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Estenosis aórtica: Catéter.
IVÁN J NÚÑEZ GIL, MD, PhD, FESC.
Cardiología Intervencionista. Hospital Clínico San Carlos, Madrid.
Cardioversias 2013 Alcalá, 24-25 mayo 2013
INTRODUCCIÓN
Edad Prevalencia
65-74 años 1-2%
75-84 3-5%
>85 6-7%
Otto CM, et al. NEJM 1999;341: 142-147. Iung et al. Eur Heart Survey. Eur Heart J 2003; 24:1231-43.
Supervivencia tras el diagnóstico de estenosis aórtica severa en ancianos
Logeais, Rennes 1995
con RVAo
Sin RVAo
Años Logeais, Rennes 1995
Contraindicación para cirugía
• “alto riesgo quirúrgico”
– EuroScore logístico >20%
– STS >10%
• “paciente inoperable” por
– enfermedad pulmonar, renal, hepática
– disfunción ventricular, hipertensión pulmonar
– radiación torácica
– aorta de porcelana
– fragilidad
Shoroyer. Ann Thorac
Surg 2003; 75:1856-65
Nashed.Eur J Cardiovasc
Surg 1999;16:9-13
Valoración pre-TAVI
• Descartar/confirmar enfermedad coronaria
• Valoración anatómica
• Valoración anatomía aortoiliaca
• Elección tipo dispositivo
• Elección tamaño dispositivo
• Elección vía: TF, TA, subclavia, otras
Cardiólogos Cirujanos
Anestesistas
Imagen (eco, TAC, RMN) Otros: Geriatras,…
TRATAMIENTO DE LA VALVULOPATÍA
Valoración anatómica de la válvula y raíz aórtica en candidatos a TAVI
• ETE, angiografía, TAC
• Diámetros tracto salida, anillo, senos de Valsalva
• Localización calcio
• Distancia del calcio al TCI
Prótesis disponibles
‘Sapien XT’ device ‘CoreValve’ device
Self expandable
Nitinol frame
Porcine
Pericardial
Tissue
European Heart Journal (2011) 32, 140–147
Montaje de la prótesis valvular
Cardiología Intervencionista Implantación Percutánea de prótesis valvulares
Evolución tecnológica, de la experiencia y de la técnica
2007 2008 2009 2010 2011-
Mas experiencia Anestesia general
ETE intra-proc Acceso/cierre
quirúrgico
18F Acceso y cierre
percutáneo Sedación
Manejo percutáneo complicac vasculares
Prevención complicaciones
vasculares, nuevas tallas
22-24 F Acceso/cierre
quirúrgico Sedación
Experiencia inicial
N = 699 N = 358 High Risk Inoperable
Symptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened
Total = 1,057 patients
2 Parallel Trials: Individually Powered
Standard Therapy
ASSESSMENT:
Transfemoral Access
Not In Study
TF TAVR
Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority)
Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority)
1:1 Randomization
VS
Yes No
N = 179 N = 179
ESTUDIO PARTNER
Study Devices
Edwards SAPIEN THV 23 and 26 mm valves
RetroFlex 22 and 24 F sheaths
Ascendra 24 and 26 F sheaths
Transfemoral Transapical
“On the basis of a rate of death from any cause at 1 year that was 20 percentage points lower with
TAVI than with standard therapy, balloon-expandable TAVIshould be the new standard of carefor
patients with aortic stenosis who are not suitable candidates for surgery“
Leon et al. NEJM 2010 10.1056/NEJMoa1008232
n = 358
Randomized Inoperable
n = 179
TAVR
n = 179
Standard therapy
124/124 patients 100% followed at 1 Yr
85/85 patients 100% followed at 1 Yr
99/102 patients* 97.1% followed at 2 Yr
56/56 patients 100% followed at 2 Yr
Study Flow Inoperable Cohort
32
• 5 withdrawals in the first year in Standard Rx arm
• *3 patients followed outside of protocol window in TAVR group
• No patients were lost to follow-up
All Cause Mortality (ITT) Landmark Analysis
All
Cause M
ort
alit
y (
%)
Months
Mortality 0-1 yr Mortality 1-2yr
Standard Rx TAVR
HR [95% CI] =
0.57 [0.44, 0.75]
p (log rank) < 0.0001
