1. Trattamento percutaneoTrattamento percutaneo
dell'insufficienza mitralicadell'insufficienza mitralica
Francesco MaisanoFrancesco Maisano
Direttore del programma “trattamentoDirettore del programma “trattamento
trans-catetere delle valvulopatie”trans-catetere delle valvulopatie”
Ospedale San Raffaele MilanoOspedale San Raffaele Milano
3. Nkomo. Lancet 2006;368:1005-11
45 45-54 55-64 65-74 >75
Prevalenza dell’insufficienza mitralica
a. L’insufficienza mitralica è la
patologia valvolare più
frequente nella popolazione
generale
b. L’incidenza aumenta con l’età
c. 1 soggetto su 10 con età
superiore a 75 anni è
portatore di insufficienza
mitralica significativa
4. Insufficienza mitralica e prognosi
Robbins. Am J Cardiol. 2003;91:360-2 Enriquez-Sarano. N Engl J Med 2005;352:875-83
a. La presenza di insufficienza mitralica si associa a riduzione
della sopravvivenza
b. Il rischio di eventi cardiovascolari avversi (es. scompenso,
decesso, aritmia) è proporzionale alla entità del rigurgito
5. Molti pazienti con insufficienza
mitralica non possono essere operati
Isolated MR
(n=877)
No Severe MR
(n=331)
Severe MR
(n=546)
No Symptoms
n=144
Symptoms
n=396
Intervention
n=203 (51%)
No Intervention
n=193 (49%)
Symptoms
missing
n=6
(Mirabel et al. Eur Heart J 2007;28:1358-65)
11. 11
Patient Accountability
ACCESS EU – HSR MitraClip Patients Preliminary Results
Treated Patients
Past 6 Month Follow-up
N = 518
Total MitraClip Patients
Treated* in ACCESS EU
N = 567
*Data as of 10/6/2011.
ACCESS EU – MitraClip Patients
Preliminary 6-Month Results
N = 443
6-month follow-up complete
86% patient data available
N = 20 Withdrawals
N = 55 Data pending
Treated Patients
Past 6 Month Follow-up
N = 62
Total MitraClip Patients
Treated** in HSR
N = 93
**Data as of 28/11/2011.
HSR– MitraClip Patients
Preliminary 6-Month Results
N = 62
6-month follow-up complete
94% patient data available
N = 0 Withdrawals
N = 0 Data pending
12. 12
Baseline Demographics and Co-Morbidities
ACCESS EU – HSR MitraClip Patients Preliminary Results
Demographics and Co-morbidities
ACCESS EU
(518)
HSR (93)
Age (mean ± SD), years 74 ± 10 71.4±11.4 (Range 25-88 )
Logistic EuroSCORE, (%)
Mean ± SD 23 ± 19 21.8 ± 14.6
EuroSCORE ≥ 20%, (%) 44 51.6
Male Gender, (%) 65 76
Coronary Artery Disease, (%) 63 37.4
Previous Cardiovascular Surgery, (%) 37 26.4
Myocardial Infarction, (%) 32 49.5
Cerebro-vascular Disease, (%) 13 12.1
Moderate to Severe Renal Failure, (%) 43 39.3
Atrial Fibrillation, (%) 69 39.6
13. 13
Baseline Demographics and Co-Morbidities
ACCESS EU – HSR MitraClip Patients Preliminary Results
Demographics and
Co-morbidities
ACCESS EU (518) HSR (93)
Mitral Regurgitation Grade
≥ 3+, (%)
97 100
NYHA Functional Class III
or IV, (%)
85 73.1
Ejection Fraction < 40%,
(%)
52 62.4
Functional MR, (%) 77 67.7
- Ischemic 41 73
- Non-ischemic 59 27
Degenerative MR, (%) 23 32.3
14. 14
Kaplan-Meier Freedom from Death
HSR MitraClip Patients Preliminary Results
At Risk
N 93 61 31 10
98.8% ± 1.1
At 6 Months 89.1% ± 3.9
At 12 Months 85.8% ± 4.9
at 20 Months
Hospital mortality, 1%
17. 17
NYHA Functional Class
ACCESS EU – HSR MitraClip Patients Preliminary Results
II
III
IV
II
III
IV
I
N = 340
Matched Cases
p<0.0001
I
70%NYHA
ClassIorII
at6Months
II
III
IV
II
III
IV
I
N = 66
Matched Cases
p<0.0001
88,7%NYHA
ClassIorII
at6Months
18. 18
Quality of Life Score (MLWHF)
ACCESS EU – HSR MitraClip Patients Preliminary 6-Month
Results
Data presented as mean ± 95% confidence interval
p<0.0001
Baseline 6 Months
N = 277
Matched Cases
41
29
12 point
improvement
p<0.0001
Baseline 6 Months
N = 63 Matched
Cases
36,3
21,3
15 point
improvement
19. 19
6-Minute Walk Distance
ACCESS EU – HSR MitraClip Patients Preliminary 6-Month
Results
Data presented as mean ± 95% confidence intervals
Baseline 6 Months
N = 233
Matched
Cases
p<0.0001
66 meter
improvement
263
329
Baseline 6 Months
N = 63
Matched
Cases
p<0.0001
110 meter
improvement
197
307
21. MitraClip anatomical
patient selection considerations
• Moderate to severe MR
(Grade 3 or more out of 4 grades)
• Pathology in A2-P2 area
• Coaptation length > 2 mm
(depending on leaflet mobility)
• Coaptation depth < 11 mm
• Flail gap < 10 mm
• Flail width < 15 mm
• Mitral valve orifice area > 4cm2
(depending on leaflet mobility)
• Mobile leaflet length > 1 cm
Recommended criteria1
Maisano et al, recommendations from the Crossroads
institute.
23. Transcatheter MVR
• Larger device
• Anchoring
• Asymmetric anatomy
• Interaction with the aortic valve and
LVOT
• PVL more problematic
24. 24
Conclusioni
MitraClip è una valida alternativa alla
chirurgia in pazienti ad alto rischio o
inoperabili
MitraClip è versatile: si applica alla FMR
e alla DMR nei pazienti che soddisfano i
criteri anatomici
MitraClip è un device per la terapia dello
scompenso, più sicuro della chirurgia, e
con efficacia provata in pz non responder
alla CRT
MitraClip è il primo di una serie di
dispositivi per il trattamento percutaneo
della insufficienza mitralica
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518 patients have reached their 6-month follow-up
- However, AVSH still has not received 6-month visit data on 55 patients
AVSH has complete 6-month data on 443 patients
443/518 = 86%
