mitraclip san raffaele experience
TRANSCRIPT
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Trattamento percutaneo Trattamento percutaneo dell'insufficienza mitralicadell'insufficienza mitralica
Francesco MaisanoFrancesco MaisanoDirettore del programma “trattamento Direttore del programma “trattamento
trans-catetere delle valvulopatie”trans-catetere delle valvulopatie”Ospedale San Raffaele MilanoOspedale San Raffaele Milano
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L’insufficienza mitralica
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Nkomo. Lancet 2006;368:1005-11
45 45-54 55-64 65-74 >75
Prevalenza dell’insufficienza mitralica
①L’insufficienza mitralica è la patologia valvolare più frequente nella popolazione generale
②L’incidenza aumenta con l’età
③1 soggetto su 10 con età superiore a 75 anni è portatore di insufficienza mitralica significativa
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Insufficienza mitralica e prognosi
Robbins. Am J Cardiol. 2003;91:360-2 Enriquez-Sarano. N Engl J Med 2005;352:875-83
① La presenza di insufficienza mitralica si associa a riduzione della sopravvivenza
② Il rischio di eventi cardiovascolari avversi (es. scompenso, decesso, aritmia) è proporzionale alla entità del rigurgito
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Molti pazienti con insufficienza mitralica non possono essere operati
Molti pazienti con insufficienza mitralica non possono essere operati
Isolated MR(n=877)
No Severe MR(n=331)
Severe MR(n=546)
No Symptomsn=144
Symptomsn=396
Interventionn=203 (51%)
No Interventionn=193 (49%)
Symptoms missing
n=6
(Mirabel et al. Eur Heart J 2007;28:1358-65)
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Maisano et al, J Am Coll Cardiol 2011;58: 2174–82
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Il Signor TL….
• Ottobre 2010• 62 anni, cardiomiopatia dilatativa post-ischemica• Pregresso By-pass aortocoronarico e
angioplastiche plurime• Portatore di defibrillatore e resincronizzazione
biventricolare• Copatologie. Insufficienza epatica, ipertensione,
dislipidemia• Sintomatico per dispnea (Classe IV, MLHF 36)
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Il sig TL, 62 anni, cardiopatico
• EDV 223 ml• ESV 177 ml• EDD 78 mm• ESD 65 mm• EF 25%
• Euroscore 36%
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Impianto di MitraClip
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Intervento versatile
FMR DMR
San Raffaele, 2008-2011: 94 pts, 30%DMR, 70%FMR
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Patient AccountabilityACCESS 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 complete86% 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 complete94% patient data available
N = 0 Withdrawals
N = 0 Data pending
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Baseline Demographics and Co-MorbiditiesACCESS EU – HSR MitraClip Patients Preliminary Results
Demographics and Co-morbiditiesACCESS 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
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Baseline Demographics and Co-MorbiditiesACCESS 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
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Kaplan-Meier Freedom from DeathHSR MitraClip Patients Preliminary Results
At Risk
N 93 61 31 10
98.8% ± 1.1
At 6 Months 89.1% ± 3.9At 12 Months 85.8% ± 4.9
at 20 Months
Hospital mortality, 1%
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Mitral Regurgitation GradeACCESS EU – HSR MitraClip Patients Preliminary Results
80%
MR
≤ 2
+at 6
Mon
ths
3+
4+
3+
2+
1+
0 +
p<0.0001
N = 351 Matched Cases
2+
4+
79,3
% M
R ≤
2+
at 6
Mon
ths
3+
4+
3+
2+
1+
0 +
p<0.0001
ACCESS EU HSR
N = 62 Matched Cases
4+
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Ventricular RemodelingHSR MitraClip Patients Preliminary Results
VTS
VTD
VTS
VTD
DTS
DTD
DTS
DTD
P=0.003
P=0.01
P<0.001
P=0.02
N = 62Matched
Cases
N = 62Matched Cases
mm ml
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NYHA Functional ClassACCESS EU – HSR MitraClip Patients Preliminary Results
II
III
IV
II
III
IV
I
N = 340 Matched
Cases
p<0.0001
I
70%
NY
HA
C
lass I o
r IIat 6
Mon
ths
II
III
IV
II
IIIIV
I
N = 66Matched
Cases
p<0.0001
88,7
% N
YH
A
Cla
ss I o
r IIat 6
Mon
ths
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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 MonthsN = 277
Matched Cases
4129
12 pointimprovement
p<0.0001
Baseline 6 MonthsN = 63
Matched Cases
36,3
21,3
15 pointimprovement
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6-Minute Walk DistanceACCESS 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
263329
Baseline 6 Months
N = 63 Matched
Cases
p<0.0001
110 meter improvement
197
307
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Il signor TL… a 2 anni di follow-up
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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.
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Oltre la MitraClip: Annuloplastica
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Transcatheter MVR• Larger device• Anchoring• Asymmetric anatomy• Interaction with the aortic valve and
LVOT• PVL more problematic
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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