Sandbox: TAVI - AUC

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Template:TAVI - AUC Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1],Associate Editor(s)-in-Chief: Arzu Kalayci, M.D. [2]

ACC/AATS/AHA/ASE/EACTS/ HVS/SCA/SCAI/SCCT/SCMR/STS 2017 Appropriate Use Criteria for the Treatment of Patients With Severe Aortic Stenosis

Asymptomatic, High-Gradient, Severe AS

Appropriate Use Median Score (1–9)

Indication No Intervention AVR (TAVR or SAVR)
- LVEF ≤50%

- Vmax 4.0–4.9 m/sec - Negative exercise stress test

- No predictors of symptom onset or of rapid progression (e.g., DVmax >0.3 m/s/y, severe valve calcification, elevated BNP, or excessive LV hypertrophy in the absence of hypertension) - High or intermediate surgical risk

A (7) M (5)
- LVEF ≤50%

- Vmax 4.0–4.9 m/sec - Negative exercise stress test

- No predictors of symptom onset or of rapid progression (e.g., DVmax >0.3 m/s/y, severe valve calcification, elevated BNP, or excessive LV hypertrophy in the absence of hypertension) - Low surgical risk

A (7) M (5)
- LVEF ≥50%

- Vmax 4.0–4.9 m/sec - High-risk profession (e.g., airline pilot) or lifestyle (e.g., competitive athlete) or anticipated prolonged time away from close medical supervision

- Low surgical risk

M (4) A (7)
- LVEF ≥50%

- Vmax 4.0–4.9 m/sec - High-risk profession (e.g., airline pilot) or lifestyle (e.g., competitive athlete) or anticipated prolonged time away from close medical supervision

- Low surgical risk

M (4) A (7)
- LVEF ≥50%

- Vmax 4.0–4.9 m/sec - Negative exercise stress test

- ≥1 predictor(s) of symptom onset or of rapid progression (e.g., DVmax >0.3 m/s/y, severe valve calcification, elevated BNP, or excessive LV hypertrophy in the absence of hypertension) - High or intermediate surgical risk

M (4) A (7)
- LVEF ≥50%

- Vmax 4.0–4.9 m/sec - Negative exercise stress test

- ≥1 predictor(s) of symptom onset or of rapid progression (e.g., DVmax >0.3 m/s/y, severe valve calcification, elevated BNP, or excessive LV hypertrophy in the absence of hypertension) - Low surgical risk

M (4) A (8)
- LVEF ≥50% - Vmax 4.0–4.9 m/sec

- Abnormal exercise stress test - High or intermediate surgical risk

R (3) A (8)
- LVEF ≥50%

- Vmax 4.0–4.9 m/sec - Abnormal exercise stress test

- Low surgical risk

R (2) A (8)
- LVEF ≥50%

- Very severe AS (Vmax ≥5 m/sec or mean gradient ≥60 mmHg) - High or intermediate surgical risk

M (4) A (7)
- LVEF ≥50%

- Very severe AS (Vmax ≥5 m/sec or mean gradient ≥60 mmHg) - Low surgical risk

R (2) A (8)
- LVEF <50%

- Very severe AS (Vmax ≥4 m/sec or mean gradient ≥40 mmHg) - High or intermediate surgical risk

R (2) A (8)
- LVEF <50%

- Very severe AS (Vmax ≥4 m/sec or mean gradient ≥40 mmHg) - Low surgical risk

R (1) A (9)
- Undergoing another cardiac surgery or ascending aortic surgery R (1) A (9)
A = Appropriate; AS = aortic stenosis; AVR = aortic valve replacement; BNP = b-type natriuretic peptide; LV = left ventricular/left ventricle; LVEF = left ventricular ejection fraction; M = May Be Appropriate; R = Rarely Appropriate; SAVR = surgical aortic valve replacement; TAVR = transcatheter aortic valve replacement; Vmax = peak aortic valve velocity.

