XIII Reunión anual de la sección de Insuficiencia Cardiaca de la SEC OVIEDO, 16-18 JUNIO 2016 HOSPITAL UNIVERSITARIO CENTRAL DE ASTURIAS (HUCA) http://secardiologia.es/insuficiencia/cientifico/ic-oviedo-2016 Simposio: Abordaje integral y multidisciplinar de la Insuficiencia Mitral VIERNES, 17 DE JUNIO 12:45-14:00 SALA A Posibilidades del tratamiento percutáneo Xavi Freixa Rofastes, Barcelona

1. Insuficiencia Mitral Severa
Posibilidades de Reparación
Percutánea
Xavier Freixa, Md, PhD
Hospital Clinic de Barcelona
Universitat de Bercelona

2. • Second valvulopathy after aortic stenosis (33.6%)1
• High prevalence in elderly patients (13% in >75 years)1
• Younger patients than aortic stenosis, but higher
comorbidity:
Myocardial infarction in 26.1%
Coronary revascularization in 13.6%
Renal insufficiency in 4.6%
Heart Failure. NYHA III or IV in 43.3%
Mitral Regurgitation
Lung B et al. Curr Probabl Cardiol. 2007

3. Bursi et al. Circulation 2003:111:295–301
Nkomo et al. Lancet 2006; 368:1005
Iung et al. Eur Heart J 2003;24:1231
• ~24% valvulopathies
• ~7-9% prevalence >75 y
• ≈ 50% patients with CMP
Prevalence of Valve Disease

4. MR Classification
Organic / Degenerative
Defect of at least one of the structures of the mitral
apparatus (leaflet, chords, papillary mussels).
Functional:
Dysfunction and/or ventricular dilation that causes an
abnormal function of the mitral apparatus.

5. Surgical Repair in Degenerative MR

6. What Does it Work?
Basic Principles:
1- Restore leaflet movement
2- Restore leaflet coaptation
3- Annulus remodeling/stabilization
With these principles:
1- Predictibility
2- Durability
3- Efficacy
4- Low risk
Surgical Repair in Degenerative MR

7. Castillo et al. J Thorac Cardiovasc Surg 2012;144:308-12
744 patients with degenerative MR
(2002-2010)
Successful rate 99.9%
Surgical Repair in Degenerative MR

8. David TE et al. Circulation 2013;127:1485-92
• 1985 - 2004
• 840 consecutive patients
• Follow-up every 2 years
• TTE follow-up in 94.9% (mean10.3 years (0-26 years)
• Operative mortality 0.9%
Conclusions
MV repair for degenerative MR restored life span to normal except in
patients with symptoms at rest and impaired LVEF. Advanced aged and
complex mitral valve pathologies increased the risk of recurrent MR.
Surgical Repair in Degenerative MR

9. What Does Not Work?
Surgical Repair in Degenerative MR

10. Get your mitral fixed anywhere does not work
Centers of Excellence
Surgical Repair in Degenerative MR

11. Capacity to perform multiple repair techniques
Castillo et al. J Thorac Cardiovasc Surg 2012;144:308-12
Mitral Annuloplasty in 100%
David TE et al. Circulation 2013;127:1485-92
Surgical Repair in Degenerative MR

12. Surgical Repair in Functional MR
What does it Work?
What does not Work?
Much less clear than
degenerative MR

13. Mechanisms:
1- Valvular tenting/tethering
2- Annular dilation
3- Annular contraction loss
4- Papillary muscles atrophy
Implications:
1- Normal valvular structure (less options to correct)
2- Dynamic and progressive process
3- Annular contraction loss
4- Limitations to achieve proper coaptation
5- Risk of valvular stenosis (high-risk patients)
Surgical Repair in Functional MR

14. No differences in death and MACCE
- 251 patients with severe ischemic MR.
- Randomization to repair vs. valve replacement
- 2-year follow-up
Surgical Repair in Functional MR
Goldstein et al. NEJM 2015;

15. Surgical Mitral Repair
Very good option for Degenerative MR
Not that clear for Functional MR

16. MR Treatment

17. Patient Selection

18. >30,000
∼300
∼50
∼60
∼70
MitraClip
Data on file at Abbott Vascular as of 03/31/2015
MR Percutaneous Techniques

19. TVMR in MR

20. MitraClip Repair
Based on the Alfieri Stitch Technique

21. MitraClip Repair
• Venous Access (24 French).
• Transeptal Puncture (TEE guided).
• Guidance with Fluroscopy and TEE 2D-3D.
• General anesthesia.
• Heparin ev (ACT>250).
• No contrast (renal protection).
• Repositionable and retrievable (no rush).

