2. Base Teórica
• Embolização de debris da placa de ateroma é
uma das principais causas de no reflow e
elevação de biomarcadores após ACTP.
• Os dispositivos de proteção podem minimizar
as consequenciais da embolização distal
melhorando resultados.
3. Aumento de CK-MB após ACTP com sucesso em
CK-MB Rise in SVG Interventions
Enxertos Venosos (EV)
Rates After Successful SVG Intervention
• 1056 intervenções em EV bem-sucedidas
n=1056 consecutive SVG interventions
Normal CK-MB
1-5x CK-MB
>5x CK-MB
P < 0.05
P < 0.05
• 47% had CK-MB rise,
even after successful
PCI
• 15% had major CK-MB
rise
• Even minor CK-MB
rise related to
mortality increase
• Patients with major
CK-MB rise had 2.5x
the mortality as those
with normal CK-MB
15% 11.7%
Hong, et al., Circulation. 1999;100:2400-2405.
53%
4.8%
32%
6.5%
60%
50%
40%
30%
20%
10%
0%
Prevalence 1 Year Mortality
• Pequeno
aumento de CK-MB
tem relação
com aumento de
mortalidade
Hong, et al., Circulation. 1999;100:2400-2405.
4. Prevenção de No-Reflow em Intervenção
em Enxertos Venosos
• Vasodilatadores
• “Undersized”stents
• Baixas pressões de liberação
• Trombectomia
• Dispositivos de proteção para embolização distal
5. Embolic ProtDecistipoon sDiteivvicoess available in
the US for SVG interventions in 2012
Device Manufacturer Approval date
Guardwire Medtronic 6/2001
Filterwire Boston
Scientific
6/2003
Spider ev3 6/2006
7. 1. Guardwire
1.Guardwire
0.014 guidewire with distal balloon
6 French
NA
2.5-5.0 and 3.0-6.0
300 cm, 200 cm
2.1 and 2.7 French
≥20 mm
Design 0.014 Guide catheter 6 French
Design 0.014 guidewire with Pore distal size balloon
NA
Diameters 2.5-Length 300 Crossing profile 2.1 Landing zone ≥20 Guide catheter 6 French
Pore size NA
Diameters 2.5-5.0 and 3.0-6.0
Length 300 cm, 200 cm
Crossing profile 2.1 and 2.7 French
Landing zone ≥20 mm
8. SAFER Trial
Saphenous vein graft Angioplasty Free of
Emboli Randomized
801 pacientes com lesões em enxertos venosos
Guardwire
(n= 406)
Sem proteção
(n = 395)
• Não-inferioridade
9. SAFER Trial
The Trial
Saphenous vein graft Angioplasty Free of Emboli
Application of the ® System
Randomized
A. Lesion crossed with GuardWire®
B. GuardWire® balloon inflated and
intervention performed under
Lesion crossed with GuardWire®
B. GuardWire® balloon inflated and
intervention performed under
The SAFER Trial
Application of the GuardWire® System
10. The SAFER Trial
Use Use of GuardWireof GuardWire® System
® System
Export® Aspiration catheter
D. GuardWire® balloon Export® Aspiration catheter
D. GuardWire® balloon deflated
11. Desfechos em 30 dias
SAFER: Primary Endpoint
42% redução relativa MACE em 30 dias
1.2
3.2
7.4
9.6 8.6
8.3
13.7
1.3
14.7
16.5
20
15
10
5
0
With Protection n = 406 Without Protection n = 395
p = 0.005
p = 0.04
p = 0.008
p = 1.0
p = 0.004
Percent MACE
30 Day Outcomes
30 Day All Q-wave Non No-reflow
MACE MI MI Q-wave MI
42% relative reduction in MACE
12. GuGauradrwdwiriree TTiippss aanndd T rTicrkicsk s
• 7Fr system can increase back-up support
• Prep carefully
Do a
“d
u
mmy ” inflatiohn out of te body
• If tortuosity prox or distal may need to cross
with a
“b
u
ddy wire” first (rare)
• Inflate at least 30mm distal to lesion
• Inflate at a location where the Ref Vessel
Diameter is steady
Diameter does not adapt to vessel size
• Test to verify graft occlusion
• Work fast but keep device in FIXED position
• Flush aspiration system and use for distal
delivery of vasodilators (as needed)
13. Guardwire Tips and Tricks
• Lesões abordadas devem ter pelo menos 5mm
de distância do óstio e >20 mm de distância
da anastomose distal
14. 2. Filterwire
2.Filterwire
2.Filterwire
Design Polyurethane filter basket
Guide catheter 6 French
Pore size 110 μm
Diameters 2.25-3.5 and 3.5-5.5
Length 300 cm, 190 cm
Crossing profile 3.2 French
Landing zone >25 mm (2.25) or >30 mm (3.5)
Design Polyurethane filter basket
profile 3.2 Landing zone >25 Design Polyurethane Guide catheter 6 Pore Guide catheter 6 French
Pore size 110 μm
Diameters 2.25-3.5 and 3.5-5.5
Length 300 cm, 190 cm
Crossing profile 3.2 French
Landing zone >25 mm (2.25) or >30 mm (3.5)
size 110 Diameters 2.25-Length 300 Crossing
15.