Flow, Gradient and Ejection Fraction

Appropriate Use Median Score (1–9)

Indication No Intervention BAV (as Bridge to Decision) AVR (TAVR or SAVR)
Reduced Ejection Fraction (<50%)
- AVA ≤1.0 cm2 (or indexed AVA ≤0.6 cm2/m2) on resting echo

- LVEF 20% to 49% - Low flow

- Low gradient - Flow reserve on low-dose dobutamine echo

- Truly severe AS - High or intermediate surgical risk

bgcolor="LightCoral" | R (1) R (3) A (8)
- AVA ≤1.0 cm2 (or indexed AVA ≤0.6 cm2/m2) on resting echo

- LVEF 20% to 49% - Low flow

- Low gradient - Flow reserve on low-dose dobutamine echo

- Truly severe AS - Low surgical risk

bgcolor="LightCoral" | R (1) R (2) A (9)
- AVA ≤1.0 cm2 (or indexed AVA ≤0.6 cm2/m2) on resting echo

- LVEF 20% to 49% - Low flow

- Low gradient - Flow reserve on low-dose dobutamine echo

- Pseudosevere AS

bgcolor="LightGreen" | A (8) R (2) R (2)
- AVA ≤1.0 cm2 (or indexed AVA ≤0.6 cm2/m2) on resting echo

- LVEF 20% to 49% - Low flow

- Low gradient - No flow reserve on low-dose dobutamine echo

- Very calcified aortic valve on echo and/or CT, suggesting truly severe AS, or calculation of a projected valve area that remains severely reduced - High or intermediate surgical risk

bgcolor="LemonChiffon" | M (4) M (5) A (7)
- AVA ≤1.0 cm2 (or indexed AVA ≤0.6 cm2/m2) on resting echo

- LVEF 20% to 49% - Low flow

- Low gradient - No flow reserve on low-dose dobutamine echo

- Minimal calcification on aortic valve on echo and/or CT - High or intermediate surgical risk

bgcolor="LightGreen" | A (7) R (3) R (2)
- AVA ≤1.0 cm2 (or indexed AVA ≤0.6 cm2/m2)

- LVEF <20% - Vmax ≥4 m/sec or mean gradient ≥40 mmHg on resting echo

- High or intermediate surgical risk

bgcolor="LightCoral" | R (3) M (4) A (7)
- AVA ≤1.0 cm2 (or indexed AVA ≤0.6 cm2/m2)

- LVEF <20% - Mean gradient <20 mmHg on resting echo

- No flow reserve on low-dose dobutamine echo - High or intermediate surgical risk

bgcolor="LightGreen" | A (7) M (4) R (3)
- AVA ≤1.0 cm2 (or indexed AVA ≤0.6 cm2/m2) on resting echo

- LVEF <20% - Low flow

- Low gradient - Flow reserve on low-dose dobutamine echo

- Truly severe AS - High or intermediate surgical risk

bgcolor="LightCoral" | R (3) M (5) A (7)
- AVA ≤1.0 cm2 (or indexed AVA ≤0.6 cm2/m2) on resting echo

- LVEF <20% - Low flow

- Low gradient - Flow reserve on low-dose dobutamine echo

- Pseudosevere severe AS - High or intermediate surgical risk

bgcolor="LightGreen" | A (7) R (2) R (2)
Preserved Ejection Fraction (≥50%)
- AVA ≤1.0 cm2 (or indexed AVA ≤0.6 cm2/m2)

- Vmax ≥4 m/sec or mean gradient ≥40 mmHg on resting echo - Symptomatic

- High or intermediate surgical risk

R (1) R (2) A (9)
- AVA ≤1.0 cm2 (or indexed AVA ≤0.6 cm2/m2)

- Vmax ≥4 m/sec or mean gradient ≥40 mmHg on resting echo - Symptomatic

- Low surgical risk

R (1) R (1) A (9)
- AVA ≤1.0 cm2 (or indexed AVA ≤0.6 cm2/m2)

