Università degli Studi di Torino
Ospedale San Giovanni Battista - Molinette
L’ ASSISTENZA VENTRICOLARE:
TIMING e MODELLI ORGANIZZATIVI
Prof. Mauro Rinaldi, Dott. Paolo Centofanti, Dott. Matteo Attisani
Sulle Sponde del Ticino
Novara, 14-15 gennaio 2011
INTERMACS: Patient Selection
Patient Profile/ Status: INTERMACS 7 Levels
•
Critical cardiogenic shock
(“crash and burn”)
•
Progressive decline
(“sliding fast”)
•
Stable but inotrope dependent
(stable but dependent)
•
Recurrent advanced HF
((“frequent
frequent flyer”)
flyer )
•
Exertion intolerant
•
Exertion limited NYHA IIIb
•
Advanced NYHA III
(“walking wounded”)
% Surrvival
INTERMACS: Survival Curves
Level 3 (Stable but Inotrope Dependent)
n=172, deaths=20
100
90
80
70
60
50
40
30
20
10
Level 1 (Critical Cardiogenic Shock)
n=481, deaths=121
Level 2 (Progressive Decline)
n=514, deaths=102
0
3
6
9
12
155
188
Months after Device Implant
21
24
Optimal Time of VAD Implantation
Prognostic modeling
to identifyy higher
g
risk
subgroups
7
6
INTERMACS Level
Disease Progression
5
“Optimal
Destination
Therapy”
4
3
“Too Late”
2
1
When it is too early - when too late?
LVEF (%)
35
30
25
20
15
<10
LVEDD (mm)
65
70
75
80
85
>90
Cardiac Index (l/min/m2) 2,4
2,2
2
1,8
1,6
1,4
CVP tor
10
12
14
16
18
>20
APACHE II
<10
<10
11-15
11-15
16-20
>20
Inotropes (days)
0
0
1
2-4
5-10
>10
Hepatic failure (bilirubin) <1
<1.5
<2
<3
<5
>5
RVF (RVFAC)%
>40
>40
>35
>30
>25
<20
Ventilation (days)
0
0
<1
1-3
4-6
>7
MCS (days)
0
0
<1
1-3
4-6
>7
MOF (organs)
0
1
1
2
3
>3
INTERMACS Level I e II Patients
Short – Term VAD per il trasporto del paziente
ECMO
CentriMAG
Tandem
(Levitronix)
Heart
Fino a 8 l/min
Fino a 7
l/min
Fino a 6
l/min
Fino a 2,5
l/min
Fino a 5
l/min
Periferica / Centrale
Periferica /
Centrale
Periferica
Periferica
Periferica /
Centrale
10 giorni
2 settimane
2 settimane
2 settimane
ACT > 180
ACT > 160
ACT > 180
aPTT > 60 sec
(Biomedicus, Rotaflow,
p, LifeBridge)
g )
CardioHelp,
Portata
Cannulazione
Durata max del
supporto
Anticoagulazione
Impella Recover
INDICAZIONI AL VAD
Bridge to decision
Long-term VAD
Short-term VAD
Causes of Cardiogenic Shock
(Topalian S. Crit Care Med 2008)
ECMO…..nuove frontiere
Network Regionale
• Definizioni comuni di diagnosi
• Elaborazione di Linee Guida per i vari quadri clinici
• Consapevolezza delle potenzialità e dei limiti delle procedure proposte
• Analisi periodica prospettica dei risultati
• Rielaborazione dei protocolli operativi
Modello “Hub and Spoke”
Shock Cardiogeno
Centro SPOKE
I Livello
II Livello
Centro HUB
III Livello
Organizzazione territoriale
Primary VAD Screening
Emodinamica avanzata - Cardiochirurgia
• Terapia chirurgica convenzionale
• Short-term VAD
Bridge to decision
Organizzazione territoriale
Secondary VAD Screening
Centro di riferimento regionale VAD
•
•
•
•
Coordinamento
Impianto assistenze maggiori
Indicazione al Trapianto di Cuore
I di i
Indicazione
alla
ll destination
d ti ti therapy
th
Terapia a lungo termine
Secondary VAD screening: Long term VAD
Flusso
VAD
1° Generazione
2° Generazione
3° Generazione
Pulsatile
Assiale
Centrifugo
Berlin Heart
DeBakey
Excor /
LVAD /
CardioWest
Jarvik 2000
aPTT
(sec)
50 - 100
60-70
(+TEG)
(+TEG)
INR
3.0 - 3.5
(2.0) 2.5 – 3.0
HeartMate
II
45 - 50
2.0 – 2.5
Berlin
DuraHeart
Heart
/
Incor
HeartWare
60 – 70
(+TEG)
50 – 60
55 – 65
(+TEG)
(+TEG)
2.5 - 3.5
2.0 – 3.0
2.5 – 3.0
HeartWare
BVAD
5° Generazione
Evoluzione dei devices
92 grammi
4° Generazione
100 grammi
3° Generazione
G
i
500 grammii
2° Generazione
300 grammi
100 grammi
1° Generazione
750 grammi
1000 grammi
Evoluzione dei devices
1984
2010
Rete Regionale per l’Assistenza
Meccanica al Circolo
Network Regionale
Cardiologia avanzata – Cardiochirurgia
