AHA/ACC SCIENTIFIC STATEMENT (2024)

Circulation

AHA/ACC SCIENTIFIC STATEMENT

Supervised Exercise Training for Chronic Heart

Failure With Preserved Ejection Fraction:

A Scientific Statement From the American Heart

Association and American College of Cardiology

This statement is endorsed by the Heart Failure Society of America, the American Association of Cardiovascular and

Pulmonary Rehabilitation, and the American Association of Heart Failure Nurses.

Vandana Sachdev, MD, Chair*†; Kavita Sharma, MD, Vice Chair; Steven J. Keteyian, PhD; Charina F. Alcain, DNP, ACNP-BC;

Patrice Desvigne-Nickens, MD†; Jerome L. Fleg, MD, FAHA†; Viorel G. Florea, MD, PhD; Barry A. Franklin, PhD, FAHA;

Maya Guglin, MD, PhD; Martin Halle, MD; Eric S. Leifer, PhD†; Gurusher Panjrath, MD, FAHA; Emily A. Tinsley, PhD†;

Renee P. Wong, PhD†; Dalane W. Kitzman, MD, FAHA*; on behalf of the American Heart Association Heart Failure and

Transplantation Committee of the Council on Clinical Cardiology; Council on Arteriosclerosis, Thrombosis and Vascular Biology;

and American College of Cardiology

ABSTRACT: Heart failure with preserved ejection fraction (HFpEF) is one of the most common forms of heart failure; its

prevalence is increasing, and outcomes are worsening. Affected patients often experience severe exertional dyspnea

and debilitating fatigue, as well as poor quality of life, frequent hospitalizations, and a high mortality rate. Until recently,

most pharmacological intervention trials for HFpEF yielded neutral primary outcomes. In contrast, trials of exercise-based

interventions have consistently demonstrated large, significant, clinically meaningful improvements in symptoms, objectively

determined exercise capacity, and usually quality of life. This success may be attributed, at least in part, to the pleiotropic

effects of exercise, which may favorably affect the full range of abnormalities-peripheral vascular, skeletal muscle, and

cardiovascular-that contribute to exercise intolerance in HFpEF. Accordingly, this scientific statement critically examines the

currently available literature on the effects of exercise-based therapies for chronic stable HFpEF, potential mechanisms for

improvement of exercise capacity and symptoms, and how these data compare with exercise therapy for other cardiovascular

conditions. Specifically, data reviewed herein demonstrate a comparable or larger magnitude of improvement in exercise

capacity from supervised exercise training in patients with chronic HFpEF compared with those with heart failure with reduced

ejection fraction, although Medicare reimbursement is available only for the latter group. Finally, critical gaps in implementation

of exercise-based therapies for patients with HFpEF, including exercise setting, training modalities, combinations with other

strategies such as diet and medications, long-term adherence, incorporation of innovative and more accessible delivery

methods, and management of recently hospitalized patients are highlighted to provide guidance for future research.

Key Words: AHA Scientific Statements ◼ aged ◼ cardiac rehabilitation ◼ exercise therapy ◼ exercise tolerance ◼ heart failure

here have been several exercise-based therapeutic

primary outcomes with relatively large, clinically meaningful

trials in patients with chronic heart failure (HF) with

effect sizes. Whereas pharmacological studies focused on

preserved ejection fraction (HFpEF). In contrast to

clinical outcomes, the smaller exercise-based trials focused

the pharmacological trials, most of them reported positive

primarily on aerobic exercise capacity and quality of life, and

*V. Sachdev and D.W. Kitzman contributed equally.

†Disclaimer: The content of this manuscript is solely the responsibility of the authors and does not necessarily reflect the official views of the National Heart, Lung, and

Blood Institute, National Institutes of Health, or the US Department of Health and Human Services.

Supplemental Material is available at https://www.ahajournals.org/doi/suppl/10.1161/CIR.0000000000001122.

Circulation is available at www.ahajournals.org/journal/circ

Circulation. 2023;147:e699-e715. DOI: 10.1161/CIR.0000000000001122

April 18, 2023

e699

Sachdev et al

Supervised Exercise Training for Chronic HFpEF

none were adequately powered for events. However, exer-

mechanisms for its development and prognosis.^4,5,9,10 Hy-

cise capacity (ie, cardiorespiratory fitness) is an independent,

pertension is a major risk factor for HF development and

clinically meaningful patient outcome, and its measurement

is highly prevalent in those with HFpEF. Although there

is valid, objective, and reproducible. These positive data on

is evidence that treatment of hypertension may prevent

exercise capacity for patients with chronic HFpEF provided

HFpEF development,¹¹ there appears to be less effect

the impetus for the current American Heart Association

from blood pressure lowering on reducing morbidity and

and American College of Cardiology scientific statement,

death once HFpEF is established.¹¹ Overweight or obe-

which describes the quantification of exercise intolerance

sity is present in >80% of patients with HFpEF,¹² making

and its underlying mechanisms, critically examines currently

excess adiposity and the associated metabolic derange-

available data on exercise-based therapies, and discusses

ments the most common HFpEF phenotype. Multiple

the rationale for their promotion and wider dissemination.

lines of evidence indicate that body habitus, particularly

excess intra-abdominal fat stores,¹² plays a pivotal role

in the development of obese or metabolic HFpEF and

BACKGROUND

independently influences the severity of outcomes, in-

cluding both exercise capacity and subsequent clinical

HF Definition and Classification

events.¹³ Approximately 25% to 50% of patients with

Ejection fraction (EF) has traditionally been used to classify

HFpEF have diabetes, and this proportion is expected to

patients with HF because of its prognostic and therapeu-

increase. Diabetes has adverse prognostic significance

tic implications. The definitions of HFpEF have varied over

in patients with HFpEF, likely because of overlapping

time and among the studies cited, including both exercise

pathophysiological sequelae, including neurohormonal

and pharmacological trials. Thus, interpretation of results

activation, inflammation, and impaired skeletal muscle

for any subgroup of HF could differ somewhat depend-

function. Coronary artery disease is common in patients

ing on study population selection criteria. Clinical trials have

with HFpEF and is associated with a greater deteriora-

used an EF ≤35% or 40% to define HF with reduced EF

tion in left ventricular systolic function and worse out-

(HFrEF). HFpEF trials have used variable EF thresholds

comes.¹⁴ Pulmonary hypertension is common in HFpEF

of >40%, 45%, or 50% for patient selection. In 2021, a

and develops as a result of elevated left atrial pressures

universal definition of HF was proposed: “HF is a clinical

and progressive pulmonary vascular disease. There is a

syndrome with symptoms and/or signs caused by a struc-

bidirectional relationship between the heart and kidney

tural and/or functional cardiac abnormality and corroborat-

dysfunction that mediates volume overload and conges-

ed by elevated natriuretic peptide levels and/or objective

tion and is correlated with poor clinical outcomes.⁷

evidence of pulmonary or systemic congestion.”¹ In addi-

There is a high burden of sarcopenia and frailty in

tion, the following classifications were proposed and have

patients with HFpEF, and these factors are associated

been incorporated into the most recent HF guidelines²:

with worse quality of life and increased clinical events.^15,16

HFrEF includes patients with an EF ≤40%; HF with mildly

Reduced physical activity with aging and low cardiorespi-

reduced EF (HFmrEF) includes those with an EF of 41%

ratory fitness are important contributors to the develop-

to 49%; and HFpEF includes those with an EF ≥50%.¹

ment of HFpEF,^17,18 and emerging evidence demonstrates

that among patients with HFpEF, these impairments can

be improved with exercise training interventions.

Epidemiology of HFpEF

HFpEF affects approximately half of all patients with

Clinical Management of HFpEF

HF (ie, >3 million Americans), with women dispropor-

tionately affected compared with men. Its prevalence is

Patients with HFpEF may have frequent episodes of

increasing relative to HFrEF,^3-5 largely because of the

acute decompensation with volume overload and con-

aging of the population and an increasing burden of co-

gestion, often leading to hospitalizations.^4,20 However,

morbidities that contribute to its development.^4-7 HFpEF

even when their congestion has been effectively treated

has profound health consequences, including severe ex-

and they are well-compensated, stable, and nonedema-

ercise intolerance manifested by exertional dyspnea and

tous, patients with chronic, stable HFpEF often experi-

early-onset fatigue with even brief bouts of mild physical

ence severe exercise intolerance, exertional fatigue,

activity, impaired health-related quality of life, frequent

and dyspnea. Indeed, exercise intolerance is the primary

hospitalizations, loss of functional independence, in-

manifestation of chronic HFpEF and is associated with

creased death, and high healthcare use and costs.⁸

poor health-related quality of life⁴ and other adverse out-

comes. Acknowledging the importance of exercise ca-

pacity and quality of life in these patients,⁷ a recent US

Common Comorbidities

Food and Drug Administration statement emphasized

Comorbid medical conditions not only are highly prev-

that reducing symptoms and enhancing physical function

alent in HFpEF but also are linked to the underlying

are valid end points for HF drug development.²¹

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Sachdev et al

Supervised Exercise Training for Chronic HFpEF

Until recently, most HFpEF trials of pharmacologi-

Current Guidelines for HFpEF Management

cal therapy were neutral on their primary outcomes of

A new version of the American College of Cardiology/

clinical events (eg, HF hospitalizations and cardiovascu-

American Heart Association guidelines for HF manage-

lar death).^4,22 In February 2021, the US Food and Drug

ment was recently released, and HFpEF treatment rec-

Administration reviewed data on the effect of sacubitril/

ommendations have been added for sodium-glucose

valsartan and spironolactone treatment for HFpEF and

cotransporter 2 inhibitors (Class of Recommendation

granted approval for the use of sacubitril/valsartan in

2a), mineralocorticoid receptor antagonists (Class of

selected patients with HFpEF based largely on the PAR-

Recommendation 2b), and angiotensin receptor nepri-

AGON-HF (Prospective Comparison of ARNI with ARB

lysin inhibitors (Class of Recommendation 2b).² Current

Global Outcomes in HF with Preserved Ejection Fraction)

guidelines also include a Class 1 recommendation (Level

trial.²² Despite promising results from post hoc analyses

of Evidence A) for exercise training in patients with HF.²

of data from the TOPCAT trial (Treatment of Preserved

Although this recommendation does not distinguish be-

Cardiac Function Heart Failure With an Aldosterone

tween HFpEF and HFrEF, the supporting evidence for

Antagonist),²³ no final determination on spironolactone

this recommendation emanates largely from studies of

use was issued. Results from 2 unequivocally positive tri-

supervised exercise training (SET) in patients with chronic

als for HFpEF, EMPEROR PRESERVED (Empagliflozin

HFrEF. Guidelines also include comorbidity management

Outcome Trial in Patients With Chronic Heart Fail-

in the treatment of HFpEF, and patients with hyperten-

ure With Preserved Ejection Fraction)²⁴ and DELIVER

sion, obesity, and diabetes may also benefit from SET.

(Dapagliflozin Evaluation to Improve the Lives of Patients

With Preserved Ejection Fraction Heart Failure),²⁵ were

recently published and showed a reduction in the com-

ASSESSMENT AND QUANTITATION OF

bined risk of HF hospitalizations or cardiovascular death

EXERCISE INTOLERANCE IN HFpEF

with empagliflozin and dapagliflozin treatment.

In HFpEF drug trials that evaluated exercise capacity

Aerobic exercise capacity can be quantified objectively

as a primary or secondary end point, changes in exer-

and reproducibly in patients with HFpEF as peak Vo₂

cise capacity with most drugs,⁴ including spironolactone

by expired gas analysis.³⁴ Peak Vo₂ is physiologically

(mean difference in peak oxygen uptake [Vo₂] compared

meaningful because it measures the ability to transport

with control subjects, -0.4 mL∙kg-1∙min-1; P=0.38),26

(cardiac output) and use (arteriovenous O₂ difference)

sacubitril/valsartan (mean difference in 6-minute walk

oxygen. Peak Vo₂ is severely reduced by ≈30% in pa-

distance [6MWD], -2.5 m; P=0.42),²⁷ and empagliflozin

tients with HFpEF compared with age-matched healthy

(mean difference in 6MWD, 4 m; P=0.37),²⁸ have been

individuals and is similar to that in age-matched patients

disappointing. In October 2021, the first drug trial to

with HFrEF (13-14 mL∙kg^-1∙min^-1).³⁵ This reduced level

improve exercise capacity and quality of life in patients

of peak Vo₂ is below established thresholds required for

with HFpEF was published. The PRESERVED-HF trial²⁹

functional independence, including normal activities of

(Dapagliflozin in Preserved Ejection Fraction Heart Fail-

daily living such as carrying groceries.³⁶ Peak Vo₂ also

ure) showed that dapagliflozin significantly improved

has significant prognostic value in patients with HF-

the Kansas City Cardiomyopathy Questionnaire Clini-

pEF,³⁷ potentially greater than in patients with HFrEF.³⁸

cal Summary score by 5.8 points at 12 weeks, and an

However, in contrast to SET studies in patients with

increase (8.2%) in the 6MWD was observed. As previ-

HFrEF,³⁹ the relationship between changes in peak Vo₂

ously noted, these trials used varying EF thresholds

and clinical outcomes in HFpEF has not been examined.

(40%, 45%, 50%) for inclusion of patients.

