tavi ecuador
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TAVI: Resultados de lo último en Tecnología
Dr. Paulo Roberto Lunardi Prates
Cirurgião Cardiovascular
Instituto de Cardiologia – FUC FUNDAÇÃO UNIVERSITÁRIA DE CARDIOLOGIA
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Conflito de Interesses
Proctor TAVI Medtronic
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TAVI transcatheter aortic valve implantion
Background • First-in-human Cribier and colleagues em 2002
• 200.000 implantadas no mundo
• 2000 no Brasil sendo que 1000 estão no registro
• > 100 Publicações
• Real world data to confirm consistent safety and effectiveness of TAVR to compare with results from controlled clinical trials.
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Próteses
A-Edwards Sapien THV B-Sapien XT THV C-CoreValve Medtronic D-Evolut Medtronic E-Lotus Boston F-Direct Flow G-HLT Bracco H-Portico StJude I-Engager Medtronic J-JenaClip JenaValve K-Acurate Symetis L-Inovare Braile
FE HG
I J K L
D
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Concepts
• Balloon-expandable • Edwards
• Braile
• Self-expandable • CoreValve Medtronic
• Mechanical-expandable • Lotus
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Pre-TAVI work-up
• Patients considered at very high risk or nonsurgical candidates
• Evoluation by a Heart-team • Coronary angiography • TT or TE echocardigram • CT aortic and iliofemoral angiography
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MSCT Allows for Multiple Measurements of Aortic Annulus
Perimeter Area Diameters
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Aumentar a complexidade
é seguro e prudente
Trans-aortic
Approaches used for TAVI
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Trnsfemoral Approach
• First choice in the majority centers
• Accurate evaluation of the iliofemoral anatomy
• Can be performed in the cath lab or hybrid room
• The procedure can be performed without general anesthesia – transesophageal echocardiographic guindance
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Transapical Approach
• Was first reported in 2006 – Litchenstien and colleagues
• Small left lateral thoracotomy and direct puncture oh the left ventricular apex
• Advantages • Avoidance of using large catheters though the iliofemoral
system, aortic arch, ascending aorta and aortic valve • Improve coaxility of the valve prothesis and aortic
annulus • Reduction in the amount of contrast
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• Disadvanteges • Need thoracotomy
• Myocardial injury
• Potentially life-threatening bleeding complications
Transapical Approach
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Transaxillary approach
• Has emerged as a alternative to the transfemoral approach
• Surgical cut-down is needed
• O uso de um conduto • PTFE 8mm
• Dacron 8mm
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Transaortic Approach
• 2009-2010 transaortic approach through small right or mild sternotomy
• Requiring sternotomy
• Avoidance of using large catheters though the iliofemoral system, aortic arch, ascending aorta and avoids puncture of the ventricular apex
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Indicações para TAVI: Alto Risco Cirúrgico
Estenose aórtica severa /regurgitação(?)/AVA <1 cm2
Status clinico: CCS ≥ 2; NYHA ≥ 2; síncope
Idade ≥ 75;
EUROSCORE Logístico ≥ 15
Idade > 65 mais 1 ou 2: Aorta em Porcelana; Tórax hostil (radiação, queimaduras)
CRM prévia ou AVC Disfunção neurológica; Cirrose
IRC, DPCO; FEV1 < 71% Doenças graves do colágeno
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ü Velho…muito velho…
ü Frágil…muito frágil…
ü Várias co-‐morbidades… ü CRM prévia (disfunção de VE)
ü IRC ü DPOC grave ü DVP ü FA crônica ü Câncer em remissão
O Fpico paciente transcateter
…mas ainda aproveitando a vida!
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Implante Transcateter Valvar Aórtico (TAVI)
Lower mortality vs. medical therapy Similar survival rate vs. surgery
PARTNER Cohort. TCT 2012 PARTNER Cohort A. ACC 2012
Dados epidemiológicos sugerem Ø ~2-5% dos adultos >65 anos apresentam estenose aórtica
grave Ø ~30% - 40% tem a cirurgia contraindicada
TAVI: tratamento alternativo para a estenose aórtica sintomática grave
Better survival rate vs. surgery
COREVALVE US PIVOTAL TRIAL. NEJM 2014
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Taxas de mortalidade reduzindo drasticamente...
