FLETCHER
ET AL., 33RD BETHESDA CONFERENCE: Preventive Cardiology: How Can
We Do Better?
J Am Coll Cardiol 2002;40:4:579-651
BETHESDA
CONFERENCE REPORT
33rd Bethesda Conference: Preventive Cardiology: How Can We Do Better?
Emelia
J. Benjamin, MD, SCM, FACC, Co-Chair, Sidney C. Smith, JR,
MD, FACC, Co-Chair, Richard S. Cooper, MD, FACC, Martha N.
Hill, RN, PHD, FAAN, Russell V. Luepker, MD, MS, FACC
Task
Force #1Magnitude of the Prevention Problem: Opportunities
and Challenges
Cardiovascular disease (CVD) is the leading cause of death and disability
in most Western industrialized countries including the U.S., cutting
across all ethnic, racial, and gender groups. Despite the tremendous
body of research to support the efficacy and cost-effectiveness
of CVD prevention, interventions to prevent CVD are universally
underutilized. This section describes what is known about the epidemiology
of CVD, the distribution of CVD risk factors, and the impact of
treating CVD risk factors. The following is a broad overview of
the barriers to achieving CVD risk-factor reduction and the measures
that must be pursued to enhance risk-factor reduction and CVD prevention.
Research, funding, and policy recommendations that would improve
CVD prevention, if embraced, will be provided.
Epidemiology
of CVD
Global burden. Cardiovascular disease includes common
conditions, such as coronary heart disease (CHD), stroke, hypertension,
and heart failure (HF), and those less common, such as congenital
heart disease, cardiomyopathy, and peripheral vascular disease (1).
Cardiovascular disease is increasing in prevalence in many regions
of the world, particularly in developing countries and in formerly
socialist countries (2). Worldwide, it is estimated that death from
CHD will increase 100% in men and 80% in women from 1990 to 2020,
with the majority of that increase coming from Asia, Africa, and
Latin America (2). Similarly, disability-adjusted life-years lost
will increase 107% in men and 74% in women worldwide (2).
The
reasons for this epidemic are easily identifiable. The 20th century
saw dramatic economic improvement, with declines in major infectious
diseases and malnutrition in industrialized countries. Associated
with a longer life span and affluence has been the emergence of
chronic diseases that occur among those living past middle age.
Changes that were seen in the 20th century in industrialized countries
are now increasingly observed in the developing world. Technology
and the expanding control over the environment have resulted in
abundant food supplies in many nations. Industrialization of everyday
life with laborsaving devices and motor transportation results in
a loss of regular physical activity and the assumption of a sedentary
lifestyle. The combination of inactivity and surplus calories (particularly
from animal products) contributes to abnormal blood lipids and elevated
blood pressure (BP) and results in widespread obesity, diabetes,
and excessive risk of CVD. Inexpensive machine-made cigarettes and
the social acceptance of tobacco smoking result in widespread nicotine
addiction and the many chronic illnesses associated with tobacco.
These dramatic changes in the social and economic environment, which
are unparalleled in human history, are resulting in massive elevations
in both the risk and expression of CVD (3).
Genetic
influences. The transformation of the social environment, coupled
with increased longevity, have unmasked a genetic susceptibility
to a number of chronic diseases. Although it is very unlikely that
evolution would result in genes that promote lethal diseases, it
is hypothesized that so-called "thrifty genes" were adaptive
in a primitive world of deprivation and danger. The retention of
sodium, storing of food calories, and preparation for severe stress
were protective of humankind's existence (3). However, in an aging
society of affluence, such genes may promote high BP, obesity, and
maladaptive responses to stress. The effect of the environment on
genetic susceptibility is best exemplified in evaluative studies
of individuals from low-risk, low-CVD cultures who migrate to Western
cultures, such as Japanese from Japan to California. The low-risk
Japanese become like their white neighbors in disease-risk factors
and expression when they assume their high-risk environment and
behaviors (4).
Gender.
Cardiovascular diseases are manifest earlier in the lives of men,
and much of the focus of research has been on this group. Although
women manifest CVD 10 to 15 years later than men, the overall morbidity
and mortality over a lifetime is similar in men and women (1). Many
Americans do not realize that CVD mortality for both men and women
is higher than mortality from all cancers combined. Women are now
appropriately recognized as frequent victims of CVD; thus, programs
oriented to the diagnosis and treatment of CVD in women as well
as men increasingly are being emphasized in the U.S.
Racial
and socioeconomic disparities. In a period of epidemiological
transition, chronic disease epidemics usually emerge first among
economically advantaged segments of society, and the burden is subsequently
shifted to the working class and minority populations (5,6).
Cardiovascular disease represents one of the most dramatic examples
of this process. Not only has the overall rate of CVD changed dramatically
in the U.S. over the last 50 years, the distribution of disease
burden among sociodemographic subgroups has changed as well. Although
virtually every U.S. subpopulation has experienced a decline in
mortality from CHD, the rate of decline has been much steeper among
those of higher socioeconomic status. National data by social class
are limited, because the required information was not collected
on death certificates until the 1990s. However, trends by geographic
and racial/ethnic categories confirm these growing disparities in
CVD (7). Income inequality is correlated with CVD incidence and
may partially account for these worsening trends (8). Black Americans
now experience the highest age-adjusted rates of heart disease,
in addition to the highest rates of stroke, as has been noted for
many years (7). Native Americans, Asians, and Hispanics, on the
other hand, currently have rates of both CHD and stroke that are
substantially lower than among the white majority population (9),
although the limited data that are available suggest relative increases
in rates of CVD among Native Americans. Economically disadvantaged
neighborhoods (10) and regions of the country (e.g., Appalachia
and the South) experience higher rates of CVD (7). One of the most
extreme examples can be found among blacks in Mississippi, in whom
CHD rates are still rising in absolute terms, and a very large gap
has emerged in comparison to the majority population. This heterogeneity
in trends requires a broadening of the definition of "high-risk."
Whereas the term previously referred to individuals whose coronary
profile put them at increased risk of CVD, high-risk population
subgroups can now be identified on the basis of sociodemographic
profiles.
Temporal
trends. Perhaps the most striking disease trend in the U.S.
during the 20th century was the rise of age-adjusted CVD to a peak
in the 1960s and a subsequent decline. Similar, although somewhat
delayed, patterns were observed in much of Western Europe. In many
of the former socialist countries and the developing world, increasing
rates of CVD continued in the last part of the 20th century (1,11).
