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TAVI 2013 Dr. Claudio Cigalini
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INDICACIONES
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ESTENOSIS AORTICA
• I - Est.Ao severa sintomática;
• I - Est.Ao severa sintomática o no, en contexto de CRM, CRV ò cirugía de Aorta;
• I - Est.Ao severa y Fey < 50%
• IIa - Est.Ao moderada en contexto de CRM, CRV, o cirugía de Aorta;
• IIa - Est.Ao severa asintomática y Fey < 50% o respuesta anormal al ejercicio (hipotensión);
• IIb - Est.Ao severa asintomática con TV, o con excesiva HVI (>15mm), ò con estenosis valvular crítica;
• IIb - Est.Ao severa y alta probabilidad de progresión rápida (edad, calcificación, enf.coronaria);
• III - Prevención de muerte súbita en pacientes asintomáticos.
Task Force Valvulopatìas, AHA/ACC, 2006
INDICACIONES DE REEMPLAZO VALVULAR
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ESTENOSIS AORTICA
• I - Est.Ao severa sintomática;
• I - Est.Ao severa sintomática o no, en contexto de CRM, CRV ò cirugía de Aorta;
• I - Est.Ao severa y Fey < 50%
• IIa - Est.Ao moderada en contexto de CRM, CRV, o cirugía de Aorta;
• IIa - Est.Ao severa asintomática y Fey < 50% o respuesta anormal al ejercicio (hipotensión);
• IIb - Est.Ao severa asintomática con TV, o con excesiva HVI (>15mm), ò con estenosis valvular crítica;
• IIb - Est.Ao severa y alta probabilidad de progresión rápida (edad, calcificación, enf.coronaria);
• III - Prevención de muerte súbita en pacientes asintomáticos.
Task Force Valvulopatìas, AHA/ACC, 2006
INDICACIONES DE TVAR
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(EACTS/ESC/EAPCI Position Statement, Eur Heart J, 2008; 29: 1463-1470,
Eur J Cardiothorac Surg 34 (2008) 1-8, Eurointerv. 2008; 4:193-199)
“El elemento clave para establecer si los pacientes son de alto riesgo para la cirugía es el juicio clínico, que debe ser utilizado en asociación con uno evaluación cuantitativa, basado en la combinación de varios validados scores "
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Edwards CoreValve
Dispositivos Actuales
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Edwards
•Pericardio bovino
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Dos tipos de accesos
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CoreValve
Válvula de Pericardio Porcino
Stent autoexpandible de nitinol
Parcialmente reposicionable
18Fr
1° Generación 25F
2° Generación 21F
3° Generación 18F
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Biocompatibilidad e Integración
Noble S. Bonan R. et al Eurointervention 2009;1:5, 78-86
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Access site – peripheral anatomy Abdominal and thoracic aorta Ascending aorta and aortic arch Aortic root and valve anatomy Left ventricle and coronary arteries
Anatomical Considerations
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Selección de Pacientes
CLINICA
ANGIOGRAFIA
E.T.E.
ANGIO TC MS
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ANGIOGRAM CT SCAN
Minimal Tortuosity ≥ 6mm Diameter
Abdominal Aorta & Runoffs
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Acceso femoral o subclavio
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Navegabilidad aortica
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Aortic Arch
Diameter
Angulation
Stenosis
Ulceration
Calcification
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Computed Tomography
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Parámetros Anatómicos
A=22 mm
B=30 mm
C=33 mm
D=19 mm
CoreValve 26 mm CoreValve 29 mm
A = Diámetro Anillo 20-23 mm 24-27 mm
B = Diámetro SV ≥27 mm ≥ 29 mm
C = Diámetro Ao Ascendente
≤ 40 mm ≤ 43 mm
D = Altura SV ≥ 15 mm ≥ 15 mm
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Parámetros ecográficos
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Parámetros angiográficos
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Parámetros tomográficos
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Exact Location and Severity of Aortic Valve Calcification
Heavily calcified
AoV, > at the tips
of the leaflets.
Midly calcified AoV.
small isolated
spots
Moderate
calcified AoV, >
at base of the
leaflets.
•incomplete or nonuniform expansion .
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Left Ventricle
• No moderate to severe LV hypertrophy (≥ 1.4 cm
wall thickness),
• No evidence of subaortic stenosis, including
Hypertrophic Obstructive Cardiomyopathy (HOCM)
or Idiopathic Hypertrophic Subaortic Stenosis
(IHSS)
• No significant coronary artery disease,
• No Horizontal Ventricle.
