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

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

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

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

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

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

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

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

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

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.

Symptomatic, High-Gradient, Severe AS with Associated CAD

Appropriate Use Median Score (1–9)

Indication TAVR TAVR + PCI SAVR SAVR + PCI SAVR + CABG
- 1- or 2-vessel CAD, no proximal LAD involvement

- High or intermediate surgical risk

A (7) A (7) M (4) M (4) A (7)
- 1- or 2-vessel CAD, no proximal LAD involvement

- Low surgical risk

R (3) R (3) M (6) M (5) A (7)
- 1- or 2-vessel CAD, including LAD involvement

- High or intermediate surgical risk

M (4) A (7) R (3) M (4) A (7)
- 1- or 2-vessel CAD, including LAD involvement

- Low surgical risk

R (2) R (3) R (3) R (3) A (9)
- 3-vessel disease; SYNTAX <22

- High or intermediate surgical risk

M (4) A (7) R (3) M (4) A (7)
- 3-vessel disease; SYNTAX <22

- Low risk

R (2) R (3) R (2) M (4) A (9)
- 3-vessel disease; SYNTAX ≥22

- High or intermediate surgical risk

R (3) M (6) R (3) M (4) A (7)
- 3-vessel disease; SYNTAX ≥22

- Low surgical risk

R (1) R (2) R (2) R (3) A (9)
- Left main; SYNTAX <33

- High or intermediate surgical risk

R (2) A (7) R (2) R (3) A (8)
- Left main; SYNTAX <33

- Low surgical risk

R (1) R (2) R (2) R (3) A (9)
- Left main; SYNTAX ≥33

- High or intermediate surgical risk

R (2) M (6) R (2) R (3) A (8)
- Left main; SYNTAX ≥33

- Low surgical risk

R (1) R (2) R (1) R (2) A (9)
A = Appropriate; AS = aortic stenosis; AVA = aortic valve area; CABG = coronary artery bypass grafting; CAD = coronary artery disease; LAD = left anterior descending; M = May Be Appropriate; PCI = percutaneous coronary intervention; R = Rarely Appropriate; SAVR = surgical aortic valve replacement; SYNTAX = synergy between PCI with TAXUS drug-eluting stent and cardiac surgery; TAVR = transcatheter aortic valve replacement; Vmax = peak aortic valve velocity.

Non cardiac Surgery

Appropriate Use Median Score (1–9)

Indication No Intervention BAV AVR (TAVR or SAVR)
- Symptomatic severe / critical AS

- Elective major surgery - Nonobstructive CAD

R (1) M (4) A (8)
- Symptomatic / severe critical AS

- Urgent major surgery - Nonobstructive CAD

R (2) M (6) A (7)
- Asymptomatic severe / critical AS

- Elective major surgery - Nonobstructive CAD

- No signs of cardiac decompensation

M (4) R (3) A (7)
- Asymptomatic severe / critical AS

- Urgent major surgery - Nonobstructive CAD

- No signs of cardiac decompensation

M (5) M (4) M (5)
A = Appropriate; AS = aortic stenosis; AVR = aortic valve replacement; BAV = balloon aortic valvuloplasty; CAD = coronary artery disease; M = May Be Appropriate; R = Rarely Appropriate; SAVR = surgical aortic valve replacement; TAVR = transcatheter aortic valve replacement.
Median Score 1–3: Rarely Appropriate care for specific indication (treatment is not generally acceptable and is not a reasonable approach for the indication). Median Score 4–6: May Be Appropriate care for specific indication (treatment may be generally acceptable and may be a reasonable approach for the indication). Median Score 7–9: Appropriate care for specific indication (treatment is generally acceptable and is a reasonable approach for the indication).