The most commonly used practical alternative for as-

Several device-based solutions to relieve symptoms

sessing exercise performance in HFpEF is the 6MWD,

and to improve the clinical course of patients with HFpEF

demonstrating values that are comparable to those in

have been evaluated. Use of a wireless pulmonary artery

patients with HFrEF and markedly reduced relative to

pressure monitoring device reduced hospitalizations in all

control subjects. However, there are few or no data cor-

patients with HF³⁰; an exploratory subgroup analysis found

relating this parameter with clinical event outcomes in

that this effect was also seen in patients with HFpEF.³¹

patients with HFpEF.^40,41

Placement of an interatrial shunt device to reduce pulmo-

nary capillary wedge pressure during exercise did not reduce

HF events in patients with HFpEF.³² However, prespecified

MECHANISMS OF EXERCISE

analyses showed that latent pulmonary vascular disease in

INTOLERANCE IN CHRONIC HFpEF AND

one-third of patients identified worse outcomes, suggesting

BENEFITS FROM EXERCISE TRAINING

that two-thirds of patients may benefit.³³ Despite this recent

progress in drugs and devices, a paucity of interventions for

Several pathophysiological mechanisms are responsible for

HFpEF remains, highlighting the need to evaluate poten-

the severely reduced aerobic exercise capacity in patients

tially therapeutic lifestyle interventions.

with HFpEF. These can be broadly categorized as cardiac,

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April 18, 2023 e701

Sachdev et al

Supervised Exercise Training for Chronic HFpEF

pulmonary, vascular, and skeletal muscle. Other factors

cise intolerance in HFpEF, a reduced arteriovenous O₂

that contribute to exercise intolerance in these patients

difference accounts for >50% of the reduction in peak

involve common, coexisting risk factors and comorbidities,

Vo₂ and is a stronger independent predictor of peak Vo₂

including sedentary behavior; atrial fibrillation, which is ac-

than exercise cardiac output.^44,52 Reduced peak exercise

companied by a worse prognosis^10,42; and obesity, which

arteriovenous O₂ difference in HFpEF may be attributed

may be associated with increased plasma volume, cardiac

to the aforementioned convective and diffusive oxygen

remodeling, and potentially pericardial restraint.⁴³ Excess

delivery abnormalities, as well as multiple skeletal mus-

intra-abdominal adiposity is pivotal and has been linked to

cle abnormalities that impair oxygen utilization, including

systemic inflammation, mitochondrial dysfunction, capillary

reduced muscle mass, excess adipose infiltration, and,

rarefaction, and reduced nitric oxide bioavailability.^10,13

most important, impaired mitochondrial function.^53-59

The strongest evidence that abnormal skeletal mus-

cle mitochondrial function contributes to aerobic exer-

Cardiac and Pulmonary Mechanisms

cise intolerance was provided by phosphorous magnetic

Impaired cardiac output reserve during exercise is attrib-

resonance spectroscopy measurement of ATP and cre-

utable to modest blunting of stroke volume augmenta-

atine phosphate concentrations and turnover rates dur-

tion and to chronotropic incompetence, which occurs in

ing and after handgrip exercise using a small mass of

up to ≈50% of patients with HFpEF.⁴⁴ The blunting of

exercising muscle, a model that excluded any limitation in

stroke volume occurs despite an exaggerated increase in

cardiac output as a contributor.⁵⁹ These studies showed

filling pressures with exercise.⁴⁵ Left ventricular systolic

that patients with HFpEF have rapid muscle ATP deple-

and diastolic dysfunction and left atrial dysfunction may

tion, which was observed early during exercise, further

also impair exercise capacity.

excluding abnormalities in cardiac output and muscle

Chronically elevated left ventricular filling pressures

blood flow reserve as causes.

lead to pulmonary vascular remodeling and impaired gas

The presence of multiple skeletal muscle abnormali-

exchange with decreased lung diffusion capacity and

ties^{53,54,56,58,59} suggests that, independently of any limi-

alveolar ventilation.⁴⁶ Pulmonary hypertension is present

tations in cardiac output, patients with HFpEF have a

in >50% of patients with HFpEF; right ventricular dys-

skeletal muscle myopathy similar to that described in

function is seen in approximately one-third of patients;

HFrEF.^53,60 Furthermore, these abnormalities are not

and both can contribute to exercise intolerance and a

merely secondary to deconditioning because (1) they

poor prognosis.³⁶

develop even when physical activity is maintained dur-

ing the development of HF⁶⁰ and (2) the pattern of

abnormalities differs from deconditioning, particularly

Vascular Mechanisms

the fiber-type shift, which is the opposite of that seen

Exercise intolerance in patients with HFpEF is also asso-

in deconditioning. The intrinsic nature of skeletal muscle

ciated with abnormalities in central artery (ie, proximal tho-

dysfunction is consistent with the current HFpEF para-

racic aorta) distensibility, peripheral (eg, femoral, brachial)

digm that it is a systemic syndrome, likely triggered by

artery vasodilator capacity, and microvascular diffusive

circulating factors such as inflammatory cytokines that

function (O₂ movement from hemoglobin to mitochon-

cause dysfunction in multiple organ systems.¹⁰

dria).⁴⁷ Specifically, increased central artery stiffness cor-

relates with the observed reduction in peak Vo₂.⁴⁸ Among

Mechanisms of Benefits From Exercise Training

patients who are free of clinically manifest coronary ath-

erosclerosis, flow-mediated endothelial function is abnor-

Studies indicate that peripheral adaptations, particularly

mal compared with younger healthy individuals; however,

in skeletal muscle, are the primary mechanism for im-

this may be an age-related phenomenon because the re-

provement in peak Vo₂after exercise training in patients

duction in vasodilatory responsiveness is apparently not

with HFpEF.⁶ The reason may be that, compared with

different when patients with HFpEF are compared with

cardiac muscle, skeletal muscle is more plastic and has

healthy age-matched control subjects.^49,50 Last, microvas-

potential for rapid, large improvements in function after

cular function, which influences the diffusion of O₂ within

even a brief period of exercise.⁶¹

both the myocardium and skeletal muscle and is partly

Exercise has a broad range of benefits that are rel-

dependent on both local autoregulatory mechanisms and

evant to HFpEF, including anti-inflammatory, rheological,

capillary density, is reduced in individuals with HFpEF

lipid-lowering, antihypertensive, positive inotropic, posi-

compared with age-matched control subjects.⁵¹

tive lusitropic, negative chronotropic, vasodilation, diuretic,

weight-reducing, hypoglycemic, hypnotic, and antidepres-

sive qualities.⁶² These pleiotropic systemic effects (Fig-

Skeletal Muscle Mechanisms

ure 1) are potentially well suited for the treatment of both

Although reduced exercise cardiac output is sometimes

the cardiac and, in particular, the extracardiac abnormali-

assumed to be the primary mechanism for severe exer-

ties that contribute to exercise intolerance in HFpEF.^6,63

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Sachdev et al

Supervised Exercise Training for Chronic HFpEF

Figure 1. Pleiotropic effects of SET in chronic HFpEF.

A-Vo₂Diff indicates arteriovenous O₂ difference; HFpEF, heart failure with preserved ejection fraction; KCCQ, Kansas City Cardiomyopathy

Questionnaire; LV, left ventricular; MLHF, Minnesota Living With Heart Failure Questionnaire; and SET, supervised exercise training.

Many studies have demonstrated improvements in physi-

Of the 11 RCTs included in this review (Table 1), 8

cal function with exercise training in patients with HFpEF

had data available to calculate the effect of SET on the

and have shown favorable cardiac adaptations (increased

baseline-to-follow-up change in peak Vo₂. Two of the

maximal cardiac output), peripheral vascular changes, and

studies did not have a control group,^76,77 and 1 study did

skeletal muscle adaptations (increased oxidative muscle

not have a peak Vo₂ measurement.⁷⁵ With regard to the

fibers, reduced muscle wasting).^6,61,64-66 Compared with

evolving definition of HFpEF and its classification, 6 of 8

most drugs that have failed to show benefits, exercise

trials included in the meta-analysis used the current EF

training has shown consistent improvements in exercise

classification of HFpEF. One study used an EF of 40%

capacity in patients with HFpEF.

and 1 used 45%; both of these studies included patients

with HF with mildly reduced EF and patients with HFpEF

based on current definitions.

CRITICAL ANALYSIS OF DATA FROM

AEROBIC EXERCISE TRAINING TRIALS IN

Demographics of the Patient Population and

CHRONIC HFpEF

Potential Limitations

Because earlier randomized controlled trials (RCTs)

There was substantial variation in the baseline charac-

of SET in HF were not blinded for assessment of out-

teristics of patients with chronic HFpEF who underwent

come measures,⁴¹ this scientific statement focuses on

aerobic exercise interventions. Some studies excluded

single-blinded HFpEF trials from 2010 onward (Table 1

patients with atrial fibrillation, chronic obstructive pulmo-

and Supplemental Table 1).^67-77 Trials included in this

nary disease, and coronary artery disease, despite the

analysis were identified from a 2019 Cochrane review

fact that these comorbidities are common in individu-

of exercise-based cardiac rehabilitation (CR) for adults

als with HFpEF. Moreover, individuals with demographic

with HF⁷⁸ and related reviews and meta-analyses from

characteristics prevalent in population studies of HFpEF

PubMed.^79-83 Studies were required to have aerobic ex-

were often underrepresented, including older adults,

ercise capacity parameters as outcomes, and those that

women, individuals of lower socioeconomic status, and

enrolled both patients with HFpEF and patients with

underrepresented racial and ethnic groups. Similar to

HFrEF were excluded if results for HFpEF were not

SET studies in HFrEF, patients were clinically stable with

presented separately. Two exercise training studies were

no recent acute hospitalization. Accordingly, these exclu-

excluded because of a lack of randomization, and 5 stud-

sions limit somewhat the generalizability of the results

ies of other exercise forms (classes, functional electrical

and preclude extrapolation to patients with more severe

stimulation, tai chi, resistance training only) were exclud-

disease, particularly those with recent hospitalization who

ed (Supplemental Figure 2).

have much more severe and broader deficits in physical

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April 18, 2023 e703

Sachdev et al

Supervised Exercise Training for Chronic HFpEF

Table 1.

RCTs of Facility-Based SET in HFpEF

Study size:

Primary

exercise/

end points

Study

control

(unless

Cardiac and

author,

(blinded:

Centers,

Patient popula-

SET pro-

otherwise

vascular end

QOL end

year

Aim of study

yes/no)

tion

Type of ET

gram

noted)

points

Kitzman

To evaluate the ef-

26 ET/27

EF ≥50%, NYHA

Walking

3 times per

Improved

No change in

No change

et al,⁶⁷

fect of ET on peak

control

II-III, age 70±6 y,

wk for 4 mo

peak Vo₂,

cardiac pa-

in MLHF or

2010

Vo₂ and QOL

(yes)

17% male

ex test time,

rameters

SF36 score

6MWD

Edel-

To evaluate the effect

44 ET/20

EF ≥50%, NYHA

Bike+resistance

3 times per

Improved

Decreased

Improved

mann

of ET on functional

control

II-III, age 64±8 y,

wk, 35 min

peak Vo₂,

E/e' and LAVI

MLHF, SF36

et al,⁶⁸

capacity, cardiac

(yes)

45% male

each, for

ex test time,

score

2011

function, and QOL

6 mo

6MWD

Smart

To evaluate the effect

14 ET/16

EF ≥45%, NYHA

Bike

3 times per

Improved

No change in

et al,⁶⁹

of ET on functional

control (echo

II-III, age 67±6 y,

wk, 30 min

peak Vo₂

cardiac pa-

MLHF score

2012

capacity, cardiac

blinded, not

58% male

each, for

rameters

function, and QOL

mentioned

4 mo

for exercise

testing)

Kitzman

To evaluate the ef-

24 ET/30

EF ≥50%, NYHA

Walking+arm

3 times per

Improved

No change in

Improved

et al,⁷⁰

fect of ET on FMD,

control

II-III, age 70±7 y,

aerobics

wk for 4 mo

peak Vo₂,

FMD (primary),

SF36 score,

2013

arterial stiffness,

(yes)

28% male

ex test time,

arterial stiff-

no change in

and peak Vo₂

6MWD

ness, or cardi-

MLHF score

(secondary)

ac parameters

Kalt-

To compare danc-

18 dancing,

EF ≥40%, NYHA

Greek dance vs

3 times per

Both danc-

None

Both danc-

satou

ing vs ET vs control

17 ET/16

II-III, age 67±7 y,

bike/treadmill+

wk, 30 min

ing and ET

et al,⁷¹

on functional ca-

control

100% male

resistance vs

each, for

improved

2014

pacity

(yes)

control

1 mo

peak Vo₂, ex

SF36 score

test time

Fu et

To explore how

30 ET/29

HFpEF, HFrEF, 2

Bike (3-min in-

3 times per

Improved

Decreased

Improved

al,⁷²

aerobic interval

control (echo

control groups;

tervals)

wk, 30 min

peak Vo₂

E/e' ratio

MLHF, SF36

2016

training affects cen-

blinded, not

EF ≥50%, NYHA

each, for

scores

tral and peripheral

mentioned

II-III, age 61±3 y,

3 mo

hemodynamics

for exercise

67% male

testing)

Kitzman

To determine

46 ET/46

EF ≥50%, NYHA

2×2 factorial:

3 times per

Improved

No change

et al,⁷³

whether caloric

control

II-III, age 67±6 y,

diet, walking,

wk, 60 min

peak Vo₂,

in cardiac

in MLHF,

2016

restriction or SET

(yes)

20% male, BMI

both, control

each, for

ex test time,

function, arte-

KCCQ, or

improves exercise

≥30 kg/m²

5 mo

6MWD

rial stiffness

SF36 score

capacity and QOL

unchanged

Mueller

To compare HIIT,

58 HIIT/58

EF ≥50%, HF/high

HIIT cycle (4-

3 times

Improved

No change

No change in

et al,⁷⁴

MCT, and guideline-

MCT/60

filling pressures and

min intervals) vs

per wk all,

peak Vo₂ at

in diastolic

KCCQ score

2021

based physical

control (no)

