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©2017 MFMER | 3645199-1 Rick A. Nishimura, M.D. MACC MACP 2 nd Annual New York Valve Conference Valvular Heart Disease State of the Art 2020

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Page 1: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-1

Rick A. Nishimura, M.D. MACC MACP2nd Annual New York Valve Conference

Valvular Heart DiseaseState of the Art 2020

Page 2: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-2

Rick A. Nishimura, M.D. MACC MACP2nd Annual New York Valve Conference

Valvular Heart DiseaseState of the Art 2020

Page 3: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-3

Rick A. Nishimura, M.D.

No disclosures

Page 4: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-4

Valvular Heart Disease – State of the Art 2020

What we did

What we are doing

What we need to do

From the perspective of a plain old

clinical cardiologist

Page 5: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-5

©2012

MFMER |

3200979-

2003-5

AorticStenosis

Page 6: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-6

©2012

MFMER |

3200979-

2003-6

Intervention

Benefit >> Risk

Page 7: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-7

Valvular Heart Disease – State of the Art 2020

What we did

What we are doing

What we need to do

Page 8: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-8

S1 S2

S4

3/6

LV

Ao

Severe aortic stenosis

✓ Gradient > 50 mmHg

✓ Gradient > 40 mmHg

✓ AVA < 1.0 cm2

✓ AVA < .7 cm2

✓ AVA < .5 cm2/m2

Page 9: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-9

0

20

40

60

80

100

0 10 20 30 40 50 60 70 80

Natural History of Aortic Stenosis

0 2 4 6

Avg survival (yr)

Angina

Syncope

Failure

Age (yr)

Latent period(increasing obstruction,myocardial overload)

Onset severe symptoms

Average death

age ( )

Ross J Jr. and Braunwald E: Circ 38(Suppl 5):61, 1968

Page 10: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-10

High operative risk

8-10%

Adverse outcome of AVR

50% emboli or bleed – 10 years

50% tissue degeneration

Only indication for AVR

Symptoms

Severe stenosis

Page 11: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-11

Valvular Heart Disease – State of the Art 2020

What we did

What we are doing

What we need to do

Page 12: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-12

Long Term Followup of

Asymptomatic Severe Aortic

StenosisPellikka et al

Circulation 2005:3290

622 patients

Followup 5.3-10.6 years

Asymptomatic

Peak Vel > 4 m/s

Page 13: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-13

Years

Su

rviv

al

free o

f sym

pto

ms (

%)

0 1 2 3 4 5 6 7 8 9 10

100

60

20

0

80

40

Circulation 2005

Pellikka et al

Asymptomatic Severe Aortic Stenosis

At 5 yrs

72% CHF or died

Page 14: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-14

Low operative risk

< 1%

Better AVR

Emboli, bleed < 1% yr

Longevity tissue valves

With lower risk AVR and better outcomes

Further risk stratification

Page 15: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-15

ACC/AHA Valve Disease Guidelines

Stage A - D

At risk for disease

Progressive disease

Severe disease

(asymptomatic)

Severe disease

(symptomatic)

Stage A

Stage B

Stage C

Stage D

Define “severe”

based on

outcome studies

Grad > 40 mmHg

AVA < 1.0 cm2

Page 16: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-16

ACC/AHA Valve Disease Guidelines

Stage A - D

At risk for disease

Progressive disease

Severe disease

(asymptomatic)

Severe disease

(symptomatic)

C1: Compensated LV

C2: Decompensated LV

Page 17: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-17

ACC/AHA Valve Disease Guidelines

Stage A - D

Definition of “decompensated LV”

➢ Long standing pressure overload on the LV

➢ Ventricular state when

➢ Outcome is reduced

➢ LV function postop is reduced

Page 18: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-18

ACC/AHA Valve Disease Guidelines

Aortic Stenosis

Stage C: Severe

disease

(asymptomatic)

Stage D: Severe

disease

(symptomatic)

C1:EF > 50%

C2:EF < 50%

D1: high gradient

D2: low gradient (low EF)

D3: low gradient (normal EF)

AV Velocity > 4m/s

Page 19: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-19

ACC/AHA Valve Disease Guidelines

Stage A - D

At risk for disease

Progressive disease

Severe disease

(asymptomatic)

Severe disease

(symptomatic)

Observe

Intervene

C1

C2Intervene

?

Page 20: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-20

©2012

MFMER |

3200979-

2003-20

Results of Exercise TestingEvent-Free Survival

Amato et al: Heart 86:381, 2001

Months

P=0.0001

Positive (44 patients)

Negative (22 patients)

0.0

0.2

0.4

0.6

0.8

1.0

0 12 24 36 48 60

Negative

Positive

Further risk stratification by exercise testing

Page 21: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-21

Rosenhek et al: Circ 121:151, 2010

Event-

free s

urv

ival (%

)