22. 0
10
20
30
40
50
60
70
Q4
2010
Q1
2011
Q2
2011
Q3
2011
Q4
2011
Q1
2012
Q2
2012
Q3
2012
Q4
2012
Q1
2013
Q2
2013
Q3
2013
Q4
2013
Q1
2014
Q2
2014
Q3
2014
Q4
2014
Q1
2015
Q2
2015
Q3
2015
Q4
2015
Q1
2016
Q2
2016
Portugal España Acum. Centros
*Datos a 31 de mayo de 2016
MitraClip in Spain/Portugal

25. 4.4 cm

31. Symptomatic patients.
Suitable anatomy.
Inoperable or high-risk.
Life expectancy > 1 year.
Degenerative MR (Indication IIb, C)
Functional MR (Indicaction IIb, C)
Guidelines on the management of valvular
heart disease (version 2012)
Symptomatic patients.
Suitable anatomy.
Optimal CRT (if candidates).
Inoperable or high-risk.
Life expectancy > 1 year.

32. Scientific Evidence
1- Randomized Studies
• EVEREST II: Mitraclip vs. Mitral Surgery
• RESHAPE-2 (Inclusion): FMR  MitraClip vs. Control (Med)
• COAPT (Inclusion): FMR  MitraClip vs. Control (Med)
2- Registries
• GRASP (ITALY)
• TRAMI (GERMANY)
• FRENCH / SPANISH / BELGIUM
• ACCESS EU
3- Meta-analysis
• Mitraclip vs. Surgery in high risk patients.

33. - MitraClip vs. Surgery
- Degenerative (73%) vs. Functional MR (27%)
- LVEF 25 to 60% (LVEDD<55mm)
• Similar mortality among groups (17.4% vs. 17.8%)
• Residual MR >3 similar between groups (21.7% vs. 24.7%)
• 90% of patients in NYHA class I or II at 4-5 years
• More need of mitral surgery in Mitraclip patients (24.8% vs. 5.5%; p<0.001)
Mauri et al. JACC. 2013
Everest II – 4 years FU

34. Everest II – 5 years
Long-term Durability
Mauri et al. JACC. 2013

35. Everest II – 4 years
Mauri et al. JACC. 2013

36. “Real life” practice
EVEREST II GRASP TRAMI ACCESS-EU FRENCH SPANISH
FMR
Success
98
27
79
88
96
24
58
91
77
88
74
85
n 184 n 117 n 1164 n 567 n 62 n 62

37. Common clinical scenarios

38. Meta-analysis comparing Mitraclip and mitral Surgery in high risk patients
(Euroscore >18 and STS score > 10)
Procedural complications
Acute Events Mitraclip
n 3195
MV Surgery
n 3265
Procedural Success 96.3% 98.1%
Cardiac tamponade 0.8% 5.4%
Urgent surgery 2.7% 0.6%
30-Day Events Mitraclip
n 3195
MV Surgery
n 3265
Death 3.3% 16.2%
Stroke 1.1% 4.5%
Bleeding 4.2% 59%
Prolonged ventilation 1.7% 36.3%
Philip et al. CCI. 2014

39. LVEF and Mitraclip
Patients with advanced heart failure and severe LV dysfunction can be safely
treated with Mitraclip with clinical benefit at 6 months
Franzen et al. Eur J Heart Failure.
2011

40. However, low LVEF (<20%) is associated with a higher mortality
Scäfer et al. EuroPCR . 2015
LVEF and Mitraclip

41. Outpatient
Hospitalized
LV support
Registries
EVEREST II
Courtesy F. Maisano
Natural history of HF and FMR

42. - Symptom improvement
- Improvement QOL
- Survival?
- Symptom improvement
- Improvement QOL
- Inverse remodeling
- Prolongs survival
Courtesy F. Maisano
Natural history of HF and FMR

43. Not the finest technique but very acceptable outcomes
Low incidence of complications
Suitable for inoperable or high-risk patients
Venous Access
Beating Heart
No rush
Very safe in expert hands
Comparable results in FMR and DMR
Valid alternative to surgery in FMR
MITRACLIP REPAIR

44. Patient with MR
Need to Correct
Suitable for Mitraclip
Degenerative MR
Inoperable
MitraClip
High Risk
Suitable for
Surgical Repair
Surgery
YesNo
Heart Team
Functional MR
InoperableHigh Risk
MitraClip
Low Risk
Heart Team

45. • MR is a highly prevalent valvulopathy.
• More than half of the patients with indication for surgery are not
operated (even more in FMR).
• There are many percutaneous devices for mitral repair but so far,
only the Mitraclip system has shown more solid results.
• The Mitraclip system is associated with a low rate of procedural
complications and mortality and seems to be effective at long-
term.
Conclusions

46. Conclusions
• The Mitraclip is effective in either DMR and FMR.
• In DMR however, cardiac surgery is associated with much better
results at long-term. This difference is not so clear in FMR.
• Therefore, in DMR, cardiac surgery must always be the first
option unless there is a formal contraindication.
• In FMR, the MitraClip repair might be a valid alternative to
mitral surgery, especially in high risk patients.
• We should treat patients NOT TOO LATE!!!