There
are other trends in CVD not readily apparent in the overall age-adjusted
data. For example, although age adjusted rates have declined steadily,
absolute mortality (i.e., the total number of deaths) has changed
little in the past two decades (12,13). Cardiovascular diseases
are still highly prevalent but have been pushed into older age groups,
a trend obscured by age adjustment.
Also
apparent in the mortality trend is the wide difference between in-hospital
and out-of-hospital mortality. Out-of hospital mortality accounts
for approximately two-thirds of all deaths from CHD (14).
Whereas in the 1970s and early 1980s, in-hospital and out-of-hospital
mortality fell in a parallel fashion, more recent data from the
late 1980s and 1990s found in-hospital mortality falling more rapidly.
Sudden, out-of-hospital death comprises an increasing proportion
of the mortality burden. This pattern, combined with increasing
rates of HF mortality and a gradual leveling of stroke mortality,
finds overall age-adjusted CVD mortality still falling, but more
slowly than during the period from 1970 to 1990 (Figure
1) (13). Finally, these trends
are not equally manifest in all ethnic groups, with the poor and
ethnic minorities manifesting less positive changes, as noted earlier.
Many
factors have been invoked to explain these trends. In earlier years,
better detection and treatment of hypertension contributed to declines
in CHD, stroke, and HF mortality. Similarly, falling levels of blood
cholesterol associated with improved dietary patterns influenced
the atherosclerotic diseases. Finally, cigarette smoking decreased,
dramatically influencing many diseases (15).
However, in the 1990s, risk factors did not decline at the same
rate. In fact, obesity and diabetes are increasing in the U.S. population,
and physical inactivity is common and is not improving. At the same
time, medical care has advanced considerably leading to improved
survival (reduced case fatality) in acute myocardial infarction
(MI). While enhanced medical care reduces mortality and prolongs
survival, it adds to the number of prevalent cases in need of secondary
prevention.
These
contrasting trends lead to both optimistic and pessimistic inferences.
On the one hand, the highly dynamic nature of the trends demonstrates
that broad interventions aimed at CVD control can be highly effective.
On the other hand, the moderating decline and the fact that current
approaches apparently lack efficacy for many segments of our society
suggest that "more of the same" may not be successful
and that new interventions and implementation strategies will be
required.
Cardiovascular
Risk Factors: Distribution and Impact of Treatment
Relationship of risk factors to major CVDs. Atherosclerosis
and hypertension are lifelong processes that result in diseased
arterial vessels that ultimately restrict blood flow, reaching the
clinical spectrum in late middle age. This pathology is manifest
as MI, stroke, congestive HF, peripheral vascular disease, and other
conditions (Figure 2). The scientific
understanding of the origins of this lifelong illness and its etiologic
mechanisms is substantial. To the classical risk factors of hypertension,
hypercholesterolemia, and cigarette smoking are added diabetes,
obesity, and sedentary lifestyle. Genetic factors play an important
role in the development of these risk factors (e.g., familial hypercholesterolemia)
and susceptibility to the progression to CVD. A second level of
risk factors associated with the atherosclerotic lesions, more recently
described, may play an important role in combination with classic
risk factors. Such factors include inflammation, endothelial dysfunction,
hypercoagulability, insulin resistance, and others. Finally, acute
risk factors may precipitate atherosclerotic plaque rupture and
be crucial in sudden out-of-hospital cardiac death, acute MI, and
stroke. Such factors include heavy physical exertion, sexual activity,
emotional stress, and nicotine (16).
Knowledge about the detection, treatment, and control of risk factors
provides the impetus and rationale for CVD prevention.
Global
distribution of risk factors. The distribution of risk factors
in different parts of the world varies considerably, resulting in
high- and low-risk cultures. Key observations that led to the identification
of classical CVD risk factors have come from international comparisons
such as the Seven Countries Study (17). This study demonstrated
that differences in disease rates among the U.S., various nations
in Europe, and Japan were directly related to BP, eating patterns,
blood cholesterol, and cigarette smoking. More recent comparisons
with similar findings were found in the Monitoring Trends and Determinants
in Cardiovascular Disease (MONICA) Study, which principally included
centers not only in Europe but also in North America, Australia,
and Asia (18).
Just
as the global burden of CVD is great, the burden of risk factors
within geographic areas closely matches those disease patterns.
In addition to the substantial continuing burden of CVD risk factors
in Western industrialized countries, there is an increasing burden
of risk in other parts of the world. Rich diets, obesity, sedentary
lifestyle, cigarette smoking, hypertension, elevated blood lipids,
and diabetes, common in the U.S., are increasingly observed in developing
nations. These observations underlie the concerns about a coming
global epidemic (3).
Age.
The major CVDs are conditions associated with gains in life span
(e.g., atherosclerotic lesions increase with advancing age). While
19% of all deaths in the 35- to 44-year-old age category are due
to CVD , 53% of deaths are CVD-related by age 85 years (13). This
age-disease relationship is consistent across genders and ethnic
groups in the U.S. (1). The prevalence of classic risk factors of
blood cholesterol and cigarette smoking in the population declines
with age. For example, smoking rates are under 10% for those over
age 84 (19). The decline in smoking with advancing age is partially
due to smoking cessation in the elderly and to selective attrition
as those at highest risk succumb to the disease. Systolic BP climbs
with age, presumably as a result of increasingly noncompliant blood
vessels, and continues to carry increased risk. Although the average
prevalence and relative risk of risk factors are lower in the older
adult group, blood lipids, cigarette smoking, and hypertension remain
predictive of mortal and morbid outcomes, and the absolute risk
of these risk factors is greater, resulting in an enormous burden
in the older adult population (20).
The
crucial importance of aging as a risk factor for CVD relates in
part to the aging of the population. In 2000, the U.S. life expectancy
at birth achieved a new high of 76.9 years (21), up almost 30 years
from 1900, when life expectancy was 47 years. It is estimated that
currently one in every eight Americans is age 65 years or older;
a number expected to increase to one in five by 2030 (22). Because
the incidence of CVD, such as HF, MI, atrial fibrillation, and stroke,
increases dramatically with advancing age, CVD will place an increasing
burden on the health care system in the new millennium.
Gender.
