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KEY WORDS ACC/AHA Performance Measures,

Low-gradient severe mitral stenosis: hemodynamic

twenty-year study of one thousand patients undergo-

performance measures, quality indicators,

profiles, clinical characteristics, and outcomes. J Am

ing closed mitral valvuloplasty. Circulation. 1973;48:

quality measures, structural heart disease,

Heart Assoc. 2019;8:e010736.

357-364.

valvular heart disease

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APPENDIX A. VHD MEASURE SET

Performance Measures for VHD

SHORT TITLE: PM-1: VKA for Mechanical Heart Valves (Outpatient Setting)

PM-1: Percentage of Patients With Mechanical Heart Valves Who Are Prescribed Anticoagulation With VKA (Outpatient Setting)

Measure Description: Percentage of patients age $18 y with any mechanical heart valve who are prescribed* a VKA

Numerator

Patients who are prescribed* a VKA

Denominator

Patients age $18 y with any mechanical heart valve or history of mechanical heart valve in the medical record

Denominator Exclusions Hospice, palliative care, or comfort care only

Denominator Exceptions Documentation of medical reason(s) for not prescribing a VKA (eg, major bleeding during the assessment period, patient on heparin because of

pregnancy, or other medical reasons during the assessment period)

Documentation of patient reason(s) for not being on VKA (eg, patient preference, patient lost to follow-up)

Measurement Period

12 mo

Sources of Data

EHR data

Administrative data/claims

Administrative data/claims expanded (multiple sources)

Paper medical records

Attribution

Individual practitioner (eg, cardiologist, primary care physician)

Care Setting

Outpatient

Rationale

All patients with mechanical valves require lifelong anticoagulant therapy with a VKA.33-36,44 In addition to the thrombogenicity of the intravascular prosthetic material,

mechanical valves impose abnormal flow conditions, with zones of low flow within their components, as well as areas of high-shear stress, which can cause platelet

activation that leads to valve thrombosis and embolic events. Therapy with an oral VKA at an INR goal appropriate for the comorbidity of the patient and the type and

position of the mechanical valve prosthesis is required to decrease the incidence of thromboembolism and associated morbidity. Data show that anticoagulation with

a VKA is protective against valve thrombosis (OR: 0.11 [95% CI: 0.07-0.2]) and thromboembolic events (OR: 0.21 [95% CI: 0.16-0.27]). It is preferable to specify a

single INR target for each patient and to recognize that the acceptable range includes 0.5 INR units on each side of this target. A specific target is preferable because

it reduces the likelihood of patients having INR values consistently near the upper or lower boundary of the range. Fluctuations in INR are associated with an increased

incidence of complications in patients with prosthetic heart valves.45,46

Clinical Recommendation(s)

2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease³

1. In patients with a mechanical prosthetic valve, anticoagulation with a VKA is recommended.33-36,44 (Class 1, Level of Evidence: A)

*Prescribed may include prescriptions given to the patient for a VKA at most recent office visit, or documentation that the patient is already taking a VKA.

ACC indicates American College of Cardiology; AHA, American Heart Association; EHR, electronic health record; INR, international normalized ratio; OR, odds ratio; PM, performance

measure; and VKA, vitamin K antagonist.

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APPENDIX A. CONTINUED

SHORT TITLE: PM-2: AV Intervention for Severe Symptomatic AS (Outpatient Setting)

PM-2: Percentage of Patients With Severe Symptomatic AS Who Undergo AV Intervention Within 3 Months of Diagnosis (Outpatient Setting)

Measure Description: Percentage of patients age $18 y diagnosed with severe symptomatic AS who undergo either surgical AVR or TAVI within 3 mo of diagnosis

Numerator

Patients who undergo either surgical AVR or TAVI within 3 mo of diagnosis

Denominator

Patients age $18 y who are diagnosed with severe symptomatic AS who are eligible* for AV intervention

Denominator Exclusions

Hospice, palliative care, or comfort care only

Denominator Exceptions

Documentation of medical reason(s) for not undergoing surgical AVR or TAVI (eg, severe noncardiac organ dysfunction, frailty, expected

minimal improvement in quality of life, contraindications)

Documentation of patient reason(s) for not undergoing surgical AVR or TAVI (eg, patient preference)

Measurement Period

12 mo

Sources of Data

EHR data

Administrative data/claims

Administrative data/claims expanded (multiple sources)

Paper medical record

Attribution

Individual practitioner (eg, cardiologist)

Care Setting

Outpatient

Rationale

Patients with severe symptomatic AS have a high risk of death if AV intervention (eg, SAVR or TAVI) is not performed, as high as 50% at 1 y. Both SAVR and TAVI have

been shown to be effective across the spectrum of surgical risk, with significant improvements in morbidity, death, and functional status.

Symptoms of severe AS may include the following: exertional dyspnea, decreased exercise tolerance, HF symptoms, exertional angina, exertional syncope, or presyncope.

Severe AS is usually defined by the following valve hemodynamics: AV Vmax $4 m/s, mean DP $40 mm Hg, or AVA typically #1.0 cm² (or AVAi #0.6 cm²/m²) but

may be larger with mixed AS/AR. However, in the setting of low LVEF (<50%), these hemodynamic thresholds may not be achieved, at which time dobutamine stress

echocardiography or other adjunctive diagnostic modalities may be needed to accurately confirm the diagnosis of severe AS.³

In symptomatic patients with severe high-gradient AS (Stage D1), ample evidence demonstrates the beneficial effects of AVR on survival, symptoms, and LV systolic

function.^47-51 The most common initial symptom of AS is exertional dyspnea or decreased exercise tolerance. Clinical vigilance is needed to recognize these early

symptoms and proceed promptly to AVR. More severe “classical” symptoms of AS, including HF, syncope, or angina, can be avoided by appropriate treatment at the

onset of even mild symptoms. Outcomes after surgical or transcatheter AVR are excellent in patients who do not have a high procedural risk.47,49,50,52

Outcomes are poor with severe low-gradient AS but are still better with AVR than with medical therapy in those with a low LVEF, particularly when contractile reserve is

present. The document “Echocardiographic Assessment of Valve Stenosis: EAE/ASE Recommendations for Clinical Practice” defines severe AS on dobutamine stress

testing as a maximum velocity >4.0 m/s with a valve area #1.0 cm² at any point during the test protocol, with a maximum dobutamine dose of 20 mcg/kg/min.⁵³

A subset of patients with severe AS present with symptoms and with a low velocity, low gradient, and low stroke volume index, despite a normal LVEF. Low-flow, low-

gradient severe AS with preserved LVEF should be considered in patients with a severely calcified AV, an AV peak velocity <4.0 m/s (mean pressure gradient <40

mm Hg), and a valve area #1.0 cm² when stroke volume index is <35 mL/m². Typically, the LV is small, with thick walls, diastolic dysfunction, and a normal LVEF

($50%).

The survival and symptom reduction benefit of TAVI is seen only in appropriately selected patients. Baseline clinical factors associated with a poor outcome after TAVI

include advanced age, frailty, smoking or chronic obstructive pulmonary disease, pulmonary hypertension, liver disease, previous stroke, anemia, and other systemic

conditions. The STS estimated surgical risk score provides a useful measure of the extent of patient comorbidities and may help identify which patients will benefit

from TAVI. Patients with a mechanical impediment to SAVR, such as a porcelain aorta or previous chest radiation damage, may have better outcomes after TAVI than

do patients who are frail or those with moderate to severe disease in >1 other organ system.39,40,54 The likely benefits and risks of TAVI are considered in weighing

the risk-benefit ratio of intervention in an individual patient. TAVI is not recommended in patients with 1) a life expectancy of <1 y even with a successful procedure;

or 2) those with a chance of “survival with benefit” of <25% at 2 y.

Clinical Recommendation(s)

2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease³

1. In adults with severe high-gradient AS (Stage D1) and symptoms of exertional dyspnea, HF, angina, syncope, or presyncope by history or on exercise testing,

AVR is indicated.39,40,54-58 (Class 1, Level of Evidence: A)

2. In symptomatic patients with low-flow, low-gradient severe AS with reduced LVEF (Stage D2), AVR is recommended.37,59-65 (Class 1, Level of Evidence: B-

NR)

3. In symptomatic patients with low-flow, low-gradient severe AS with normal LVEF (Stage D3), AVR is recommended if AS is the most likely cause of

symptoms.38,41,42 (Class 1, Level of Evidence: B-NR)

4. For symptomatic patients with severe AS for whom predicted post-TAVI or post-SAVR survival is <12 months or for whom minimal improvement in quality of

life is expected, palliative care is recommended after shared decision-making, including discussion of patient preferences and values. (Class 1, Level of

Evidence: C-EO)

*Eligible patients are those with severe AS (Vmax $4 m/s, mean DP $40 mm Hg, or AVA typically #1.0 cm² [or AVAi #0.6 cm²/m²]; however, in the settings of low LVEF [<50%] or

low stroke volume, these hemodynamic thresholds may not be achieved, at which time dobutamine stress echocardiography or other adjunctive diagnostic modalities are needed) and

accompanying symptoms (eg, exertional dyspnea, decreased exercise tolerance, HF symptoms, exertional angina, exertional syncope, or presyncope).