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No Horizontal Ventricle
this angle should be < 30°.
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Symptomatic Severe Aortic Stenosis
ASSESSMENT: High Risk AVR Candidate
3105 Total Patients Screened
PARTNER Study Design
High Risk TA
ASSESSMENT: Transfemoral Access
TAVI
Trans
femoral
Surgical
AVR
High Risk TF
Primary Endpoint: All Cause Mortality (1 yr)
(Non-inferiority)
TAVI
Trans
Apical
Surgical
AVR
1:1 Randomization 1:1 Randomization
VS
VS
Standard
Therapy
(usually BAV)
ASSESSMENT: Transfemoral Access
Not In Study
TAVI
Trans
femoral
Primary Endpoint: All Cause Mortality over
length of trial (Superiority)
1:1 Randomization
VS
Total = 1058 patients
2 Parallel Trials:
Individually Powered High Risk n= 700 Inoperable n=358
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Patient Characteristics - 1
Characteristic TAVI n=179
Standard Rx n=179
P value
Age - yr 83.1 ± 8.6 83.2 ± 8.3 0.95
Male sex (%) 45.8 46.9 0.92
STS Score 11.2 ± 5.8 12.1 ± 6.1 0.14
Logistic EuroSCORE 26.4 ± 17.2 30.4 ± 19.1 0.04
NYHA
I or II (%)
III or IV (%)
7.8
92.2
6.1
93.9
0.68
0.68
CAD (%) 67.6 74.3 0.20
Prior MI (%) 18.6 26.4 0.10
Prior CABG (%) 37.4 45.6 0.17
Prior PCI (%) 30.5 24.8 0.31
Prior BAV (%) 16.2 24.4 0.09
CVD (%) 27.4 27.5 1.00
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Patient Characteristics - 2
Characteristic TAVI
n=179
Standard Rx n=179
P value
PVD (%) 30.3 25.1 0.29
COPD
Any (%)
O2 dependent (%)
41.3
21.2
52.5
25.7
0.04
0.38
Creatinine >2mg/dL (%) 5.6 9.6 0.23
Atrial fibrillation (%) 32.9 48.8 0.04
Perm pacemaker (%) 22.9 19.5 0.49
Pulmonary HTN (%) 42.4 43.8 0.90
Frailty (%) 18.1 28.0 0.09
Porcelain aorta (%) 19.0 11.2 0.05
Chest wall radiation (%) 8.9 8.4 1.00
Chest wall deformity (%) 8.4 5.0 0.29
Liver disease (%) 3.4 3.4 1.00
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All Cause Mortality
Numbers at Risk
TAVI 179 138 122 67 26
Standard Rx 179 121 83 41 12
Standard Rx
TAVI
All-
cause m
ort
alit
y (
%)
Months
∆ at 1 yr = 20.0%
NNT = 5.0 pts
50.7%
30.7%
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0 6 12 18 24
Cardiovascular Mortality
Numbers at Risk
TAVI 179 138 122 67 26
Standard Rx 179 121 83 41 12
Standard Rx
TAVI
Card
iovascu
alr m
ort
alit
y (
%)
Months
0
20
40
60
80
100
∆ at 1 yr = 24.1%
NNT = 4.1 pts
44.6%
20.5%
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0 6 12 18 24
Mortality or Repeat Hosp
Standard Rx
TAVI
All-
cause m
ort
alit
y o
r
Repeat H
ospitaliz
ation (
%)
Months
0
20
40
60
80
100
Numbers at Risk
TAVI 179 117 102 56 22
Standard Rx 179 121 49 23 4
HR [95% CI] =
0.46 [0.35, 0.59]
P (log rank) < 0.0001
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Outcome 30 Days n=179
TAVI Standard
Rx P-value
1 Year n=179
TAVI Standard
Rx P-value
Clinical Outcomes at 30 Days & 1 Year
Myocardial infarction
All (%) 0 0 . 0.6 0.6 1.00
Peri-procedural (% 0 0 . 0 0 .