0

20

40

60

80

100

0 1 2 3YearsPatients at risk

82 69 59 3872 53 29 1844 20 11 5

AV-Vel

4.0-5.0 m/sec

AV-Vel

5.0-5.5 m/sec

AV-Vel

≥5.5 m/sec

P<0.0001

Further risk stratification by stenosis severity

Stenosis Severity – Doppler VelocityEvent-Free Survival

Page 22: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-22

Aortic Stenosis : ACC AHA Guidelines

• Indications for SAVR – all patients

• Symptoms (any)

• Drop in EF

• Indications for SAVR – asymptomatic low risk patients

• Positive TMET

• Very severe AS

Page 23: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-23

Then came transformation

Page 24: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-24

©2012

MFMER |

3200979-

2003-24

A dramatic relief of obstruction within seconds

Page 25: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-25

©2012

MFMER |

3200979-

2003-25

TAVR(Transcatheter Aortic Valve Replacment)

• TAVR - inoperable pts

• Lower mortality vs medical Rx

• TAVR - high risk patients

• Comparable to SAVR

• TAVR – intermediate risk patients

• Comparable to SAVR

• TAVR – low risk patients

• Comparable (maybe even better)

Page 26: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-26

Evaluation of patients with aortic stenosisChanging paradigm

Low Intermediate High InoperableRisk

SAVR TAVR

SAVR

vs

TAVR

Nothing

(futile)Rx

2014 Guidelines

Page 27: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-27

Evaluation of patients with aortic stenosisChanging paradigm

Low Intermediate High InoperableRisk

SAVR TAVRSAVR vs TAVRNothing

(futile)Rx

2017 Guidelines

Page 28: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-28

Evaluation of patients with aortic stenosisChanging paradigm

Low Intermediate High InoperableRisk

TAVRSAVR vs TAVRNothing

(futile)Rx

Page 29: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-29

Evaluation of patients with aortic stenosisChanging paradigm

Low Intermediate High InoperableRisk

TAVRSAVR vs TAVRNothing

(futile)Rx

Dependent upon anatomy

Longevity (patient and valve)

Page 30: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-30

Valvular Heart Disease – State of the Art 2020

What we did

What we are doing

What we need to do

Page 31: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-31

Valvular Heart Disease – State of the Art 2020

We now have better and better interventions

But if we only intervene according to guidelines

CV death still occurs following AVR

Persistent heart failure symptoms occur

Page 32: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-32

Pressure overload

Compensatory hypertrophy

(normalize wall stress)

MVO2

Mismatch

Myocardial

Ischemia

Fibrosis

Scarring

Page 33: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-33

Bing et al JACC

Imaging 2019:12:283

Papanastasiou et al

JACC Imaging 2019

2x increase mortality

with GDE defects

By the time we operate now, the LV

is already damaged

Page 34: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-34

What we are finding out – “conventional” criteria too late

• Even “moderate” AS portends poorer outlook

• Outdated “cut-off” – peak velocity > 4.0 m/s

Page 35: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-35

“Moderate” aortic stenosis

Outcome similar to

“Severe” aortic stenosis

Page 36: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-36

What we are finding out – “conventional” criteria too late

• Even “moderate” AS portends poorer outlook

• EF < 60% may be “decompensated”

Page 37: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-37

EF < 60%, not 50%

Poorer prognosis

Ito et al JACC 2019;71;11

Page 38: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-38

What we are finding out – “conventional” criteria too late

• Even “moderate” AS portends poorer outlook

• EF < 60% may be “decompensated”

• Other measures of LV performance – prognostic value over EF

• Stroke volume index, diastolic parameters

• Myocardial strain and DTI

• Other clinical parameters important

• Body mass, nutrition, gait speed

Page 39: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-40

EF

Symptoms

Gradient

Valve area

Current criteria

Timing of AVR

Page 40: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-41

EF

Symptoms

Gradient

Valve area

Diastolic SVI

Strain Biomarkers

Torsion

GDE

Page 41: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-42

Machine learning processes to

provide precise phenotypic risk

assessment for an individual

patient

EF

Symptoms

Gradient

Valve area

Diastolic SVI

Strain Biomarkers

Torsion

GDE

??????

Page 42: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-43JACC CVI:2019:12:236-48

Page 43: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-44

A general perspective on aortic stenosis

Better and better interventions

Need lower and lower thresholds

Identify higher risk patients

Prevent adverse consequences of pressure overload

Machine learning - precise individualized risk assessment

Page 44: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-45

A general perspective on primary MR

We are operating too late

After the onset of irreversible LV dysfunction

Need lower risk interventions

Need effective durable interventions

Intervene earlier and earlier

Page 45: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-46

A general perspective on secondary MR

We always thought this was a disease of the LV

We are just finding out that correcting the MR

percutaneously itself may be beneficial

We need to determine who will benefit

Page 46: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-47

RV

RA

A general perspective on tricuspid regurgitation

A growing problem

Device leads

Atrial fibrillation

We have been reluctant to intervene

We need alternative approaches

Page 47: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-48

What we did

What we are doing

What we need to do

From the perspective of a plain old

clinical cardiologist

Page 48: Valvular Heart Disease State of the Art 2020 · Valvular Heart Disease –State of the Art 2020 We now have better and better interventions But if we only intervene according to guidelines

©2017 MFMER | 3645199-49