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Cardiac risk stratification in cardiac rehabilitation programs: a review of protocols

Anne Kastelianne França da SilvaI; Marianne Penachini da Costa de Rezende BarbosaI; Aline Fernanda Barbosa BernardoI; Franciele Marques VanderleiII; Francis Lopes PacagnelliIII; Luiz Carlos Marques VanderleiII

DOI: 10.5935/1678-9741.20140067

ABBREVIATIONS AND ACRONYMS

AACVPR: American Association of Cardiovascular and Pulmonary Rehabilitation

ACSM: American College of Sports Medicine

AHA: American Heart Association

BSC: Brazilian Society of Cardiology

CR: Cardiac rehabilitation

CVD: Cardiovascular diseases

HRF: Heart rate frequency

METs: Metabolic equivalent

SFC: Société Française de Cardiologie

INTRODUCTION

Cardiovascular diseases (CVD) are currently the leading cause of mortality worldwide, generating significant economic costs to the health system[1,2]. In Brazil, they are responsible for about 20% of all deaths in individuals over 30 years-old[3] and ischemic heart disease, strokes, hypertension and other heart diseases are responsible for 16 million deaths annually[4].

This scenario points to the need for effective low-cost interventions of a preventive nature to reduce cardiovascular events and improve survival in patients with CVD[5]. In this context, programs for cardiac rehabilitation (CR) emerge as a major tool because studies show that the practice of physical exercise safely improves aerobic capacity, cardiovascular function, and quality of life of cardiac patients[6,7].

In addition, regular physical exercise may, among other effects, promote benefits of a psychological nature, improve levels of adherence to pharmacological therapy[8], control risk factors, contribute to the reduction in mortality and improve symptoms of CVD[9], reducing clinical manifestations such as acute myocardial infarction, cardiac arrest or sudden death[10] and favorably influencing surgical outcomes[11].

However, to obtain the beneficial effects and ensure safety during physical exercises it is essential that it be prescribed correctly. To prescribe the appropriate exercise intensity for each individual it is first necessary to know the patient's level of risk, and for this purpose cardiac risk stratification becomes critical.

Cardiac risk stratification means careful evaluation of the clinical and functional status of the patient, starting with clinical history and physical, laboratory and ancillary tests, in order to classify the subject individually in a risk range (low, moderate, and high)[12]. This procedure provides indications for the appropriate targeting of the patient throughout the rehabilitation process, and the identification of risk levels, making it an integral part of the management of patients during and after an acute myocardial event[13].

In recent years, different protocols for cardiac risk stratification for participation in exercise programs were developed and validated by several national and international entities, such as multivariate analyzes, which have provided clinicians and researchers with a wide range of information and, consequently, a reduction in the probability of acute cardiovascular events occuring while performing an exercise program[12,14].

Despite the importance of this process of risk stratification in physical exercise programs for cardiac patients, to our knowledge there are no publications that gather information and describe the characteristics of different protocols. Thus, this study aimed to gather information and describe the general characteristics of different existing risk stratification protocols, which may assist researchers and clinicians in targeting safer behaviors and interventions in physical exercise programs for cardiac patients.

 

METHODS

Search strategy

This study was constructed from a survey of data found in existing literature. We conducted a literature search to update ourselves on methods for cardiac risk stratification in patients undergoing exercise, without language restrictions.

The articles selected were obtained through a literature search conducted in December 2013 in the following online databases: LILACS, IBECS, MEDLINE, the Cochrane Library and SciELO, covering the last 20 years, i.e. from January 1993 to December 2013. For this research cross-references were made of the following keywords in English (MeSH - Medical Subject Headings): Cardiovascular Diseases, Rehabilitation Centers, and Exercise Practice Guideline. The keyword "Risk Stratification" was also included because of its extreme relevance to the topic under focus.

Selection of studies

For this review, we initially carried out the screening of titles related to the topic in question. This selection was based first on titles that addressed the main idea: cardiovascular rehabilitation, cardiovascular diseases, physical training, safety in physical training for cardiac patients, cardiovascular events, cardiac risk, and methods of cardiac risk stratification; then, on titles that focused on activities to combat sedentary lifestyle. At the end of the search, repeated titles were removed, since they were held in various databases.

