intervention
n=226 (52%)
NYHA I-II: 171
NYHA III-IV: 266
Angina: 168
Mirabel Eur H Journal 2007

9. Surgery is Rare when EF is below 40%
Most FMR patients
fall in this range
Mirabel Eur H Journal 2007

10. Functional MR
Disease of the left ventricle NOT of the mitral valve
MR caused by apical lateral distraction of the papillary muscles tethering the leaflets
Annular dilatation is secondary and occurs greatest in the septal- lateral (anterior-posterior) dimension
Surgical repair based on over correction of the annular dilitation 10

11. Wu AH et al. J Am Coll Cardiol. 2005;45:381–7
No impact of MV annuloplasty on survival in patients with ischemic Cardiomyopthy
There is no clear mortality benefit by MVA for patients with severe LV dysfunction and significant MR
In this highly cited paper in JACC WU et al showed that There is no clearly demonstrable mortality benefit conferred by MVA for significant MR with severe LV dysfunction
Wu AH et al. J Am Coll Cardiol. 2005;45:381–7

12. Percutaneous Mitral Valve Repair
What do we know on percutaneous mitral valve repair?

13. Options for Degenerative MR
Edge to Edge
Artificial Chords

14. EVEREST Safety and Midterm Durability
Feldman, JACC 2009

15. Feldman, JACC 2009

16. But with higher success rate
STS Data
But with higher success rate

17. 1% non embolic stroke
Feldman, JACC 2009

18. 30 %
Feldman, JACC 2009

19. 30 %
Feldman, JACC 2009

20. Survival and IMR severity: ERO
100 80
61±6% 60
Survival (%)
47±8%
ERO 40
1-19
> 20
29±9%
In this slide from the same study you can see the importance of quantifying IMR. When the ERO IS MORE THAN 20 MM2 THAN THE FIVE YEARS SURVIVAL IS VERY LOW 29% This is why in IMR we consider LOWER CUT OFF OF ERO FOR SEVERE MR
P < 20 12 24 36 48 60
Time (months)
Grigioni et al., Circulation. 2001;103:1759.

21. EVEREST II High Risk 78 Enrolled KEY INCLUSION CRITERIA
Predicted procedural mortality risk
>12% (STS calculated or Surgeon estimated based on pre-specified co-morbidities)
Symptomatic 3+ or 4+ MR
Degenerative or Functional
78 Enrolled
FMR
N=46
(59%)
DMR/Mixed
N=32
(41%)
KEY EXCLUSION CRITERIA
EF ≤ 20% and/or LVESD >60mm
MVA <4cm2
Leaflet anatomy unsuitable for MitraClip device
Saibal Kar, PCR 2009

22. CS annuloplasty- implant success
Carillion- 66/113 (58%)
Edwards Monarc- 59/72 (82%)
Viacor- 9/31(29%)
Overall
136/216 (63%)

23. Percutaneous Mitral Valve Repair
Edge to Edge (2)
Evalve- Pivotal Completed (CE)
Edwards Mobius Closed!
Coronary Sinus Annuloplasty (3)
Edwards Monarc
Cardiac Dimension Carillion (CE)
Viacor PTMA
Direct Annuloplasty (6)
Mitralign
GDS
QuantamCor
Cordis DPA
Micardia- Hybrid
Mitral Solutions- Hybrid
Indirect Annuloplasty (3)
Ample PS3 closed!
St Jude AAR closed!
Myocori-Coapsys closed!
Valve Replacement (2)
Endovalve (pre-clinical)
Cardiaq (pre-clinical)

24. Summary
Aprox % of the patients with symptomatic MR do not undergo surgical repair
For these high surgical risk patients a less invasive alternative may be needed, but, it is still not proved that annuloplasty will improve clinical outcomes in those pts
Devices for the coronary sinus show short term efficacy in only 60% of patients.
Future studies will show, whether direct annuloplasty approaches to the mitral annulus are more effective
The MitraClip seems to be more effective (but also more invasive and complex)
A combined approach of Edge-to-Edge repair and mitral annuloplasty may be supplementary in selected patients
In the near future, trans catheter MVR may prove to be a more plausible solution

25. Comment I: Requirements for device development
Unmet need for novel therapy
Large size of treatment population
Safe and as effective!!! vs. existing therapy
Development at reasonable cost and timeline
Device/ procedure user friendly

26. Comment II: Why TAVI may be a success?
Singular pathology (familiar concept- narrowed tube)
User friendly delivery systems developed
Conventional imaging works
Large clinical unmet need

27. Comment III: Progress of trans-catheter treatment of MR will be much slower
Complex valvular anatomy
Variable pathology
Complex delivery systems
Limited early success
Established therapy
Surgery- degenerative
Medical therapy- functional
Problematic trial design
Heart failure trial
Functional Class, 6MWT, QOL, MR severity

28. Is it a perfect storm for failure??
So,
Long time to market approval
Excessive capital needs
Crowded field with uncertain future
Anticipation of diminished reimbursement
Technical failures
Is it a perfect storm for failure??

29. Percutaneous mitral valve repair is feasible and probably relatively safe, but…