Cardiovascular (CV) risk factors differ by gender, as does their
treatment. Mean blood cholesterol levels are higher in men than
in women until the sixth decade, and higher in women after that
(14). Women are less likely to be treated for elevated blood cholesterol
than men (23). Blood pressure and the prevalence of hypertension
are higher in men than in women across the age spectrum, though
the differences narrow in the elderly. However, high BP is more
likely to be detected, treated, and controlled among women (24).
Rates of smoking in the U.S. and most Western industrialized nations
were higher in men than in women for many years, but women have
lagged behind men in the decline in smoking prevalence. Hence, the
gap between male and female smoking rates has narrowed (25). Although
there are differences, other major risk factors, including obesity
and diabetes, are high and increasing for men and women.
Ethnicity
and socioeconomic status. As is well known, a fundamental racial/ethnic
differential for BP is found in the U.S., with twofold excess of
hypertension among black Americans. Mean blood pressures are approximately
5 mm Hg higher in the adult black population; treatment and control
rates are currently somewhat better for whites than blacks (26).
As in the past, this differential accounts for some of the excessive
CVD mortality. Among Mexican Americans, hypertension rates are similar
to whites; however, the rate of detection, treatment, and control
is low. Among men in this ethnic group, for example, only 11% of
those with hypertension are controlled, compared with a national
average of 28% (27).
Racial
and economic disparities in cigarette smoking also have been observed.
Native Americans have the highest rates of cigarette use, whereas
Asian and Hispanic women have the lowest. Tobacco use declined through
the early 1990s and appears to have leveled at 25% of the population
(7). Further declines appear to have slowed for all ethnic groups.
The greatest declines have been among persons with a college education.
White
and black Americans have similar levels of total serum cholesterol,
although blacksparticularly black menhave higher levels
of high-density lipoprotein cholesterol and lower triglycerides
(28). Other U.S. ethnic groups have usually been found to have lower
cholesterol. A positive social class gradient (i.e., lowest levels
among persons with the least educational or occupational attainment)
was observed in surveys in the 1960s; however, by 1990 that gradient
had been reversed.
Among
the most important emerging differentials in CVD risk is that observed
for obesity and diabetes (26). A sharp social class gradient exists
for obesity, especially among women, and is associated with a similar
pattern for type II diabetes. All the major ethnic subpopulations
in the U.S., with the exception of Chinese and Japanese, have twofold
greater prevalence of diabetes than do whites.
Temporal
trends: risk factors are changing in the U.S. population. Risk
factors in the U.S. population continue to change in a complex pattern.
Currently, within the U.S., elevated risk factors are quite common,
with hypertension affecting 25%, hypercholesterolemia 20% to 50%,
and cigarette smoking 25% of the adult population. The classic risk
factors consistently improved through the 1970s and 1980s. Perhaps
the most outstanding success story is that of cigarette smoking.
Cigarette consumption per capita for individuals age 18 years and
older rose steadily from 1900 through the late 1960s. Since that
time, it has steadily declined, though in recent years that decline
has been slower (29). The National Health Interview Survey found
that 37.6% of adult men smoked in 1980 and 28.4% in 1990. Similar
declines were noted among women. However, there is significant variability
by region of the country. In 1999, the percentage of adults who
smoked ranged from a high of 29.7% in Kentucky to a low of 13.9%
in Utah (30). In states such as California and Massachusetts, where
increased taxes have been used for tobacco education and research,
some of the lowest smoking rates (18.7% and 19.4%, respectively)
have been observed.
Similar
to cigarette smoking, there was a consistent fall in elevated blood
cholesterol and hypertension between the Second National Health
and Nutrition Examination Survey (NHANES II) (1976 to 1980) and
the Third National Health and Nutrition Examination Survey (NHANES
III) (1988 to 1991) studies. Between NHANES II and NHANES III, the
prevalence of hypertension fell 42.5% in men and 38.9% in women
(31). These data, while somewhat inaccurate because of differing
measurement methodologies, are observed in other population studies
(32). In addition, blood cholesterol above 240 mg/dl (greater or
equal to 6.2 mmol/L) dropped 28.9% in men and 27.6% among women,
and the mean cholesterol in adults decreased from 220 mg/dl to 205
mg/dl in the same period. This striking difference results largely
from dietary changes in the population, as few individuals during
this period were under treatment with cholesterol-lowering medications
(14). However, more recent data suggest that despite the availability
of more effective pharmacologic treatment methods, blood cholesterol
in the population is no longer falling (23).
Likewise,
leisure time physical inactivity has not declined in recent years
(33). Approximately 25% of Americans age 18 and older report no
leisure-time physical activity, and only 23% of American adults
report vigorous sustained physical activity of any intensity lasting
30 min or more five times a week. The majority of Americans fail
to reach the recommended amount of physical activity. Inactivity
is more prevalent among women than men, among blacks and Hispanics
than whites, and among older than younger adults (34). Physical
inactivity is closely related to obesity, hypertension, and unfavorable
lipid levels.
Finally,
other risk factors are moving in the opposite, unhealthy direction.
The population is gaining weight at an alarming rate. The prevalence
of obesity (body mass index greater than 30 kg/m2) increased 61.8%
in men and 50.9% in women between NHANES II and NHANES III (35).
Increasing obesity affects both genders and all race groups but
is particularly marked in black women (26). Associated with increasing
obesity is type II diabetes, which is also increasing in the population
(1). Diabetics also frequently have hypertension, hyperlipidemia,
and other conditions that add to their risk of CVD. The Framingham
Study found that diabetics have double the age-adjusted CVD risk
in men and triple in women compared with non-diabetics (1,36).
In
summary, the prevalence of CV risk factors is changing. Although
some of these changes are in a favorable direction, such as cigarette
smoking, cholesterol, and BP, the majority of other risk factors
in the 21st century are not showing similar trends. The loss of
momentum is a cause for concern.
CVD
Prevention
Primordial prevention with health promotion. Considerable
progress in the primary and secondary prevention of CVD has occurred
in the past 30 years. Risk factors are identified and treated in
those not yet ill (primary prevention) and among those with established
CVD to prevent recurrent events (secondary prevention). It is time
to consider whether elevated risk factors are, in fact, necessary
and inevitable. Should we consider primordial prevention (i.e.,
the prevention of risk factors) in the first place? This may be
the only viable strategy if ultimately we are to eliminate these
diseases and expand the achievements of primary and secondary prevention
(Figure 3).