Then, a detailed reading of the article abstracts was undertaken to select only those that dealt exclusively with CR and the methods used for cardiac risk stratification for performing exercise. Having excluded abstracts that did not deal with the issue, the full texts were evaluated and those did not meet the exclusion criteria were included in the final results of the search. In addition, all references to the studies selected were reviewed to supplement the search. A single evaluator, under the supervision of a senior reviewer, undertook all stages of the search.

Inclusion criteria

The inclusion criteria were the following: a) studies published in all languages; b) the latest update of the stratification method, when updates occur periodically; c) articles published in the past 20 years; and d) works that specifically addressed strategies for cardiac risk assessment in cardiac patients undergoing exercise.

Exclusion Criteria

The exclusion criteria were the following: a) studies that did not mention the need for risk stratification in individuals practicing CR; b) authors who quoted in their work methods previously published by other entities; c) works in which risk assessment only covered risk factors for CVD; d) publications that dealt only with the prescription of exercise without describing a method for risk stratification; e) those articles that did not contain all the information found in the abstract; and f) full articles that were impossible to obtain for analysis after direct contact with the author or co-author.

Analysis of Data

Data were described according to the methods of risk stratification performed, references used for the development of the protocol, the clinical condition of the patient, the population addressed, and summary of the test protocol.

 

RESULTS

Eight methods of risk stratification were extracted from the databases searched. The general characteristics of the protocols found can be seen in Chart 1.

 

Protocol of the American College of Sports Medicine[14]

The guidelines of the American College of Sports Medicine (ACSM) for assessment and prescription of exertion were drawn up taking into account the participation of any person in an exercise program[14]. Thus, the main feature of the criteria for risk stratification of this entity is its simplicity (Chart 2). The presence of features in a higher risk class determines the range of risk and intensity of the training of each individual. Moreover, according to the guidelines, the presence of a negative risk factor (high serum HDL cholesterol) eliminates a positive risk factor so that an individual being rated in the moderate risk by having three positive risk factors may be reclassified in the low risk range if high serum HDL cholesterol is present. This highlights the importance of investigating laboratory tests, clinical and family history, and conducting physical assessments to determine the range of appropriate risk for each individual.

 

ACSM does not delimit the period in which the individual must be reassessed. However, the use of this protocol alone requires extreme caution in patients with heart disease whose clinical condition has become unstable[14].

Thus, the objective of this protocol is to identify the need to refer an individual at increased risk for a medical evaluation and possibly undergo an exercise test. The ACSM itself recognizes the guidelines of the AACVPR and the AHA and recommends that heart patients be stratified based on the criteria of those institutions[14].

Protocol of the Brazilian Society of Cardiology[15]

The protocol of the Brazilian Society of Cardiology (BSC) is mainly based on results obtained with the maximal exercise test. According to BSC, it is essential to carry out the progressive maximal exercise test to identify myocardial ischemia, ventricular dysfunction, cardiac arrhythmias and atrioventricular conduction disorders. Based on the results obtained in the supplementary examination patients should be stratified to start a cardiac rehabilitation program[15]. Chart 3 shows the criteria used by BSC for risk stratification.

 

According to BSC, patients referred to as low risk should be reassessed every year, whereas patients with moderate and high risk should be reassessed earlier, that is, every six months or whenever any clinical modification occurs[15].

The presence of any of the characteristics listed in the moderate or high classifications is sufficient for classification of patients in that category.

Protocol of the American Heart Association[16]

The American Heart Association (AHA) developed a more extensive system of risk classification for the medical release of cardiac patients, described in Chart 4A and 4B. The AHA guidelines provide recommendations for the monitoring and supervision of participants and/or patients as well as for possible restriction of activities[16]. Unlike previous guidelines, AHA classifies individuals into risk classes (A, B, C and D), and within the B and C classes there are further criteria that determine the clinical characteristics and the presence of symptoms that characterize the evolution of Congestive Heart Failure, pinpointed by the "Functional Classification of the New York Heart Association." If the individual chooses not to undergo a stress test, he should follow the guidelines described in Class B.

