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#postACC14
ENFERMEDAD VALVULAR
Tomás Ripoll Vera
Hospital Son Llatzer
Palma de Mallorca
#postACC14
A Randomized Comparison of Self-expanding
Transcatheter and Surgical Aortic Valve
Replacement in Patients with Severe Aortic
Stenosis Deemed High-Risk for Surgery
CoreValve US Pivotal TrialCoreValve US Pivotal Trial
#postACC14
CoreValve US Pivotal TrialCoreValve US Pivotal Trial
#postACC14
Characteristic
TAVR
N=390
SAVR
N=357
Age, years 83.1 ± 7.1 83.2 ± 6.4
Men, % 53.1 52.4
STS Predicted Risk of Mortality, % 7.3 ± 3.0 7.5 ± 3.4
Logistic EuroSCORE, %
17.7 ± 13.1 18.6 ± 13.0
NYHA Class III/IV, % 85.6 86.8
Diabetes Mellitus, % 34.9* 45.4*
Insulin Requiring Diabetes, % 11.0 13.2
Prior Stroke, % 12.6 14.0
Modified Rankin 0 or 1, % 74.5 87.2
Modified Rankin > 1, % 25.5 12.8
STS Severe Chronic Lung Disease, % 13.3 9.0
Baseline DemographicsBaseline Demographics
*P < 0.01 4
ACC 2014
19.1%
4.5%
Surgical
14.2%
P = 0.04 for superiority
3.3%
Transcatheter
Primary Endpoint: 1 Year All-cause MortalityPrimary Endpoint: 1 Year All-cause Mortality ACC 2014
5
ACC 20142-Year All-cause Mortality2-Year All-cause Mortality ACC 2014
ACC 2014All StrokeAll Stroke
#postACC14
• We assessed the safety and effectiveness of TAVR with the
CoreValve prosthesis compared to surgical valve replacement in
symptomatic patients with severe aortic stenosis at increased
surgical risk
• The rate of death from any cause at 1 year was significantly
reduced with TAVR performed with the CoreValve prosthesis
ConclusionConclusion
8
CoreValve US Pivotal TrialCoreValve US Pivotal Trial
#postACC14
• Población de menor riesgo que en criterios de inclusión.
• Podría explicar las diferencias con Partner: no diferencias
en mortalidad, > ictus…
• Mayor necesidad de marcapasos.
• Menos FA -> menos ictus.
ComentariosComentarios
9
CoreValve US Pivotal TrialCoreValve US Pivotal Trial
#postACC14
#postACC14
CHOICE
#postACC14
CHOICE
#postACC14
CHOICE
#postACC14
CHOICE
#postACC14
CHOICE
#postACC14
CHOICE
Comentarios
• Estudio no promovido por la industria
• No muchos pacientes
• End point primario: éxito procedimiento a 30 d
• No diferencias en mort / ictus/ sangrados /
complic.vasc.
• Grupo Corevalve: > mcp, > IAo, > rehospit, <
mejora NHYA y calidad de vida.
#postACC14
#postACC14
TAVI registry USA
#postACC14
TAVI registry USA
#postACC14
One Year Follow-up of the
MelodyTM Transcatheter Pulmonary
Valve Multicenter
Post-Approval Study
Aimee K. Armstrong, MD1, David Balzer, MD2, Allison Cabalka3, MD, Robert
Gray, MD4, Alexander Javois, MD5, Jacqueline Kreutzer, MD6, John Moore,
MD7, Jonathan Rome, MD8, Daniel Turner, MD9, Thomas Zellers, MD10
1University of Michigan, 2St. Louis Children’s Hospital, 3Mayo Clinic Rochester, 4University of
Utah, 5Hope C
h
i ldr en’ s Hospital, 6University of Pittsburgh Medical Center, 7Rady Children’s
Hospital, 8Children’s Hospital of Philadelphia, 9Children’s Hospital of Michigan, 10Children’s
Medical Center Dallas
#postACC14
MELODY
MELODYTM TPV
RV-PA Conduits
#postACC14
MELODY
#postACC14
MELODY
MELODYTM TPV
Post-Approval Study
Primary Endpoint
#postACC14
MELODY
MELODYTM TPV
Post-Approval Study
One Year Acceptable
Hemodynamic Function
#postACC14
MELODY
MELODYTM TPV
Post-Approval Study
99 99 98 89
99 99 98 89
99 98 96 88
Freedom from TPV Dysfunction,
Reoperation, and Reintervention
Number At Risk
IDE Trial: 93.5± 2.4% at 1 year
#postACC14
INTERVENCIONISMO
CORONARIO
Tomás Ripoll Vera
Hospital Son Llatzer
Palma de Mallorca
#postACC14
NEXT
#postACC14
Comentarios
• Por tanto, no diferencias a los 2 años en
eficacia ni seguridad, entre ambos polímeros.
• 2 años de seguimiento quizás no suficiente
para evaluar diferencias entre polímeros.
• Incluyó mayoritariamente pacientes con
enfermedad coronaria estable (>80%).
• Si son iguales, Biolimus más barato….
#postACC14
ZEUS
#postACC14
ZEUS
#postACC14
ZEUS
#postACC14
ZEUS
#postACC14
ZEUS
#postACC14
ZEUS
#postACC14
ZEUS
#postACC14
ZEUS
#postACC14
HEAT-PPCI
#postACC14
HEAT-PPCI
COMENTARIOS:
•Heparina mejor que Bivalirudina en ICP
primaria:
– menor MACE a 28 d (NNT 33)
– menor sangrado (no significativo)
– menos trombosis aguda (3.4 vs 0.9).
•Diseño del estudio cuestionado (C.I. post)

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