José María Hernández

Transcripción

1 José María Hernández

2 1.Introduction 2.PARTNER Trials 3.COREVALVE Trials 4.Current Guidelines 5.Intermediate Risk 6.Low Risk 7.Conclusions

3 < Rigorous Clinical Research PubMed annual number TAVI references Since 2010 the NEJM has featured nine reports on pivotal registries or randomized TAVR trials PARTNER 1B New Engl J Med 107 Corevalve High Risk New Engl J Med PARTNER 1A New Engl J Med st SURTAVI Patient 807 Corevalve Extreme Risk J Am Coll Cardiol PARTNER 1011 Intermediate Risk N Engl J Med Corevalve Intermediste Risk N Engl J Med > patients included in FDA TAVI studies

4 Second Generation TAVI Systems Lotus Direct Flow Engager Symetis Jena Sapien III Portico Evolut Centera HLT Colibri AorTx Trinity UCL Vanguard II

5 Current Generation Devices PORTICO SAPIEN 3 J - VALVE LOTUS ACCURATE EVOLUT JENAVALV E DIRECT- FLOW

6 1.Introduction 2.PARTNER Trials 3.COREVALVE Trials 4.Current Guidelines 5.Intermediate Risk 6.Low Risk 7.Conclusions

7 PARTNER-B 2-year outcomes At 1 years = 20% NNT= 5 pts At 2 years = 24,3% NNT= 4,1 pts N Engl J Med 2010;363: N Engl J Med 2012;366:

8 CLINICAL OUTCOMES POST-BAV Cumulative clinical outcome during follow-up Mortality according to receiving BAV compared to those undergoing TAVI Favorable outcomes at least for the first 6 month PARTNER Cohorte B

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10 PARTNER-A 2-year outcomes N Engl J Med 2011;364: N Engl J Med 2012;366:

11 TAVI SAVR Daubert M. J Am Coll Cardiol Img 2016

12 1.Introduction 2.PARTNER Trials 3.COREVALVE Trials 4.Current Guidelines 5.Intermediate Risk 6.Low Risk 7.Conclusions

13 Corevalve High Risk Patients N Engl J Med 2014;370:

14 Corevalve High risk patients 2-year Follow-up Death from any cause All Stroke MACE Ao valve area N Engl J Med 2014;370:

15 1.Introduction 2.PARTNER Trials 3.COREVALVE Trials 4.Current Guidelines 5.Intermediate Risk 6.Low Risk 7.Conclusions

16 Recommendations for the use of transcatheter aortic valve implantation

17 1.Introduction 2.PARTNER Trials 3.COREVALVE Trials 4.Current Guidelines 5.Intermediate Risk 6.Low Risk 7.Conclusions

18 2016 The year the treatment of aortic stenosis was transformed

19 April 2016 Total cohort Transfemoral P=0.05 Leon MB. N Engl J Med 2016; 347:

20 Subgroup Analyses of Death from Any Cause or Disabling Stroke

21 March 2016 Large, multicentre non-randomized patients registry undergoing treatment with the next-generation SAPIEN 3 transcatheter heart valve (THV). 583 High surgical risk or inoperable patients Intermediate risk patients. Mean STS score: 5,3 % Kodali S. Eur Heart J 2016 doi: /eurheartj/ehw112

22 March 2016 % % 10 P : ,7 1,1 0,9 1 Kansas City Cardiomyopathy Questionnaire Kodali S. Eur Heart J 2016 doi: /eurheartj/ehw112

23 All-Cause Mortality at 30 Days Edwards SAPIEN Valves (As Treated Patients) PARTNER I and II Trials Overall and TF Patients SAPIEN SXT SAPIEN 3

24 TAVI. PACIENTES RIESGO INTERMEDIO PACIENTES DE RIESGO INTERMEDIO COMPARADO CON CIRUGIA AORTICA PARTNER 2 PROPENSITY SCORE PREESTABLECIDO ESTUDIO PARA NO INFERIORIDAD Y SUPERIORIDAD

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26 April days 1 year 46,7 TAVI TAVI 29,2 7,4 13 8,1 8,2 4,5 4,6 5,9 2,3 5,9 12,4 9,4 4,6 6,1 5,4 0,5 3,3 Bleeding Vasc ComplicationsKidney Injury 88% ACCESO TRANSFEMORAL Thourany V. LANCET

27 August 2016 Reardom M. JAMA Cardiol June. doi: /jamacardio

28 Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease March 2017

29 TAVI is recommended for inoperable symptomatic patients with severe aortic stenosis

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31 March 2017 N Engl J Med March. DOI: /NEJMoa

32 March 2017 Death from Any Cause or Disabling Stroke Death from Any Cause Disabling Stroke Observed-to-expected 30- day surgical mortality 94% ratio ACCESO ( TRANSFEMORAL 0.38). N Engl J Med March. DOI: /NEJMoa

33 March 2017 Echocardiographic Findings Procedure related complications at 30 Days (%) TAVI 43 25,9 12,9 6,6 6 1,1 1,7 4,4 New PM Vascular Comp. A Fibrilation AKI N Engl J Med March. DOI: /NEJMoa

34 1.Introduction 2.PARTNER Trials 3.COREVALVE Trials 4.Current Guidelines 5.Intermediate Risk 6.Low Risk 7.Conclusions

35 NOTION PARTNER 3 US EVOLUT R LR UK TAVI EuroIntervention 2016;12:Y51-Y55

36 1.Introduction 2.PARTNER Trials 3.COREVALVE Trials 4.Current Guidelines 5.Intermediate Risk 6.Low Risk 7.Conclusions

37 CONCLUSIONES 1.TAVI es el tratamiento de elección de los pacientes con estenosis aórtica grave sintomática no candidatos a cirugía. 2.TAVI es,al menos, igual a la cirugía en los pacientes de elevado riesgo quirúrgico. 3.TAVI es alternativa a la cirugía en los pacientes de riesgo intermedio. 4.La durabilidad de la prótesis percutánea, junto a los ensayos en curso, será el determinante para el TAVI en pacientes de bajo riesgo y sobre todo mas jóvenes.

38 SITUACION CLINICA DEL PACIENTE Y COMORBILIDADES EVIDENCIA CIENTIFICA COSTES: POSIBILIDADES DE CADA SISTEMA SANITARIO PREFERENCIAS DE LOS PACIENTES (DEBIDAMENTE INFORMADOS) CONOCIMIENTO DE LOS RESULTADOS PROPIOS EN CIRUGIA Y TAVI

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