BNP, mean age 70

MCT vs control

3 mo SET,

3 mo in HIIT

function or

at 3 mo; im-

activity on peak Vo₂

y, 33% male, mean

follow-up to

and MCT

NT-proBNP

provement in

change

BMI 30 kg/m²

12 mo

groups

MCT group

at 12 mo

Alves

To investigate the

HFpEF (EF

Treadmill or bike

3 times per

Improved

EF, E/A in-

None

et al,⁷⁵

effect of ET on exer-

HFpEF, 33

>55%), HFmrEF

wk for 4 mo

METs in

creased; DT

2012

cise tolerance and

HFmrEF/34

(EF 45%-54%),

HFpEF and

decreased

cardiac function

HFrEF (yes)

HFrEF (EF <45%),

HFmrEF

in HFpEF

control; age 63±10

groups

and HFmrEF

y, 71% male

groups

Angadi

To determine wheth-

9 HIIT/6

NYHA II-III, age

HIIT treadmill

3 times per

HIIT im-

HIIT did not

None

et al,⁷⁶

er HIIT improves

MCT (yes)

69±6 y, 89% male

(2-min intervals)

wk, 60 min

proved peak

change FMD

2015

peak Vo₂, endothe-

vs MCT

each, for

Vo₂ (sec-

(primary), HIIT

lial dysfunction, and

8 mo

ondary)

improved dia-

diastolic dysfunction

stolic function

vs aerobic continu-

ous training

Donelli

To compare the ef-

10 HIIT/9

EF ≥50%, NYHA

HIIT treadmill

3 times per

Peak Vo₂

E/e' ratio

MLHF score

da Sil-

fectiveness of HIIT

MCT (yes)

II-III, age 60±9 y,

(4-min intervals)

wk for 3 mo

improved

improved in

improved

veira

vs MCT in HFpEF

37% male

vs continuous

22% with

both groups

et al,⁷⁷

HIIT, 11%

2020

with MCT

BMI indicates body mass index; BNP, brain natriuretic peptide; DT, deceleration time; EF, ejection fraction; ET, exercise training; ex test time, exercise test time or

duration; FMD, flow-mediated dilation; HFmrEF, heart failure with mildly reduced ejection fraction; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart

failure with reduced ejection fraction; HIIT, high-intensity interval training; KCCQ, Kansas City Cardiomyopathy Questionnaire; LAVI, left atrial volume index; MCT,

moderate continuous training; MET, metabolic equivalent; MLHF, Minnesota Living With Heart Failure Questionnaire; NT-proBNP, N-terminal pro-B-type natriuretic

peptide; NYHA, New York Heart Association class; QOL, quality of life; RCT, randomized controlled trial; SET, supervised exercise training; SF36, 36-item Short Form

Health Survey; 6MWD, 6-minute walk distance; and Vo₂, oxygen consumption.

e704

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Sachdev et al

Supervised Exercise Training for Chronic HFpEF

function and may be better served by interventions other

(n=228) increased by 12% (2.0 mL∙kg^-1∙min^-1; from 15.7

than standard aerobic-based SET.^84,85

to 17.7 mL∙kg^-1∙min^-1), whereas control subjects (n=212)

had a 2% decrease (0.4 mL∙kg^-1∙min^-1; from 16.0 to 15.6

mL∙kg^-1∙min^-1; P=0.001; absolute treatment effect, 2.4

Types of Exercise Used in Clinical Trials

mL∙kg^-1∙min^-1; DerSimonian-Laird meta-analysis treat-

Exercise studies in patients with chronic, stable HFpEF

ment effect, 2.2 mL∙kg^-1∙min^-1; Supplemental Figure 2).

used various approaches for training, including walk-

Previous meta-analyses^79-81,93,94 reported similar training-

ing, stationary cycle ergometry, high-intensity interval

related increases in peak Vo₂ ranging from 1.7 to 2.7

training (HIIT), strength training, and dancing.^67-73,75-77

mL∙kg^-1∙min^-1. An increase of peak Vo₂ >6% to 7% (≈1.0

Eleven studies^{47,67-72,74-77} used facility-based SET (Ta-

mL∙kg^-1∙min^-1) is considered a clinically meaningful im-

ble 1), and 4 studies^86-89 used home-based exercise

provement in patients with HFrEF,^95,96 suggesting that the

training (Supplemental Table 1). HIIT studies used

training-related increases observed with SET in HFpEF

2- to 4-minute exercise bouts with the treadmill or

are meaningful.

cycle ergometer.^74,76,77 Although the training frequen-

Although 5 of the 8 trials in this meta-analysis are

cy was generally 3 sessions per week, the duration

single-center studies (Table 1), the recently published

ranged from 1 to 8 months, and the intensity of train-

multicenter OptimEx-Clin study⁷⁴ (Optimising Exercise

ing, when specified, varied considerably (40%-90%

Training in Prevention and Treatment of Diastolic Heart

of exercise capacity), as did the individual session

Failure), the largest trial of exercise training for chronic,

length (25-60 min).

stable HFpEF to date (n=176), also found substantial

improvements in peak Vo₂ after 3 months of HIIT (1.1

mL∙kg^-1∙min^-1) and moderate-intensity continuous train-

Outcome Measures in SET Trials

ing (MCT; 1.6 mL∙kg^-1∙min^-1) compared with control

Patients with HFpEF are often older and frail with severe,

subjects (-0.6 mL∙kg^-1∙min^-1). Although the trial did not

chronic symptoms that significantly compromise quality

meet its overly ambitious, large a priori threshold of a

of life. Thus, it is not surprising that they may place higher

2.5 mL∙kg^-1∙min^-1 improvement, there were clear ben-

value on improving symptoms rather than prolonging sur-

efits in both exercise arms, particularly with MCT, which

vival compared to other groups. In the 2017 American

may be a preferable approach in the older, frail, chronic

Heart Association statement “Prioritizing Functional Ca-

HFpEF population. This trial used an EF criterion of

pacity as a Principal End Point for Therapies Oriented to

≥50%, which is consistent with the current definition of

Older Adults With Cardiovascular Disease,” Forman et al⁹⁰

HFpEF.

emphasized that a large body of literature demonstrates

In 5 studies, total exercise time was measured and

that older adults respond favorably to and value the

shown to be increased by 21% (1.9 minutes) in the

benefits of exercise training programs. Patient-reported

SET group compared with a 1% decrease (0.1 min-

surveys indicate that improved physical function and

utes) in control subjects (P=0.003). For comparative

quality of life are preferred outcomes.⁹¹ Accordingly, pri-

purposes, a 1-minute or 10% increase in exercise

mary outcome measures for most SET studies reviewed

time is considered meaningful and has been used by

here included exercise capacity, expressed as peak Vo₂,

the US Food and Drug Administration for approval of

exercise test time or duration, 6MWD, or a combination

drugs for angina pectoris. In the 4 studies that mea-

of these measures.

sured 6MWD, distance in the SET group increased

9% (40 m) compared with a 3% (12 m) increase in

control subjects (P=0.03).

Meta-Analysis of the Effect of SET on Exercise

Capacity

Impact of SET on Quality of Life

For this scientific statement, we conducted a random-ef-

fects meta-analysis of 8 RCTs of aerobic exercise training

The effects of SET on general quality-of-life metrics have

that indicated that SET significantly improved peak Vo₂, to-

been assessed in RCTs using the 36-item Short Form

tal exercise test time, and 6MWD. Among the patients ran-

Health Survey^67,68,70-73 and on disease-specific quality of

domized to SET (n=258), baseline peak Vo₂ increased by

life with the Minnesota Living With Heart Failure Ques-

14% (2.2 mL∙kg^-1∙min^-1; from 15.8 to 18.0 mL∙kg^-1∙min^-1),

tionnaire^{67-70,72,73,77} and Kansas City Cardiomyopathy

whereas control subjects (n=245) had a 2% decrease (0.3

Questionnaire.⁷³ Although some studies show no change

mL∙kg^-1∙min^-1; from 16.2 to 15.9 mL∙kg^-1∙min^-1; P=0.002;

in quality-of-life measures,^67,70,73 others report significant

absolute treatment effect, 2.5 mL∙kg^-1∙min^-1; DerSimonian-

improvements after SET.^{68,71,72,74,77} Effect sizes from previ-

Laird⁹² meta-analysis treatment effect, 2.8 mL∙kg^-1∙min^-1;

ous meta-analyses^79-81,93,94 also show varied results, with

Figure 2; Supplemental Table 1 provides details). Among

improvement (decrease) in Minnesota Living With Heart

the 6 studies that used EF ≥50% for the definition of

Failure Questionnaire scores ranging from 4.0 to 9.1

HFpEF, baseline peak Vo₂ in patients randomized to SET

units from baseline to follow-up.

Circulation. 2023;147:e699-e715. DOI: 10.1161/CIR.0000000000001122

April 18, 2023 e705

Sachdev et al

Supervised Exercise Training for Chronic HFpEF

Figure 2. Forest plot of peak Vo₂

increase in randomized exercise

training trials in chronic HFpEF.

HFpEF indicates heart failure with

preserved ejection fraction.

Cardiovascular and Peripheral Effects of SET

proved survival in patients with and without cardiovas-

cular disease^98,99; however, this relationship has not

Multiple studies have examined the cardiovascular and pe-

been systematically examined in patients with HFpEF.

ripheral effects of SET in patients with HFpEF to better un-

To clarify this outcome, some studies of home-based

derstand the mechanisms underlying the pleiotropic effects

exercise training in HFpEF have explored its impact

(Figure 1). Among studies that examined alterations in select-

on clinical events. Although none of the studies had

ed cardiac parameters, some reported no change,^{67,69,70,73,74,87}

adequate statistical power, a recent pilot study of 50

whereas others found improvement in diastolic function

patients⁸⁶ reported fewer hospitalizations in the ex-

measures.^{68,72,75-77,88} In an observational study in which 7 of

ercise intervention group. Similarly, a rehabilitation

11 patients with HFpEF underwent cardiac catheterization

program that included home-based exercise in 85

before and after 12 months of SET,⁹⁷ there was no discern-

patients with HFpEF showed a trend toward fewer

ible impact on left ventricular filling pressures or pressure-

cardiac events in the exercise training group.⁸⁸ The

volume loops, suggesting that ventricular compliance and

inadequacy of current data highlights the need for

cardiac index remained largely unchanged.

larger-scale, longer-term studies to examine the ef-

Peripheral measures of flow-mediated dilation and

fects of SET on clinical events in HFpEF.

arterial stiffness in patients with HFpEF have dem-

onstrated abnormalities at baseline but no significant

changes in large-vessel function after SET.^70,73,76 Stud-

Safety of SET in Chronic, Stable HFpEF

ies evaluating peripheral adaptations have reported

Although regular physical activity reduces the risk of car-

increases in peak arteriovenous O₂ difference after

diovascular disease, vigorous physical activity, particularly

SET with no significant changes in peak exercise car-

when episodic and performed by unfit, inactive individu-

diac output or stroke volume.^65,72 These findings suggest

als with known or occult coronary artery disease, can

that improvements in peak Vo₂ after SET are attributable

trigger acute cardiovascular events.¹⁰⁰ Nonetheless, the

predominantly to peripheral adaptations (eg, increased

safety of SET has been consistently demonstrated in se-

mitochondrial density and function, myoglobin content,

lected middle-aged and older patients with chronic, sta-

capillary density, blood flow redistribution) that result in

ble HFpEF. A meta-analysis of 276 patients from 6 RCTs

increased diffusion capacity and oxygen extraction by

reported no exercise-related major adverse events.⁷⁹ Two

the exercising muscles.^61,66 These improvements in the

of the trials noted occasional minor, although expected,

skeletal muscle myopathy of HFpEF are not unexpected

adverse exercise responses (eg, palpitations, musculo-

and represent a promising target for novel interventions

skeletal discomfort, transient hypoglycemia).^68,70 Studies

because skeletal muscle has a much greater capacity for

of home-based exercise training reported no serious

repair and regeneration after SET than cardiac muscle.⁶¹

events. The safety of exercise in these studies may be at-

tributed partly to the careful selection of clinically stable

Effect of SET on Clinical Outcomes

patients with compensated chronic HF, no recent hospi-

Higher aerobic exercise capacity is associated with

talization, and monitoring and medical supervision during

fewer subsequent cardiovascular events and im-

exercise.