ACC indicates American College of Cardiology; AHA, American Heart Association; AR, aortic regurgitation; AS, aortic stenosis; ASE, American Society of Echocardiography; AV, aortic

valve; AVA, aortic valve area; AVAi ¼ indexed aortic valve area; AVR, aortic valve replacement; EAE, European Association of Echocardiography; EHR, electronic health record; HF, heart

failure; LV, left ventricle (left ventricular); LVEF, left ventricular ejection fraction; PM, performance measure; SAVR, surgical aortic valve replacement; STS, Society of Thoracic

Surgeons; TAVI, transcatheter aortic valve implantation; and Vmax, maximal velocity.

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APPENDIX A. CONTINUED

SHORT TITLE: PM-3: AV Surgery for Chronic Severe AR (Outpatient Setting)

PM-3: Percentage of Patients With Chronic Severe AR Who Are Eligible for AV Surgery and Undergo AV Surgery Within 3 Months of Diagnosis

(Outpatient Setting)

Measure Description: Percentage of patients age $18 y diagnosed with chronic severe AR who are either symptomatic or asymptomatic with LV systolic

dysfunction (LVEF #55%) who are eligible for AV surgery and who undergo AV surgery within 3 mo of diagnosis

Numerator

Patients who undergo AV surgery within 3 mo of diagnosis

Denominator

Patients age $18 y who are diagnosed with chronic severe AR who are eligible for AV surgery and are: (1) symptomatic or

(2) asymptomatic with LV systolic dysfunction (LVEF #55%)

Denominator Exclusions

Hospice, palliative care, or comfort care only

Denominator Exceptions

Documentation of medical reason(s) for not undergoing AV surgery (eg, comorbidities making AVR extreme or prohibitive risk [such as

severe pulmonary, renal, hepatic disease], contraindications)

Documentation of patient reason(s) for not undergoing AV surgery (eg, patient preference)

Measurement Period

12 mo

Sources of Data

EHR data

Administrative data/claims

Administrative data/claims expanded (multiple sources)

Paper medical records

Attribution

Individual practitioner (eg, cardiologist)

Care Setting

Outpatient

Rationale

Symptoms are an important indication for AVR in patients with chronic severe AR, and the most important aspect of the clinical evaluation is taking a careful, detailed

history to elicit symptoms or diminution of exercise capacity. Patients with chronic severe AR who develop symptoms have a high risk of death if AVR is not

performed,⁶⁶ and survival and functional status after AVR are related to the severity of preoperative symptoms, assessed either subjectively or objectively with

exercise testing.^67-70 Even among symptomatic patients with a severe reduction in LVEF (<35%), AVR results in improved survival rate.^71-73

In patients with isolated severe AR who have indications for SAVR and are candidates for surgery, TAVI should not be performed.³

LV systolic function is an important determinant of survival and functional status after AVR.68,70,71,74-85 Outcomes are optimal when surgery is performed before LVEF

decreases below 55%.^86-88 In asymptomatic patients with LV systolic dysfunction, postoperative outcomes are better if AVR is performed before onset of

symptoms.⁷⁴

Symptoms of chronic severe AR may include the following: exertional dyspnea, angina, or more severe HF symptoms. Imaging and/or angiographic criteria defining

severe AR include: a Doppler jet width $65% of LVOT, a vena contracta >0.6 cm, holodiastolic flow reversal in the proximal abdominal aorta, regurgitant

volume $60 mL/beat, regurgitant fraction $50% ERO $0.3 cm², angiography grade 3 to 4. In addition, diagnosis of chronic severe AR requires evidence of LV

dilation.³

Clinical Recommendation(s)

2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease³

1. In symptomatic patients with severe AR (Stage D), aortic valve surgery is indicated regardless of LV systolic function.^67-73 (Class 1, Level of Evidence: B-NR)

2. In asymptomatic patients with chronic severe AR and LV systolic dysfunction (LVEF #55%) (Stage C2), aortic valve surgery is indicated if no other cause for

systolic dysfunction is identified.68,71,78,79,81,89,90 (Class 1, Level of Evidence: B-NR)

ACC indicates American College of Cardiology; AHA, American Heart Association; AR, aortic regurgitation; AV, aortic valve; AVR, aortic valve replacement; EHR, electronic health

record; ERO, effective regurgitant orifice; HF, heart failure; LV, left ventricle (left ventricular); LVEF, left ventricular ejection fraction; LVOT, left ventricular outflow tract; PM,

performance measure; SAVR, surgical aortic valve replacement; and TAVI, transcatheter aortic valve implantation.

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APPENDIX A. CONTINUED

SHORT TITLE: PM-4: TTE for Asymptomatic Chronic Severe Primary MR (Inpatient and Outpatient Setting)

PM-4: Percentage of Asymptomatic Patients With Chronic Severe Primary MR Who Received a TTE Within the Past 12 Months (Inpatient and

Outpatient Setting)

Measure Description: Percentage of patients age $18 y with asymptomatic chronic severe primary MR who received a TTE within the past 12 mo

Numerator

Patients who received a TTE within the past 12 mo

Denominator

Patients age $18 y with asymptomatic chronic severe primary MR (eg, mitral valve with prolapse)

Denominator Exclusions

Hospice, palliative care, or comfort care only

Denominator Exceptions

Documentation of medical reason(s) for not doing a TTE (eg, patient had an alternative imaging modality)

Documentation of patient reason(s) for not doing a TTE (eg, patient preference, patient moved to another facility for care or lost to

follow-up)

Measurement Period

12 mo

Sources of Data

EHR data

Administrative data/claims

Administrative data/claims expanded (multiple sources)

Paper medical records

Attribution

Individual practitioner (eg, cardiologist, primary care physician)

Care Setting

Inpatient

Outpatient

Rationale

TTE provides valuable information for surveillance of LV function (estimated by LVEF and LVESD) and PAP in asymptomatic patients with severe primary MR (Stage C1) if

performed every 6 to 12 mo.^91-99 Chronic severe MR is tolerated poorly, reaching a trigger for surgery at an average rate of about 8%/y.91,97 This progression varies

from patient to patient, and because prognosis worsens if correction of MR is delayed beyond the onset of these triggers, referral to a Comprehensive Valve Center

for early repair or careful surveillance is of value. Because echocardiographic measurements are variable, management decisions that rest on these measurements

should be confirmed by repeat sequential TTE. In patients with milder chronic primary MR (Stages A and B), TTE is indicated periodically to evaluate for changes in MR

severity, depending on valve anatomy and other considerations, because regurgitation may worsen over time. Because this process may develop slowly, MR can

become severe and even lead to LV dysfunction in the absence of symptoms or clinical signs.100,101

Imaging and angiographic criteria defining chronic severe MR include the following: central jet MR >40% LA, holosystolic eccentric jet MR, vena contracta $0.7 cm,

regurgitant volume $60 mL, regurgitant fraction $50%, ERO $0.40 cm², angiographic grade 3þ to 4þ.³

Clinical Recommendation(s)

2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease³

1. For asymptomatic patients with severe primary MR (Stages B and C1), TTE is indicated every 6 to 12 months for surveillance of LV function (estimated by

LVEF, LVEDD, and LVESD) and assessment of pulmonary artery pressure.^91-101 (Class 1, Level of Evidence: B-NR)

ACC indicates American College of Cardiology; AHA, American Heart Association; EHR, electronic health record; ERO, effective regurgitant orifice; LA, left atrium (left atrial); LV, left

ventricle (left ventricular); LVEDD, left ventricular end-diastolic dimension; LVEF, left ventricular ejection fraction; LVESD, left ventricular end-systolic dimension; MR, mitral

regurgitation; PAP, pulmonary artery pressure; PM, performance measure; and TTE, transthoracic echocardiogram.

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APPENDIX A. CONTINUED

SHORT TITLE: PM-5: Mitral Valve Intervention for Chronic Severe Primary MR (Outpatient Setting)

PM-5: Percentage of Patients with Chronic Severe Primary MR Who Undergo Mitral Valve Intervention Within 3 Months of Diagnosis (Outpatient

Setting)

Measure Description: Percentage of patients age $18 y diagnosed with chronic severe primary MR who are either symptomatic (regardless of LV systolic function)

or asymptomatic but have LVSD (LVEF #60%), and who are eligible for mitral valve intervention and undergo mitral valve intervention (mitral valve surgery or

TEER) within 3 mo of diagnosis

Numerator

Patients who undergo mitral valve intervention (mitral valve surgery or TEER) within 3 mo of diagnosis

Denominator

Patients age $18 y who are diagnosed with chronic severe primary MR who are eligible for mitral valve intervention and are:

(1) symptomatic, regardless of LV systolic function or (2) asymptomatic with LVSD (LVEF #60%)

Denominator Exclusions

Hospice, palliative care, or comfort care only

Denominator Exceptions

Documentation of medical reason(s) for not undergoing mitral valve intervention (eg, severe comorbidities, limited quality of life, poor

functional status, prohibitive risk for mitral valve surgery and anatomy not amenable for TEER, contraindications)

Documentation of patient reason(s) for not undergoing mitral valve intervention (eg, patient preference)

Measurement Period

12 mo

Sources of Data

EHR data

Administrative data/claims (inpatient or outpatient claims)

Administrative data/claims expanded (multiple sources)

Paper medical record

Attribution

Individual practitioner (eg, cardiologist)

Care Setting

Outpatient

Rationale

Primary MR is a mechanical problem of the leaflet coaptation that only has a mechanical solution-that of mitral valve mechanical intervention. The onset of symptoms

that results from severe MR worsens prognosis even when LV function appears to be normal,102,103 and the negative prognosis extends even to mild symptoms.¹⁰²

Thus, the onset of symptoms is an indication for prompt mitral valve surgery.