16. FilterWire EX Randomized Evaluation
(FIRE)
651 pacientes com lesões em enxertos venosos
Filterwire
(n= 332)
Guardwire
(n = 319)
• Não-inferioridade
17. Desfechos em 30 dias
FilterWire EX Randomized Evaluation (FIRE)
p = 0.99
p = 0.53
p = 0.69
p = 0.99
p = 0.49
Percent MACE
30 Day Outcomes
30 Day All Q-wave Non Death
MACE MI MI Q-wave MI
Stone et al. CircSutloantieo ent 2a0l. 0C3ir;c1u0la8t:i5o4n8 2-500533; 108:548-553
18. Filterwire Tips and Tricks
Filterwire Tips and Tricks
• Steeinr wr e ad advance “en bloc”
wire+filter
• KEEP IT FIXED DURING CATHETER
EXCHANGES
• If slow flow post-stent do manual
aspiration – if slow flow persists remove
filter
• Do not use buddy wires (increased risk for
entrapment)
• May have difficulty advancing retrieval
catheter: important to have bent-tip
retrieval catheter and good guide support
19. FilterWire Tips and Tricks
• Assegurar distância > 2.5 cm entre a lesão e a
anastomose distal do enxerto
• Liberar o dispositivo FilterWire em segmento
sem tortuosidade (>2cm)
• Assegurar aposição do filtro antes da
angioplastia
20. 3. SPIDER
3. SPIDER
3. Spider
Retrieval
Retrieval
Retrieval
Design Nitinol mesh-with Design Nitinol mesh-filter / coated
Design Nitinol mesh-filter / coated
with heparin
with heparin
Guide catheter 6 French
Pore size 70 μm distal end, 165 μm
Guide catheter 6 French
Pore size 70 μm distal end, 165 μm
mid, 200 μm proximal end
mid, 200 μm proximal end
Diameters 3, 4, 5, 6, 7
Length 320 can convert to 190 cm
Crossing profile 3.2 French
Landing zone ≥40-50 mm
heparin
Guide catheter 6 French
Pore size 70 μm distal mid, 200 μm Diameters 3, 4, 5, 6, 7
Diameters 3, 4, 5, 6, 7
Length 320 can convert to 190 cm
Crossing profile 3.2 French
Landing zone ≥40-50 mm
Length 320 can convert Crossing profile 3.2 French
Landing zone ≥40-50 mm
21. SPIDER: Saphenous Vein Graft Protection In
a Distal Embolic Protection Randomized
Trial
732 pacientes com lesões em enxertos venosos
SPIDER
(n= 375)
Filterwire ou
Guardwire
(n = 357)
• Não-inferioridade
22. SDPeIDsEfeRc: hPorismeamry 3E0n ddpiaosint
p = 0.79 for superiority
P=0.012 for non-inferiority
Percent MACE
30 Day Outcomes
30 Day All Q-wave Non Death
MACE MI MI Q-wave MI
Dixon and O’Neill, TCT 2005
23. Spider Tips and Tricks
Spider Tips and Tricks
• Can cross lesion using any 0.014
guidewire
• Wire can shorten from 320 cm to 190
cm by breaking it
• Yellow wire color
• Reverse end of delivery sheath
serves as retrieval sheath
24. Filtros X Dispositivos de Oclusão
Vantagens
• Preservam o fluxo
anterógrado
• É possível contrastar a
imagem durante o
procedimento
• Lesões ostiais
• Simples de usar
Desvantagens
• Podem não capturar todos os
debris
• Dificuldade em verificar os debris
capturados durante o
procedimento
• Possibilidade de oclusão do filtro
• Embolização antes da liberação
do filtro
• Recolhimento pode lesar os
stents
25. Problemas
• Cruzar a lesão com o dispositivo
• Lesões próximas a bifurcações
• No reflow mesmo com dispositivo de proteção
• Lesões distais
• Aprisionamento do filtro na malha do stent
26. Recomendações
• Gu2id0e1lin1e A PCCI CAC/AC/HAHAA P 2C01I1 Guidelines
Embolic protection devices
(EPDs) should be used during
saphenous vein graft PCI when
technically feasible
I IIa IIb III
B
27. Recomendações
• GuideliEnSeC R/EeAvCaTsScu relavraiszcautliaorniz aEtSioCn 2g0ui1d0elines 2010
Wijns et al. EHJ 2010
SAFER
FIRE
PROXIMAL