ControversiaEstenosis aórtica riesgo moderado

Intermediate risk aortic StenosisTAVI

Lino Patricio, MD,PhDH.S.Marta Lisbon

H.S.E.S. ÉvoraPortugal

Coronary TreatmentRecent Cardiology History

1970/

1980

1990/

2000

2000/

2005

2005/2008

2008 20102010/2015

CASS/VACABG

SVGFailure

BMS/ISRLIMA

ARTS-II/CABGPCI/CABG

ARTSERACI-II

SoSMASS-II

PCI/CABG

DESNo ISR No DM

LIMA/ECC

SYNTAX

FAME

TAXUSSYNTAXScore

FFR-PCI

COURAGECarminzid

OMTSAT

FAME-2

DES-2;3 GSyntax

Funtional

Intervention enthusiasm

FREEDOM

OCTIVUS

Surgery Enthusiasm

ITT population

P=0.048

8.8%0

Months Since Allocation

Cum

ula

tive E

vent

Rate

(%

)

TAXUS (N=903)CABG (N=897)

Coronary TreatmentAll-Cause Death to 4 Years

25

50

Before 1 year*

3.5% vs 4.4%P=0.37

1-2 years*

1.5% vs 1.9%P=0.53

2-3 years*

1.9% vs 2.6%P=0.32

3-4 years*

2.2% vs 3.2%P=0.22

11.7%

0 12 4824 36

Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates

Aortic Valve TreatmentRecent Cardiology History

1970/

1980

1990/

2000

2000/

2005

2005/2008

2008 20102010/2015

Intervention enthusiasmSurgery Enthusiasm

Valve Prosthesis

Balloon Valvuloplasty

TAVI

Aortic Repair

0

100

200

300

400

500

600

700

800

900

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

TAVI number of publications

Pubmed

Publications / week

0

5

10

15

20

25

30

TAVI CTO Mitral

AHA/ACC Valvular Heart Disease Guidelines

170Leon M.B., Smith C.R., Mack M., et al; Transcatheter aortic-valveimplantation for aortic stenosis in patients who cannot undergosurgery. N Engl J Med. 2010;363:1597-1607.

171Makkar R.R., Fontana G.P., Jilaihawi H., et al; Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012;366:1696-1704

172Smith C.R., Leon M.B., Mack M.J., et al; Transcatheter versus surgicalaortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187-2198.

173Murphy E.S., Lawson R.M., Starr A., et al; Severe aortic stenosisin patients 60 years of age or older: left ventricular function and 10–yearsurvival after valve replacement. Circulation. 1981;64:II184-II188.

Aortic stenosisHigh Risk patients

CoreValve US Pivotal Trial

12

13

CoreValve US Pivotal Trial

CoreValve US Pivotal Trial

CoreValve US Pivotal Trial

CoreValve US Pivotal Trial

CoreValve US Pivotal Trial

CoreValve US Pivotal Trial

CoreValve US Pivotal Trial

CoreValve US Pivotal Trial

SAVRTAVR

CoreValve US Pivotal TrialProcedural Outcomes

SAVRTAVR

CoreValve US Pivotal TrialAortic Gradient

Aortic Regurgitation

Results

Hemodynamic Assessment of Percutaneous Versus Surgical Bioprostheses for Aortic Stenosis During Exercise: A Pilot Study

P=0,0019 para repouso e p= 0,01 para pico de esforçoP=0,003 para repouso e p= 0,004 para pico de esforço

Prostheses Aortic GradientDuring Exercise

Intermediate risk aortic Stenosis

8,2

9,4

7,6 7,6 7,5

6,9

6

5,3

9,7

8,05

7,15

6,1

5,35,5

5

0

1

2

3

4

5

6

7

8

9

10

2006 2007 2008 2009 2010 2011 2012 2013

Vancouver Quebec

Evolution of STS in Vancouver and Quebec

Mediana STS

417 P

Intra Hospital MortalityQuebec

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2007-08 2009 2010 2011 2012 2013

vivos Muertos

15% 19% 8.5%4% 6% 3%

Coronary TreatmentRecent Cardiology History

ICP begun with simple cases and it was not competitive with surgery - with complex cases never