The goal of therapy in MR is to correct it before the onset of LVSD and its subsequent adverse effect on patient outcomes. The ideal time for mitral valve surgery is when

the patient’s LV approaches but has not yet reached the parameters that indicate systolic dysfunction (LVEF #60% or LVESD $40 mm).43,94,98,101,104,105 Because

symptoms do not always coincide with LV dysfunction, imaging surveillance is used to plan surgery before severe dysfunction has occurred. If moderate LV

dysfunction is already present, prognosis is worse after mitral valve operation.43,101,104-107 Thus, further delay (although symptoms are absent) will lead to greater LV

dysfunction and a still worse prognosis. Because the loading conditions in MR allow continued late ejection into a lower-impedance LA, a higher cutoff for “normal”

LVEF is used in MR than in other types of heart disease. Although it is clearly inadvisable to allow patients’ LV function to deteriorate beyond the benchmarks of an

LVEF #60% or LVESD $40 mm, some recovery of LV function can still occur even if these thresholds have been crossed.104,108

Symptoms of chronic severe MR may include decreased exercise tolerance, exertional dyspnea, or more severe HF symptoms. Imaging and angiographic criteria defining

chronic severe MR include the following: central jet MR >40% LA, holosystolic eccentric jet MR, vena contracta $0.7 cm, regurgitant volume $60 mL, regurgitant

fraction $50%, ERO $0.40 cm², angiographic grade 3þ to 4þ.³

Clinical Recommendation(s)

2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease³

1. In symptomatic patients with severe primary MR (Stage D), mitral valve intervention is recommended irrespective of LV systolic function.102,103 (Class 1,

Level of Evidence: B-NR)

2. In asymptomatic patients with severe primary MR and LV systolic dysfunction (LVEF #60%, LVESD $40 mm) (Stage C2), mitral valve surgery is

recommended.43,94,98,100,101,104,106,107 (Class 1, Level of Evidence: B-NR)

ACC indicates American College of Cardiology; AHA, American Heart Association; EHR, electronic health record; ERO, effective regurgitant orifice; HF, heart failure; LA, left atrium (left

atrial); LV, left ventricle (left ventricular); LVEF, left ventricular ejection fraction; LVESD, left ventricular end-systolic dimension; LVSD, left ventricular systolic dysfunction; MR, mitral

regurgitation; PM, performance measure; and TEER, transcatheter edge-to-edge repair.

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APPENDIX A. CONTINUED

Quality Measures for VHD

SHORT TITLE: QM-1: Documentation of Risk and Heart Team Discussion Before SAVR or TAVI (Inpatient Setting)

QM-1: Percentage of Patients Who Have Documentation of Risk Score(s) and Heart Valve Team Discussion Before SAVR or TAVI (Inpatient Setting)

Measure Description: Percentage of patients age $18 y who have documentation of objective risk score(s) and heart valve team discussion before SAVR or TAVI

Numerator

Patients who have preprocedural documentation of: (1) an objective procedural risk score (eg, STS risk scores) and (2) a heart valve team

discussion

Denominator

Patients age $18 y who underwent SAVR or TAVI

Denominator Exclusions

None

Denominator Exceptions

Documentation of medical reason(s) for not having risk score(s) or heart valve team discussion (eg, cardiogenic shock or acute aortic

dissection requiring emergent procedure)

Measurement Period

During hospitalization or admission for index procedure (SAVR or TAVI)

Sources of Data

EHR data

Administrative data/claims (inpatient or outpatient claims)

Administrative data/claims expanded (multiple sources)

Paper medical records

Attribution

Facility

Individual practitioner (eg, cardiologist, cardiac surgeon)

Care Setting

Inpatient

Rationale

The decision to intervene, as well as the type of procedure recommended, is based on an assessment of patient-specific, procedure-specific, and institution- or operator-

specific short-term risks and long-term benefits. Surgical mortality rate and major morbidity risks can be calculated with a web-based tool derived from the STS Adult

Cardiac Surgery database for 6 specific procedures (http://riskcalc.sts.org/stswebriskcalc/calculate). TAVI-specific risk prediction tools are also available (http://tools.

acc.org/TAVRRisk/#!/content/evaluate/).^109-114 Frailty assessment for at-risk patients is routine.^115-119 Patients toward the higher end of the risk spectrum, for whom

intervention would be futile or associated with a high likelihood of a poor outcome, should be identified.54,120-125 Risk prediction tools for transcatheter mitral valve

repair are comparatively less robust.13,121,122 The relationship between operator or institutional case volume and outcomes has been explored for surgical¹²⁶ and

transcatheter^127-129 AVR, surgical mitral valve repair and replacement,^130-138 and transcatheter mitral valve repair.¹³⁹ The potential to return to activities of daily living

after an intervention must be considered.

The MDT is an established feature of heart valve programs¹⁴⁰ and has been formally endorsed by the ACC, the ASE, the SCAI, the AATS, and the STS.¹⁸ Key members of

the MDT include cardiologists with subspecialty expertise in the clinical evaluation of patients with VHD, as well as specialists in advanced cardiovascular imaging. For

the evaluation of the patient with secondary MR and TR, a specialist in HF is included. Interventional cardiologists with training and expertise in VHD and surgeons

experienced in the treatment of VHD anchor the MDT. Other team members include cardiovascular nurses, cardiovascular anesthesiologists, and intensivists involved

in periprocedural care. Finally, the engagement of the primary clinical cardiologist and patient is of critical importance. The MDT facilitates presentation of all

appropriate options for medical, interventional, and surgical treatment to the patient in a balanced manner, using tools and techniques for shared decision-making in

which patient preferences are considered.

Clinical Recommendation(s)

2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease³

1. For patients with VHD for whom intervention is contemplated, individual risks should be calculated for specific surgical and/or transcatheter procedures,

using online tools when available, and discussed before the procedure as a part of a shared decision-making process. (Class 1, Level of Evidence: C-EO)

2. Patients with severe VHD should be evaluated by a Multidisciplinary Heart Valve Team (MDT) when intervention is considered. (Class 1, Level of Evidence: C-

EO)

AATS indicates American Association for Thoracic Surgery; ACC, American College of Cardiology; AHA, American Heart Association; ASE, American Society of Echocardiography; AVR,

aortic valve replacement; EHR, electronic health record; HF, heart failure; MDT, multidisciplinary heart valve team; MR, mitral regurgitation; QM, quality measure; SAVR, surgical aortic

valve replacement; SCAI, Society for Cardiovascular Angiography and Interventions; STS, Society of Thoracic Surgeons; TAVI, transcatheter aortic valve implantation; TR, tricuspid

regurgitation; and VHD, valvular heart disease.

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APPENDIX A. CONTINUED

SHORT TITLE: QM-2: AVR for Asymptomatic AS With LV Systolic Dysfunction (Outpatient Setting)

QM-2: Percentage of Asymptomatic Patients With Severe AS Who Are Eligible for AVR (LVEF <50%) and Who Undergo AVR Within 3 Months of

Diagnosis (Outpatient Setting)

Measure Description: Percentage of patients age $18 y diagnosed with severe AS who are asymptomatic and eligible for AVR (LVEF <50%) who undergo AVR

(SAVR or TAVI) within 3 mo of diagnosis

Numerator

Patients who undergo AVR (SAVR or TAVI) within 3 mo of diagnosis

Denominator

Patients age $18 y who are diagnosed with severe AS who are asymptomatic and are eligible for AVR (LVEF <50%)

Denominator Exclusions

Hospice, palliative care, or comfort care only

Denominator Exceptions

Documentation of medical reason(s) for not undergoing AVR (eg, severe comorbidities, limited quality of life, poor functional status,

contraindications)

Documentation of patient reason(s) for not undergoing AVR (eg, patient preference)

Measurement Period

12 mo

Sources of Data

EHR data

Administrative data/claims

Administrative data/claims expanded (multiple sources)

Paper medical record

Attribution

Individual practitioner (eg, cardiologist)

Care Setting

Outpatient

Rationale

In asymptomatic patients with severe AS and normal LV systolic function, the survival rate during the asymptomatic phase is similar to that of age-matched controls,

with a low risk of sudden death (<1%/y) when patients are followed prospectively and when patients promptly report symptom onset. However, in patients with low

LVEF and severe AS, survival is better in those who undergo AVR than in those treated medically. The depressed LVEF in many patients is caused by excessive

afterload (afterload mismatch), and LV function improves after AVR in such patients. If LV dysfunction is not caused by afterload mismatch, survival is still improved,

likely because of the reduced afterload with AVR, but improvement in LV function and resolution of symptoms might not be complete after AVR.60,62,65,141-147