 

 

Individuals classified in Class A (Chart 4A) have no restrictions except for basic advice, with supervision and monitoring during exercise deemed unnecessary. It is suggested that people classified as Class A-2 and, in particular, class A-3 undergo a medical examination and possibly an exercise stress test under medical supervision before starting vigorous exercise[16].

For those assigned to either Class B (Chart 4A) or C (Chart 4B), the guideline recommends that activities be individualized and prescribed by qualified persons. In addition, initial medical supervision is considered useful until such time when the individual can perform his or her activities safely and without supervision, usually between the 6th and 12th session, always accompanied by the monitoring of blood pressure and electrocardiogram[16].

After successfully completing a series of supervised exercise sessions in Class C, the patient may be reclassified to Class B, provided that it is safe to undertake that activity with the prescribed intensity and that he has demonstrated the capacity for self-monitoring. No activity for the purpose of training is recommended for those classified in Class D (Chart 4B), but daily activities are prescribed, so that the individual may be gradually restored to Class C[16].

It should be recognized that the AHA guidelines do not take into account co-morbidities (for example, type 1 diabetes, morbid obesity, severe lung disease or debilitating neurological or orthopedic conditions) that could result in modification of recommendations for monitoring and supervision during exercise training[14].

Protocol designed by Frederic J. Pashkow[13]

In 1993, Pashkow developed a model for risk stratification based on the orientation of important guidelines at the time as well as new means of risk identification. He summarized them in three levels: low, moderate and high risk; considered by him to be extremely useful for the planning of the program[13].

His model is aimed at those who have suffered cardiac events such as myocardial infarction[13] and it uses important features of ancillary exams, such as the progressive exercise test, electrocardiogram, and echocardiogram.

The author argues that risk stratification should be a continuous process within or outside a rehabilitation program, since it evaluates the evolution of risk of each individual and determines the prognosis of any patient after an acute myocardial infarction. Moreover, the process of stratification makes it possible to identify individuals at risk of death or reinfarction and those who require only conventional therapy to achieve a good prognosis, such as those considered low risk[13].

The low, moderate and high risk levels suggested by Pashkow are described in Chart 5. The presence of a feature in the highest risk range classifies the individual in that category.

 

Protocol of the American Association of Cardiovascular and Pulmonary Rehabilitation[12]

The guideline of the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) uses variables common to those established models and allows for categorization in simple classes of risk, divided into: low, moderate, and high risk for participating in exercises. The low-risk patients do not exhibit any of the characteristics mentioned. Patients at greatest risk have any one of the characteristics mentioned. Those who do not fit into any classification are considered moderate risk[12].

This guidance is based primarily on the findings of an exercise test. It states that those who do not undergo the test before entering the program or those with undiagnosed exercise testing may be categorized inadequately using these criteria, and it suggests that these patients should be treated more cautiously with regard to risk stratification and that they should be monitored with a more conservative methodology for the prescription of exercise[12]. Chart 6 describes the definitions of low, moderate and high risk suggested by the AACVPR guideline.

 

For individuals classified as low-risk for participating in exercise, the guideline recommends that direct supervision of the exercise should occur for at least 6-18 workouts or 30 days after the event or post-procedure. For those with moderate risk, direct supervision should occur for at least 12 to 24 sessions or 60 days after the event or post-procedure, and high-risk patients should be monitored for at least 18 to 36 exercise sessions or 90 days after the event or post-procedure[12].

Protocol of the Société Française de Cardiologie[17]

The Société Française de Cardiologie (SFC) adapted the recommendations on exercise prescription of the European Society of Cardiology and the AACVPR in preparing its method of risk stratification[17]. This model is based on the patient's history and clinical examination and, systematically, on the stress test and echocardiogram[17]. This protocol recommends that after the initial assessment, the patient may be included in one of three risk categories described in Chart 7. However, the SFC suggests as an initial and temporary contraindication those who present: pericardial effusion, phlebitis, thrombus in the left ventricle or decompensated heart failure[17].

 

According to the SFC, patients with low or intermediate risk are able to start a classical training program, the structure of which is currently based primarily on the training heart rate frequency (HRF) determined during the stress test[18].

High-risk patients, combined with indicators of poor prognosis (low ejection fraction, early and severe ischemia, serious ventricular arrhythmias) are patients for whom training poses greater risks, but, on the other hand, gains are high in terms of quality of life. The prescription of exercise is more cautious here, and it usually begins with mild sessions and a higher level of monitoring during the first days, allowing for adaptation and subsequent resistance training[18].