Precardiotomia
Scompenso
p
Cardiaco
Acuto Refrattario
Criteri emodinamici:
• IC < 2.2 L/min/m2
• Wedge
W d pressure > 20 mmHg
H
• PA sistolica < 80 mmHg
• SvO2
S O2 < 60%
Postcardiotomia
Rete Regionale per l’Assistenza
Meccanica al Circolo - Torino
n°
AHF and
d VAD Therapy
Th
18
16
14
12
10
8
6
4
2
0
2005
2006
2007
2008
Year
2009
2010
Rete Regionale per l’Assistenza
Meccanica al Circolo - Torino
Assistenze Maggiori
gg
Mono-Biventricolari
12
10
10
8
8
8
6
4
2
2
2
2006
2007
0
2008
2009
2010
Turin Experience 2004 – 2010
VAD IImplants:
l
32
25
20
15
10
5
0
Incor I
Berlin Heart- Jarvik 2000 Heart Mate II Heart Ware
E
Excor
HUB and SPOKESPOKE- Regione
g
Piemonte
Luglio 2005- Dicembre 2010
6
30
27
12
Long-term VAD
Short-term VAD (Impella)
75 pazienti
69 urgenza
urgenza//emergenza
INTERMACS livello 1 e 2
ECMO
19 Incor
I
RVAD
1 HeartWare
H tW
1 HeartMate II 4 Excor BiVAD
4 Jarvik 2000
1 Excor LVAD
Rete Regionale per l’Assistenza
Meccanica al Circolo
Eziologia
i
i
4%
12%
37%
47%
Postcardiotomy
Post-AMI
Idiopatic CMD
Miocarditis
Rete Regionale per l’Assistenza
M
Meccanica
i all Circolo
Ci l
Provenienza dal Territorio
11%
41%
11%
5%
11%
11%
5% 5%
Ospedale di Alessandria
Ospedale di Novara
Ospedale di Cuneo
Ospedale Mauriziano
Ospedale di Rivoli
Ospedale di Moncalieri
Ospedale San Giovanni Bosco Torino
Ospedale Molinette Torino
n= 75 patients Acute Heart Failure
27 pts postcardiotomy
48 pts precardiotomy
BRIDGE to DECISION (46 pt))
Mean time 5,6 days (1- 23)
27 ECMO
Rotaflow-BiomedicusLevitronix
6 RVAD
Biomedicus-Rotaflow
13 LVAD
Impella
BRIDGE to TRANSPLANT (22 pts)
pts) DESTINATION THERAPY (8 pts)
pts)
Mean time 6,1 months (9 – 633)
4 BiVAD 18 Long-term LVAD
Excor
Incor
8 Long-term LVAD
Jarvik 2000 – HM II – Incor - HVAD
TRANSPLANTATION
25 Urgent HTx
18 Elective HTx
Decision making progress and outcomes
Turin experience 20052005 2010
In-hospital
InMortality
• Single Bridge 67 pts 89%
Short-term VAD
Long-term VAD
53 pts
14 pts
(20/53)
36%
(2/14)
14%
(1/8)
12%
(24/75)
30%
(included destination therapy)
• Double Bridge 8 pts 11%
(short-to-long term VAD therapy)
Overall
Considerations::
Considerations
• Implantation
I l t ti off MCS in
i the
th terminal
t
i l phases
h
off heart
h t
failure, Patient Profile 1 (Critical cardiogenic shock) is
associated with a significantly decreased survival
compared to Patient Profiles 2 through 7.
• The use of Patient Profiles simplifies the assessment
of MCS implant risk.
• Further development of Patient Profiles may help
refine selection and timing for MCS devices.
devices
Lesson from INTER
INTERMACS
MACS experience…
experience
BTT patients always includes 4 categories:
Listed
Likely to be listed
Moderately likely to be listed
U lik l to be
Unlikely
b listed
li d
Unknown patients!!
The concept of BRIDGE to CANDIDACY
VAD Implant Strategy
Strategy:: Static or Dynamic
Dynamic??
Critical patients is frequently “unknown
unknown patient”
patient
VAD is a dynamic state during which recipients
g ffrequent
q
re-evaluation
undergo
Turin Experience 2000 – 2010:
VAD and Transplants
30
VAD
Transplant
25
20
15
10
5
0
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Year
HTx after VAD
2007
3% (1/30)
2008
12% (3/2
(3/25))
2009
26% (7/27)
2010
15% (4/26)
Considerations::
Considerations
• In
I our experience
i
VAD implantation
i l t ti seems to
t be
b a
better alternative to urgent list
• Hemodynamic stabilization of critically ill patients
can get to elective cardiac transplantation (gold
standard therapy)
• Newer indications for VAD might include long term
mechanical support rather than the premature
assignment to transplant with uncertain results
(recipient donor optimization)
INTERMACS
INTER
MACS:: last report 2009