The
predominant focus on the manifest-disease end of the spectrum of
risk factors may have inadvertently robbed the community of opportunities
for prevention. Although the development of risk-factor thresholds
(e.g., hypertension being defined as a BP greater than 140/90 mm
Hg, systolic and diastolic, respectively) has helped patients and
clinicians focus on treatment objectives, such cut points have obscured
the continuum of risk. Normal levels are inappropriately assumed
to be desirable. For instance, BP levels considered by most clinicians
and patients to be "normal" (systolic pressure of 130
to 139 mm Hg, or diastolic pressure of 85 to 89 mm Hg, or both)
are associated with a risk-factors-adjusted hazard for CVD of 2.5
in women and 1.6 in men (37).
If
studies of individuals at the healthiest end of the risk-factor
spectrum are examined, successful primordial prevention would shift
the population distribution to a higher prevalence of individuals
with optimal risk factors. Such a shift would end the CVD epidemic
and would significantly extend life expectancy (38-41). The definition
of "optimal" or "low risk" varies somewhat from
study to study but generally includes a combination of having low
cholesterol (less than 200 mg/dl), low BP (less than or equal to
120/80 mm Hg), desirable body weight (body mass index is less than
25 kg/m2), no current smoking, and an absence of diabetes and prior
CVD. Currently, the percentage of individuals in the U.S. and Europe
with low risk-factor profiles is low, on the order of 3% to 10%.
(38,39). Of note, individuals with low-risk profiles have markedly
better prognoses, with an 80 to 90% decrease in coronary events
and CVD mortality (38,39) and an estimated gain in life span of
6 to 10 years (38).
Progress
toward the goal of primordial prevention has achieved mixed results.
For most risk factors (e.g., high cholesterol) a basis for action
exists, effective results have been demonstrated in trials, and
reductions in cholesterol have been observed in the population.
The Dietary Approaches to Stop Hypertension study has demonstrated
that nutritional intervention reduces high-normal BP and cholesterol
in adults (42). Observational data from the Nurses' Health Study
suggests that 91% of cases of diabetes were associated with unhealthy
behaviors and habits (43). A recent trial from Finland testing the
efficacy of moderate weight loss and exercise (44), and data from
the larger Diabetes Prevention Program clinical trial examining
diet and exercise, demonstrate that diet and exercise significantly
lower the risk of diabetes (45). Hence, the available evidence supports
recommendations for exercise and for healthy eating patterns (low
sodium, low saturated fat, low cholesterol, and high intake of fruits
and vegetables), to prevent a number of chronic diseases.
Is
primordial prevention feasible? A primordial prevention strategy
will require a very different approach from the current high-risk
strategies. The campaign will need to confront many of the social,
cultural, and community aspects of elevated risk. Primordial prevention
will require a focus on youth and a particular emphasis on exercise
and diet (minimizing fat, calories, and sodium) (46). There are
data on the positive effects of programs beginning in youth, though
further research is clearly needed (47-49). Healthy communities
and healthy societies should be the goal. While risk factors in
the U.S. track from childhood, there are many societies in the world
that do not have a progressive elevation of BP with age and do not
increase their lipids after adolescence. In these societies, physical
activity and healthy diets are the norm, and CVD does not occur
at epidemic levels. Such is the hope, promise, and challenge of
primordial prevention of CVD.
Primary
prevention. The undeniable health and survival benefits of optimizing
of CVD risk factors have been documented by numerous observational
and randomized controlled trials and have been incorporated into
widely disseminated guidelines (50,51). Meta-analyses and cost-benefit
analyses (reviewed in depth in Task Force 2) of BP reduction (52),
cholesterol lowering (53,54), increased physical activity (55),
glucose control in diabetics (56), weight loss among obese individuals
(57), and smoking cessation (58,59) reveal significant reductions
in a wide variety of CVD end points (including MI and stroke), health
care expenditures, and death.
Evaluating
the individual's global risk is essential in gauging the intensity
of intervention, as has been highlighted by a previous Bethesda
Conference (60). Until recently, practitioners and professional
societies have focused on treating individual risk factors in treatment
plans and practice guidelines. However, risk factors frequently
cluster in the individual, and risk escalates dramatically with
the accumulation of risk factors (61). This is particularly true
of patients affected by the metabolic syndrome, wherein insulin
resistance is accompanied by obesity, hypertension, and an unfavorable
lipid profile (62). The presence of diabetes is now understood to
confer equivalent risk on established CVD (63), and hence recent
guidelines emphasize that subjects with diabetes are appropriately
treated with secondary prevention thresholds developed for patients
with prior CVD events (64). Despite the rapid growth in scientific
knowledge, as previously described, evidence suggests that the decline
in most risk factors seen from 1970 to the 1990s has either slowed
or stopped. A number of factors may be responsible. The segments
of the population that are most willing to adopt preventive recommendations
have been reached. Remaining obstacles are often deeply embedded
in the structure of our society-for example, the high salt content
of processed food and the lack of opportunity to maintain an active
lifestyle in many communities. Regaining the momentum in primary
prevention will require widespread policy changes and education.
Primary
prevention encompasses strategies to prevent clinical events after
the development of risk factors that require drug treatment. Unless
we effectively implement primordial prevention, 21st century public
health may have to incorporate lifelong "pill taking"
among those at high risk. As we develop new policy directions in
primary prevention, the magnitude of the challenge to control risk
factors in those who have already developed them is becoming better
recognized. In the U.S. the prevalence of hypertension is 25%, and
18% of the population meets the new criteria for drug treatment
of hypercholesterolemia (65). To reach this large a segment of the
population, new approaches to detection, drug distribution, and
strategies to maintain adherence will be required.
Secondary
prevention. The implementation of preventive therapies after
a clinical event or manifestation of an underlying atherosclerotic
process, termed "secondary prevention," has received increased
attention and emphasis during the past decade. This emphasis on
secondary prevention has been attributable largely to the increase
in survival resulting from an improved treatment of patients presenting
with acute coronary syndromes and the emergence of several landmark
studies demonstrating the efficacy of preventive interventions in
reducing subsequent mortality and morbidity in this patient population.