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Sachdev et al

Supervised Exercise Training for Chronic HFpEF

Adherence to SET and Long-Term Maintenance

Alternative Exercise Training Models: Home-

Data on patient adherence to the exercise program

Based and Hybrid Exercise Training

were provided in 7 of the 11 SET trials summarized

To the best of our knowledge, only 4 trials of home-based

here. Completion rates ranged from 84% to 90% in 5

exercise training for patients with chronic HFpEF have

studies.^{67,70,71,73,76} One study reported that one-third of

been published (Supplemental Table 1).^86-89 All reported

patients completed >90% of sessions and half com-

improved exercise capacity and quality-of-life metrics.

pleted 70% to 90%,⁶⁸ and the largest study (OptimEx-

However, because of the short duration (3-6 months)

Clin) reported that 80% of the HIIT group and 76%

and small number of exercising subjects (n=67) includ-

of the MCT group completed >70% of the exercise

ed, the safety and efficacy of these training regimens

sessions.⁷⁴ Interventions to promote uptake and ad-

remain unproven. Home-based CR is a relatively new

herence to exercise-based therapy may require tar-

strategy that incorporates remote coaching and supervi-

geting of patient-specific barriers to enrollment and

sion of exercise interventions that may be used alone or

participation.¹⁰¹

in combination with facility-based training (hybrid CR). To

Most SET trials have been relatively short term (3-6

date, no studies have compared these 2 approaches in

months) and were unable to address long-term adher-

patients with HFpEF. Hybrid models, in which patients

ence. Indeed, an important limitation of these studies

participate initially in medically supervised followed by

is the relatively poor long-term maintenance of benefit,

home-based activities, may reduce cost and enhance ac-

partly the result of challenges associated with continued

cessibility for eligible patients.¹⁰² The widespread avail-

patient adherence.⁴¹ In the SET trial with the longest

ability of activity trackers, smartphones, telehealth, and

duration,⁷⁶ an 8-month HIIT regimen improved peak Vo₂,

internet-based programs markedly enhances the abil-

whereas MCT showed no improvement.⁷⁶ In the recent

ity to monitor patient adherence to, responses to, and

OptimEx-Clin trial, which had a home-based exercise

progress in home-based CR programs. Future research

phase for months 4 to 12, adherence decreased to

is needed to evaluate integration of other technology ap-

56% of the HIIT group and 60% of the MCT group

plications and novel strategies and to assess their impact

completing >70% of sessions by 12 months. Long-

on patient adherence and outcomes.

term adherence to exercise training remains a critical

challenge regardless of the regimen used and should

be addressed in future studies.

CURRENT APPLICATIONS OF EXERCISE-

BASED THERAPIES FOR HFpEF AND

Effect of Combining SET and Caloric Restriction

COMPARISON WITH OTHER CONDITIONS

Given the high prevalence of the obese HFpEF pheno-

There are several types of exercise-based therapies.

type and well-documented adverse effects of excess

Self-directed exercise training is performed without

adiposity on aerobic exercise capacity, interventions

supervision and with no formal exercise prescription.

combining SET and caloric restriction may have inde-

Contemporary guidelines for all Americans recommend

pendent and additive benefits in this population. In a

≥150 min/wk of moderate-intensity physical activity

single-center 2×2 factorial trial of obese patients with

(eg, 30 minutes on 5 d/wk) and ≥2 d/wk of muscle-

HFpEF (body mass index ≥30 kg/m²) who were ≥60

strengthening activities.¹⁰³ However, there are no data

years of age and randomized to caloric restriction, SET,

on the safety and efficacy of self-directed exercise in

both, or neither, Kitzman et al⁷³ found that caloric re-

patients with HFpEF, who have far greater functional im-

striction (ie, ≈400 fewer kcal/d for 20 weeks) resulted

pairments, symptomatology, and cardiovascular risk.

in significantly greater weight loss compared with no

In clinical practice, SET is prescribed by health care

restriction (-7 kg [95% CI, -9 to -5]; P<0.001). Ex-

professionals to improve both aerobic exercise capacity

ercise also resulted in significantly greater weight loss

and quality of life. It is most often conducted in a clini-

than no exercise (-3 kg [95% CI, -5 to -1]; P<0.001)

cal setting with monitoring and typically includes at least

and significantly improved indices of inflammation

3 sessions per week of aerobic-type exercises such as

and cardiac remodeling. Peak Vo₂ improved similarly

walking on a treadmill or stationary cycling. Other types

with caloric restriction (1.3 mL∙kg-1∙min-1 [95% CI,

of activities such as muscle strengthening may also be

0.8-1.8]; P<0.001) and SET (1.2 mL∙kg^-1∙min^-1 [95%

included, and 36 visits are generally prescribed/allowed

CI, 0.7-1.7]; P<0.001). Both diet and SET resulted in

by third-party payers within a 12-week period. Structured

significant improvement in HF-specific quality-of-life

disease management interventions are not included in

measures by the Kansas City Cardiomyopathy Ques-

this model.

tionnaire, and the combination of caloric restriction

Exercise-based CR combines SET with education

and SET doubled the improvement in peak Vo₂ (2.5

that targets risk factor modification, tailored behavioral

mL∙kg^-1∙min^-1); exercise time and 6MWD also showed

interventions and counseling, psychosocial assessments,

large improvements.

and outcome (eg, clinical, behavioral, physiological)

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April 18, 2023 e707

Sachdev et al

Supervised Exercise Training for Chronic HFpEF

assessment. For covered conditions, the Centers for

HF-ACTION showed a modest, statistically significant

Medicare & Medicaid Services (CMS) typically allows 36

improvement (0.6 mL∙kg^-1∙min^-1 [4%]) in peak Vo₂ with

CR visits over a 36-week period, thus providing patients

exercise training. This effect size, which is at the lower

with more flexibility over time.

end of a clinically meaningful change, was likely attenu-

To illustrate the different SET therapies possible for

ated by suboptimal adherence; moreover, improvement in

patients with HFpEF, we describe the exercise models

quality of life was also observed.¹⁰⁷ Although interstudy

that are currently part of guideline-based therapy and

comparisons should be interpreted with caution, SET

are covered by Medicare for 2 other patient populations

studies in HFpEF have generally shown larger increases

who present with similar clinical challenges (eg, multiple

in peak Vo₂ (≈14%), above the clinically meaningful

comorbidities, exercise intolerance). Specifically, patients

threshold of a 6% to 7% increase.⁹⁵ In the only trial

with chronic, stable HFrEF have been eligible for exer-

directly comparing the effects of SET in older patients

cise-based CR coverage since

2014.¹⁰⁴ However,

with chronic HFpEF and those with chronic HFrEF, at the

patients with HFpEF were specifically excluded from

4-month follow-up, there was a large, significant peak Vo₂

Medicare coverage because of insufficient evidence at

improvement in HFpEF but not in HFrEF (18.7±17.6%

that time. Patients with symptomatic peripheral artery

versus -0.3±15.4%; P<0.001).¹⁰⁸ Overall, available data

disease (PAD) have been eligible specifically for SET

suggest that the magnitude of improvement in exercise

coverage as defined by CMS since 2017.¹⁰⁵ It is notable

capacity from SET in patients with chronic HFpEF is at

that CMS reimbursement approvals of exercise therapy,

least as great as and potentially greater than that seen in

including exercise-based CR programs for most condi-

patients with chronic HFrEF.

tions (ie, coronary artery disease, PAD, and HFrEF), were

based primarily on SET trials alone. As described, there

Comparison of SET Trials in Chronic HFpEF

is now considerable evidence for the safety and efficacy

With Trials in PAD

of SET for patients with chronic, stable HFpEF, including

exercise capacity improvements that appear similar to or

The current status of SET for patients with HFpEF is

greater than those observed in patients with HFrEF.

chronologically similar to that for patients with PAD 4 to 5

years ago. Numerous studies had consistently demonstrat-

ed a benefit in walking distance after SET in patients with

How HFpEF and HFrEF Trials Compare

PAD and intermittent claudication (Supplemental Table 2).

After many single-site studies demonstrated the benefits

In 2017, the CMS evaluated evidence on the effects of

of SET on exercise capacity in patients with HFrEF, the

SET compared with usual care in patients with PAD and

multicenter HF-ACTION trial (Heart Failure and a Con-

found that “absolute change in maximum walking distance

trolled Trial to Investigate Outcomes of Exercise Training)

and quality of life were considered the most important out-

was implemented to determine the effect of aerobic ex-

comes in measuring the success of exercise therapy.”¹⁰⁵

ercise training on clinical outcomes. This trial randomized

On the basis of these outcomes, the CMS approved SET

2331 patients with chronic HFrEF to usual care compared

coverage for patients with PAD and intermittent clau-

with usual care plus 36 supervised exercise sessions fol-

dication.¹⁰⁵ The American Heart Association/American

lowed by home exercise training.⁴¹ All-cause death or hos-

College of Cardiology clinical practice guidelines also rec-

pitalization was nonsignificantly reduced in the exercise

ommend SET as first-line therapy for this patient subset to

group compared with the usual care group (hazard ratio,

improve functional status and quality of life and to reduce

0.93 [95% CI, 0.84-1.02]; P=0.13). After adjustment for

symptomatology.¹⁰⁹ Medically supervised PAD exercise

highly prognostic baseline characteristics chosen by a pre-

programs are typically conducted in hospitals or associ-

specified, treatment-blinded selection algorithm, exercise

ated outpatient facilities, most often within the constructs

training was associated with a significant reduction in this

of a comprehensive CR service.¹⁰⁹ The current evidence

combined end point (0.89 [95% CI, 0.81-0.99]; P=0.03).

supporting improvements in exercise capacity and qual-

Largely on the basis of these findings, the American Heart

ity of life after SET in patients with HFpEF closely paral-

Association/American College of Cardiology established

lels that for PAD and supports the rationale for extending

SET as a Class 1 recommendation for the treatment of

exercise-based therapy to patients with HFpEF.

patients with HF (regardless of EF criteria), and HFrEF

was added by the CMS as an indication for CR that is cov-

ered for Medicare beneficiaries.¹⁰⁴ However, subsequent

IMPLEMENTATION OF CURRENT

meta-analyses in chronic HFrEF have shown conflicting

KNOWLEDGE, EXISTING GAPS, AND

results, with 1 analysis of 18 trials showing no signifi-

FUTURE RESEARCH DIRECTIONS

cant difference in death or hospitalizations¹⁰⁶ and another

showing some reduction in hospitalizations,⁷⁸ thus shifting

The strength of currently available data on SET for chronic,

the focus of SET benefits back to improvement of exer-

stable HFpEF and the paucity of effective pharmacologi-

cise capacity and quality of life.

cal therapies provide substantial rationale for increasing

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Sachdev et al

Supervised Exercise Training for Chronic HFpEF

populations; using innovative technology to facilitate

Table 2. Critical Gaps in Exercise-Based Therapy in HFpEF

cost-effectiveness; and implementing larger, longer-

Recommended focus areas for future trials

term trials to determine the potential effect of exercise-

Setting: supervised, community based, home based, or hybrid

based therapies on hospitalization, death, cardiovascular

Modalities: HIIT, continuous aerobic training, strength training, or combi-

events, and health care expenditures. Our meta-analysis

nation

included only 2 studies that enrolled both patients with

Combination with other lifestyle interventions or medications: dietary

weight loss, comprehensive CR, or ET alone

HFpEF and patients with HF with mildly reduced EF

according to current definitions. Therefore, more studies

Strategies for long-term adherence: most trials are short-term and long-

term maintenance is modest

on the HF with mildly reduced EF subgroup may help

clarify their response to SET. Although there is sufficient

Strategies to increase accessibility: particularly for underresourced populations

evidence to support improvement in exercise capacity

Minimize costs: can specific settings/modalities improve access and

minimize costs

with exercise-based treatments in patients with HFpEF,

there may also be a role for these interventions in the

Role in management of recently hospitalized, older adults: frailty, impaired

balance, and cognition may require innovative interventions

prevention of HFpEF. Further studies of SET and home-

based exercise to prevent the development of HFpEF in

Effect on clinical events (hospitalization, death): larger studies and long-

term follow-up are necessary

patients with multiple risk factors are warranted.

Preventing the development of HFpEF: supervised or home-based train-

An additional key evidence gap concerns the use of

ing in patients with multiple risk factors

exercise therapy in patients recently hospitalized with

CR indicates cardiac rehabilitation; ET, exercise training; HFpEF, heart failure

acute, decompensated HF, a high-risk population distinct

with preserved ejection fraction; and HIIT, high-intensity interval training.

from those with chronic, stable HF. Such patients have high

rates of frailty (>90%) and marked impairments in bal-

efforts to promote and implement exercise-based thera-

ance, mobility, and strength, in addition to poor endurance,²⁰

pies for this large, inadequately treated, growing patient

which is the primary domain impairment in chronic, stable

population. Many RCTs have demonstrated that SET is

HF. Exposing such patients to standard SET can potentially

safe and effective for the entire spectrum of chronic HF,

limit efficacy and increase injuries and falls.¹¹¹ In the recent

including HFpEF. Implementation efforts are warranted

REHAB-HF trial (Rehabilitation Therapy in Older Acute

and include frameworks for improving referral rates, strat-

Heart Failure Patients), which included patients with HFrEF

egies to increase access to exercise-based programs,

and HFpEF, a novel, tailored, progressive, transitional, mul-

and methods to facilitate adherence. Exercise training

tidomain physical rehabilitation intervention initiated during

is significantly underused in patients with HF, with much

hospitalization improved frailty, physical function, and qual-

lower participation among women and Black patients

ity of life but had no significant effect on rehospitalization

highlighting existing disparities.¹¹⁰ Several strategies have

or death.¹¹² A secondary analysis of the trial found that at

been proposed to address this implementation gap, in-

baseline, among the 53% of patients with HFpEF, frailty,

cluding educating patients and physicians about the ben-

physical function, and quality of life were significantly worse

efits of SET, addressing logistical and social determinants

than in those with HFrEF, and benefits appeared greater in

of health challenges for patients and communities, and

patients with HFpEF.¹⁹ There also appeared to be a trend

broadening criteria for referrals and reimbursement.¹¹⁰

for reduced rehospitalization and death in patients with

Simultaneously, additional research is needed to

HFpEF but not in those with HFrEF.¹⁹ However, this was

extend access to exercise-based therapy for patients

an exploratory analysis of an underpowered, phase 2 trial;

with HFpEF. Although implementation of SET for chronic,

a larger trial is needed to definitively test this novel reha-

stable HFpEF appears reasonable on the basis of the

bilitation strategy for patients recently hospitalized with

considerable volume of data, available evidence on the

acute HFpEF.¹⁹ A recently instituted National Institutes of

safety and efficacy of exercise therapy in other settings

Health-sponsored multicenter, RCT (NCT05525663) is

such as community and home-based programs is more

specifically designed to address this key gap.

limited and is especially important for underrepresented

groups. The coronavirus disease 2019 (COVID-19) pan-

CONCLUSIONS

demic has increased the urgency of defining alterna-

tive rehabilitation delivery models that are effective for

Improved management of the large, inadequately treated

patients with chronic HF. These are key areas of focus

population of patients with HFpEF represents an urgent

for future research efforts. Additional important evidence

unmet need. HFpEF prevalence continues to increase

gaps include the following (Table 2): clarifying the opti-

as a result of aging of the population and the growing

mal exercise modalities; delineating the independent and

prevalence of risk factors such as obesity and diabetes.

additive benefits of combining exercise interventions with

It is now well accepted that despite similar clinical pre-

other lifestyle interventions and medications; identifying

sentations for all patients with HF, HFrEF and HFpEF

strategies to increase long-term adherence; improving

are mechanistically distinct diseases. In support of this

accessibility of these interventions to underresourced

concept is the lack of efficacy of multiple drug classes

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April 18, 2023 e709

Sachdev et al

Supervised Exercise Training for Chronic HFpEF

in HFpEF trials although they had been proven effec-

ARTICLE INFORMATION

tive in patients with HFrEF. HFpEF is a complex and

The American Heart Association and the American College of Cardiology make

heterogeneous clinical syndrome with pathophysiologi-

every effort to avoid any actual or potential conflicts of interest that may arise as

a result of an outside relationship or a personal, professional, or business interest

cal mechanisms linked to chronic systemic inflammation

of a member of the writing panel. Specifically, all members of the writing group

and metabolic stress from comorbid conditions. Although

are required to complete and submit a Disclosure Questionnaire showing all such

outcomes remain poor for all patients with HF, population

relationships that might be perceived as real or potential conflicts of interest.