was better than surgery

1970/

1980

1990/

2000

2000/

2005

2005/2008

2008 20102010/2015

CASS/VACABG

SVGFailure

BMS/ISRLIMA

ARTS-II/CABGPCI/CABG

ARTSERACI-II

SoSMASS-II

PCI/CABG

DESNo ISR No DM

LIMA/ECC

SYNTAX

FAME

TAXUSSYNTAXScore

FFR-PCI

COURAGECarminzid

OMTSAT

FAME-2

DES-2;3 GSyntax

Funtional

Intervention enthusiasm

FREEDOM

OCTIVUS

Surgery Enthusiasm

Aortic Valve TreatmentRecent Cardiology History

1970/

1980

1990/

2000

2000/

2005

2005/2008

2008 20102010/2015

Intervention enthusiasm

Surgery Enthusiasm

Valve Prosthesis

Balloon Valvuloplasty

TAVI

Aortic Repair

TAVI begun with complex cases and it was competitive with surgery - with simple cases will be better than surgery

Por primera vez en la historia de la intervención un tratamiento percutáneo fue mejor que la cirugía

No High Risk Aortic Stenosis PatientsSelection Criteria

Heart Team

• Untreated Severe AS

• Asymptomatic Severe AS

• AS + CAD / previous surgery

• Bioprosthetic Valve Failure

• Patient (> 75 years old) refusal

No High Risk Aortic Stenosis PatientsSelection Criteria

Heart Team

No High Risk Aortic Stenosis PatientsSelection Criteria

Heart Team

Resultados

Eventos Intra-hospitalares na Substituição Valvular Aórtica Percutânea Versus Cirúrgica numa Amostra Emparelhada

No High Risk Aortic Stenosis PatientsSelection Criteria

Heart TeamPropensity score matching

No High Risk Aortic Stenosis PatientsSelection Criteria

Heart Team

• Untreated Severe AS

• Asymptomatic Severe AS

• AS + CAD / previous surgery

• Bioprosthetic Valve Failure

• Patient (> 75 years old) refusal

No High Risk Aortic Stenosis PatientsSelection Criteria

Heart Team

Patients with an AV-Vel 5.5 m/s had an event-freesurvival of 44%, 25%, 11%, and 4% at 1, 2, 3, and 4 years, Patients with an AV-Vel between 5.0 and 5.5 m/s had a even free survival of 76%, 43%, 33%, and 17% (P<0.0001).

Rosenhek, R. et al. Circulation 2010;121:151-156

No High Risk Aortic Stenosis PatientsSelection Criteria

Heart Team

No High Risk Aortic Stenosis PatientsSelection Criteria

Heart Team

• Untreated Severe AS

• Asymptomatic Severe AS

• AS + CAD / previous surgery

• Bioprosthetic Valve Failure

• Patient (> 75 years old) refusal

No High Risk Aortic Stenosis PatientsSelection Criteria

Heart Team

No High Risk Aortic Stenosis PatientsSelection Criteria

Heart Team

No High Risk Aortic Stenosis PatientsSelection Criteria

Heart Team

• Untreated Severe AS

• Asymptomatic Severe AS

• AS + CAD / previous surgery

• Bioprosthetic Valve Failure

• Patient (> 75 years old) refusal

No High Risk Aortic Stenosis PatientsSelection Criteria

Heart Team

TAVI

Patient Selection

Heart Team

/ previous surgery/ previous surgery

• Untreated Severe AS

• Asymptomatic Severe AS

• AS + CAD / previous surgery

• Bioprosthetic Valve Failure

• Patient (> 75 years old) refusal

No High Risk Aortic Stenosis PatientsSelection Criteria

Heart Team

No High Risk Aortic Stenosis PatientsSelection Criteria

Heart Team

Por primera vez en la historia de la medicina un tratamiento percutáneo fue mejor que la cirugía

Inoperable patient selection criteria Strict Perspectiveis an historical, unadjusted option

The Strict Board criteria excluded the patients morefavorable to TAVI and don’t have ethical strength toexclude patients with heavy comorbidities not suitablefor any type of intervention (TAVI or AVR)

TAVI

Patient Selection

Heart Team

Time trends in transaortic mean gradient

Gurvitch, R. et al. Circulation 2010;122:1319-1327

Time trends in aortic valve area (mean{+/-}SD)‏

TAVI

Patient Selection

Heart Team