Patients
with established CVD are at high risk for future events and therefore
merit the implementation of aggressive secondary prevention therapies
(65,66). Sudden death is 4 to 6 times more frequent among survivors
of MI than in the normal population. Patients who survive MI until
discharge have a one-year mortality rate as high as 26% to 36% if
they have moderate or severely decreased left ventricular systolic
dysfunction and clinical or radiographic signs of HF during hospitalization
(67). Increasing numbers of patients are being diagnosed and hospitalized
with CHD. From 1979 to 1998, hospital discharges for CHD increased
24.5% for men and 26.4% for women (1).
The
American Heart Association (AHA), American College of Cardiology
(ACC), and other professional and governmental organizations have
endorsed secondary prevention interventions through the formulation
of guidelines, which should be widely used for the secondary prevention
of atherosclerotic CVD (66,68). These recommendations generally
include: 1) smoking cessation; 2) BP control to a goal of less than
140/90 mm Hg (or lower with co-morbidity); 3) management of dyslipidemia
to a target low-density lipoprotein cholesterol level less than
100 mg/dl using dietary measures and lipid-lowering therapy; 4)
regular exercise; 5) weight management; 6) diabetes management;
7) angiotensin-converting enzyme inhibitor therapy (ACE-I), especially
for those with depressed ventricular function; 8) antiplatelet therapy;
and 9) beta-blocker therapy. Similar guidelines for the treatment
of HF have also been developed (69). The evidence-based support
for these recommendations is compelling. Most of the interventions
are associated with reductions of 20% to 30% in total mortality,
similar reductions in recurrent CV events including stroke, and
the need for revascularization procedures (70). Adherence to the
treatment guidelines is also associated with improved quality of
life (71).
Unfortunately,
secondary prevention therapies are not fully implemented. Studies
from the Health Care Financing Agency (now called Centers for Medicare
and Medicaid Services) and several large registries indicate that
on average, among ideal candidates, appropriate treatment is received
by less than 25% for lipid-lowering therapy, less than 25% for smoking
cessation, and less than 65% for ACE-I and beta-blockers (72-74).
A recently published study from the NHANES III database suggests
that among survivors of stroke or MI almost half of the subjects
with hypertension, hypercholesterolemia, and diabetes have inadequate
riskfactor control (75). There is significant regional variation
in the U.S. in the use of secondary prevention therapies; with the
greatest implementation generally in the Northeast and the lowest
in the Southeast. There is also reported lower use of secondary
prevention therapies among the elderly (73,76) and certain ethnic
groups, particularly black Americans (75). Of concern is the low
utilization of cardiac rehabilitation programs nationwide, estimated
to be less than 20%, which offer the potential for support of secondary
prevention therapies. Similar to other preventive modalities, cardiac
rehabilitation programs are disproportionately underutilized by
the elderly, women, minorities, and those living in the southern
U.S. (77). It is important to recognize that lack of insurance coverage
may contribute to underutilization of cardiac rehabilitation.
Studies
using hospital-based secondary prevention treatments have been initiated
by several groups including the AHA and the ACC. The initial results
from these programs suggest that significant improvement in treatment
rates, which are associated with reductions in one-year mortality,
can be achieved (78,79).
In addition, analyses of the economic benefits suggest that the
implementation of secondary prevention treatments would be cost-effective
compared with standard high-technology approaches (see Task
Force #2) (80,81).
Barriers
to Achieving Risk-Factor Reduction
Community and societal barriers to the prevention of CVD.
The fundamental contribution of lifestyle behaviors to the prevention
and reduction of risk factors, and the high prevalence of risk factors
in most population groups, mandate a public health approach to preventing
CVD. Community-wide as well as clinical strategies must be employed
in an effort to reduce both individual and population risk.
As
reviewed in depth by Task Force #3, research has demonstrated that
interventions to date have increased knowledge, changed lifestyle
behaviors, and improved risk factors. However, CVD morbidity and
mortality in the intervention communities did not exceed the gains
observed in control communities (82). Only one of the six community
CVD Prevention studies (83-89), the Franklin Cardiovascular Health
Program, has demonstrated a reduction in mortality. It is possible
that secular trends were shifting the population distribution of
risk factors during these years. Confounding changes, such as the
rise in obesity, may have blunted the effect of the interventions.
Furthermore, none of these studies had the statistical power necessary
to examine subgroup differences that might illustrate significant
effects of the interventions. It may be that study designs other
than clinical trials, which evaluate the effects of more intensive
interventions or interventions delivered over longer periods of
time, would result in more encouraging results.
Despite
the difficulties of effective intervention, the importance of community,
socioeconomic, and environmental barriers to risk reduction has
been demonstrated by numerous studies (90). In Harlem, a survey
was conducted to examine the prevalence and social correlates of
CVD (91). A high prevalence of major risk factors and the presence
of multiple risk factors were observed. Income and education were
inversely related to hypertension, smoking, and physical inactivity.
Having three or more risk factors was associated with low income,
low education, and a history of unstable work or homelessness.
Recently,
the National Heart, Lung, and Blood Institute (NHLBI) as part of
a Request for Application (RFA) targeting underserved minorities,
funded several studies examining community-based hypertension programs
and the extent to which they are linked to clinical care. A clinical
trial in Seattle assessed the effectiveness of enhanced tracking
and follow-up services provided by community health workers in promoting
medical follow-up of persons whose elevated BP was detected at community
sites. The enhanced community health worker intervention increased
medical follow-up by 39% (92). Ward et al. (93) in Los Angeles are
conducting a clinic- and community-based study of hypertension control
focusing on environmental and psychological factors related to treatment
adherence. The investigators are examining the effects of three
interventions: individualized counseling sessions, home visits/discussion
groups, and a computerized appointment-tracking system to evaluate
how to most effectively enhance adherence to hypertension treatment.
Studies of this nature will provide valuable insights into patient
adherence.
Community-based
studies have contributed to our understanding of the importance
of the environmental, social, and cultural context of individuals'
CV risk. Environmental stressors and accepted cultural "norms"
may be barriers to achieving CV risk reduction and must therefore
be identified and addressed to realize the reductions. Similarly,
an understanding of changes in cultural norms (e.g., increased hours
and pace of work, decreasing leisure time, and increased consumption
of fast food) will inform community-level strategies to reduce risk.
The variation in the composition of subgroups of individuals who
respond to various aspects of community CVD interventions illustrates
the necessity for the development and evaluation of interventions
that are targeted to specific age, socioeconomic, and cultural subgroups.