This document was approved by the American Heart Association Science Ad-

and clinical trials of chronic, stable HFpEF show lower

visory and Coordinating Committee September 12, 2022, and the American Heart

death and cardiovascular hospitalization rates compared

Association Executive Committee September 26, 2022, and the American College

with HFrEF, making a large clinical trial for these events

of Cardiology Clinical Policy Approval Committee September 26, 2022.

The American Heart Association requests that this document be cited as

in HFpEF more challenging.

follows: Sachdev V, Sharma K, Keteyian SJ, Alcain CF, Desvigne-Nickens P, Fleg

Our review demonstrates that in multiple RCTs of SET

JL, Florea VG, Franklin BA, Guglin M, Halle M, Leifer ES, Panjrath G, Tinsley EA,

in selected patients with chronic, stable HFpEF, exer-

Wong RP, Kitzman DW; on behalf of the American Heart Association Heart Fail-

ure and Transplantation Committee of the Council on Clinical Cardiology; Council

cise is safe and provides substantial, clinically relevant

on Arteriosclerosis, Thrombosis and Vascular Biology; and American College of

improvements in aerobic exercise capacity and quality of

Cardiology. Supervised exercise training for chronic heart failure with preserved

life. Surveys in older patients have shown that they value

ejection fraction: a scientific statement from the American Heart Association

and American College of Cardiology. Circulation. 2023;147:e699-e715. doi:

these as important outcomes, and these outcomes are

10.1161/CIR.0000000000001122

considered to be appropriate end points for drug devel-

This article has been copublished in the Journal of the American College of

opment by the US Food and Drug Administration. The

Cardiology.

Copies: This document is available on the websites of the American Heart

magnitude of benefits on exercise capacity and quality of

Association (professional.heart.org) and the American College of Cardiology

life appears comparable to or potentially greater than that

(www.acc.org). A copy of the document is also available at https://professional.

for other cardiovascular conditions (eg, HFrEF, PAD) for

heart.org/statements by selecting the “Guidelines & Statements” button. To

purchase additional reprints, call 215-356-2721 or email Meredith.Edelman@

which exercise-based therapies (eg, CR) are now typically

wolterskluwer.com.

covered by third-party payers such as Medicare. These

The expert peer review of AHA-commissioned documents (eg, scientific

findings highlight the importance of exercise-based ther-

statements, clinical practice guidelines, systematic reviews) is conducted by the

AHA Office of Science Operations. For more on AHA statements and guidelines

apies for chronic, stable HFpEF and for pursuing referral,

development, visit https://professional.heart.org/statements. Select the “Guide-

adherence, and coverage efforts during implementation.

lines & Statements” drop-down menu near the top of the webpage, then click

Future research should focus on maximizing the benefits

“Publication Development.”

Permissions: Multiple copies, modification, alteration, enhancement, and dis-

and accessibility of SET for chronic HFpEF; extending its

tribution of this document are not permitted without the express permission of the

availability to medically supervised group, home-based,

American Heart Association. Instructions for obtaining permission are located at

and hybrid CR settings; and addressing common barriers

Form” appears in the second paragraph (https://www.heart.org/en/about-us/

to long-term adherence.

statements-and-policies/copyright-request-form).

Disclosures

Writing Group Disclosures

Writing

Other

Speakers’

group

research

bureau/

Expert

Ownership

Consultant/

member

Employment

Research grant

support

honoraria

witness

interest

advisory board

Other

Vandana

National Heart, Lung, and

None

Sachdev

Blood Institute

Kavita

Johns Hopkins University

Amgen (research

None

Amgen*;

None

Alleviant (unpaid)*;

None

Sharma

School of Medicine

grant funding)†;

Bayer*;

AstraZeneca*;

AHA†

Janssen*

Bayer*; Boehringer-

Ingelheim*; Novar-

tis*; NovoNordisk*;

RIVUS*

Charina F.

University of Chicago

None

Alcain

Patrice

National Heart, Lung, and

None

Desvigne-

Blood Institute

Nickens

Jerome L.

National Heart, Lung, and

None

Fleg

Blood Institute

Viorel G.

Minneapolis VA Health Care

None

Florea

System

(Continued )

e710

April 18, 2023

Circulation. 2023;147:e699-e715. DOI: 10.1161/CIR.0000000000001122

Sachdev et al

Supervised Exercise Training for Chronic HFpEF

Writing Group Disclosures Continued

Writing

Other

Speakers’

group

research

bureau/

Expert

Ownership

Consultant/

member

Employment

Research grant

support

honoraria

witness

interest

advisory board

Other

Barry A.

Beaumont Health Preventive

None

Franklin

Cardiology and Cardiac Re-

habilitation

Maya Guglin

Indiana University

None

Martin Halle

Technische Universitaet

NIH (clinical trial)†

None

Medical Park

Muenchen (Germany)

Rehabilitation

Group (medical

supervisor)†

Steven J.

Henry Ford Health

NIH (clinical trial)†

None

Abt, Inc†

None

Keteyian

Dalane W.

Wake Forest University

Novo Nordisk

None

NIH*; Novo Nord-

None

Kitzman

School of Medicine

(clinical trial)†; NIH

isk†; Rivus† Boeh-

(funded clinical

ringer-Ingleheim†;

studies)†; Rivus

Astra Zeneca†

(clinical trial)†; Pfiz-

er (clinical study)†;

Astra Zeneca (clini-

cal study)†; Bayer

(clinical study)†

Eric S. Leifer

National Heart, Lung, and

None

Blood Institute

Gurusher

George Washington Uni-

None

Defen-

None

Panjrath

versity

dant†

Emily A.

National Heart, Lung, and

None

Tinsley

Blood Institute

Renee P.

National Heart, Lung, and

None

Wong

Blood Institute

This table represents the relationships of writing group members that may be perceived as actual or reasonably perceived conflicts of interest as reported on the

Disclosure Questionnaire, which all members of the writing group are required to complete and submit. A relationship is considered to be “significant” if (a) the person

receives $5000 or more during any 12-month period, or 5% or more of the person’s gross income; or (b) the person owns 5% or more of the voting stock or share of the

entity, or owns $5000 or more of the fair market value of the entity. A relationship is considered to be “modest” if it is less than “significant” under the preceding definition.

*Modest.

†Significant.

Reviewer Disclosures

Other

Speakers’

Consultant/

Research

research

bureau/

Expert

Ownership

advisory

Reviewer

Employment

grant

support

honoraria

witness

interest

board

Other

Susan D’Anna

Dartmouth Hitchcock Medical Center

None

Nasrien Ibrahim

Massachusetts General Hospital

None

Richard Josephson

University Hospitals

None

Ran Lee

Cleveland Clinic Foundation

None

Ambarish Pandey

University of Texas Southwestern

None

Medical Center

David Whellan

Thomas Jefferson University

None

This table represents the relationships of reviewers that may be perceived as actual or reasonably perceived conflicts of interest as reported on the Disclosure

Questionnaire, which all reviewers are required to complete and submit. A relationship is considered to be “significant” if (a) the person receives $5000 or more during

any 12-month period, or 5% or more of the person’s gross income; or (b) the person owns 5% or more of the voting stock or share of the entity, or owns $5000 or

more of the fair market value of the entity. A relationship is considered to be “modest” if it is less than “significant” under the preceding definition.

2. Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM,

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April 18, 2023 e715

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

VOL.

-, NO. -, 2024

ª 2024 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION AND THE

AMERICAN HEART ASSOCIATION, INC. PUBLISHED BY ELSEVIER.

PERFORMANCE AND QUALITY MEASURES

2024 ACC/AHA Clinical Performance

and Quality Measures for Adults With

Valvular and Structural Heart Disease

A Report of the American Heart Association/American College of Cardiology Joint Committee on

Performance Measures

Developed in Collaboration With the American Association for Thoracic Surgery and the Society for

Cardiovascular Angiography and Interventions

Endorsed by the American Society of Echocardiography and the Heart Rhythm Society

Writing

Hani Jneid, MD, FACC, FAHA, FSCAI, Chair*y

Arunima Misra, MD, FACC, FASE

Committee

Joanna Chikwe, MD, FACC, FAHA, Vice Chair

Manesh R. Patel, MD, FACC, FAHA{

Members

Ranya N. Sweis, MD, MS, FACC, FSCAI

Suzanne V. Arnold, MD, MHA, FAHA

Molly Szerlip, MD, FACC, FSCAI

Robert O. Bonow, MD, MS, MACC, FAHAz

Steven M. Bradley, MD, MPH, FACC, FAHA

*ACC/AHA Joint Committee on Clinical Data Standards liaison.

Edward P. Chen, MD, FAHA

ySociety for Cardiovascular Angiography and Interventions

Rebecca L. Diekemper, MPHx

representative.

Setri Fugar, MD

z2020 ACC/AHA Valvular Heart Disease Guideline liaison.

Douglas R. Johnston, MDk

xAHA/ACC joint staff representative.

kAmerican Association for Thoracic Surgery representative.

Dharam J. Kumbhani, MD, SM, MRCP, FACC, FAHA,

{AHA/ACC Joint Committee on Performance Measures liaison.

FSCAI

Roxana Mehran, MD, FACC, FAHA, MSCAI

AHA/ACC Joint

Biykem Bozkurt, MD, PhD, FACC, FAHA, Chair

Hani Jneid, MD, FACC, FAHA, FSCAI#

Committee on

Boback Ziaeian, MD, PhD, FACC, FAHA, Chair-Elect

Sabeeda Kadavath, MD

Performance

Dinesh Kalra, MD, FACC

Measures

Zaid Almarzooq, MB BCh, FACC#

Sadiya S. Khan, MD, MSc, FAHA

H. Vernon (Skip) Anderson, MD, FACC, FAHA, FSCAI

Chayakrit Krittanawong, MD#

Ingabire Grace Balinda, MD, MS, FACC

Christopher Lee, PhD, RN, FAHA

Ankeet Bhatt, MD, MBA#

Leo Lopez, MD, FACC, FAHA#

Jeffrey Bruckel, MD, MPH, FACC

Jeffrey W. Olin, DO, FACC, FAHA#

Leslie Cho, MD, FACC, FSCAI

Gurusher Panjrath, MD, FACC, FAHA

Sandeep Das, MD, MPH, FACC, FAHA#

Puja B. Parikh, MD, MPH, FACC, FAHA, FSCAI

Michael Dorsch, PharmD, MS, FACC, FAHA

Manesh R. Patel, MD, FACC, FAHA#

Daniel Duprez, MD, PhD, FACC, FAHA

Faisal Rahman, BM, BCh#

Joao F. Monteiro Ferreira, MD, PhD, FACC#

Nosheen Reza, MD, FACC

Marat Fudim, MD, MHS#

Marlene S. Williams, MD, FACC

Stacy Garcia, MBA-HCM, BSN, RN, RT(R)

Paul L. Hess, MD, MHS

#Former Joint Committee on Performance Measures member; current

member during initiation of the writing effort.

Caitlin W. Hicks, MD, MS#

**Former Joint Committee on Performance Measures chair; chair during

P. Michael Ho, MD, PhD, FACC, FAHA**

initiation of the writing effort.

ISSN 0735-1097/$36.00

https://doi.org/10.1016/j.jacc.2023.12.006

Jneid et al

JACC VOL.