Prospective clinical studies demonstrate that disease progression occurs in nearly all patients with severe asymptomatic AS. Symptom onset within 2 to 5 y is likely when

AV peak velocity is $4.0 m/s or mean pressure gradient is $40 mm Hg. The additive risk of AVR at the time of other cardiac surgery is less than the risk of reoperation

within 5 y.^148-155

Severe AS is usually defined by the following valve hemodynamics: AV Vmax $4 m/s, mean DP $40 mm Hg, or AVA typically #1.0 cm² (or AVAi #0.6 cm²/m²) but may

be larger with mixed AS and AR. However, in the setting of low LVEF (<50%), these hemodynamic thresholds may not be achieved, at which time dobutamine stress

echocardiography or other adjunctive diagnostic modalities may be needed to accurately confirm the diagnosis of severe AS.³

Clinical Recommendation(s)

2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease³

1. In asymptomatic patients with severe AS and an LVEF <50% (Stage C2), AVR is indicated.^156-159 (Class 1, Level of Evidence: B-NR)

ACC indicates American College of Cardiology; AHA, American Heart Association; AR, aortic regurgitation; AS, aortic stenosis; AV, aortic valve; AVA, aortic valve area; AVAi ¼ indexed

aortic valve area; AVR, aortic valve replacement; EHR, electronic health record; LV, left ventricle (left ventricular); LVEF, left ventricular ejection fraction; QM, quality measure; SAVR,

surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation; and Vmax, maximal velocity.

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APPENDIX A. CONTINUED

SHORT TITLE: QM-3: TAVI for Severe Symptomatic AS >80 Years of Age (Outpatient Setting)

QM-3: Percentage of Patients With Severe Symptomatic AS >80 Years of Age Who Undergo TAVI Within 3 Months of Diagnosis (Outpatient Setting)

Measure Description: Percentage of patients age >80 y diagnosed with severe symptomatic AS who are eligible for AV intervention and who undergo TAVI within

3 mo of diagnosis

Numerator

Patients who undergo TAVI within 3 mo of diagnosis

Denominator

Patients >80 y who are diagnosed with severe symptomatic AS and are eligible for AV intervention

Denominator Exclusions

Hospice, palliative care, or comfort care only

Denominator Exceptions

Documentation of medical reason(s) for not undergoing TAVI (eg, anatomic contraindications to transfemoral TAVI, severe comorbidities,

frailty, poor quality of life expected)

Documentation of patient reason(s) for not undergoing TAVI (eg, patient preference)

Measurement Period

12 mo

Sources of Data

EHR data

Administrative data/claims

Administrative data/claims expanded (multiple sources)

Paper medical records

Attribution

Individual practitioner (eg, cardiologist, cardiac surgeon)

Care Setting

Outpatient

Rationale

TAVI is a safe and effective procedure for treatment of severe symptomatic AS in all adults regardless of estimated surgical risk. The mortality rate for transfemoral TAVI

is lower than that for SAVR (HR: 0.88 [95% CI: 0.78-0.99]) in a meta-analysis of RCTs. TAVI also is associated with a lower risk of stroke (HR: 0.81 [95% CI: 0.68-

0.98]; P ¼ 0.028), major bleeding, and AF, as well as a shorter hospital length of stay, less pain, and more rapid return to normal activities.¹⁶⁰ Compared with SAVR,

TAVI results in higher rates of vascular complications, paravalvular regurgitation, permanent pacemaker implantation, and valve intervention, but most patients will

consider that the advantages of TAVI outweigh these disadvantages. TAVI valves are durable to at least 5 y, and the limited data on TAVI durability are of less concern

to most patients >80 y of age because the valve durability is likely to be longer than the patient’s life expectancy.¹⁶¹ If significant valve deterioration does occur, a

second TAVI within the first prosthesis (called a valve-in-valve TAVI) is likely to be possible. When a transfemoral approach is not possible, other factors, such as

alternative vascular access, comorbid cardiac and noncardiac conditions, expected functional status and survival after AVR, and patient values and preferences must

be considered. The specific choice of a balloon-expandable valve or self-expanding valve depends on patient anatomy and other considerations.^162-167

The survival and symptom reduction benefit of TAVI is seen only in appropriately selected patients. Baseline clinical factors associated with a poor outcome after TAVI

include advanced age, frailty, smoking or chronic obstructive pulmonary disease, pulmonary hypertension, liver disease, previous stroke, anemia, and other systemic

conditions. The STS estimated surgical risk score provides a useful measure of the extent of patient comorbidities and may help identify which patients will benefit

from TAVI. Patients with a mechanical impediment to SAVR, such as a porcelain aorta or previous chest radiation damage, may have better outcomes after TAVI than

do frail patients or those with moderate to severe disease in >1 other organ system.39,40,54 The likely benefits and risks of TAVI are considered in weighing the risk-

benefit ratio of intervention in an individual patient. TAVI is not recommended in patients with 1) a life expectancy of <1 y even with a successful procedure; or 2)

those with a chance of “survival with benefit” of <25% at 2 y.

Clinical Recommendation(s)

2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease³

1. For symptomatic patients with severe AS who are >80 y of age or for younger patients with a life expectancy <10 y and no anatomic contraindication to

transfemoral TAVI, transfemoral TAVI is recommended in preference to SAVR.9,10,168-173 (Class 1, Level of Evidence: A)

2. For symptomatic patients with severe AS for whom predicted post-TAVI or post-SAVR survival is <12 mo or for whom minimal improvement in quality of life

is expected, palliative care is recommended after shared decision-making, including discussion of patient preferences and values. (Class 1, Level of Evidence:

C-EO)

ACC indicates American College of Cardiology; AF, atrial fibrillation; AHA, American Heart Association; AS, aortic stenosis; AV, aortic valve; AVR, aortic valve replacement; EHR,

electronic health record; HR, hazard ratio; QM, quality measure; RCT, randomized controlled trial; SAVR, surgical aortic valve replacement; STS, Society of Thoracic Surgeons; and TAVI,

transcatheter aortic valve implantation.

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APPENDIX A. CONTINUED

SHORT TITLE: QM-4: Post-AVR Echocardiogram (Outpatient Setting)

QM-4: Percentage of Patients Who Have TTE Within 3 Months After TAVI or SAVR (Outpatient Setting)

Measure Description: Percentage of patients age $18 y who have TTE within 3 mo after TAVI or SAVR

Numerator

Patients who have TTE within 3 mo after their procedure or surgery

Denominator

Patients $18 y who underwent TAVI or SAVR

Denominator Exclusions

Hospice, palliative care, or comfort care only

Patients who die or are lost to follow-up within 3 mo after procedure

Denominator Exceptions

Documentation of patient reason(s) for not doing a TTE (eg, patient preference)

Measurement Period

12 mo

Sources of Data

EHR data

Administrative data/claims (inpatient or outpatient claims)

Administrative data/claims expanded (multiple sources)

Paper medical record

Attribution

Individual practitioner (eg, cardiologist, cardiac surgeon)

Care Setting

Outpatient

Rationale

TTE after valve implantation or repair provides an assessment of the procedural results and serves as a baseline against which comparison can be made for any change.

TTE provides accurate measurements of transvalvular velocities and pressure gradients, as well as detection and quantitation of transvalvular and paravalvular

leak.^174-177 Normal transvalvular velocities and gradients vary across different types and sizes of prosthetic valves but are also affected by patient-specific factors,

including body size and cardiac output. The postoperative study, recorded when the patient is asymptomatic and hemodynamically stable, provides Doppler flow data

for a specific valve in an individual patient. In addition, TTE provides assessment of other valve disease(s), pulmonary artery pressure, atrial size, LV and RV size and

function, and pericardial disease.

TTE is the primary imaging modality for postoperative assessment of prosthetic valve or repaired native valve function. Additional imaging, such as TEE, cardiac CT, or

fluoroscopy, may be required when valve dysfunction is suspected and in the context of the clinical presentation.³

Clinical Recommendation(s)

2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease³

1. In patients with a surgical or transcatheter prosthetic valve and in patients who have had valve repair, an initial postprocedural TTE study is recommended

for evaluation of valve hemodynamics and ventricular function.^174-177 (Class 1, Level of Evidence: B-NR)

ACC indicates American College of Cardiology; AHA, American Heart Association; AVR, aortic valve replacement; CT, computed tomography; EHR, electronic health record; LV, left

ventricle (left ventricular); QM, quality measure; RV, right ventricle (right ventricular); SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation; TEE,

transesophageal echocardiography (echocardiogram); and TTE, transthoracic echocardiogram.