HR [95% CI] =
0.58 [0.37, 0.92]
p (log rank) = 0.0194 50.7%
30.7%
35.1%
18.2%
Numbers at Risk
TAVR 179 138 124 110 83
Standard Rx 179 121 85 62 42
33
Repeat Hospitalization (ITT)
Numbers at Risk
TAVR 179 115 100 89 64
Standard Rx 179 86 49 30 17
Repeat
Hospitaliz
ation (
%)
Standard Rx
TAVR
∆ at 2 yr = 37.5%
NNT = 2.7 pts
72.5%
35.0%
∆ at 1 yr = 26.9%
NNT = 3.7 pts 53.9%
27.0%
35
Months
HR [95% CI] =
0.41 [0.30, 0.58]
p (log rank) < 0.0001
Perc
ent
Treatment Visit Baseline 1 Year 2 Year
p = 0.61 p < 0.0001 p < 0.0001
92.2%
57.5%
16.9% 23.7%
60.8%
93.9%
NYHA Class Over Time Survivors
36
All Stroke (ITT)
Numbers at Risk
TAVR 179 128 116 105 79
Standard Rx 179 118 84 62 42
Incid
ence (
%)
Months
Standard Rx
TAVR
∆ at 2 yr = 8.3%
5.5%
13.8%
∆ at 1 yr = 5.7%
5.5%
11.2%
37
HR [95% CI] =
2.79 [1.25, 6.22]
p (log rank) = 0.009
Mortality or Stroke (ITT)
Numbers at Risk
TAVR 179 128 116 105 79
Standard Rx 179 118 84 62 42
All
Cause M
ort
alit
y o
r S
troke (
%)
Months
Standard Rx
TAVR
∆ at 2 yr = 21.9%
NNT = 4.6 pts
68.0%
46.1%
∆ at 1 yr = 16.1%
NNT = 6.2 pts 51.3%
35.2%
38
HR [95% CI] =
0.64 [0.49, 0.84]
p (log rank) = 0.0009
Mean G
radie
nt
(mm
Hg)
Error bars = ± 1 Std Dev
EOA
Mean Gradient
N = 158
N = 162
N = 137
N = 143
N = 84
N = 89
N = 65
N = 65
N = 9
N = 9
AV
A (c
m²)
Mean Gradient & Valve Area
39
28 26 25 24 16
108 80 76 67 52
43 32 23 19 15
Death
Incid
ence (
%)
Months
STS <5 STS 5-14.9
Months
STS ≥15
p value (log rank) = 0.012 p value (log rank) = 0.676
12 8 7 6 5
119 84 59 42 29
47 29 19 14 8
Mortality Stratified by STS Score (ITT)
TAVR Standard Rx
Numbers at Risk
40
N = 179
N = 358 Inoperable
Standard Therapy
ASSESSMENT:
Transfemoral Access
Not In Study
TF TAVR
Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority)
Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority)
1:1 Randomization
VS
Yes No
N = 179
TF TAVR AVR
Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority)
TA TAVR AVR VS VS
N = 248 N = 104 N = 103 N = 244
PARTNER Study Design
Symptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened
Total = 1,057 patients
2 Parallel Trials: Individually Powered
N = 699 High Risk
ASSESSMENT:
Transfemoral Access
Transapical (TA) Transfemoral (TF)
1:1 Randomization 1:1 Randomization
Yes No
Publications in NEJM
1-Year outcomes published on-line June 5, 2011
@ NEJM.org and in print June 9, 2011
2-Year outcomes published on-line March 26, 2012
@ NEJM.org and print May 3, 2012
Baseline Patient Characteristics Demographics
Characteristic
TAVR
(n=348)
AVR
(n=351)
n n
Age – years (Mean ± SD) 348 83.6 ± 6.8 349 84.5 ± 6.4
Male 201 57.8% 198 56.7%
NYHA Class III or IV 328 94.3% 328 94.0%
Previous CABG 148 42.5 152 43.6
Cerebrovascular disease 96 29.4 87 26.8
Peripheral vascular disease 149 43.2 142 41.6
STS Score (Mean ± SD) 347 11.8 ± 3.3 349 11.7 ± 3.5
Characteristic
TAVR
(n=348)
AVR
(n=351)
n % n %
COPD – Any 152 43.7 151 43.0
COPD – O2 dependent 38 17.3 38 16.6
Creatinine >2mg/dL 37 10.8 22 6.4
Atrial fibrillation 81 40.7 75 43.6
Pacemaker implant 69 19.8 76 21.8
Pulmonary hypertension 126 42.7 111 36.8
Baseline Patient Characteristics Other Co-morbidities
All-Cause Mortality (ITT) Landmark Analysis
All-C
au
se M
ort
ality
Months
Mortality starting at 1 yr
AVR
TAVR
HR [95% CI] =
1.02 [0.74, 1.40]
p (log rank) = 0.922
26.8%
24.3%
10.7%
12.4%
Numbers at Risk
TAVR 348 298 261 239 222 187 149
AVR 351 252 236 223 202 174 142
24.5%
26.3%
Perc
en
t o
f P
ati
en
ts
Baseline 30 Days 2 Years 1 Year
94%
15%