-, NO. -, 2024

2024 ACC/AHA Valvular and Structural Heart Disease Measures

-, 2024:---

TABLE OF CONTENTS

TOP 10 TAKE-HOME MESSAGES

4.AREAS FOR FURTHER RESEARCH

PREAMBLE

REFERENCES

APPENDIX A. VHD MEASURE SET

1.INTRODUCTION

Performance Measures for VHD

1.1 Scope of the Problem

Short Title: PM-1: VKA for Mechanical Heart Valves

1.2. Disclosure of Relationships With Industry and

(Outpatient Setting)

Other Entities

Short Title: PM-2: AV Intervention for Severe

Symptomatic AS (Outpatient Setting)

2.METHODOLOGY

Short Title: PM-3: AV Surgery for Chronic Severe

AR (Outpatient Setting)

2.1. Literature Review

Short Title: PM-4: TTE for Asymptomatic Chronic

2.2. Definition and Selection of Measures

Severe Primary MR (Inpatient and

Outpatient Setting)

Short Title: PM-5: Mitral Valve Intervention for

3.ACC/AHA VHD MEASURE SET

Chronic Severe Primary MR (Outpatient Setting)

3.1. Discussion of VHD Measure Set

Quality Measures for VHD

3.1.1. Retired Measures

Short Title: QM-1: Documentation of Risk and

3.1.2. Revised Measures

Heart Team Discussion Before SAVR or TAVI

3.1.3. New Measures

(Inpatient Setting)

The Measure is not a clinical practice guideline, does not establish a standard of medical care, and has not been tested for all potential

applications.

The Measure, although copyrighted, can be reproduced and distributed, without modification, for noncommercial purposes (eg, use by

health care professionals in connection with their practices). Commercial use is defined as the sale, license, or distribution of the Measure for

commercial gain or incorporation of the Measure into a product or service that is sold, licensed, or distributed for commercial gain.

Commercial uses of the Measure require a license agreement between the user and the American College of Cardiology (ACC) or the

American Heart Association (AHA). The ACC, AHA, and their members shall not be responsible for any use of the Measure.

The ACC and AHA encourage use of the Measure by other health care professionals, where appropriate.

The Measure and specifications are provided “as is” without warranty of any kind.

Limited proprietary coding is contained in the Measure specifications for convenience. Users of the proprietary code sets should obtain all

necessary licenses from the owners of these code sets. The ACC and AHA, and their members, disclaim all liability for use or accuracy of any

Current Procedural Terminology or other coding contained in the specifications.

This document underwent a 14-day peer review between April 12, 2023, and April 26, 2023, and a 30-day public comment period between

April 12, 2023, and May 12, 2023.

This document was approved by the American College of Cardiology Clinical Policy Approval Committee and the American Heart As-

sociation Science Advisory and Coordinating Committee in December 2023; and by the American College of Cardiology Science and Quality

Committee, the American Heart Association Executive Committee, the American Association for Thoracic Surgery, and the Society for

Cardiovascular Angiography and Interventions in January 2024.

The American College of Cardiology requests that this document be cited as follows: Jneid H, Chikwe J, Arnold SV, Bonow RO, Bradley SM,

Chen EP, Diekemper RL, Fugar S, Johnston DR, Kumbhani DJ, Mehran R, Misra A, Patel MR, Sweis RN, Szerlip M. 2024 ACC/AHA clinical

performance and quality measures for adults with valvular and structural heart disease: a report of the American Heart Association/

American College of Cardiology Joint Committee on Performance Measures. J Am Coll Cardiol. 2024;XX:XXX-XXX.

This article has been copublished in Circulation: Cardiovascular Quality and Outcomes.

Copies: This document is available on the websites of the American College of Cardiology (www.acc.org ) and the American Heart As-

sociation (professional.heart.org). For copies of this document, please contact Elsevier Inc.’s Reprint Department via fax (212-633-3820) or e-

mail (reprints@elsevier.com).

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2024 ACC/AHA Valvular and Structural Heart Disease Measures

Short Title: QM-2: AVR for Asymptomatic AS With

and relative exceptions, which may be medical- or

LV Systolic Dysfunction (Outpatient Setting)

patient-related (eg, active bleeding, patient refusal).

Short Title: QM-3: TAVI for Severe Symptomatic AS

7. Of the performance measures, 4 are related to proven

>80 Years of Age (Outpatient Setting)

therapies (1 is a medical treatment and 3 are surgical

Short Title: QM-4: Post-AVR Echocardiogram

or catheter-based interventions), and 1 pertains to a

(Outpatient Setting)

diagnostic modality.

Short Title: QM-5: Adequate BP Control in AR

8. The 1 performance measure pertinent to medical

Patients (Outpatient Setting)

treatment pertains to the prescription of a vitamin K

Short Title: QM-6: Treatment for Symptomatic

antagonist (eg, warfarin) in patients with mechanical

Severe Rheumatic MS (Outpatient Setting)

prosthetic valves, which has been proven to prevent

valve thrombosis and thromboembolic events.

APPENDIX B. AUTHOR RELATIONSHIPS WITH

9. Three performance measures pertain to the imple-

INDUSTRY AND OTHER ENTITIES

mentation of an appropriate valve intervention in

(COMPREHENSIVE)

patients with the following: (1) severe symptomatic

aortic valve stenosis; (2) chronic severe aortic regur-

APPENDIX C. REVIEWER RELATIONSHIPS WITH

gitation (symptomatic, or asymptomatic with left

INDUSTRY AND OTHER ENTITIES

ventricular systolic dysfunction); and (3) chronic se-

(COMPREHENSIVE)

vere primary mitral regurgitation (symptomatic, or

asymptomatic

with

left

ventricular

systolic

dysfunction).

TOP 10 TAKE-HOME MESSAGES FOR

10. A notable quality measure is the objective documen-

ADULTS WITH VALVULAR AND STRUCTURAL

tation of risk while using a procedural risk score (eg,

HEART DISEASE

the web-based Society of Thoracic Surgeons Risk

Calculator), and documentation of a multifaceted

1. The current document includes a comprehensive list

heart valve team discussion whenever a valvular

of 11 measures (5 performance measures and 6 quality

procedure

surgical

intervention

being

measures) that can be clinically used in patients with

considered.

valvular heart disease.

2. All 5 performance measures fulfill the attributes of

performance measures (eg, high impact, targeting

PREAMBLE

meaningful gaps in care, actionable, relatively low

abstraction burden [in terms of cost, effort, and time],

The American Heart Association (AHA)/American College

unlikely to have unintended consequences with their

of Cardiology (ACC) performance measurement sets serve

implementation), and are based on Class 1 clinical

as vehicles to accelerate translation of scientific evidence

practice guideline recommendations.

into clinical practice. Measure sets developed by the AHA/

3. The 5 performance measures listed are appropriate for

ACC are intended to provide practitioners and institutions

public reporting or pay-for-performance programs.

that deliver cardiovascular services with tools to measure

4. The quality measures are not ready for public report-

the quality of care provided and identify opportunities for

ing or pay for performance but may be useful for cli-

improvement.

nicians and health care organizations for internal

Writing committees are instructed to consider the

review and quality improvement. Quality measures

methodology of performance measure development1,2

may be upgraded in the future to a performance

and to ensure that the measures developed are aligned

measure status after being assessed in real-world

with ACC/AHA clinical practice guidelines. The writing

clinical practice, or can be completely retired in

committees are also charged with constructing measures

certain instances. For example, instances in which

that maximally capture important aspects of care quality,

performance measures could be retired include very

including timeliness, safety, effectiveness, efficiency,

high levels of performance ("topping out") or new

equity, and patient-centeredness, while minimizing,

evidence showing marginal clinical impact or un-

when possible, the reporting burden imposed on hospi-

foreseen adverse consequences, such as risk aversion.

tals, practices, and practitioners.

5. All measures pertain to the outpatient setting except 1

Potential challenges from measure implementation

quality measure that applies predominantly to the

may lead to unintended consequences. The manner in

inpatient setting.

which challenges are addressed is dependent on several

6. The measures are well defined and include definite

factors, including the measure design, data collection

exclusions (eg, hospice, palliative care, comfort care)

method, performance attribution, baseline performance

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rates, reporting methods, and incentives linked to these

Table 2, which provides information on the measure

reports.

number, measure title, and care setting. The detailed

The AHA/ACC Joint Committee on Performance Mea-

measure specifications (Appendix A) provide not only the

sures (Joint Committee) distinguishes performance mea-

information included in Table 2 but also provide more

sures from quality measures. Performance measures are

detailed information, including the measure description,

generally selected from the highest level of evidence,

numerator, denominator (including denominator exclu-

usually from Class 1 or 3 recommendations of clinical

sions and exceptions), rationale for the measure, guide-

practice guidelines. They are commonly used for national

line that supports the measure, measurement period,

quality improvement efforts, public reporting, and pay-

source of data, and attribution.

for-performance programs. In contrast, quality measures

The writing committee developed a comprehensive

may not have as much evidence base and generally

VHD measure set of 11 measures that includes 5 perfor-

comprise metrics that may be useful for local quality

mance measures and 6 quality measures as summarized

improvement but are not yet appropriate for public

in Table 2 and Appendix A. The writing committee be-

reporting or pay-for-performance programs. New mea-

lieves that implementation of this measure set by health

sures are initially evaluated for potential inclusion as

care practitioners and facilities will improve care and

performance measures. In some cases, a measure is

outcomes and will help measure and compare health care

insufficiently supported by the clinical practice guide-

among practitioners and facilities.

lines. In other instances, when the clinical practice

1.1. Scope of the Problem

guidelines support a measure, the writing committee may

feel it is necessary to have the measure tested to identify

VHD encompasses a large spectrum of diseases with var-

the consequences of measure implementation. Quality

iable pathophysiology, valve hemodynamics, clinical

measures then may be promoted to the status of perfor-

presentation, impact on cardiac structure and function,

mance measures as supporting evidence becomes

and outcomes. Common VHDs include-but are not

available.

limited to-aortic stenosis (AS), aortic regurgitation,

Biykem Bozkurt, MD, PhD, FACC, FAHA

mitral stenosis, mitral regurgitation (MR), tricuspid ste-

Chair, AHA/ACC Joint Committee on

nosis, tricuspid regurgitation, pulmonic stenosis, and

Performance Measures

pulmonic regurgitation. The realm of VHD expands to also

include the management of prosthetic valve disease and

1. INTRODUCTION

issues related to anticoagulation therapies, as well as

prevention and management considerations for infective

In 2021, the Joint Committee convened the writing com-

endocarditis and rheumatic fever prophylaxis. Although

mittee to begin the process of developing a performance

rheumatic valve disease has an infectious etiology at its

measure set for valvular heart disease (VHD). The writing

origin, it is a rare form of VHD in the United States, and

committee was charged with the task of developing new

most VHDs fall within the category of chronic non-

measures to evaluate the care of patients in accordance

communicable diseases. In the age of delayed degenera-

with the “2020 ACC/AHA Guideline for the Management

tive diseases, VHDs are highly prevalent and are expected

of Patients With Valvular Heart Disease.”³

to further increase in prevalence as the population ages,

This performance and quality measure set addresses

therefore representing a major cause of morbidity and

care in the inpatient and outpatient settings. All Class 1

death.

(strong) and 3 (no benefit or harmful, process to be avoi-

In a cohort of 2,500 subjects who were $65 years of age

ded) guideline-recommended treatments or care pro-

and identified from a primary care population, a com-

cesses were considered for inclusion as performance and

munity screening protocol by transthoracic echocardiog-

quality measures. The current Class of Recommendation

raphy detected newly identified VHD in 51% of subjects.⁴

and Level of Evidence guideline classification scheme

The most common of those were mild lesions, namely

used by the ACC and AHA in their clinical practice

aortic valve sclerosis and MR, which accounted for 56% of

guidelines is shown in Table 1. The value (benefit and

all newly identified VHDs. On the other hand, clinically

cost) of a treatment or process of care was also consid-

significant VHD (eg, undiagnosed moderate or severe le-

ered. If high-quality, published, cost-effectiveness

sions) was identified in 6.4% of subjects.⁴ Importantly,

studies indicated that a Class 1 guideline recommenda-

the likelihood of undiagnosed VHD was higher in the low

tion for a treatment or process of care is considered a poor

socioeconomic groups, which increases the importance of

value by ACC/AHA standards, then it was not included as

accounting for social determinants of health when

a performance measure.

screening and diagnosing various patient populations for

The performance and quality measures for VHD

VHD. Based on the findings from their community

included in the measure set are briefly summarized in

screening project, the investigators estimated that the

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Notably, outcomes associated with VHD have improved

1.2. Disclosure of Relationships With Industry and Other

markedly over time due to significant advances in diag-

Entities

nostic measures and new therapeutic approaches. The

The Joint Committee makes every effort to avoid actual,

former includes measures targeting at-risk patients and

potential, or perceived conflicts of interest that could

those with established VHD, in addition to harnessing the

arise as a result of relationships with industry or other

advances in multimodality imaging, whereas the latter is

entities (RWI). Information about the ACC/AHA policy on

promulgated by enhanced surgical techniques and novel

RWI can be found online. All members of the writing

catheter-based interventions. Surgical valve replacement

committee, as well as those selected to serve as peer re-

and repair have been long-standing mainstay treatment

viewers of this document, were required to disclose all

modalities for VHD. However, transcatheter-based thera-

current relationships and those existing within the 12

pies are rapidly evolving and have obtained progressively

months before the initiation of this writing effort. ACC/

expanded clinical therapeutic indications over the past

AHA policy also requires that the writing committee chair

decade.^8-13 Surgical and transcatheter interventions are

and at least 50% of the writing committee have no rele-

performed primarily in patients with severe symptomatic

vant RWI. Writing committee members are excluded from

VHD, although evolving evidence supports its likely

writing or voting on sections to which their specific RWI

benefit in patients with severe asymptomatic VHD and

may apply.

even moderate VHD. Accurate diagnosis and periodic

Any writing committee member who develops new

monitoring are critical to assess the need and timing of

RWI during his or her tenure on the writing committee is

intervention, which may depend on a myriad of factors,

required to notify staff in writing. These statements are

such as the severity of the VHD, presence of symptoms, its

reviewed periodically by the Joint Committee and by

impact on cardiac anatomy and function (eg, left ven-

members of the writing committee. Author and peer

tricular dilation or dysfunction), as well as its effects on

reviewer RWI that are pertinent to the document are

the pulmonary circulation (eg, pulmonary hypertension).