Numerous
studies in community settings, such as the work site, show that
it is possible to increase access, convenience, and continuity of
care and to reduce the cost of preventive health care for eligible
individuals. However, over time, even in fully insured health workers
receiving free medication, BP control rates averaged only 12% (94).
As Alderman (95) suggested, "Blood pressure treatment is preventive
medicine and it may not mix well with sick care, which is what the
American medical care system is about." Inequities in health
status have long been associated with education, poverty, inadequate
housing, unemployment, lack of health insurance, racism, and gender
barriers (96). The gap in income in the U.S. between those well
above and well below the poverty line continues to widen, and the
disproportionate prevalence of risk factors and receipt of medical
services among racial and ethnic groups across the income continuum
persists (97). Health providers' lack of understanding, stereotypical
perceptions, and insensitive communication pose major challenges
in practice and research among our increasingly diverse population
(98). Social, economic, and environmental risk factors, as well
as individual differences in risk factors, and community participation
in the design and conduct of studies need to be major foci of community-based
research.
Medical
setting barriers. There is a disappointing discrepancy between
the efficacy of treatments in randomized trials and their effectiveness
in clinical practice (99) For many
years, the onus for the gap between the expectations for CVD prevention
and the reality of practice was placed on the patient's "failing
to follow doctor's orders" (100).
However, virtually every study of preventive therapies, including
hypertension control, smoking cessation and cholesterol lowering,
has demonstrated that physicians have not pursued the goals of prevention
outlined in widely disseminated guidelines. It is tempting to blame
individual physicians as lacking the knowledge or the motivation
to effectively implement preventive practices. However, marked gaps
between risk-factor reduction goals and achieved results have been
documented in a broad range of medical settings throughout the developed
world, including nations with national health care systems (101,102).
Thus, increasingly, experts have looked to the health care system
to explain the lack of adherence to prevention guidelines. The systemic
barriers include a complex weave of attitudinal, knowledge,
and systemic limitations (Figure 4)
(103).
The
attitudinal barriers in the medical system involve both priorities
and beliefs (as reviewed in depth by Task Force
#5). The emphasis in medical school and training is on diagnosing
and treating acute illness. Physicians receive very little education
in prevention and the management of chronic conditions (104). Cardiologists,
in particular, often view their role as managing the acute event;
they frequently defer long-term prevention issues to primary care
providers. But the lack of specialist attention reinforces the perception
on the part of primary care providers and patients that the treatment
of chronic risk factors and lifestyle modification are discretionary
practices (104,105). Another barrier for physicians is their perception
of their role as teachers rather than as facilitators of medical
treatments. The difference in responsibilities is captured in the
very language we use to describe the failure of patients to follow
advice and take medications. The term "compliance" implies
a passive role for patients, rather than more contemporary terms
such as concordance or adherence, which emphasize interactive problem
solving between patients and doctors to achieve the desired endrisk-factor
modification (adherence is also reviewed in the Task
Force #4 report) (106,107). Still another belief, referred to
as "poor outcome expectancy," that acts as a barrier to
improving risk factors in the public is the ubiquitous perception
that counseling about lifestyle modification, such as smoking, is
ineffective (108), despite published studies to the contrary (109).
Part
of the gap in risk-factor reduction may be the result of knowledge
deficits. The quantity of accumulated observational
and randomized studies linking a multitude of risk
factors to CVD is staggering; it is increasingly difficult for
the busy clinician to "keep up" with the literature in
any area
of medicine. Professional societies and experts have looked
to guidelines to summarize the existing literature and provide
the clinician with direction in best practices. Unfortunately,
there is an extensive literature on the failure of guidelines to
live up to expectations, highlighting attitudes, knowledge,
and behavior as barriers to implementation (103). Attitudinal
barriers, alluded to earlier, include a lack of outcome
expectancy, lack of self-efficacy, and lack of motivation (103).
Many physicians resent the rigidity of guidelines and the attendant
loss in autonomy (110) because they misunderstand the concept of
guidelines. Guidelines are not intended as rigid rules but rather
as an evidence-based framework within which clinicians should exercise
their judgment. Others have raised concerns about the scientific
rigor and independence of guidelines (111). A lack of knowledge
of the content of guidelines constitutes another barrier to their
implementation. In one study, 41% of physicians were unaware of
or unfamiliar with, the Joint National Committee Guidelines on the
Prevention, Detection, Evaluation, and Treatment of High Blood Pressure,
and this lack of familiarity translated into less adherence to the
Guidelines' recommendations (112). The lack of familiarity with
a specific set of guidelines is not surprising, as it has been estimated
that general practitioners have as many as 25 guidelines to follow
on a wide range of medical conditions (113). Disagreement among
guidelines, which sometimes conflict in their assessment of risk
and their recommendations, has also been a deterrent to their implementation
(114,115).
The
plethora of available guidelineswhich have focused on the
relative risk of specific risk factors rather than on absolute risk
of CHD given the presence of several risk factors in an individual
patienthas also contributed to confusion (116). The physician
and patient may feel overwhelmed as to how to prioritize risk factor
reduction in a realistic and cost-effective manner. Health care
providers need to understand and be able to communicate what the
anticipated absolute benefit of a given risk-factor reduction strategy
is in a specific patient. Recognizing the importance of these barriers,
the ACC and the AHA have endorsed consensus guideline statements
for the primary and secondary prevention of atherosclerotic CVD.
As discussed later in this report, the secondary prevention guidelines
have been successfully incorporated into the ACC
Guidelines Applied in Practice project (117) and the AHA Get
with the Guidelines program. Health care provider compliance with,
and utilization of, secondary prevention therapies has risen dramatically
in hospitals where these programs have been implemented.
The
other major knowledge deficit for most providers is in techniques
for enhancing adherence to medication and lifestyle changes. Although
95% of medical schools currently instruct students in communication
skills (118), these skills are rarely reinforced in postgraduate
training and continuing medical education programs. There is a large
body of literature in health social psychology that provides insights
into effective health counseling techniques (106). However, most
physicians have little exposure to current theories in health psychology
and effective counseling in health behavior change, such as the
4As (ask about the problem, advise with clear recommendations about
desired behavior change, assist in problem solving to overcome barriers
to behavior change, arrange follow-up) (118). Hence, most physicians
lack confidence in their ability to enhance their patients' adherence
to medication and behavior-change regimens (100).