47. Thank You Very
Much!!

48. • Advanced age
• Advanced symptoms
• Severe LV dilation
• PHT
• Renal dysfunction
• High NT-pro-BNP
• RV dysfunction
Factors associated with worse MC outcome

49. Clinical Case 1
• 71 year-old man.
• CVRF: HTA, DL, DM (OAD)
• Moderate COPD
• Ischemic MCD. CABG 2010.
– Ischemic MCD. LVEF 15-20%
– Severe FMR
– NYHA 3-4/4.
– Recent admission for CHF.
• Normal renal function

54. 2 MitraClip

56. • Optimal clinical evolution.
• TTE at 24 hours without complications
• Discharge at 48 hours.
• Control at 6 months:
– TEE: Mild residual MR. LVEF 20-25%.
– NYHA 2/4.
Clinical Case 1

59. • 12-month Control:
– Clinical stability. No admission for CHF.
– NYHA 1-2/4.
– TTE: Mild residual MR. LVEF 20%.
Clinical Case 1

61. Clinical Case 2
• 36 year-old man.
• CVRF: HTA and DL
• Non Compacted MCD
– LVEF 25% . PAP 50 mmHg
– NYHA 3/4. Recent admission for CHF.
– Levosimendan / 2 weeks.
– Evaluated for heart transplantation.

64. 4 MitraClip

67. • Optimal clinical evolution.
• TTE at 24 hours without complications (MR 1)
• Discharge at 48 hours.
• Clinical control a 1-month:
– NYHA 2/4
– TTE: Residual MR (2+). LVEF 20%.
Clinical Case 2

70. • 59 years-old male.
• CVRF: Hypertension.
• Ischemic-Alcoholic cardiomyopathy.
– KT: CTO of the RCA (RMN without viability)
– LVEF15-20%. Massive FMR
– NYHA 4/4. Recent admission for CHF
• Tracheostomy since 2012 after an episode of
prolonged intubation after respiratory infection/CHF.
Clinical Case 3

73. 2 MitraClips

77. Clinical Case 3
• Good clinical evolution.
• TTE at 24 hours without complications.
• Discharge at 48 hours.
• Control after 1month:
– TEE: Mild residual MR. LVEF 20%.
– NYHA 2/4 (large clinical improvement).

80. Clinical Case 4
• 68 years old lady.
• CVRF: DL.
• Idiopathic cardiomyopathy:
– Normal coronary arteries.
– LVEF 25%. Moderate-Severe FMR.
– NYHA 3/4. Recent admission for CHF.
• Chronic limphatyc leukemia (contraindication for
heart transplant)

83. 1 MitraClip

85. Clinical Case 3
• Good clinical evolution.
• TTE at 24 hours (no complications)
• Discharge after 7 days.
• Control at 1 month:
– TEE: Mild-moderate residual MR. LVEF 20%.
– No clinical improvement (NYHA 3/4)

87. Clinical Case 4
• Control at 3 months.
– TTE: Mild-moderate MR. LVEF 20%.
– NYHA 3/4 (no improvement). Admission for CHF.
• Control at 6 months.
– TTE: Mild-moderate MR. LVEF 20%.
– NYHA 3-4/4
– Pre-transplant study  Procedural complication
during RHC  Exitus letalis after 2 months.

88. Clinical Case 5
• 75 years old male.
• CVRF: HT, DL and DM2
• Ischemic Cardiomyopathy:
– SCASEST  RCA (no suitable for revascularization)
– LVEF 20-25%. Massive FMR.
– NYHA 4/4. Admission for 2 months for refractory
CHF (2 intubations and daily CPAP). Not possible to
discharge
• CRI with basal creatinine of 2 mg/dL

91. 2 MitraClips

95. Clinical Case 5
• Excellent clinical evolution.
• TTE at 24 hours without complications
• Discharge four days after the procedure (after a 2
month admission).
• Control at 3,6 and 12 months:
– TTE: Mild residual MR. LVEF 20%.
– NYHA 1-2/4 (spectacular clinical improvement)

96. Muchas gracias!!!
Moltes gràcies!!!