La Mitraclip nel Trattamento dell’ Insufficienza …Percutaneous Mitral Valve Repair is an...
Transcript of La Mitraclip nel Trattamento dell’ Insufficienza …Percutaneous Mitral Valve Repair is an...
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La Mitraclip nel Trattamentodell’ Insufficienza Mitralica:Indicazioni, Tecnica ed Outcome
Renato RosielloStruttura Complessa di Cardiologia
Asst - Mantova
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Epidemiologia dell’Insufficienza Mitralica
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• L’insufficienza mitralica (IM) è la seconda valvulopatia più frequente nel mondooccidentale. Qualora il vizio mitralico risulti severo, l’aspettativa di vita e la libertà daeventi risultano fortemente compromesse. Nonostante le attuali linee guida siano benchiare nell’indicare l’intervento chirurgico, riparativo o sostitutivo, come trattamento discelta nei pazienti con IM severa, esistono tuttavia condizioni complesse in pazienti conIM severa e scompenso cardiaco (SC) in fase avanzata
• Nell’EuroHeart Survey viene evidenziato come il 50% di pazienti anziani, sintomaticiper IM severa, non vengano sottoposti a chirurgia a causa dell’età o delle co-patologie.Per questo motivo sono stati sviluppati diversi dispositivi per effettuare una correzionedell’IM in maniera meno invasiva (percutanea) e ridurre i rischi legati alla chirurgia.
• IM significativa è presente in circa il 30% dei pazienti con pregresso infarto miocardicoe nel 35% dei pazienti con SC cronico. Dati derivati da diversi studi osservazionalipubblicati in letteratura dimostrano come la mortalità raddoppi quando lo SC in stadioavanzato si associa alla presenza di severo rigurgito mitralico.
• La prevalenza di insufficienza almeno moderata negli individui più giovani di 50 anni èinferiore all’1%, mentre viene identificata in 1 individuo su 10 oltre i 70 anni.
Epidemiologia dell’insufficienza mitralica
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• Le forme più comuni di insufficienza mitralica nei pazienti sottoposti a interventochirurgico nei paesi occidentali sono la forma degenerativa (60-70% dei casi), seguitadalla forma funzionale ischemica (20%), endocardite (2-5%), reumatica (2-5%), e altreforme (1%).
• La storia naturale e i risultati clinici nei pazienti trattati in terapia medica o conintervento chirurgico differiscono nel caso di IM funzionale o degenerativa
• Il tasso di mortalità annuo nei pazienti con IM degenerativa significativa varia dall’1% al9%. La mortalità è più alta nei pazienti con dilatazione ventricolare sinistra e neipazienti sintomatici (classe NYHA III o IV).
• Per quanto riguarda l’IM funzionale, numerosi studi osservazionali hanno mostrato unaumento della mortalità nei pazienti con scompenso cardiaco in presenza di rigurgitomitralico significativo.
Storia naturale dell’insufficienza mitralica
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Catheter-Based Mitral Valve RepairMitraClip® System
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Indicazioni all’impianto di Mitraclip
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Endovascular Valve Edge-to-Edge REpairStudy (EVEREST II)
Randomized Clinical Trial: Primary Safety and Efficacy Endpoints
Ted Feldman, Laura Mauri, Elyse Foster, Don Glower on behalf of the EVEREST II Investigators
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9 Investigational Device only in the US; Not available for sale in the US
Device (%)n=184
Control (%)n=95 P
Age (mean) 67.3 years 65.7 years 0.32
Male 62.5 66.3 0.60
Congestive heart failure 90.8 77.9 <0.01
Coronary artery disease 47.0 46.3 >0.99
Myocardial infarction 21.9 21.3 >0.99
Angina 31.9 22.2 0.12
Atrial fibrillation 33.7 39.3 0.42
Cerebrovascular disease 7.6 5.3 0.62
Peripheral vascular disease 6.5 11.6 0.17
Cardiomyopathy 17.9 14.7 0.61
Hypercholesterolemia 61.0 62.8 0.80
Hypertension 72.3 78.9 0.25
Moderate to severe renal disease 3.3 2.1 0.72
Diabetes 7.6 10.5 0.50
Previous cardiovascular surgery 22.3 18.9 0.54
MR Severity: 3+ to 4+ 95.7 92.6 0.48
MR Etiology: Degenerative / Functional 73 / 27 73 / 27 0.81
EVEREST II Randomized Clinical TrialBaseline Demographics & Co-morbidities
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EVEREST II Randomized Clinical TrialAdditional Analyses
Intention to Treat• Safety
– Major Adverse Event Rate at 30 days
• Effectiveness– Freedom from the combined outcome of death, MV surgery >90 days
or re-operation for valve dysfunction >90 days post Index procedure, and MR >2+ at 12 months
Clinical Benefit (per protocol cohort)
• MR Severity
• Left Ventricular Function
• NYHA Functional Class
• Quality of Life (SF-36 Survey)
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In Italia attivi 47 centri
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Degenerative mitral valve regurgitation
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Prolasso mitralico complesso
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Insufficienza mitralica : funzionale
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ENDOCARDITE
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LESIONE CALCIFICA ANULUS MITRALICO
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LESIONE CALCIFICA ANULUS MITRALICO
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M. DI BARLOW
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M. DI BARLOW
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FLAIL
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FLAIL
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FLAIL