Finally,
there are profound systemic and organizational barriers to
the optimal implementation of risk-factor modification in clinical
practice. The lack of clinician knowledge in effective adherence
techniques stems in part from a lack of research on the subject.
There has been an emphasis on technology and treatment, with comparatively
little attention to factors that enhance adherence to recommended
treatments. For instance, there have been few randomized controlled
trials with adherence as the outcome-and even fewer that have focused
on techniques to increase long-term adherence (119,120). Reviews
of treatment-adherence studies reveal that many are methodologically
flawed, prohibiting firm recommendations on how to improve adherence
(121). Fortunately, recent grants from the NHLBI are beginning to
address the deficits in research on physician compliance with guidelines,
by researching minority and low socioeconomic status patients' adherence
to risk-factor intervention (e.g., http://grants.nih.gov/grants/guide/rfa-
files/RFA-HL-01-005.html).
Fundamentally,
preventive services and risk-factor modification have not been given
high priority by health care organizations and third-party payors,
either public or private. For instance, Medicare and many insurance
companies do not reimburse for preventive screening, medications,
or cardiac rehabilitation (e.g., for patients with HF or coronary
artery disease not immediately post-MI). Individual physicians are
offered little incentive and organizational support to pursue prevention
in their practices. Preventive services require time and effective
communication, which often is not reimbursed, and which competes
with addressing the immediate problems of patients (119).
Patient-related
barriers to CVD prevention. The risk status of individuals without
CVD varies greatly, and this variability mandates a range in the
type, frequency, and intensity of intervention (60). The Framingham
Heart Study and other studies have demonstrated that the major risk
factors for CVD are multiplicative in predictive power, and many
epidemiologic studies have identified a high prevalence of multiple
risk factors within individuals (62,122). Cardiovascular disease
intervention programs increasingly target multiple risk factors.
Successful risk-factor reduction requires a targeted approach, with
consideration given to individual barriers to modifying major independent
risk factors prevalent in both symptomatic and asymptomatic individuals.
A
recent review of the hypertension literature revealed numerous patient
barriers, including deficient knowledge about the severity and controllability
of risk factors, a lack of health insurance or a primary care provider,
economic constraints to cover the cost of medication, and challenges
to adhering to a complex lifestyle and medication regimen (100).
These and other barriers, such as lack of confidence in one's ability
to control risk factors, perceptions that the benefits of risk reduction
do not exceed the risks associated with control of the risk factors,
and competing priorities in patients' lives, make it difficult for
some patients to commit to achieving risk-factor control and to
actively engage in care.
The
National Council on Aging conducted a national survey in January
2000 comprising 1,500 persons age 50 and older. The Council reported
the following findings from telephone interviews: 46% believed that
a stressful life causes high BP; 51% did not recognize kidney failure
as a consequence of untreated hypertension; nearly half (45%) did
not know their recent BP numbers, yet 80% had had their BP checked
within the past four months; and surprisingly, 69% of the men and
women surveyed had not discussed the health consequences of high
BP with their health care providers in the past year (http://www.ncoa.org/news/hypertension/hypertension.html).
The results of this study highlight the prevalence of inadequate
knowledge about risk factors.
One
potential explanation for the lack of information about the assessment
of patient barriers, other than lack of knowledge and insurance,
is the inattention to myths about coronary artery disease. Jan Breslow,
MD, PhD, highlighted these myths, during his 1996 to 1997 presidency
of the American Heart Association as follows: 1) heart disease is
going away; 2) living with heart disease is not so bad; 3) heart
disease is a good way to die; 4) only older people have strokes;
5) women do not get heart disease; and 6) no more research is needed.
Little is known about the extent to which myths such as these influence
patients' prevention related to behavior. The influence of myths
on patient behavior and the effect of dispelling myths are important
areas for study.
Approaches
to Barriers in CVD Prevention
A number of approaches to the barriers outlined in this report have
been identified and will be reviewed in depth by Task Forces #3,
#4, and #5. While there is overlap, the proposed solutions
can be analyzed as addressing knowledge, attitudes, and structural
barriers in the community, in the medical setting, and at the patient
level.
In
the case of preventive CV medicine, advances in knowledge
have been incorporated into guidelines. Critiques of guidelines
have emphasized that guidelines must be straightforward, concise,
multidisciplinary, and evidencebased. The goal is to develop guidelines
that provide clinicians with a rapid understanding of the strength
of the research supporting the guideline, the desired treatment
goal, and the relevance and anticipated benefit of risk-factor treatment
to the specific patient (111,113,123).
To this end, computerized risk-factor assessment tools have been
developed (including a Personal Digital Assistant version available
here)
(122,124). Similarly,
the consolidation of primary and secondary prevention guidelines
for multiple cardiac risk factors into one guideline by the AHA
and the ACC is useful (50,66,68). There is a great deal known about
specific risk factors and efficacious treatment, but research must
address the major scientific deficits in our understanding of how
to improve both provider and patient long-term adherence to preventive
treatments and lifestyle modifications.
To
change provider attitudes about prevention, organizations
have pursued strategies of increasing incentives for risk-factor
achievement, in part by using professional societies and opinion
leaders to promulgate the prevention message, and in part through
quality improvement activities. The National Committee for Quality
Assurance is a voluntary accreditation program with participation
of 48% of the nation's 650 medical care organizations. The Health
Plan Employer and Data Information Set (HEDIS) has begun to require
health plans to report the percentage of hypertensive patients who
achieve BP levels less than 140/90 mm Hg and the percentage of patients
who achieve low-density lipoprotein cholesterol levels less than
130 mg/dl within one year after CV events (http://www.ncqa.org/Programs/HEDIS/)
(125). Twenty-seven U.S. medical care organizations have developed
a CHD outcomes management program that follows the quality improvement
model of assessing the baseline condition and strategizing for improvement
(phase 1), intervening (phase 2), and subsequent follow-up assessment
and modification (phase 3). As noted by the investigators, these
programs provide several incentives to medical care organizations-the
potential to reduce case management costs, improve patient care,
and enhance perceived value to potential plan purchasers (125).
Similar primary and secondary prevention projects following the
quality improvement model have been pursued in Texas. The model
of empowering site specific problem solving for quality improvement
has been demonstrated to improve adherence to guidelines (126,127).
There
have been several organizational interventions designed to
enhance the adherence of medical organizations to risk-factor modification.