Técnicas atuais e futuros dispositivos só aceitarão “ótimos” resultados
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TVT-R CoreValve Consistent with Pivotal Clinical Trials
1 Month
1 Year
TVT Registry vs Clinical Trial
TVT TAVR O/E Ratio = 0.60
All-Cause Mortality
All#C
ause)M
ortality)(%
))
Months)No.)at)Risk:)
TVT#R) 6160) 4244)Pivotal) 1030) 959) 859) 799)
0%)
10%)
20%)
30%)
40%)
50%)
60%)
70%)
80%)
0) 1) 2) 3) 4) 5) 6) 7) 8) 9) 10) 11) 12)
Pivotal)
TVT#R)
6.9)
5.2)
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TVT-R CoreValve Consistent with Pivotal Clinical Trials
19
TVT Registry vs Clinical Trial Extreme Risk
High Risk
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Durabilidade sendo comprovada
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Taxas de AVC em 30 dias
1Meredith, et al., presented at PCR London Valves 2014; 2Adams, et al., N Engl J Med 2014; 370: 1790-‐8; 3Leon, et. al. presented at ACC 2013; 4Schofer, et al., J Am Coll Cardiol 2014; 63: 763-‐8; 5Popma, et al., J Am Coll Cardiol 2014; 63: 1972-‐81; 6Manoharan, et al., et. al. presented at TCT 2014; 7Kodali, et al., presented at ACC 2015; 8Holmes, et al., JAMA 2015; 313: 1019-‐28 9Meredith, et al., presented at ACC 2015
6,8%
4,9% 4,3% 4,1% 4,0% 4,0% 3,9%
2,6% 2,5%
1,5%
0,0% 0%
1%
2%
3%
4%
5%
6%
7%
8%
% P
atie
nts
wit
h St
roke
at
30 D
ays
Curva de aprendizado; Perfil dos dispositivos; Gravidade dos casos
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Complicações vasculares e mortalidade
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Complicações vasculares relacionadas ao TAVI
Razões para redução das complicações vasculares Ø Maior experiência com dispositivos de oclusão vascular Ø Uso da tomografia como screening tornou-se rotina Ø Transição para dispositivos de menor calibre Ø Seleção de acessos alternativos
Uma relação introdutor arterial/vaso ≥ 1.05 é preditora de complicações vasculares maiores e mortalidade
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Necessidade de marcapasso
Sem diferenças em mortalidade!
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Mor
talit
y
Numbers at Risk
None-Tr 135 125 115 101 68 31 11
Mild 165 139 121 111 71 33 16
Mod-Sev 34 25 22 19 15 6 2
None - Trace Mild
Moderate - Severe 50.7%
26.3%
33.4% 35.3%
12.7%
26.2%
p (log rank) < 0.001
Months Post Procedure
Para-valvular AR Total AR and Mortality
TAVR Patients (AT)
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Para-valvular AR after TAVR Causes and Predictors
A = severe Ca++ or eccentric annulus B = too high C = too low D = undersized cw annulus measurements
Sinning JM, et al. JACC 2012;59:1134-41
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Taxas de PVL moderado e severo em 30 dias
24,2%
16,9%
11,4%
9,0%
4,0% 3,8% 3,4%
1,4% 0,6%
0%
5%
10%
15%
20%
25%
30%
SAPIEN XT PARTNER
IIB N=236
SAPIEN PARTNER
IIB N=225
CoreValve Extreme Risk
N=418
CoreValve High Risk
N=356
Portico CE Study N=75
SAPIEN 3 PARTNER II
S3 N=1504
Evolut R CE Study N=60
Direct Flow DISCOVER
N=74
LOTUS REPRISE II
+ Ext N=177
% P
atie
nts
wit
h M
oder
ate
/ Se
vere
PV
L a
t 30
Day
s
1Leon, et. al. presented at ACC 2013; 2Popma, et al., J Am Coll Cardiol 2014; 63: 1972-‐81; 3Adams, et al., N Engl J Med 2014; 370: 1790-‐8; 4Manoharan, et al., et. al. presented at TCT 2014; 5Kodali, et al., presented at ACC 2015; 6Meredith, et al., presented at ACC 2015; 7Schofer, et al., J Am Coll Cardiol 2014; 63: 763-‐8; 8Meredith, et al., presented at PCR London Valves 2014
As novas tecenologias estão reduzindo a incidência
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PotenRal to Expand IndicaRons
New Access Routes
-- Carotid --
Failed Bioprothesis
Pure Aortic
Insufficiency
Bicuspid Valve
Moderate Risk
Population
