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Dispositivos de proteção distal
This document discusses distal embolic protection devices used during percutaneous coronary interventions (PCI) of saphenous vein grafts. It provides background on how embolization of plaque debris can cause no-reflow and increased biomarkers. Three main devices are described - the Guardwire balloon occlusion catheter, the Filterwire embolic protection filter, and the Spider filter. Clinical trial results for each device showing reductions in major adverse cardiac events compared to no protection are presented. Tips for using each device safely and effectively are also provided. The document concludes with recommendations from guidelines supporting the use of embolic protection devices when technically feasible for saphenous vein graft PCI.
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Dispositivos de proteção distal
- 1. Dispositivos de Proteçãopara Embolização Distal Apresentação: R1 Cristina Silveira
- 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-MBapós 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-Reflowem Intervenção em Enxertos Venosos • Vasodilatadores • “Undersized”stents • Baixas pressões de liberação • Trombectomia • Dispositivos de proteção para embolização distal
- 5. Embolic ProtDecistipoon sDiteivvicoessavailable 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
- 6. Dispositivos Oclusão /Aspiração • Guardwire Filtros • Filterwire • Spider
- 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 Saphenousvein 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 TheTrial 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 30dias 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 aannddT 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 andTricks • 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
- 16. FilterWire EX RandomizedEvaluation (FIRE) 651 pacientes com lesões em enxertos venosos Filterwire (n= 332) Guardwire (n = 319) • Não-inferioridade
- 17. Desfechos em 30dias 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 andTricks 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 andTricks • 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 VeinGraft 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 3E0nddpiaosint 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 andTricks 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 Dispositivosde 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 • Cruzara 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 • Gu2id0e1lin1eA 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 • GuideliEnSeCR/EeAvCaTsScu relavraiszcautliaorniz aEtSioCn 2g0ui1d0elines 2010 Wijns et al. EHJ 2010 SAFER FIRE PROXIMAL