To overcome barriers to adherence will require adequate reimbursement
for preventive activities as well as modification of practice settings
to implement technological and health care team approaches to enhancing
risk-factor control. Examples of an organizational approach to improving
risk-factor modification, involving quality improvement activities
that provide direct feedback on preventive medicine outcomes to
plans and providers, are the HEDIS and Texas projects described
earlier. In addition, there is increasing evidence that computer
software can enhance clinical performance in assessing CV risk and
implementing preventive care by providing accurate assessments of
risks and reminders of desired treatment goals (128,129). Critical
pathways (management algorithms that specify the sequence and timing
of optimal treatment) (130) and initiation of preventive treatment
before hospital discharge for an acute coronary event can also improve
the utilization of preventive therapy. Acknowledging the importance
of critical pathways and hospital initiation of treatment, the AHA
has launched a national program with web-based
resources to encourage acute care hospitals to "Get with
the Guidelines" for secondary prevention. Case management systems
integrating the services of a variety of CV specialists, including
physicians, nurses, and nutritionists, have also improved adherence
to preventive treatments (131). Yet another structural mechanism
for improving the delivery of preventive cardiology is achieved
by ensuring that patients have adequate benefit coverage and that
providers receive appropriate remuneration for preventive cardiology
activities (132).
As
noted throughout this report, despite the proliferation of guidelines,
the wealth of medications, and the increase in knowledge about the
benefits of risk-factor reduction, studies have demonstrated a leveling
off, and in some instances an increase in CV risk factors in the
U.S. A tremendous amount of money and effort continues to be devoted
to finding increasingly effective drugs. However, at least one analysis
of hypertension drugs suggested that improving treatment compliance
would create the highest gain in cost-effectiveness and efficiency
(133). Some have suggested a departure from standard approaches
to prevention. Experts have provocatively suggested that the same
marketing strategies aggressively and strategically employed by
tobacco, pharmaceutical, and advertising companies be used in medical
education for professionals and to educate our patients and the
public (106,134).
Patient
factors influencing CV health have been conceptualized as predisposing,
enabling, and reinforcing by Green and Kreuter (135)
(Figure 5). This approach integrates
health education, behavioral change and maintenance principles,
culturally sensitive strategies, social action, and social learning
theory. This conceptual approach also allows for the incorporation
of economic, psychosocial, and behavioral factors as antecedents
to behavior change. Patients' knowledge, beliefs, values, and attitudes
provide the rationale or motivation for the healthy behavior. Enabling
factors allow a predisposition to be translated into behavior, such
as accessing health care resources or acquiring appropriate skills.
Reinforcing factorssuch as family, peer, or health care provider
supportand supportive social services provide continuing support,
reward, or incentives, reinforcing maintenance of healthy behaviors.
Further
research is needed to better understand the extent to which patient
beliefs, expectations, and preferences influence provider-patient
communication, shared decision making, greater achievement of risk-factor
reduction, and prevention of CVD. This is particularly needed in
underserved minority groups that suffer a disproportionate CV risk
burden. For many patients, perhaps particularly for those living
in poverty with social, environmental, and behavioral burdens, daily
burdens are of greater priority than preventive CV health care and
are obstacles to health improvement. Consideration of an individual's
environmental, social, and cultural context is paramount in addressing
and overcoming individual barriers to risk reduction.
Summary
At the beginning of the 21st century, the record in the fight against
CVD has been mixed. Tremendous gains have been seen in our understanding
of the etiology, treatment, and prevention of CVD. There has been
modest success in implementing preventive risk-reduction therapies.
For instance, the prevalence of smoking has declined, and significant
gains have been made in the development and the implementation of
effective secondary prevention measures. However, in the face of
these successes, disturbing trends have emerged. Obesity and diabetes
mellitus are increasing in epidemic proportions, and gains in smoking
cessation and physical activity appear to be stagnating. Furthermore,
as affluent Americans are receiving increasingly better CV care
and enjoying a longer life span free of CVD, the ethnic and economic
disparities are widening. In addition, in all economic strata, ethnicities,
and regions, the gap between primordial, primary, and secondary
CVD prevention goals and the reality of implementation is enormous.
Despite
the emergence of these new challenges, unprecedented opportunities
exist for CVD prevention. Given the breadth and richness of the
accumulated knowledge base, society is now in a position to envision
the ultimate control of CVD. The fundamental causes of atherosclerosis,
hypertension, and diabetes are increasingly understood; highly effective
preventive interventions are known; and many therapeutic modalities
are available to treat patients with established disease. Based
on an examination of the last four decades, when overall CVD death
rates in the U.S. have declined an average of 2.5% per year, a future
date can be projected when mortality from CVD will be markedly lower
assuming that the current rate of decline continues (Table
1). Furthermore, based on accumulated epidemiological experience
worldwide, a population lifestyle can be specified that would be
associated with very low or absent rates of atherosclerosis. Thus,
eliminating smoking, reducing total fat to less than 25% to 30%
of calories and saturated fat to less than 7%, reducing dietary
salt to less than 3 g/day, eliminating obesity, encouraging moderate
daily physical activity, and treating high BP and high cholesterol
with available drugs can confidently be predicted to reduce CHD
rates to very low levels, perhaps less than 10% to 15% of all deaths.
That level of mortality should qualify as an achievable goal over
the next 20 years. Achieving a lifestyle that promotes that level
of CV health for all members of society remains an enormous practical
challenge in political terms, requiring fundamental changes in food
production and marketing, community design, work routines, and patterns
of care delivery. Nonetheless, attempts should continue to communicate
more forcefully the enormous success of the scientific enterprise
in its evolution of the position that CVD would now be controlled
if existing knowledge were put into practice.
The
cardiology community thus has a unique obligation to promote CV
health, particularly in the medical setting. The cardiology community
must partner with others to remove obstacles to disease prevention
in the health care environment, including the community, the medical
setting, and patients. To achieve significant reductions in CVD
will require the following: 1) intensive research into the attitudinal,
knowledge, and organizational barriers that decrease adherence to
known efficacious preventive strategies; 2) the funding of commitments
to research and to the delivery of preventive services; 3) policy
changes to guarantee access to care by all members of society, to
promote healthy lifestyles and environments in the community, and
to facilitate a shift in emphasis toward prevention by health care
providers; and 4) changes in clinical practice to emphasize prevention.
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