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APPENDIX A. CONTINUED

SHORT TITLE: QM-5: Adequate BP Control in AR Patients (Outpatient Setting)

QM-5: Percentage of Patients With Chronic AR and Hypertension Whose Blood Pressure Is Optimally Treated (Outpatient Setting)

Measure Description: Percentage of patients age $18 y diagnosed with chronic AR (Stages B and C) and hypertension (SBP >140 mm Hg) whose blood pressure is

optimally treated

Numerator

Patients with optimal BP treatment*

Denominator

Patients age $18 y who are diagnosed with chronic AR (Stages B and C) and hypertension (SBP >140 mm Hg)

Denominator Exclusions

Hospice, palliative care, or comfort care only

Denominator Exceptions

Documentation of medical reason(s) for not doing optimal BP treatment (eg, contraindications to lower BP such as stroke patients, patient

intolerance)

Documentation of patient reason(s) for not doing optimal BP treatment (eg, patient preference)

Measurement Period

12 mo

Sources of Data

EHR data

Administrative data/claims (outpatient claims)

Administrative data/claims expanded (multiple sources)

Paper medical record

Attribution

Individual practitioner (eg, cardiologist, primary care physician)

Care Setting

Outpatient

Rationale

There is no evidence that vasodilating drugs reduce severity of AR or alter the disease course in patients with significant AR in the absence of systemic hypertension.³

Recommendations for GDMT for hypertension and HF apply to patients with chronic asymptomatic AR as for the general population.

Severe AR is associated with a wide pulse pressure, such that systolic blood pressure is higher than in patients without AR even when systemic vascular resistance is

normal. Transaortic stroke volume increases further with medications that lower heart rate, such as beta-blockers, which may result in a paradoxical apparent increase

in blood pressure. Vasodilating drugs, such as ACE inhibitors or ARBs, do not affect heart rate and thus may reduce systolic blood pressure without a substantial

reduction in diastolic blood pressure in patients with chronic AR.^178-183

In symptomatic patients who are candidates for surgery, medical therapy is not a substitute for AVR. However, medical therapy is helpful for alleviating symptoms in

patients who are considered to be at very high surgical risk because of concomitant comorbid medical conditions.178,184

Clinical Recommendation(s)

2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease³

1. In asymptomatic patients with chronic AR (Stages B and C), treatment of hypertension (systolic blood pressure >140 mm Hg) is recommended.179,182,185

(Class 1, Level of Evidence: B-NR)

*Adequate treatment of BP in patients with chronic progressive (stage B) or severe AR (stage C) is for a target systolic BP <140 mm Hg.

ACC indicates American College of Cardiology; ACE, angiotensin-converting enzyme; AHA, American Heart Association; AR, aortic regurgitation; ARB, angiotensin receptor blocker;

AVR, aortic valve replacement; BP, blood pressure; EHR, electronic health record; GDMT, guideline-directed management and therapy; HF, heart failure; QM, quality measure; and SBP,

systolic blood pressure.

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APPENDIX A. CONTINUED

SHORT TITLE: QM-6: Treatment for Symptomatic Severe Rheumatic MS (Outpatient Setting)

QM-6: Percentage of Patients With Symptomatic Severe Rheumatic MS Who Undergo PMBC or Mitral Valve Surgery Within 3 Months of Diagnosis

(Outpatient Setting)

Measure Description: Percentage of patients age $18 y diagnosed with symptomatic severe rheumatic MS (mitral valve area #1.5 cm², Stage D) who undergo

PMBC or mitral valve surgery within 3 mo of diagnosis

Numerator

Patients who undergo PMBC or mitral valve surgery within 3 mo of diagnosis

Denominator

Patients age $18 y who are diagnosed with symptomatic severe rheumatic MS (mitral valve area #1.5 cm², Stage D) and are eligible for

PMBC or mitral valve surgery

Denominator Exclusions

Hospice, palliative care, or comfort care only

Denominator Exceptions

Documentation of medical reason(s) for not undergoing PMBC or mitral valve surgery (eg, major contraindication to or prohibitive risk for

procedure or surgery)

Documentation of patient reason(s) for not undergoing PMBC or mitral valve surgery (eg, patient preference)

Measurement Period

12 mo

Sources of Data

EHR data

Administrative data/claims (inpatient or outpatient claims)

Administrative data/claims expanded (multiple sources)

Paper medical records

Attribution

Individual practitioner (eg, cardiologist)

Care Setting

Outpatient

Rationale

The optimal treatment of patients with rheumatic MS is either PMBC or surgery.³

Mitral valve replacement is an option for treatment only if there is no other option and the patient has severe limiting symptoms.

Randomized trials have established the safety and efficacy of PMBC as compared with surgical closed or open commissurotomy in patients with a favorable valve

morphology with less than 2þ MR in the absence of LA thrombus.^186-191 PMBC is performed by advancing $1 balloon catheter across the mitral valve and inflating it,

thereby splitting the commissures. Favorable valve morphology consists of mobile and relatively thin valve leaflets, which are free of calcium, in the absence of

significant subvalvular fusion.53,192-194 An anatomic mitral morphology score can be used to determine suitability for PMBC and to evaluate the appearance of the

commissures and degree of calcification.^195-197 Clinical factors, such as age, NYHA functional class, and presence or absence of AF, are also predictive of outcome.

Older patients with lower gradients (<10 mm Hg) will not have as good an outcome as patients with higher gradients, probably because of other concomitant

problems that cause symptoms, such as LV diastolic dysfunction and LA noncompliance, measured by net atrial-ventricular compliance.^198-202 PMBC should be

performed only by experienced operators, with immediate availability of surgical backup for potential complications. Long-term follow-up has shown 70% to 80% of

patients with an initial good result after PMBC to be free of recurrent symptoms at 10 y, and 30% to 40% are free of recurrent symptoms at 20 y.188,196,203-207

Mitral valve surgery is an established therapy for rheumatic MS, with the preferred approach being commissurotomy (either closed, where the valve is opened blindly

through the LA or LV, or open, which allows more extensive surgery under direct visualization) when anatomy is favorable.^208-213 However, in the presence of severe

valvular thickening and subvalvular fibrosis with leaflet tethering, mitral valve replacement may be the best option. In addition to those who have suboptimal valve

anatomy (or failed PMBC), patients with moderate or severe TR may also have a better outcome with a surgical approach that includes tricuspid valve repair.²¹⁴

Patients undergoing mitral valve surgery at centers with a high level of expertise may have better long-term outcomes than those undergoing PMBC.188,207 Because

the natural history of rheumatic MS is one of slow progression over decades, surgery should be delayed until the patient has severe limiting symptoms (NYHA

functional class III or IV), particularly if mitral valve repair is contemplated.

Clinical Recommendation(s)

2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease³

1. In symptomatic patients (NYHA functional class II, III, or IV) with severe rheumatic MS (mitral valve area #1.5 cm², Stage D) and favorable valve morphology

with less than moderate (2þ) MR* in the absence of LA thrombus, PMBC is recommended if it can be performed at a Comprehensive Valve

Center.186-191,196,203-207 (Class 1, Level of Evidence: A)

2. In severely symptomatic patients (NYHA class III or IV) with severe rheumatic MS (mitral valve area #1.5 cm², Stage D) who 1) are not candidates for PMBC; 2)

have failed a previous PMBC; 3) require other cardiac procedures; or 4) do not have access to PMBC, mitral valve surgery (repair, commissurotomy, or valve

replacement) is indicated.188,207,215 (Class 1, Level of Evidence: B-NR)

*2þ on a 0 to 4þ scale according to Sellers’ criteria or less than moderate by Doppler echocardiography.²¹⁶

ACC indicates American College of Cardiology; AF, atrial fibrillation; AHA, American Heart Association; EHR, electronic health record; LA, left atrium (left atrial); LV, left ventricle/

ventricular; MR, mitral regurgitation; MS, mitral stenosis; NYHA, New York Heart Association; PMBC, percutaneous mitral balloon commissurotomy; QM, quality measure; and TR,

tricuspid regurgitation.

APPENDIX B. AUTHOR RELATIONSHIPS WITH INDUSTRY AND OTHER ENTITIES (COMPREHENSIVE)-2024 ACC/AHA CLINICAL PERFORMANCE

AND QUALITY MEASURES FOR VALVULAR AND STRUCTURAL HEART DISEASE

Ownership/

Institutional,

Partnership/

Personal

Organizational, or

Expert

Committee Member

Employment

Consultant

Speakers Bureau

Principal

Research

Other Financial Benefit

Witness

Hani Jneid, Chair, JCCDS Liaison,

University of Texas Medical Branch-John

None

SCAI Representative

Sealy Distinguished Centennial Chair in

Cardiology; Professor & Chief, Division of

Cardiology; Medical Director, Cardiovascular

Service Line

Joanna Chikwe, Vice Chair

Cedars-Sinai Medical Center-The Irina and

None

Not relevant:

None

George Schaeffer Distinguished Chair in

n Cedars-Sinai Medical Center*

Cardiac Surgery; Professor and Chairman,

n Edwards Lifesciences†

Department of Cardiac Surgery Smidt

Heart Institute

Suzanne V. Arnold

Saint Luke’s Mid America Heart Institute-

None

Not relevant:

None

Clinical Scholar and Cardiologist; University

n Heart Journal

of Missouri-Kansas City-Associate

Professor Department of Medicine

Robert O. Bonow,

Northwestern Memorial Hospital-Goldberg

None

Not relevant:

None

2020 ACC/AHA VHD Guideline

Distinguished Professor of Cardiology

n JAMA*

Liaison

Northwestern University

n NHLBI

Feinberg School of Medicine

Steven M. Bradley

Minneapolis Heart Institute-

Not relevant:

None

Not relevant:

None

General Cardiologist

n JAMA*

n ACC‡

n AHA‡

n CardioHealth Alliance‡

n JAMA*

n Medtronic†

Edward P. Chen

Duke University Medical Center-Professor

None

Not relevant:

None

of Surgery and Chief, Division of

n NHLBI, CTSN Working

n Allergan†

Cardiovascular and Thoracic Surgery,

Group‡

n Artivion†

Section of Surgical Disciplines

Relevant:

n Bolton Medical†

n Bolton Medical‡

n Edwards Lifesciences†

n Medtronic Cardiovascular†

n Medtronic Endovascular†

n NHLBI/Icahn School of Medicine

at Mount Sinai†

n NIH/Duke University†

n NIH/NHLBI/Emory University†

n On-X Life Technologies†

n Quark Pharmaceuticals†

n The Journal of Thoracic and Car-

diovascular Surgery‡

n W.L. Gore and Associates†

Continued on the next page

APPENDIX B. CONTINUED

Ownership/

Institutional,

Partnership/

Personal

Organizational, or

Expert

Committee Member

Employment

Consultant

Speakers Bureau

Principal

Research

Other Financial Benefit

Witness

Poonam Velagapudik

University of Nebraska Medical Center-

None

Not relevant:

None

Not relevant:

None

Chair, Early Career Section of the American

n Abiomed

College of Cardiology; Co-Chair, SCAI

Relevant:

n Chiesi

Education Committee; Assistant Professor

n Opsens

Relevant:

of Medicine; Associate Program Director,

Medical

n Boston Scientific

Cardiovascular Medicine Fellowship;

n Medtronic

Director, Digital Innovation & Social Media

Strategy, Division of Cardiology

This table represents all relationships of committee members with industry and other entities that were reported by authors, including those not deemed to be relevant to this document, at the time this document was under development. The table does

not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of $5% of the voting stock or share of the business entity or ownership

of $$5,000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. Relationships that exist with no financial benefit are also included for the

purpose of transparency. Relationships in this table are modest unless otherwise noted. Please refer to https://www.acc.org/guidelines/about-guidelines-and-clinical-documents/relationships-with-industry-policy for definitions of disclosure categories

or additional information about the ACC/AHA Disclosure Policy for Writing Committees.

*Significant relationship.

†This disclosure was entered under the Clinical Trial Enroller category in the ACC’s disclosure system. To appear in this category, the author acknowledges that there is no direct or institutional relationship with the trial sponsor as defined in the (ACCF or

AHA/ACC) Disclosure Policy for Writing Committees.

‡No financial benefit.

§Rebecca Diekemper is an AHA/ACC joint staff member and acts as the Science and Health Advisor for the “2024 ACC/AHA Clinical Performance and Quality Measures for Adults With Valvular and Structural Heart Disease.” No relevant relationships to

report. Nonvoting author on measures and not included/counted in the RWI balance for this committee.

kDuring a quarterly review of writing committee member disclosures in August 2021, Dr. Velagapudi reported receiving a speaker’s fee from Opsens Medical for a presentation on physiology-related late breaking trials. When the disclosure was reviewed

using specific ACC/AHA criteria, it was considered to represent a relevant relationship with industry. Given the current policy that at least 51% of the writing committee must be free of relevant RWI, the decision was made to remove Dr. Velagapudi from

the writing committee. The only measure that was drafted by Dr. Velagapudi was previously removed from the measure set, and she did not participate in any further discussions or review of the manuscript.

AATS indicates American Association for Thoracic Surgery; ACC, American College of Cardiology; AHA, American Heart Association; AMA, American Medical Association; CME, continuing medical education; CTSN, Cardiothoracic Surgical Trials Network;

JAMA, Journal of the American Medical Association; JCCDS, Joint Committee on Clinical Data Standards; JCPM, Joint Committee on Performance Measures; NHLBI, National Heart, Lung, and Blood Institute; NIH, National Institutes of Health; PCORI,

Patient-Centered Outcomes Research Institute; SCAI, Society for Cardiovascular Angiography and Intervention; VA, U.S. Department of Veterans Affairs; and VHD, valvular heart disease.

APPENDIX C. REVIEWER RELATIONSHIPS WITH INDUSTRY AND OTHER ENTITIES (COMPREHENSIVE)-2024 ACC/AHA CLINICAL PERFORMANCE

AND QUALITY MEASURES FOR VALVULAR AND STRUCTURAL HEART DISEASE

Institutional,

Speakers

Ownership/

Personal

Organizational, or

Reviewer

Representation

Employment

Consultant

Bureau

Partnership/Principal

Research

Other Financial Benefit

Expert Witness

Leonard N. Girardi

AATS Official Reviewer

Weill Cornell Medicine

None

Saurabh Gupta

ACC Official Reviewer

St. Charles Health System

Edwards

None

Lifesciences*

Medtronic*

Saibal Kar

SCAI Official Reviewer

HCA Healthcare

Abbott

None

n Valcare†

None

Vascular*

Boston

Scientific*

Gore*

Medtronic*

V-Wave*

Shahar Lavi

ACC Official Reviewer

London Health Sciences Centre

None

Clauden Louis

AHA Official Reviewer

BayCare Medical System

None

Puja Parikh

AHA Official Reviewer

Stony Brook University

Medtronic

None

Abbott†

None

Renaissance School of Medicine

Boehringer

Ingelheim†

Edwards

Lifesciences†

Marcella Calfon

ACC/AHA Content Reviewer

UCLA Health

Abbott

None

Cardiac Dimensions‡

None

Press

Edwards Lifesciences‡

Marc Ruel

ACC/AHA Content Reviewer

University of Ottawa Heart

Edwards

None

Artivion†

AbbVie/Allergan‡

None

Institute

Lifesciences

Medtronic†

Artivion‡

Medtronic

AstraZeneca‡

Xylocor

Medtronic‡

PhaseBio‡

Jason H. Wasfy

ACC Official Reviewer

Harvard Medical School and

ICER*

None

AHA*

Plaintiff,

Massachusetts General Hospital

Pfizer

NFLPA*

Massachusetts General

quality

NIH*

Physicians Organization*

measurement,

2022*

Jonathan Weinsaft

AHA Official Reviewer

Weill Cornell Medicine

Annapurna

General

None

Lantheus Pharmaceutical‡

Defendant,

Therapeutics*

Electric

Memorial Sloan Kettering

Cardiac

Bitterroot Bio

Cancer Center*

imaging, 2022

Lexeo

Weill Cornell Medicine*

Therapeutics*

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

VOL.

-, NO. -, 2024

ª 2024 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION

PUBLISHED BY ELSEVIER

EXPERT CONSENSUS DECISION PATHWAY

2024 ACC Expert Consensus Decision

Pathway for Treatment of Heart Failure

With Reduced Ejection Fraction

A Report of the American College of Cardiology Solution Set Oversight Committee

Writing

Thomas M. Maddox, MD, MSC, FACC, Chair

Nasrien E. Ibrahim, MD, MPH, FACC

Committee

James L. Januzzi JR, MD, FACC, Vice Chair

JoAnn Lindenfeld, MD, FACC

Frederick A. Masoudi, MD, MSPH, MACC

Larry A. Allen, MD, MHS, FACC

Shweta R. Motiwala, MD, MPH, FACC

Khadijah Breathett, MD, MS, FACC

Estefania Oliveros, MD, MSC, FACC

Sara Brouse, PHARMD, BCCP, BCPS, FACC

Mary Norine Walsh, MD, MACC

Javed Butler, MD, MBA, MPH, FACC

Alan Wasserman, MD, FACC

Leslie L. Davis, PHD, RN, ANP-BC, FACC

Clyde W. Yancy, MD, MSC, MACC

Gregg C. Fonarow, MD, FACC

Quentin R. Youmans, MD, MSC

Solution Set

Nicole M. Bhave, MD, FACC, Chair

Dharam J. Kumbhani, MD, SM, FACC

Oversight

Gurusher S. Panjrath, MBBS, FACC

Committee

Niti R. Aggarwal, MD, FACC

Barbara Wiggins, PHARMD, FACC

Katie Bates, ARNP, DNP

David E. Winchester, MD, MS, FACC

Biykem Bozkurt, MD, PHD, FACC

Megan Coylewright, MD, MPH,

John P. Erwin III, MD, FACC

FACC-Ex Officio

TABLE OF CONTENTS

OVERVIEW

2.2 Definitions

3.PATHWAY SUMMARY GRAPHIC

1.INTRODUCTION

Figure 1. Ten Pivotal Issues About HFrEF

2.ASSUMPTIONS AND DEFINITIONS

4.DESCRIPTION AND RATIONALE: ANSWERS TO 10

2.1. General Clinical Assumptions

PIVOTAL ISSUES IN HF

This document was approved by the American College of Cardiology Clinical Policy Approval Committee in February 2024.

The American College of Cardiology requests that this document be cited as follows: Maddox TM, Januzzi JL Jr, Allen LA, Breathett K, Brouse S, Butler

J, Davis LL, Fonarow GC, Ibrahim NE, Lindenfeld J, Masoudi FA, Motiwala SR, Oliveros E, Walsh MN, Wasserman A, Yancy CW, Youmans QR. 2024 ACC

expert consensus decision pathway for treatment of heart failure with reduced ejection fraction: a report of the American College of Cardiology Solution

Set Oversight Committee. J Am Coll Cardiol 2024;XX:XXX-XX.