included in the appendixes: Appendix B for comprehen-

To this effect, accurate diagnoses and classification of the

sive writing committee RWI and Appendix C for compre-

severity of VHD lesions are important. The writing com-

hensive peer reviewer RWI. Disclosure information for the

mittee for the 2020 ACC/AHA VHD guideline³ provided a

Joint Committee is also available online.

classification of the VHD stages. These stages are pro-

The work of the writing committee was supported

gressive, and continuous clinical and imaging monitoring

exclusively by the ACC and the AHA without commercial

are required. The 4 stages include: stage A (at risk for the

support. The American Association for Thoracic Surgery

development of VHD), stage B (progressive VHD: asymp-

and the Society for Cardiovascular Angiography and In-

tomatic with mild or moderate severity), stage C (severe

terventions served as collaborators on this project.

asymptomatic VHD), and stage D (severe symptomatic

Members of the writing committee volunteered their time

VHD).³

for this effort. Meetings of the writing committee were

To inform and update the practicing clinician about

confidential and attended only by writing committee

the essential elements in the diagnosis, classification,

members and staff from the ACC and AHA.

and management of patients with VHD (eg, patient ed-

ucation, periodic monitoring, medical therapy, and sur-

2. METHODOLOGY

gical and percutaneous interventions), the ACC and AHA

2.1. Literature Review

often join efforts with other societies to construct clin-

ical practice guidelines consisting of concrete and direct

In developing the updated VHD measure set, the writing

clinical recommendations. Several iterations of the VHD

committee reviewed evidence-based clinical practice

guidelines were published by the ACC and AHA over the

guidelines and scientific statements that would poten-

years,14,15 including the most recent “2020

ACC/AHA

tially impact the construct of the new measures. The

Guideline for the Management of Patients With Valvular

clinical practice guidelines and scientific statements that

Heart Disease.”³ To increase the clinical dissemination

most directly contributed to the development of these

of the most recent clinical practice guidelines³ and

measures are shown in Table 3. Notably, the “2014 AHA/

particularly to enhance the implementation of their

ACC Guideline for the Management of Patients With

evidence-based and high-impact recommendations, the

Valvular Heart Disease”¹⁵ and its 2017 focused update¹⁶

ACC and AHA have rejoined efforts to construct a set of

were not reviewed or considered, because they were

performance and quality measures for VHD and struc-

completely replaced by the “2020 ACC/AHA Guideline for

tural heart disease (SHD). These measures can be used

the Management of Patients With Valvular Heart Dis-

to assess, measure, and compare care processes of

ease.”³

Recommendations from the

“2020

AHA/ACC

patients with VHD across multiple providers and

Guideline for the Diagnosis and Treatment of Patients

institutions.

With Hypertrophic Cardiomyopathy”¹⁷ were reviewed,

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TABLE 2

2024 ACC/AHA Valvular Heart Disease Measures

Care

Measure No.

Measure Title

Setting

Attribution

Measure Domain

COR/LOE

Performance Measures

PM-1

VKA for Mechanical Heart Valves

Outpatient

Individual practitioner

Treatment

COR: 1, LOE: A

PM-2

AV Intervention for Severe

Outpatient

Individual practitioner

Treatment

COR: 1, LOE: A; COR: 1,

Symptomatic AS

LOE: B-NR; COR: 1,

LOE: C-EO

PM-3

AV Surgery for Chronic Severe AR

Outpatient

Individual practitioner

Treatment

COR: 1, LOE: B-NR

PM-4

TTE for Asymptomatic Chronic Severe

Inpatient,

Individual practitioner

Monitoring

COR: 1, LOE: B-NR

Primary MR

Outpatient

PM-5

Mitral Valve Intervention for Chronic

Outpatient

Individual practitioner

Treatment

COR: 1, LOE: B-NR

Severe Primary MR

Quality Measures

QM-1

Documentation of Risk and Heart Team

Inpatient

Facility, Individual

Patient Education

COR: 1, LOE: C-EO

Discussion Before SAVR or TAVI

practitioner

and Monitoring

QM-2

AVR for Asymptomatic AS With

Outpatient

Individual practitioner

Treatment

COR: 1, LOE: B-NR

LV Systolic Dysfunction

QM-3

TAVI for Severe Symptomatic AS >80

Outpatient

Individual practitioner

Treatment

COR: 1, LOE: A; COR: 1,

Years of Age

LOE: C-EO

QM-4

Post-AVR Echocardiogram

Outpatient

Individual practitioner

Monitoring

COR: 1, LOE: B-NR

QM-5

Adequate BP Control in AR Patients

Outpatient

Individual practitioner

Treatment

COR: 1, LOE: B-NR

QM-6

Treatment for Symptomatic Severe

Outpatient

Individual practitioner

Treatment

COR: 1, LOE: A; COR: 1,

Rheumatic MS

LOE: B-NR

ACC indicates American College of Cardiology; AHA, American Heart Association; AR, aortic regurgitation; AS, aortic stenosis; AV, aortic valve; AVR, aortic valve replacement; BP, blood

pressure; COR, Class of Recommendation; LOE, Level of Evidence; LV, left ventricle/ventricular; MR, mitral regurgitation; MS, mitral stenosis; PM, performance measure; QM, quality

measure; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation; TTE, transthoracic echocardiogram; and VKA, vitamin K antagonist.

but the consensus of the writing group was to exclude

created by the ACC and AHA in collaboration with other

measures pertinent to the hypertrophic cardiomyopathy

societies. Therefore, there are no previous measures to

from this guideline, because they were too narrowly

revise or retire.

focused and outside the scope of the current document.

3.1.2. Revised Measures

2.2. Definition and Selection of Measures

The current measure set represents the first set of per-

The writing committee considered a number of additional

formance and quality measures for VHD and SHD that are

factors, which are listed in Table 4. The potential impact,

created by the ACC and AHA in collaboration with other

appropriateness for public reporting and pay for perfor-

societies. Therefore, there are no previous measures to

mance, validity, reliability, and feasibility were consid-

revise or retire.

ered. The writing committee examined available

3.1.3. New Measures

information on current gaps in care.

After reviewing the “2020 ACC/AHA Guideline for the

3. ACC/AHA VHD MEASURE SET

Management of Patients With Valvular Heart Disease”³

and other societal position statements and documents

3.1. Discussion of VHD Measure Set

(Table 3), the writing committee initially considered a

After reviewing the existing clinical practice guidelines

preliminary set of 20 measures from definitive recom-

and scientific statements (Table 3), the writing committee

mendations with proven clinical benefit (mostly Class 1

discussed which guideline recommendations could serve

guideline recommendations), which were predominantly

as the basis for new performance or quality measures. The

pertinent to the diagnostic, monitoring, and treatment

writing committee reviewed the attributes of perfor-

domains. The initial comprehensive set included 9 per-

mance as well as the existing publicly available measure

formance measures: 2 were subsequently dropped, 2 were

sets. In the following section is a description of the new

kept with edits or modifications, and 2 were downgraded

measures that are created for both the inpatient and

to quality measures (because they were deemed to satisfy

outpatient setting.

some but not all the attributes defined in Table 4). The

final set included 5 performance measures and 6 quality

3.1.1. Retired Measures

measures, which were voted on after multiple rounds of

The current measure set represents the first set of per-

anonymous voting and meticulous consideration of the

formance and quality measures for VHD and SHD that are

attributes of performance measures. Of the initial

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TABLE 3

Associated ACC/AHA Clinical Practice Guidelines and Other Clinical Guidance Documents

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

2020 AHA/ACC Guideline for the Diagnosis and Treatment of Patients With Hypertrophic Cardiomyopathy¹⁷

2019 AATS/ACC/ASE/SCAI/STS Expert Consensus Systems of Care Document: A Proposal to Optimize Care for Patients With Valvular Heart Disease¹⁸

2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation¹⁹

2019 AHA/ACC Clinical Performance and Quality Measures for Adults With High Blood Pressure²⁰

Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke²¹

2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke²²

Surgery for Aortic Dilatation in Patients With Bicuspid Aortic Valves²³

2015 American Heart Association/American Stroke Association Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke

Regarding Endovascular Treatment²⁴

2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation²⁵

Guidelines for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack²⁶

Percutaneous Device Closure of Patent Foramen Ovale for Secondary Stroke Prevention²⁷

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

Heart Rhythm Society; SCAI, Society for Cardiovascular Angiography and Interventions; and STS, Society of Thoracic Surgeons.

comprehensive set of 20 measures, 9 measures were

All of the measures pertain to the outpatient setting,

excluded for various reasons. For example, some did not

except for 1 quality measure that applies predominantly

fit the attributes of a performance measure, or they were

to the inpatient setting.

unlikely to be upgraded in the future from a quality

All 5 performance measures fulfill the attributes of

measure. Others were considered outside the scope of the

performance measures as summarized in Table 4. All 5

current document or are covered in other performance

performance measures are high-impact measures that

measure documents. For example, statin use in patients

target meaningful gaps in the quality of care and are

with mild and moderate AS has been shown to reduce

based on Class 1 clinical practice guideline recommenda-

ischemic atherosclerotic events by 20% but not aortic

tions with a high level of evidence. They are also action-

valve-related events.30,31 This measure was deemed by

able, have a very low abstraction burden (in terms of cost,

the writing committee most suitable to be considered in a

effort, and time), and pose no unintended consequences

future atherosclerotic cardiovascular disease performance

in their implementation. Of those, 4 are related to proven

measure document. The measure related to anti-

therapies (1 is a medical treatment and 3 are surgical or

coagulation for nonvalvular atrial fibrillation (AF) has

catheter-based interventions), and 1 pertains to a diag-

been extensively covered in the performance measure

nostic modality (medical imaging test).

document in patients with AF, with 2 dedicated measures

One medical treatment performance measure pertains

related to anticoagulation prescription in the inpatient

to the prescription or treatment with a vitamin K antag-

and outpatient settings.³² In the rationales for the 2 per-

onist (eg, warfarin) in patients with mechanical prosthetic

formance measures in the aforementioned document, the

valves, which has been proven to prevent valve throm-

writing committee explicitly stated that nonvalvular AF

bosis and thromboembolic events in these patients.^33-35

increases the risk of stroke 5 times while AF in the setting

Appendix A provides a summary for the rationale and

of mitral stenosis increases the risk of stroke 20 times

evidence for the measure as well as data on its construct.

over that of patients in sinus rhythm.³² A separate mea-

Direct oral anticoagulants are not adequately studied or

sure pertinent for AF in the setting of mitral stenosis is

proven as a thromboprophylaxis therapy for mechanical

likely to be topped out and of low impact, and therefore is

prosthetic valves.³⁶ Their use is therefore not recom-

not included in the current document. The measure on

mended and does not count toward the implementation

the use of early surgery for infective endocarditis was

of this measure. On the other hand, like many perfor-

deemed to have a complex construct and to likely be too

mance and quality measures, many patients have reasons

difficult to measure, especially given issues with ascer-

to be excluded or exempted from this measure. These

taining appropriateness of surgery and its timing in these

exclusions include definite exclusions (such as being on

complex patients.

hospice, palliative, or comfort care) and relative medical-

The writing committee created a comprehensive list of

or patient-related exclusions (such as active bleeding or

11 measures that can be clinically used in patients with

patient refusal). This measure should be implemented in

VHD. This set includes 5 performance measures and 6

a shared decision-making process with the patient and

quality measures. Table 5 includes a list of the measures

the patient’s health care team (eg, the cardiologist and the

with information on the care setting and a brief rationale.

primary care professional). Therefore, the measure should

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American Heart Association/American College of Cardiology Joint Committee on Performance Measures: Attributes

TABLE 4

for Performance Measures²⁸

1. Evidence Based

High-impact area that is useful

a) For structural measures, the structure should be closely linked to a meaningful process of care that in turn is

in improving patient outcomes

linked to a meaningful patient outcome.

b) For process measures, the scientific basis for the measure should be well established, and the process should

be closely linked to a meaningful patient outcome.

c) For outcome measures, the outcome should be clinically meaningful. If appropriate, performance measures

based on outcomes should adjust for relevant clinical characteristics through the use of appropriate

methodology and high-quality data sources.

2. Measure Selection

Measure definition

a) The patient group to whom the measure applies (denominator) and the patient group for whom conformance

is achieved (numerator) are clearly defined and clinically meaningful.

Measure exceptions and exclusions

b) Exceptions and exclusions are supported by evidence.

Reliability

c) The measure is reproducible across organizations and delivery settings.

Face validity

d) The measure appears to assess what it is intended to.

Content validity

e) The measure captures most meaningful aspects of care.

Construct validity

f) The measure correlates well with other measures of the same aspect of care.

3. Measure Feasibility

Reasonable effort and cost

a) The data required for the measure can be obtained with reasonable effort and cost.

Reasonable time period

b) The data required for the measure can be obtained within the period allowed for data collection.

4. Accountability

Actionable

a) Those held accountable can affect the care process or outcome.