- Low flow - Low gradient - Symptomatic

- Evidence of a severely calcified valve - Clinical, hemodynamic, and anatomic data support valve obstruction as the most likely cause of symptoms

- High or intermediate surgical risk

R (2) R (3) A (8)
- AVA ≤1.0 cm2 (or indexed AVA ≤0.6 cm2/m2)

- Low flow - Low gradient

- Symptomatic - Evidence of a severely calcified valve

- Clinical, hemodynamic, and anatomic data support valve obstruction as the most likely cause of symptoms - Low surgical risk

R (1) R (1) A (9)
- AVA ≤1.0 cm2 (or indexed AVA ≤0.6 cm2/m2)

- Low flow - Low gradient

- Evidence of a severely calcified valve - Asymptomatic

- High or intermediate surgical risk

M (6) R (3) M (4)
- AVA ≤1.0 cm2 (and indexed AVA ≤0.6 cm2/m2)

- Low gradient - Low flow

- Evidence of a severely calcified valve - Asymptomatic

- Low surgical risk

M (6) R (2) M (4)
- AVA ≤1.0 cm2 (and indexed AVA ≤0.6 cm2/m2)

- Normal flow - Low gradient

- Confirmation of internal consistency of the AVA, flow, and gradient measurements - Evidence of a severely calcified valve

- Symptoms believed to be due to AS - High or intermediate surgical risk

R (3) M (4) A (7)
- AVA ≤1.0 cm2 (and indexed AVA ≤0.6 cm2/m2)

- Normal flow - Low gradient

- Confirmation of internal consistency of the AVA, flow, and gradient measurements - Evidence of a severely calcified valve

- Symptoms believed to be due to AS - Low surgical risk

R (3) R (3) A (7)
A = Appropriate; AS = aortic stenosis; AVA = aortic valve area; AVR = aortic valve replacement; BAV = balloon aortic valvuloplasty; CT = computed tomography; LVEF = left ventricular ejection fraction; M = May Be Appropriate; R = Rarely Appropriate; SAVR = surgical aortic valve replacement; TAVR = transcatheter aortic valve replacement; Vmax = peak aortic valve velocity.

Severe AS: High- or Extreme-Risk Patients

Appropriate Use Median Score (1–9)

Indication No Intervention BAV (as Bridge to Decision) TAVR SAVR
Due to Multiple Comorbidities
- Severe symptomatic AS

- STS-PROM 8%–15%

- Health status seems to be influenced more by comorbidities than by AS

- Anticipated life expectancy >1 y

M (4) M (5) A (7) M (4)
- Severe symptomatic AS

- STS-PROM 8%–15%

- Health status seems to be influenced more by AS than by comorbidities

- Anticipated life expectancy >1 y

R (2) M (4) A (8) M (5)
- Severe symptomatic AS

- STS-PROM 8%–15%

- Health status seems to be influenced more by comorbidities than by AS

- Anticipated life expectancy <1 y

A (8) M (5) R (3) R (1)
- Severe symptomatic AS

- STS-PROM 8%–15%

- Health status seems to be influenced more by AS than by comorbidities

- Anticipated life expectancy <1 y

M (6) M (5) M (4) R (2)
- Severe symptomatic AS

- STS-PROM >15%

- Health status seems to be influenced more by comorbidities than by AS

- Anticipated life expectancy >1 y

M (6) M (5) M (6) R (2)
- Severe symptomatic AS

- STS-PROM >15%

- Health status seems to be influenced more by AS than by comorbidities

- Anticipated life expectancy >1 y

M (4) M (5) A (7) R (3)
- Severe symptomatic AS

- STS-PROM >15%

- Health status seems to be influenced more by comorbidities than by AS

- Anticipated life expectancy <1 y

A (8) M (4) R (3) R (1)
- Severe symptomatic AS

- STS-PROM >15%

- Health status seems to be influenced more by AS than by comorbidities

- Anticipated life expectancy <1 y

A (7) M (5) R (3) R (1)
With Frailty or Disability
- Severe AS (Vmax 4–4.9 m/s)