Copies: This document is available on the website of the American College of Cardiology (www.acc.org ). For copies of this document, please contact

Elsevier Inc. Reprint Department via fax (212-633-3820) or e-mail (reprints@elsevier.com).

Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express

permission of the American College of Cardiology. Requests may be completed online via the Elsevier site (https://www.elsevier.com/about/policies/

ISSN 0735-1097/$36.00

https://doi.org/10.1016/j.jacc.2023.12.024

Maddox et al

JACC VOL.

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ACC Expert Consensus Decision Pathway for Treatment of HFrEF

-, 2024:---

4.1.

How to Initiate, Add, or Switch to Evidence-Based

5.DISCUSSIONS AND IMPLICATIONS OF PATHWAY . -

Guideline-Directed Therapy for HFrEF

4.1.1 Initiating GDMT

REFERENCES

Figure 2. Treatment Algorithm for GDMT

Figure 3. GDMT, Including Newer Therapies in

APPENDIX 1

the ECDP for Chronic HF

Author Relationships With Industry and

4.1.2 Angiotensin Receptor/Neprilysin Inhibitor . . -

Other Entities (Relevant)

4.1.3 Initiation of an ARNI De Novo Without Prior

Exposure to an ACE Inhibitor or ARB

APPENDIX 2

4.1.4 SGLT Inhibitors

Peer Reviewer Relationships With Industry and

4.1.5 Ivabradine

Other Entities (Comprehensive)

4.1.6 Vericiguat

4.1.7 Consensus Pathway Algorithm for Initiation

APPENDIX 3

and Titration of HFrEF Therapies

Abbreviations

4.1.8 Mitral Regurgitation and the Use of

Transcatheter Mitral Valve Repair

4.1.9 Patients in Whom New Therapies May Not

OVERVIEW

Be Indicated

The 2021 Update to the 2017 American College of Cardi-

4.2

How to Achieve Optimal Therapy Given Multiple

ology (ACC) Expert Consensus Decision Pathway for

Drugs for HF, Including Augmented Clinical

Optimization of Heart Failure Treatment: Answers to 10

Assessment That May Trigger Additional Changes

in GDMT (eg, Imaging Data, Biomarkers, and

Pivotal Issues About Heart Failure With Reduced Ejection

Filling Pressures)

Fraction¹ provided a practical, streamlined resource for

4.2.1 Target Doses

clinicians managing patients with heart failure with

4.2.2 Barriers to Medication Titration

reduced ejection fraction (HFrEF). The expert consensus

decision pathway (ECDP) provided guidance on intro-

4.2.3 Clinical Assessment

ducing

the

numerous

evidence-based

therapies,

Figure 4. Testing and Medication Titration

Following Diagnosis of HFrEF

improving adherence, overcoming treatment barriers,

acknowledging contraindications and situations for which

4.2.4 When to Order an Echocardiogram

little data exist, affording expensive therapies, treating

4.2.5 Biomarkers-When to Order

Natriuretic Peptides

special cohorts, and making the transition to palliative

care. Rather than focusing on extensive text, the docu-

4.2.6 Filling Pressure Assessment-When and

How to Measure Filling Pressures

ment provided practical tips, tables, and figures to make

clear the steps, tools, and provisos needed to treat the

4.3

When to Refer to an HF Specialist

patient with HFrEF successfully and expeditiously. Many

4.4

How to Optimize Care Coordination

of the pivotal issues addressed in the ECDP were not the

substance of clinical trials; rather, they represent the

4.5

How to Improve Adherence

challenge of clinical practice.

4.5.1 Medication Nonadherence

Since publication of the 2021 ECDP, new data have

4.5.2 General Approaches to

developed that necessitate an update to the ECDP,

Improving Adherence

including publication of the 2022 AHA/ACC/HFSA Guide-

4.5.3 Systems and Policies to

line for the Management of Heart Failure.² This update

Promote Adherence

thus serves as updated guidance to clinicians based on

4.6

What is Needed in Specific Patient Cohorts:

contemporary knowledge. The treatment of HFrEF can

African-American Populations, Older Adults, and

feel overwhelming, and many opportunities to improve

Patients Living With Frailty

patient outcomes are being missed; hopefully, this ECDP

4.7

How to Manage Patients’ Costs and Access to

will streamline care to realize the best possible patient

HF Medications

outcomes in HF (heart failure).

4.8

How to Manage the Increasing Complexity of

HF Management

1. INTRODUCTION

4.9

How to Manage Common Comorbidities

The prevalence of HF is escalating rapidly, with a pro-

4.10

How to Integrate Palliative Care and Transition to

jected increase of

34% in upcoming decades.3,4 Com-

Hospice Care

pounding this, HF is a syndrome that consumes

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Maddox et al

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ACC Expert Consensus Decision Pathway for Treatment of HFrEF

substantial health care resources, inflicts considerable

with left ventricular ejection fractions (LVEFs) higher

morbidity and mortality, and adversely affects quality of

than 40%, this document focuses primarily on the

life. Important breakthroughs have redefined opportu-

management of patients with chronic HFrEF with

nities to change the natural history of HF with a broad

LVEF #40% in the ambulatory setting and without

range of medical therapies, devices, and care strategies.

symptoms or signs of clinical instability. For a patient

The purpose of this document is to update the 2021

presenting with symptoms of orthopnea or uncom-

ECDP with further data from recent studies and to provide

fortable peripheral edema, the initial therapy would

succinct, practical guidance for managing patients with

include diuretic agent therapy with early follow-up to

HFrEF. The format of the

Pivotal Issues in the

ensure progress toward decongestion; following that,

prior versions of this ECDP was preserved, and their

the steps outlined in this document would apply. For

associated treatment algorithms and tables have been

more information on care of worsening HF/congestion,

updated to accommodate the evolving evidence. The

the reader is directed to the ACC ECDP on Risk

Preface and Methods sections are accessible online in the

Assessment, Management, and Clinical Trajectory of

Supplemental Appendix.

Patients Hospitalized with HF.⁶

3. The expert consensus Writing Committee endorses the

Ten Pivotal Issues in HFrEF

evidence-based approaches to HF therapy and man-

agement enumerated in the 2022 AHA/ACC/HFSA HF

1. How to initiate, add, or switch therapies with

guideline.

consideration of newer evidence-based guideline-

4. These algorithms assume the clinician will seek input

directed treatments for HFrEF.

as needed from a pharmacist, a cardiologist, an HF

2. How to achieve optimal therapy given multiple drugs

specialist, and/or a disease management program, and/

for HF, including augmented clinical assessment (eg,

or other relevant specialists (eg, endocrinologists or

imaging data, biomarkers, and filling pressures) that

nephrologists) to guide clinical management.

may trigger modifications in guideline-directed

5. In all cases, patient preferences and values, in addition

therapy.

to evidence-based clinical judgment, should guide

3. When to refer to an HF specialist.

clinical decision-making.

4. How to enhance care coordination.

6. At any point in time, these suggestions and algorithms

5. How to improve medication adherence.

6. How to tailor treatment in specific patient cohorts:

may be superseded by new data.

African-American patients, older adults, and patients

with frailty.

2.2. Definitions

7. How to manage patients’ costs and increase access to

AHA/ACC/HFSA Stages of HF:

HF medications.

n Stage A: At risk for HF but without symptoms, struc-

8. How to manage the increasing complexity of HF.

tural heart disease, or cardiac biomarkers of stretch or

9. How to manage common comorbidities.

injury (eg, patients with hypertension, atherosclerotic

10. How to integrate palliative care and the transition to

cardiovascular disease, diabetes, metabolic syndrome

hospice care.

and obesity, exposure to cardiotoxic agents, genetic

variant for cardiomyopathy, or positive family history

2. ASSUMPTIONS AND DEFINITIONS

of cardiomyopathy).

n Stage B: Structural heart disease but no prior or current

To limit inconsistencies in interpretation, specific as-

signs or symptoms of HF. Structural heart disease may

sumptions (eg, treatment effects in varied populations)

include reduced left or right ventricular function, left

were considered by the writing group in development of

ventricular (LV) hypertrophy, chamber enlargement,

the ECDP. References are supplied when applicable or

wall motion abnormalities, or valvular heart disease.

appropriate.

Additionally, evidence for increased filling pressures by

invasive hemodynamic measurements or imaging as

2.1. General Clinical Assumptions

well as elevated concentrations of B-type natriuretic

1. Although many topics are generalizable to all patients

peptide (BNP)/N-terminal pro-B-type natriuretic pep-

with HF, the focus of this effort is on patients with

tide (NT-proBNP) or high-sensitivity cardiac troponins.

HFrEF. The reader is directed to the 2023 ACC ECDP on

n Stage C: Structural heart disease with prior or current

Management of HFpEF for more focused details on

symptoms of HF.

care for this population.⁵

n Stage D: Marked HF symptoms that interfere with daily

2. Although some of the recommendations may be rele-

life, with recurrent hospitalizations despite attempts to

vant to patients hospitalized with acute HF or in those

optimize GDMT.