Protocol of the Sociedad Española de Cardiología[19,20]

The Spanish Society of Cardiology (ESC) published two papers in 2000, entitled: Guides to clinical practice in cardiovascular prevention and cardiac rehabilitation[19] and Guides to clinical practice in physical activity of the cardiac patient[20], which addressed the practice of physical activity in individuals who have suffered AMI. The guide provides recommendations for risk stratification of these individuals using criteria such as clinical assessment and examinations, including echocardiography and stress testing. Although the guidelines are similar, there are differences in the stratification of risk.

The article entitled "Guides to clinical practice in cardiovascular prevention and cardiac rehabilitation"[19] suggests that the main indication for CR is ischemic heart disease in its different aspects, but it is expandable to all CVD and should also be applied to healthy subjects presenting risk factors. The guide reports that a program of secondary prevention should always be associated with CR in order to favor control of risk factors, improve quality of life, and reduce mortality and morbidity in this population[19]. The guide stratifies cardiac patients in three risk categories (Chart 8A) and calls for supervised programs for individuals of medium and high risk, with controlled heart failure, and those with psychological manifestations such as depression. Those classified as low risk for cardiac events during exercise can be admitted to a supervised program if they present the conditions mentioned[19].

 

The article entitled "Guides to clinical practice concerning the physical activity of cardiac patients"[20] makes general recommendations regarding the practice of sports for cardiac patients. The guide stresses that before starting any physical activity, whether of a sporting nature or not, cardiac individuals should be evaluated as to their personal and family medical history as well as sports activities they have engaged in and should undergo physical assessments, including a 12-lead resting electrocardiogram and stress test to at least submaximal[20]. The guide recommends avoiding exercise in patients with unstable angina, heart failure and aortic aneurysm or severe ventricular pseudoaneurysm. It stratifies individuals into two risk classes[20].

Chart 8B refers to the risk stratification for patients undertaking sports. Some similarities with Chart 8A can be noticed: both advise that individuals should be considered low risk when presenting ejection fraction >50%, absence of arrhythmias and ischemia, and clinical hospital outcome without complications. However, when the stratification refers to cardiac patients with high risk, most of the characteristics of a group considered "moderate" are added to the criteria that describe a high-risk population, allocating to this risk range all those individuals who would be considered as moderate risk or high risk in the previous guide.

 

It is still recommended that patients at low risk should be assessed annually and they may play sports with low to moderate dynamic and static component. Those at high risk should be reassessed every six months and they are free to participate in low intensity sports. For those patients who have had a heart attack or bypass surgery recently, it is advised to join a CR program before starting any sports activity. Finally, the guide points out that patients with ischemic heart disease should not compete, and are only free to practice sports to stay healthy[20].

 

CONCLUSION

The criteria for risk stratification for events during exercise or physical activity are derived from multivariate research considering factors associated with the increased risk of morbidity and mortality in general.

The main protocols for cardiac risk stratification for participation in physical exercise programs that are currently available are organized by the following entities: the American College of Sports Medicine (ACSM), the Brazilian Society of Cardiology (SBC), the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR), the American Heart Association (AHA), the Société Française de Cardiologie (SFC) and the Spanish Society of Cardiology (SEC).

These entities regularly publish reviews of their guidelines for assessment and prescription of exertion, trying to establish standards for the assessment and prescription of exertion, including the recommendations for risk stratification of patients who wish to begin a rehabilitation program.

In addition to these entities, Pashkow developed a method of stratification aimed at those with episodes of myocardial infarction, based on current guidelines at the time and on new means of identifying risks and he summed it up into low, medium, and high risk[12].

Most protocols use additional tests as reference, among which the ergometric test can be considered as a well-established methodology for risk stratification of cardiac patients[21]. For cardiac risk stratification the metabolic equivalent (METs) obtained from the ergometric test is indicated in many of the protocols as one of the main references for determining the risk level of each individual. The METs is a unit used to quantify the intensity of physical activity and energy expenditure caused by it[12].