Stroke or TIA
All (%) 6.7 1.7 0.03 10.6 4.5 0.04
TIA (%) 0 0 . 0.6 0 1.00
Minor stroke (%) 1.7 0.6 0.62 2.2 0.6 0.37
Major stroke (%) 5.0 1.1 0.06 7.8 3.9 0.18
Death (all) or major stroke (%) 8.4 3.9 0.12 33.0 50.3 0.001
Repeat hospitalization (%) 5.6 10.1 0.17 22.3 44.1 <.0001
Death (all) or repeat hosp (%) 10.6 12.3 0.74 42.5 70.4 <.0001
Death
All (%) 5.0 2.8 0.41 30.7 49.7 0.0004
Cardiovascular (%) 4.5 1.7 0.22 19.6 41.9 <.0001
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Outcome 30 Days n=179
TAVI Standard
Rx P-value
1 Year n=179
TAVI Standard
Rx P-value
Acute kidney injury
Creatinine >3 mg/dL (%) 0 1 1.00 1.1 2.8 0.45 RRT (%) 1.1 1.7 1.00 1.7 3.4 0.50
Cardiac re-intervention
BAV (%) 0.6 1.1 1.0 0.6 36.9 <.0001
Re-TAVI (%) 1.7 na 1.7 na
AVR (%) 0 1.7 0.25 1.1 9.5 <.0001
Endocarditis (%) 0 0 . 1.1 0.6 0.31
Vascular complications
All (%) 30.7 5.0 <.0001 32.4 7.3 <.0001
Major (%) 16.2 1.1 <.0001 16.8 2.2 <.0001
Bleeding - major (%) 16.8 3.9 <.0001 22.3 11.2 0.007
Arrhythmias
New atrial fibrillation (%) 0.6 1.1 1.00 0.6 1.7 0.62
New pacemaker (%) 3.4 5.0 0.60 4.5 7.8 0.27
Clinical Outcomes at 30 Days & 1 Year
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P (log rank) = 0.069
Major Vascular Complication (n=31)
No Major Vascular Complication (n=148)
Mo
rta
lity (
%)
Months
Mortality vs. Major Vasc Complics
TAVI patients
27.7%
47.2%
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P (log rank) = 0.0046 Major Bleed (n=46)
No Major Bleed (n=133)
Mo
rta
lity (
%)
Months
Mortality vs. Major Bleeding
TAVI patients
26.3%
43.5%
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Major Stroke (n=15)
No Major Stroke (n=164)
Mo
rta
lity (
%)
Months
P (log rank) <0.0001
Mortality vs. Major Stroke
TAVI patients
27.7%
66.7%
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PARTNER ALTO RIESGO
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PARTNER ALTO RIESGO
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PARTNER ALTO RIESGO
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PARTNER ALTO RIESGO
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PARTNER ALTO RIESGO
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PARTNER ALTO RIESGO
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PARTNER ALTO RIESGO
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PARTNER ALTO RIESGO
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PARTNER ALTO RIESGO
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PARTNER ALTO RIESGO
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PARTNER ALTO RIESGO
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PARTNER ALTO RIESGO
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Predictores de requerimiento de marcapaso definitivo
• 34 ptes. con RVP; Edad media 84 años
• Entre Enero 2007 y Marzo 2008 en UK, unicéntrico
• 33% requirió MCP definitivo durante la internación.
American Heart Journal, Mayo 2009
PREDICTORES
eléctricos
anatómicos
Eje a la izquierda
c/s BCRI
Septum >17mm
(ETT)
Grosor de la valva
no coronariana
>8mm (ETE)
p=.004
p=.002
p=.045
p=.002 Sensibilidad 75%
Especificidad 100%
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CONCLUSIONES PROCEMIMIENTO: Inicialmente complejo / Cada vez más
simple.
HEMODINAMIA: gradiente abolido / buen incremento en el área/ aceptable I. Ao.
COMPLICACIONES INTRAPROCEDIMIENTO: todavía un problema /
vasculares / neurológicas / marcapasos /
RESULTADOS ALEJADOS: comparable o mejor a cirugia hasta 2 años
INDICACIONES: solamente indicada en paciente inoperables o con alto riesgo quirúrgico
DURAVILIDAD DE LA VALVULA: falta tiempo
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COREVALVE EXTREME RISK
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COREVALVE EXTREME RISK
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COREVALVE EXTREME RISK
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COREVALVE EXTREME RISK
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All Cause Mortality
Numbers at Risk
TAVI 179 138 122 67 26
Standard Rx 179 121 83 41 12
Standard Rx
TAVI
All-
cause m
ort
alit
y (
%)
Months
∆ at 1 yr = 20.0%
NNT = 5.0 pts
50.7%
30.7%
PARTNER INOPERABLES
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COREVALVE EXTREME RISK
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COREVALVE EXTREME RISK
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