Maddox et al

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ACC Expert Consensus Decision Pathway for Treatment of HFrEF

-, 2024:---

GDMT: Guideline-directed medical therapy, repre-

of the “4 pillars” of GDMT to maximize the early benefits

senting treatment options supported for use by clinical

of improvement in patient-reported outcomes, reduction

practice guidelines.

in HF hospitalizations, reduction in mortality, and

HFrEF: Clinical HF and LVEF #40%.

improved adherence to GDMT.^8-14 When using the thera-

New York Heart Association (NYHA) functional

peutic standard of a 4-drug regimen (ARNI, beta-blocker,

classification:

mineralocorticoid antagonist, SGLT inhibitor), there is an

aggregate treatment effect that includes increasing years

n Class I: No limitation of physical activity. Ordinary

of survival and years free from cardiovascular (CV) death

physical activity does not cause symptoms of HF.

As an example, 4-class medica-

or HF hospitalizations.¹⁵

n Class II: Slight limitation of physical activity. Comfort-

tion initiation reduced the hazard of CV death or hospital

able at rest, but ordinary physical activity results in

admission for HF significantly (HR: 0.38; 95% CI: 0.3-0.47)

symptoms of HF.

compared with therapy with just an ACE inhibitor/ARB

n Class III: Marked limitation of physical activity.

plus a beta-blocker.^15-18

Comfortable at rest, but less than ordinary activity

Another important development since the publication

causes symptoms of HF.

of the 2021 ECDP is the growing recognition of the safety

n Class IV: Unable to perform any physical activity

and urgency of initiating therapies rapidly. As an

without symptoms of HF, or symptoms of HF at rest.

example, the STRONG-HF (Safety, Tolerability, and Effi-

Optimal therapy: GDMT provided at either the target or

cacy of Rapid Optimization, Helped by NT-proBNP

the highest-tolerated dose for a given patient.

Testing, of Heart Failure Therapies) trial showed that

Target doses: Doses targeted in clinical trials.

among patients admitted to the hospital with acute HF,

high-intensity management that included rapid up-

3. PATHWAY SUMMARY GRAPHIC

titration of GDMT and close follow-up, with a goal of

reaching target doses within 6 weeks of discharge after

Figure 1 is an update of the 2017 ACC ECDP Summary

hospitalization, was safe, well-tolerated, and associated

Graphic outlining the 10 pivotal issues about HFrEF.

with a reduced risk of 180-day all-cause death or HF

readmission compared with usual care.18,19

4. DESCRIPTION AND RATIONALE: ANSWERS

Finally, the VICTORIA (Vericiguat Global Study in Pa-

TO 10 PIVOTAL ISSUES IN HF

tients With Heart Failure and Reduced Ejection Fraction)

trial showed that in higher-risk patients with HFrEF

4.1. How to Initiate, Add, or Switch to Evidence-Based

already on GDMT with worsening symptoms, the oral

Guideline-Directed Therapy for HFrEF

soluble guanylyl cyclase stimulator vericiguat was supe-

Although loop diuretic agents are an important part of the

rior to placebo in reducing the risk of HF hospitalization

treatment of congestion in the individual with HFrEF,

and/or CV death.²⁰ Subsequently, vericiguat was given a

once approaching or achieving euvolemia, it is critical to

Class 2b recommendation in the updated 2022 AHA/ACC/

add and optimize therapies proven to reduce morbidity

HFSA HF guideline.² In light of these developments, an

and mortality. Established pharmacological therapies for

update on when and how to add, switch, and titrate all

chronic HFrEF include renin-angiotensin inhibitors such

HFrEF therapies to maximally tolerated and, ideally,

as angiotensin II receptor/neprilysin inhibitors (ARNIs),

target doses (Figure 1, Table 1) was deemed important.

angiotensin-converting enzyme (ACE) inhibitors, and

HF is a complex clinical syndrome typically associated

angiotensin receptor blockers (ARBs), along with

with multiple comorbidities; most patients are on multi-

evidence-based beta-blockers, sodium-glucose cotrans-

ple medications. No clinical trials have specifically eval-

porter (SGLT) inhibitors, mineralocorticoid antagonists,

uated the potential for greater benefit or excessive risk of

loop diuretic agents, hydralazine/isosorbide dinitrate

indicated therapies among patients with multimorbidity.

(HYD/ISDN), ivabradine, and vericiguat. With the excep-

To assess tolerability of medications and best assess the

tion of loop diuretic agents, all of these therapies have

trajectory of HF, it is often necessary for patients to have

been shown in randomized controlled trials to improve

more frequent follow-ups, especially after initiation or

symptoms, reduce hospitalizations, and/or prolong sur-

titration of therapy. These follow-ups may be in-person or

vival.2,7 In contrast, use of digoxin as a treatment for

virtual on a case-by-case basis and depending on patient

HFrEF lacks contemporary data; most of its use in modern

stability and adjustment(s) made.

HFrEF management focuses on its role as a rate control

agent for atrial fibrillation (AF) in those with low blood

4.1.1. Initiating GDMT

pressure.

Recommendations for starting GDMT in a patient with a

Since the publication of the 2021 ECDP, more data have

new diagnosis of symptomatic HFrEF are detailed in

emerged to support early and rapid initiation and titration

Figure 2.

Maddox et al

JACC VOL.

-, NO. -, 2024

ACC Expert Consensus Decision Pathway for Treatment of HFrEF

-, 2024:---

Starting and Target Doses of GDMT for HF (Choice and timing of each therapy and who should have them added are

TABLE 1

discussed in the text)*

Starting Dose

Target Dose

Beta-blockers

Bisoprolol

1.25 mg once daily

10 mg once daily

Carvedilol

3.125 mg twice daily

25 mg twice daily for weight <85 kg

and 50 mg twice daily for weight $85 kg

Metoprolol succinate

12.5-25 mg daily

200 mg daily

ARNI

Sacubitril/valsartan

24/26 mg to 49/51 mg twice daily

97/103 mg twice daily

ACE inhibitors

Captopril

6.25 mg 3 daily

50 mg 3

daily

Enalapril

2.5 mg twice daily

10-20 mg twice daily

Lisinopril

2.5-5 mg daily

20-40 mg daily

Ramipril

1.25 mg daily

10 mg daily

ARBs

Candesartan

4-8 mg daily

32 mg daily

Losartan

25-50 mg daily

150 mg daily

Valsartan

40 mg twice daily

160 mg twice daily

Mineralocorticoid antagonists

Eplerenone

25 mg daily

50 mg daily

Spironolactone

12.5-25 mg daily

25-50 mg daily

SGLT inhibitors

Dapagliflozin

10 mg daily

Empagliflozin

10 mg daily

Sotagliflozin

200 mg daily

400 mg daily

Vasodilators

Hydralazine

25 mg 3

daily

75 mg 3

daily

Isosorbide dinitrate†

20 mg 3

daily

40 mg 3

daily

Fixed-dose combination isosorbide dinitrate/hydralazine‡

20 mg/37.5 mg (one tab) 3 daily

2 tabs 3

daily

Ivabradine

2.5-5 mg twice daily

Titrate to heart rate 50-60 beats/min.

Maximum dose 7.5 mg twice daily

Oral soluble guanylyl cyclase stimulator

Vericiguat

2.5 mg daily

10 mg daily

*Digoxin remains indicated for HFrEF, but there are no contemporary data to warrant additional comment in this document. The reader is referred to already available guideline

statements.²

†Isosorbide mononitrate is not recommended by the 2022 ACC/AHA/HFSA HF guideline.²

‡The 2022 ACC/AHA/HFSA HF guideline² considers either the fixed-dose combination or the separate combination of isosorbide dinitrate and hydralazine as appropriate guideline-

directed therapy for HF.

ACC ¼ American College of Cardiology; ACE ¼ angiotensin-converting enzyme; AHA ¼ American Heart Association; ARB ¼ angiotensin receptor blocker; ARNI ¼ angiotensin re-

ceptor/neprilysin inhibitor; GDMT ¼ guideline-directed medical therapy; HF ¼ heart failure; HFrEF ¼ heart failure with reduced ejection fraction; HFSA ¼ Heart Failure Society of

America; SGLT ¼ sodium-glucose cotransporter; tab ¼ tablet.

with a goal of reaching target or maximally tolerated

antagonists. Importantly, the STRONG-HF trial had very

doses in an even shorter period. These recommenda-

limited use of ARNI, and SGLT2 inhibitor use was not

tions are because the STRONG-HF trial showed safety

prioritized. Accordingly, recognizing the challenges

and efficacy of a goal of 50% of target doses by hospital

introduced by the additional complexity of GDMT and

discharge and

100% of target doses by

weeks

potential hemodynamic impact of the preferred ARNI

following discharge from the hospital, focusing on an

class, a longer time horizon may be necessary. The

approach that used mostly ACE inhibitors/ARBs,

Writing Committee affirms potential value from more

evidence-based beta-blockers, and mineralocorticoid

rapid titration, if safely possible. In some cases, the

AHA/ACC SCIENTIFIC STATEMENT (2024) - page 5