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PROLASSO PARACOMMISSURALE
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TETHERING
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PROLASSO + CLEFT
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Tecnicadi impianto
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ANIMAZIONE
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MITRACLIP
PUNTURA SETTALE DISTANZA PUNTURA SETTALE / COAPTAZIONE MITRALE
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ORIENTAMENTO CLIP
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MITRACLIP
CLIP 1 IM RESIDUA
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MITRACLIP
CLIP 1 CLIP 2
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MITRACLIP
CLIP 2 - IM RESIDUACLIP 1 - IM RESIDUA
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MITRACLIP
CLIP 2 CW doppler transmitralico
Gradiente medio 5 mmHg
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Risultati
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Event – free survival decreases with increasing MR severity1,2,3
MitraClip intervention in less severe MR results in better outcomes4
∆23% MitraClip patients with MR ≤2+ at 1 year
Risk of mortality increases with increasing NYHA class
For patients with MR≥3+, MitraClip intervention in less severe NYHA class results in better outcomes
Cu
mu
lati
ve r
isk
of
all-
cau
se m
ort
alit
y %
0 12 24 36 48 60
Long run test p<0.001 Follow-up in Months
1.0
0.8
0.6
0.4
0.2
0.0
Kaplan-Meier plots for cumulative probability of all-cause mortality
NYHA lV
NYHA lll
NYHA ll
NYHA l
∆22% MitraClip patients with NYHA l or ll at 1 year
Patients in NYHA class l and ll at 12 months
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0%
20%
40%
60%
80%
100%
Baseline 12 Months Baseline 12 Months
Device Group Control Group
EVEREST II RCT: MR ReductionPer Protocol Cohort
≤2+
3+/4+
≤2+
3+/4+
81.5%
18.5%3+/4+
97.0%
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0
20
40
60
80
100
Perc
ent
Patients
EVEREST II RCT: NYHA Functional ClassPer Protocol Cohort
97.6%NYHA
Class I/II
87.9%NYHA
Class I/II
I
II
III
I
II
III
IVIV
III
II
I
II
I
Device Group Control Group
Baseline Baseline12 months 12 months
p<0.0001 p<0.0001
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0
10
20
30
40
50
60
Score
EVEREST II RCT: Quality of Life, SF-36 SurveyPer Protocol Cohort
PCS MCS
Baseline
n=120, matched pairs n=64, matched pairs
30 days
Device Group
30 Day Scores
p<0.0001
PCS MCS
PSC = Physical Component SummaryMCS = Mental Component Summary
Control Group
p<0.0001
P=0.0043
P=0.2910
0
10
20
30
40
50
60
12 Months
12 Month Scores
n=60, matched pairsn=110, matched pairsMCSMCS PCSPCS
Control GroupDevice Group
P<0.0001
P<0.0001
P=0.0017
P=0.0057
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The MitraClip procedure is an important therapeutic option for selected patients with
significant mitral regurgitation given the demonstrated safety, effectiveness and
clinical benefit.
EVEREST II RCT: Conclusion
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Foglietto illustrativo
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Economic Value
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In patients with an indication for valve repair but judged inoperable or at unacceptably high surgical risk, percutaneous edge-to-edge repair may be considered in order to improve symptoms
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Transcatheter MV repair may be considered for severelysymptomatic patients (NYHA class III/IV) with chronicsevere primary MR (stage D) who have a reasonable lifeexpectancy but a prohibitive surgical risk because ofsevere comorbidities (IIb – B)
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Percutaneous Mitral Valve Repair is an Important Part of a Comprehensive Valve Center Serving Patients
Case study: Patient volume increases after introduction of MitraClip therapy
55 49 51 48 51 56 56 54 52 57
63 90 99 113 95
135164 157 174
196
8
3075
8964
0
50
100
150
200
250
300
350
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
Percutaneous Repair Replacement
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Optimal Patient Care
Multi-disciplinary TeamBridging Traditional Silos
Collaboration across specialties is critical to MitraClip Therapy Success
Heart Failure
Specialist
Cardiac
Surgery
Interventional
Cardiology
Echo
Cardiology
Anesthesiology Nursing /
Cath-Lab Staff
Plan Therapy
& Resources
Optimal Patient
Selection
Post
Procedure Care
Echo Guidance
& CommunicationPatient Referral
Collaboration
Required for:
Hospital
Administrator
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• Il trattamento chirurgico rimane il gold standard di riferimento per la terapiadel rigurgito mitralico.
• La MitraClip è una tecnica sicura ed efficace, riducendo il rigurgito mitralicoa meno di moderato.
• Il trattamento con MitraClip dovrebbe essere riservato ai pazienti affetti dainsufficienza mitralica, sintomatici e non responsivi alla sola terapia medica,considerati ad alto rischio chirurgico, anziani con importanti comorbilità odinoperabili, con caratteristiche anatomiche adeguate alla riparazione condispositivo MitraClip.
• Queste indicazioni sono in accordo con quelle recentemente sottolineatedalle linee guida della Società Europea di Cardiologia e della SocietàAmericana. Rimaniamo in attesa dei risultati degli studi randomizzati pereventualmente estendere o circoscrivere l’indicazione.
Conclusioni
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