94%
24% 15% 13%
17%
35%
348 186 205 226 250 266 307 349
I
II
III
IV
NYHA Class Survivors (ITT)
p = 0.001 p = NS p = NS p = NS
3 Years
133 151
p = NS
14% 19%
No. at Risk
Echocardiographic Findings (AT) Aortic Valve Area
TAVR
AVR
No. of Echos
p = 0.0017 p = 0.0019 p = NS p = 0.0005 p = NS
p = NS
p = NS
304 271 223 211 150 88
294 226 163 154 121 70
Echocardiographic Findings (AT) Mean & Peak Gradients
TAVR
AVR
No. of Echos 310 277 233 219 155 88
299 230 169 158 123 72
Paravalvular Aortic Regurgitation (AT)
279 228 230 173 217 158 156 122 88 72 No. of Echos
p < 0.0001 p < 0.0001 p < 0.0001 p < 0.0001 p < 0.0001
Impact of Total AR on Mortality (AT) TAVR Patients
131 121 114 102 93 80 63
171 146 125 117 110 94 62
34 24 21 18 15 12 9
None-Tr
Mild
Mod-Sev
No. at Risk
53.7%
25.6%
32.5%
38.2%
12.3%
26.0%
60.8%
35.3%
44.6%
KCCQ-Summary: Substantial Improvement* TF Subgroup
* Improvement ≥ 20 points vs. baseline among patients with available QOL data
P = 0.008
P = NS P = NS
52
KCCQ-Summary: Substantial Improvement* TA Subgroup
* Improvement ≥ 20 points vs. baseline among patients with available QOL data
P = NS at all timepoints
53
IMPLANTES EN EUROPA Top 3 highest/lowest implanting countries, by number of implants
Cumulative TAVR (%) of total implants
TAVR centers per million population, 2011
TAVR implants per center, 2011
Germany
45.9
1.1
81
Italy
14.9
1.4
22
France
12.9
0.5
74
Denmark
1.9
0.5
80
Portugal
0.6
0.3
22
Ireland
0.4
0.7
10
Heartwire, 8 mayo 2013
All Cause Mortality (ITT) Landmark Analysis
All
Cause M
ort
alit
y (
%)
Months
Mortality 0-1 yr Mortality 1-2yr
Standard Rx TAVR
HR [95% CI] =
0.57 [0.44, 0.75]
p (log rank) < 0.0001
HR [95% CI] =
0.58 [0.37, 0.92]
p (log rank) = 0.0194 50.7%
30.7%
35.1%
18.2%
Numbers at Risk
TAVR 179 138 124 110 83
Standard Rx 179 121 85 62 42
74
ES PARECIDOOO
• Respecto al recambio valvular convencional –CEC-
(alto riesgo para cirugía o condiciones especiales)
TAVR 348 298 261 239 222 187 149
AVR 351 252 236 223 202 174 142
All-Cause Mortality (ITT)
No. at Risk
HR [95% CI] =
0.93 [0.74, 1.15]
p (log rank) = 0.483
26.8%
24.3%
34.6%
33.7%
44.8%
44.2%
FUTURO
• Disminuir costes.
• Más experiencia. Bicúspides. Anatomías complejas.
• Mejorar dispositivos. – Durabilidad.
– INSUFICIENCIA AÓRTICA (leaks).
– Facilidad, instrumental.
– Otras válvulas (VM?).
– Valve in valve.
Webb et al. Circulation 2010; 121:1848-1857 Núñez Gil, et al. Eur J Echocardiogr. 2011; 12(4):335-7.
Aórtica Mitral
Pulmonar Tricúspide
Implantación en otras localizaciones
VALVE IN VALVE
Núñez Gil, et al. Eur J Echocardiogr. 2011; 12(4):335-7.
Mitral
Implantación en otras localizaciones
VALVE IN VALVE
Núñez Gil, et al. Eur J Echocardiogr. 2011; 12(4):335-7.
Mitral
Implantación en otras localizaciones
VALVE IN VALVE
Conclusiones
• Técnica ya establecida y en expansión.
• Eficaz (buen resultado hemodinámico a corto y medio plazo)
• Las mejoras técnicas y la experiencia han mejorado la aplicabilidad, la seguridad y los resultados del procedimiento.
• Queda pendiente la constatación de su durabilidad.
• Indicación en pacientes inoperables (PARTNER cohorte B).
• No inferior a la cirugía convencional en pacientes de alto riesgo quirúrgico (Estudio PARTNER cohorte A).
• Nuevas indicaciones potenciales. – Prótesis biológicas degeneradas (Valve in valve).
– Patología diferente de la estenosis aortica degenerativa (IAo)
– Pacientes menor riesgo
– Nuevas posiciones (VM, VP, VT)
• Coste-efectividad.
• Nuevos dispositivos en desarrollo