Unintended consequences avoided

b) The likelihood of negative unintended consequences with the measure is low.

be attributable to any of the health care professionals

edge repair,41,42 respectively. The tables in Appendix A

caring for the patient. The presence of a mechanical heart

include details on the construct of these measures, their

valve and the prescription or treatment with a vitamin K

rationale, as well as evidence pertinent to these disorders

antagonist should be documented within and abstracted

and their surgical or transcatheter treatments. In addi-

from the medical records (whether electronic health care

tion, there is clinical information providing descriptions

records data, administrative data, clinical registries, or

of common symptoms, definitions of severity of the valve

paper medical records). Different international normal-

disorder, and the respective thresholds for left ventricular

ized ratio target ranges apply to various patients. This is

systolic dysfunction (eg, ejection fraction 55% and #60%

outlined in the “2020 ACC/AHA Guideline for the Man-

for chronic severe aortic regurgitation and primary MR,

agement of Patients With Valvular Heart Disease,”³ which

respectively). To minimize the complexity of the valve

is dependent on various factors such as type of valve,

intervention measures and ensure feasibility, the writing

location of valve, comorbidities, and previous history of

committee included left ventricular ejection fraction

thromboembolic events. This performance measure does

thresholds but not left ventricular dimensions (eg, left

not, however, delve into the achieved international

ventricular end-systolic diameter

$40 mm for valve

normalized ratio targets, to simplify the construct of the

intervention in patients with chronic severe primary

measure and make it easier to implement.

MR).⁴³ Given the complexity of the valve intervention

There are 3 performance measures pertaining to the

decision-making in these patients, these measures are

implementation of an appropriate valve intervention in

attributed to the primary cardiologist, as opposed to the

patients with 3 valvular conditions: (1) severe symptom-

primary care health care professional, who is likely to

atic AS; (2) chronic severe aortic regurgitation (symp-

refer these patients to a specialist to determine-in shared

tomatic or asymptomatic with left ventricular systolic

decision-making with the patient-the merits of the

dysfunction); and (3) chronic severe primary MR (symp-

intervention after discussing risks, benefits, alternatives,

tomatic or asymptomatic with left ventricular systolic

and patient values, as well as other preferences.

dysfunction). Based on the available evidence, the valve

Last, 1 performance measure involves a diagnostic

intervention varies according to the valve location, pa-

modality and performance of a transthoracic echocardio-

thology, and patient symptoms, and may include aortic

gram within the preceding 12 months among patients with

valve surgery or transcatheter aortic valve implanta-

established chronic severe primary MR. It is therefore

tion,^37-40 or mitral valve surgery or transcatheter edge-to-

applicable to the outpatient setting where a transthoracic

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TABLE 5

New Measures*

Rationale for Designating as a

Measure

Quality Measure Versus a

No.

Care Setting

Measure Title

Rationale for Creating New Measure

Performance Measure

PM-1

Outpatient

VKA for Mechanical

In patients with a mechanical valve prosthesis, there is

High impact, easy to measure, satisfies

Heart Valves

high-level evidence that therapy with an oral VKA at

the attributes of a PM.

an appropriate INR goal reduces the incidence of

valve thrombosis, thromboembolic events, and

associated morbidity.

PM-2

Outpatient

AV Intervention

Patients with severe symptomatic AS have a high risk of

High impact, easy to measure, satisfies

for Severe

death if AV intervention is not performed, as high as

the attributes of a PM.

Symptomatic AS

50% at 1 y. Both SAVR and TAVI are effective across

the spectrum of surgical risk, with significant

improvements in morbidity, death, and functional

status.

PM-3

Outpatient

AV Surgery for Chronic

Patients with chronic severe AR who either have LV

High impact, easy to measure, satisfies

Severe AR

dysfunction (EF <55%) or who develop symptoms,

the attributes of a PM.

have a high risk of death, LV decompensation, and

deterioration of functional status if AVR is not

performed.

PM-4

Inpatient,

TTE for Asymptomatic

Serial echocardiograms are essential to evaluate

Actionable, easy to measure, satisfies

Outpatient

Chronic Severe

changes in LV function and structure in patients with

the attributes of a PM.

Primary MR

asymptomatic chronic severe primary MR to guide

management decisions.

PM-5

Outpatient

Mitral Valve Intervention

Patients with chronic severe primary MR who develop

High impact, easy to measure, satisfies

for Chronic Severe

symptoms or LVEF <60% have a high risk of death,

the attributes of a PM.

Primary MR

LV decompensation, and deterioration of functional

status if mitral valve intervention is not performed.

Rationale for Designating as a

Measure

Quality Measure Versus a

No.

Care Setting

Measure Title

Rationale for Creating New Measure

Performance Measure

QM-1

Inpatient

Documentation of Risk

Clinically meaningful measure that incorporates risk

QM because of moderate abstraction

and Heart Team

assessment and shared decision-making with the

and lack of robust evidence

Discussion Before

patients before intervention.

regarding its impact.

SAVR or TAVI

QM-2

Outpatient

AVR for Asymptomatic AS

Asymptomatic patients with severe AS who have LV

Complex construct and feasibility

With LV Systolic

systolic dysfunction (EF <50%) benefit from SAVR

issues make it better fit for a QM.

Dysfunction

or TAVI in particular clinical settings (low LVEF,

cardiothoracic surgery for another indication).

QM-3

Outpatient

TAVI for Severe

TAVI is preferred to SAVR in most patients >80 y of age

May have unintended consequences if

Symptomatic AS >80

because of its safety profile and lower concern for

used as a PM (eg, some elderly

Years of Age

valve durability in this age group.

patients may still be safe for

SAVR), and as such QM is more

appropriate.

QM-4

Outpatient

Post-AVR

TTE after valve implantation or repair provides an

Clinically meaningful measure but

Echocardiogram

assessment of the procedural results and serves as a

lacks strong evidence to support

baseline against which comparison can be made for

its impact.

any change.

QM-5

Outpatient

Adequate BP Control in

Adequate BP control in asymptomatic patients with

Does not fit all attributes of a PM

AR Patients

chronic AR may help prevent structural LV

(measure feasibility).

deterioration and mitigate the occurrence of HF

symptoms.

QM-6

Outpatient

Treatment for

Treatment of patients with severe symptomatic

The measure definition is complex and

Symptomatic Severe

rheumatic MS with either PMBC or surgery has

may pose abstraction burden.

Rheumatic MS

shown significant clinical benefits.

Better fit for QM (low impact).

*The current measure set represents the first ACC/AHA VHD measure set; therefore, all the measures in the measure set are new and are included in the new measures table.

ACC indicates American College of Cardiology; AHA, American Heart Association; AR, aortic regurgitation; AS, aortic stenosis; AV, aortic valve; AVR, aortic valve replacement; BP,

blood pressure; EF, ejection fraction; HF, heart failure; INR, international normalized ratio; LV, left ventricle/ventricular; LVEF, left ventricular ejection fraction; MR, mitral regurgi-

tation; MS, mitral stenosis; PM, performance measure; PMBC, percutaneous mitral balloon commissurotomy; QM, quality measure; SAVR, surgical aortic valve replacement; TAVI,

transcatheter aortic valve implantation; TTE, transthoracic echocardiogram; VHD, valvular heart disease; and VKA, vitamin K antagonist.

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2024 ACC/AHA Valvular and Structural Heart Disease Measures

echocardiogram is readily available and can be ordered by

are designed to help health care professionals reduce gaps

the cardiologist or other health care professional (thus,

in the quality of care that they provide to their patients.

attribution to a wider segment of professionals). A trans-

For more detailed information on each measure’s

thoracic echocardiogram will ascertain the severity and

construct, refer to the specifications in Appendix A.

mechanism of primary MR and assess the existence and

progression of left ventricular dysfunction or dilation (eg,

4. AREAS FOR FURTHER RESEARCH

ejection fraction or dimension), which then helps dictate

the intervention modality (eg, surgical repair, surgical

All 11 measures included in the current set are actionable,

replacement, or transcatheter edge-to-edge repair) and its

feasible, and reliable process measures with established

timing, particularly in patients who are asymptomatic.

scientific evidence and proven clinical benefit. One may

Six quality measures were selected, all of which were

argue that outcomes (eg, death, stroke, myocardial

based on Class 1 clinical practice guideline recommenda-

infarction, or reintervention) represent the ultimate

tions. These quality measures fulfill some but not all the

assessment of care. The writing committee elected not to

attributes of a performance measure. They have less

include outcome measures in this initial set of VHD

clinical impact or might be lacking in other important

measures given the heterogeneity of the VHDs and pa-

characteristics (eg, feasibility, validity, or unintended

tient populations, in addition to the lack of robust meth-

consequences) and are therefore not suitable to measure

odology for adequate adjustment for the case mix of

performance among providers and institutions or for

patients (with a few exceptions). Use of outcome mea-

public reporting. However, they can be used for internal

sures in the absence of robust adjustment models may

quality assessment and internal peer review processes.

render comparisons across institutions and providers

Many of these measures are added to clinical registries

meaningless and may create untoward and unintended

and may be upgraded in the future to a performance

consequences that would likely result in problems with

measure status after assessment in real-world practice or

implementation. Future research should focus on over-

completely retired in certain instances (eg, topped out or

coming these barriers and validating meaningful out-

emerging evidence showing marginal clinical impact).

comes for patients with VHD that can be reliably

Thus, if additional evidence supports the importance of

measured and reported.

the proposed quality measures, they may be ultimately

The current document encompasses the first set of per-

changed to performance measures. Of the 6 selected

formance and quality measures pertinent to VHD and SHD

quality measures, 4 pertain to therapeutic strategies

released by the ACC and AHA in collaboration with other

(medical, percutaneous, or surgical intervention), and the

societies. These measures should be added to future clin-

other 2 pertain to other domains (eg, patient education or

ical registries and examined for their performance in real-

monitoring). One notable quality measure involves the

world clinical practice. Notably, the current set of mea-

objective documentation of risk using a procedural risk

sures is dynamic and subject to revisions and modifications

score (eg, the web-based Society of Thoracic Surgeons

based on the availability of new clinical evidence. Future

Risk Calculator), and the documentation of a multidisci-

research should therefore focus on implementing and

plinary heart valve team discussion whenever a valvular

examining the current measures and assessing their per-

procedure or surgical intervention is being considered.

formance and utility in real-world practices. If a measure is

Although documentation of a heart team discussion and

found to be consistently topped out or performs poorly (eg,

risk stratification can be done before hospitalization, this

unintended consequences, not reliably reproducible in

is the only measure in this document pertinent to the

different clinical settings, or complex construct requiring

inpatient setting, given that risk stratification is usually a

laborious resources for abstraction), it can be dropped in

dynamic process and best reassessed before the index

the future. On the other hand, if a gap in a clinically

procedure. Although there is a paucity of high-level evi-

meaningful quality measure is evident in contemporary

dence supporting the merits of a heart team approach, the

practice and the measure is found to satisfy the attributes

writing committee agreed with the expert opinion

of a performance measure, it can be at some point elevated

expressed by the 2020 ACC/AHA VHD Guideline Writing

to a performance measure. The Society of Thoracic Sur-

Committee that a multifaceted heart team approach is

gery/ACC Transcatheter Valve Therapy Registry is a robust

important whenever a valvular procedure or surgical

clinical registry created through a collaboration of the So-

intervention is being considered, after accounting for

ciety of Thoracic Surgery and the ACC. It monitors patient

patient-specific, procedure-specific, and institution- or

safety and real-world outcomes but only includes data on

operator-specific risks and benefits.

patients undergoing transcatheter valve replacement and

Overall, the measures are structured in a typical format

repair procedures, and it is therefore not inclusive of pa-

in which the goal is to seek a higher performance score,

tients with all stages of VHD or those with severe (stages C

ideally nearing 100%. Performance and quality measures

or D) VHD who did not undergo procedures. The AHA is in

Jneid et al

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2024 ACC/AHA Valvular and Structural Heart Disease Measures

-, 2024:---

the process of developing a disease-specific database

Shae Martinez, MLS, Reference Consultant, Medical

pertinent to AS that can help examine aortic valve disease

Librarian

more comprehensively. Leveraging the resources of the

American Heart Association

AHA and ACC and other organizations, including their

Joseph C. Wu, MD, PhD, FAHA, President

registries, is therefore critically important to examine the

Nancy Brown, Chief Executive Officer

implementation and performance of these measures.

Mariell Jessup, MD, FAHA, Chief Science and Medical

Finally, new care processes and diagnostic and therapeutic

Officer

strategies should continue to be examined and considered,

Nicole Aiello Sapio, EdD, Executive Vice President, Office

especially with the emergence of new transcatheter ther-

of Science Strategies and Operations

apies or new indications of existing transcatheter therapies

Radhika Rajgopal Singh, PhD, Senior Vice President,

in the fields of VHD and SHD.

Office of Science and Medicine

PRESIDENTS AND STAFF

Prashant Nedungadi, BPharm, PhD, Vice President,

Science and Medicine, Clinical Guidelines

American College of Cardiology

Barbara Entl, MD, Science and Medicine Advisor, Office of

B. Hadley Wilson, MD, FACC, President

Science, Medicine and Health

Cathleen C. Gates, Chief Executive Officer

Courtney Goodwin, MPH, Program Manager Guidelines,

Richard J. Kovacs, MD, MACC, Chief Medical Officer

Office of Science, Medicine and Health

Mindy J. Saraco, MHA, Director, Clinical Policy and

Melanie Shahriary, RN, BSN, Senior Manager,

Guidelines

Performance Metrics Quality, Outcomes Research and

Grace D. Ronan, Senior Production and Operations

Analytics

Manager, Clinical Policy Publications

Kelly Burlison, MPH, Senior Program Development

Leah Patterson, Project Manager, Clinical Content

Manager, Healthcare Quality Measures, Quality and

Development

Health IT

American Heart Association/American College

Sana Gokak, MPH, Program Manager, Healthcare Quality

of Cardiology

Measures, Quality and Health IT

Abdul R. Abdullah, MD, Director, Guideline Science and

Jody Hundley, Senior Production and Operations Manager,

Methodology

Scientific Publications, Office of Science Operations

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