TAVI Potencial para expansão das indicações
Novos Acessos
Valve in valve
Insuf. Ao pura
Válvulas bicúspides
ModeradoRisco
Limitações da 1°geração dos dispositivos
² AVCs, sangramentos & complicações vasculares
² Desafios no posiconamento & distúrbios de rítimo
² Regurgitação paravalvar
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New devices will focus on remaining challenges
Sizing Post-implant intervention
(dilation, snare) Depth of Implant
Depth of Implant Balloon strategies
AR and PVL
Conduction Disturbances
Procedure/Technique Technology
Frame design Advanced Sealing
Positioning, Recapture
Frame design Stable deployment
with recapture
Balloon strategies Anti-coagulation mgmt
Stroke
Embolic Protection
Vascular
Complications Alternative Access
Lower profile Access specific delivery
Coatings
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“Próxima geração” de válvulas Mortality 3% Stroke 2% PVL ≥ °II 5% Pacemaker 9%
Mortality 10% Stroke 2% PVL ≥ °II 0% Pacemaker 17%
Möllmann et al., TCT 2014
Treede et al., TCT 2014
Meredith et al., ACC 2015
Mortality 0% Stroke 0% PVL ≥ °II 3% Pacemaker 12%
Symetis
Evolut R
Engager
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Mortality 1% Stroke 4% PVL ≥ °II 1% Pacemaker 17%
Mortality 4% Stroke 6% PVL ≥ °II 1% Pacemaker 29%
Mortality 5% Stroke 3% PVL ≥ °II 3% Pacemaker 13%
Meredith et al., JACC 2014
Schofer et al., JACC 2014
Webb et al., JACC 2014
Lotus
Direct Flow
Sapien S3
“Próxima geração” de válvulas
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Brazilian TAVI Registry: Inclusion
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Brazilian TAVI Registry: Inclusion by center
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TAVI Worldwide Mortality Rates vs. Brazilian Registry
Holmes, D. JAMA 2015 Bosmans JM, Interact Cardiovasc Thorac Surg. 2011;12:762-767 Gilard M, N Engl J Med. 2012;366:1705-1715 Moat NE, J Am Coll Cardiol. 2011;58:2130-2138
Rodes-Cabau J, J Am Coll Cardiol. 2010;55:1080-1090 Tamburino C, Circulation. 2011;123:299-308 Zahn R, Eur Heart J. 2011;32:198-204
9,1
7 7,1
5,4
12,4
9,7
11
12,4
0
2
4
6
8
10
12
14
Brazil US/TVT UK Italy Germany France Belgium Canada
21,6
23,7
21,4
15
24
22
24
0
5
10
15
20
25
30
Brazil US/TVT UK Italy France Belgium Canada
30-day mortality 1-year mortality
% %
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Brazilian TAVI Registry Evolution of Functional Status
* Median of follow-up: 373 days (IQR 77 – 742)
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(n = 819)
BAV, n (%) 395 (48.2%) Valve-in-Valve, n (%) 35 (4.3%) Prosthesis
CoreValve 597/819 (72.9%) Sapien XT 200/819 (24.4%) Inovare 22/819 (2.7%) Post dilatation, n (%) 303 (37%) Device Success * 634 (77.4%)
Brazilian TAVI Registry Procedural Data
* VARC criteria: a single prosthesis implanted in the correct position, with normal function, without moderate or severe AR and with a mean gradient < 20 mmHg.
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Processo decisório no paciente com estenose aórtica grave e alto risco cirúrgico: Sumário Ø TAVI já é uma realidade; faz revolução; em evolução!!!
Ø Os bons resultados dependem de uma abordagem multidisciplinar e individualização do paciente.
Ø As evidências clínicas e a segurança dos dispositivos devem nortear a sua aplicação.
Ø Performance de longo prazo parece muito boa.
Ø Seu benefício e eficácia nos pacientes com risco cirúrgico proibitivo é indiscutível.
Ø É uma excelente alternativa para pacientes com alto risco operatório
Ø Urgem análises locais de custoefetividade
Ø Aguardam-se mais evidências antes de extrapolar a técnica para pacientes de menor risco...
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FUNDAÇÃO UNIVERSITÁRIA DE CARDIOLOGIA