- STS-PROM 8%–15% - Frail

- No chest pain or syncope - Fatigue but no shortness of breath

- Normal BNP

M (5) M (4) M (5) R (3)
- Severe AS (Vmax 4–4.9 m/s)

- STS-PROM 8%–15% - Frail

- No chest pain or syncope - Fatigue but no shortness of breath

- BNP elevated

M (4) M (4) A (7) M (4)
- Severe AS (Vmax ≥5 m/s)

- STS-PROM 8%–15% - Frail

- No chest pain or syncope - Fatigue but no shortness of breath

- Normal BNP

M (4) M (5) A (7) M (4)
- Severe AS (Vmax ≥5 m/s)

- STS-PROM 8%–15% - Frail

- No chest pain or syncope - Fatigue but no shortness of breath

- BNP elevated

R (3) M (5) A (8) M (4)
- Severe AS (Vmax ≥4 m/s)

- STS-PROM 8%-15% - Dependent in >3 activities of daily living (bathing, dressing, eating, ambulating, toileting, transferring)

- Shortness of breath

M (5) M (5) M (5) R (2)
- Severe AS (Vmax ≥4 m/s)

- STS-PROM 8%-15% - Dependent in >3 activities of daily living (bathing, dressing, eating, ambulating, toileting, transferring)

- Fatigue but no shortness of breath

M (5) M (5) M (5) R (2)
Due to Anatomy
- Severe symptomatic AS

- Porcelain aorta or hostile chest - Otherwise high or intermediate surgical risk due to comorbidities

R (2) M (4) A (8) R (3)
- Severe symptomatic AS

- Porcelain aorta or hostile chest - Otherwise low surgical risk due to comorbidities

R (1) R (3) A (8) M (4)
Due to Specific Comorbidities
- Severe AS - STS-PROM 8%–15%

- Oxygen-dependent lung disease - Shortness of breath - BNP normal

M (5) M (5) A (7) R (3)
- Severe AS - STS-PROM 8%–15%

- Oxygen-dependent lung disease - Shortness of breath

- BNP elevated

R (3) M (5) A (8) M (4)
- Severe symptomatic AS

- STS-PROM >15% - End-stage renal disease

- Longstanding dialysis, not a renal transplant candidate - Multiple comorbidities

M (5) M (4) M (6) R (2)
- Severe symptomatic AS - STS-PROM 8%–15%

- End-stage renal disease - Short time on dialysis

- Renal transplant candidate - Nondiabetic, nonhypertensive ethology

R (3) R (3) A (7) A (7)
- Severe symptomatic AS

- STS-PROM 8%–15% - Cirrhosis with MELD >14

M (5) M (5) A (7) R (2)
- Severe symptomatic AS

- STS-PROM 8%–15% - Cirrhosis with MELD <10

R (3) M (4) A (7) M (5)
- Severe symptomatic AS

- STS-PROM 8%–15% - Moderate to severe dementia (minimally oriented)

- Symptoms described by family but not verbalized by the patient

A (8) R (3) R (2) R (1)
- Severe symptomatic AS

- STS-PROM 8%–15% - Malignancy

- Life expectancy >1 year

M (5) M (4) A (7) M (6)
- Severe symptomatic AS

- STS-PROM 8%–15% - Malignancy

- Life expectancy <1 year

A (7) M (5) R (2) R (1)
A = Appropriate; AS = aortic stenosis; BAV = balloon aortic valvuloplasty; BNP = b-type natriuretic peptide; M = May Be Appropriate; MELD = model for end-stage liver disease; R = Rarely Appropriate; SAVR = surgical aortic valve replacement; STS-PROM = Society of Thoracic Surgeons predicted risk of mortality score; TAVR = transcatheter aortic valve replacement; Vmax = peak aortic valve velocity.