The objective of stratifying cardiac risk goes beyond the classification of the individual's risk as it also allows the clinician to direct the therapeutic approach, to establish the level of monitoring and the appropriate dose of exercise (intensity, duration, etc.). Therefore, it is very important to implement risk stratification both for those who want to start a program of self-directed physical activity and for those who enter programs with exercises for primary or secondary prevention.

Among the protocols found for cardiac risk stratification with the exception of ACSM, all the protocols use the findings of the stress test as the main reference to stratify an individual safely, before starting exercise training, making this an extremely important tool in a CR program. Those using data from stress testing determine that the individual at greatest risk is one that presents a METs value lower than 5 METs during the test, and moderate values between 5 and 7.5 METs, enabling greater safety when choosing any of protocols, since there is no exaggerated disproportion in them.

However, only the ACSM protocol uses comorbidities such as type 1 diabetes, morbid obesity, severe pulmonary disease, and neurological conditions as stratifying criteria, which are important for planning the training as well as for a better view of the patient's condition and response to exercise.

SFC and AACVPR are the only ones that address the factor of "cardiac arrest" as a criterion to determine wheter a patient is at high risk for cardiac events during exercise, a very relevant factor when seeking to admit an individual safely into a rehabilitation program.

The SEC issued two stratification methods for cardiac patients, one for those who underwent CR and another for those who wish to practice sports competitively[19,20]. Like other entities it stratifies risks based on clinical findings and laboratory tests such as echocardiogram and stress test. For those individuals who wish to practice sports activities the criteria are more stringent when establishing the ranges of risk, because it involves a much more intense activity than that performed in a CR center.

Of all the methods mentioned here, only the ACSM is not directly aimed at patients suffering from a cardiovascular disorder, which can make its use less safe when applied to this population.

In particular, the AHA protocol is further subdivided into four risk classes, those considered healthy, those at low-risk, those at moderate to high risk, and those for whom physical training is not recommended. The other protocols classify individuals as low, moderate, and high risk. We may note another difference between protocols regarding to how up-to-date they are, given that the oldest protocol dates from 1993 and the most recent from 2013.

When assessing whether the AACVPR and AHA guidelines are really valid when predicting complications during exercise, Paul-Labrador et al.[22] found that neither were effective in assigning patients with complications to high-risk groups demonstrated by the low positive predictive values (5-7% variation) and low sensitivities (17-42% variation). However, the authors noted that these results might not be a specific failure of the guidelines, but might rather be due to the combination of an absence of potential predictors of risk and the low occurrence of serious complications in their study.

On the other hand, Zoghbi et al.[23], when evaluating the proposed AACVPR protocol in 1999 associated with noncardiac comorbidities[24], such as diabetes mellitus, chronic obstructive pulmonary disease, cerebrovascular disease, and peripheral arterial disease, among others, observed that cardiac events were best predicted when both classifications were combined, suggesting that in order to appreciate more fully the overall complexity of the disease among patients practicing CR, risk stratification should be supplemented not only with the inclusion of cardiac risk factors, as suggested in current guidelines, but also with an evaluation of non-cardiac comorbidities[25].

When stratifying the cardiac risk patients attending 65 CR centers by using the SFC protocol , Pavy et al.[26] were unable to correctly predict the risk of complications during physical training. The same occurred with Vongvanich et al.[27] when they used the AACVPR protocol. The authors attribute this result to the low frequency of serious complications during the trainings conducted.

We are not aware of studies evaluating other protocols (ACSM, SBC, and Pashkow SEC). Finally, based on the studies cited above, although risk stratification remains necessary at the beginning of a rehabilitation program, the occurrence of a major cardiovascular event seems to be difficult to predict in most cases[22-27].

Several guidelines allow risk stratification, but the criteria are derived from factors associated with an increased risk of morbidity and mortality in the general population[12]. Thus, it is not clear whether the overall risk and the risk during exercise training are similar[26].

Finally, to prescribe the appropriate exercise intensity within a CR program, it is necessary to know beforehand the level of risk that each individual faces. This stratification of cardiac risk associated with the assessment of non-cardiac comorbidities and cardiac risk factors for CVD is absolutely paramount because that way it is possible to establish the level of monitoring and the appropriate dose of exercise and consequently, it is essential for the start of a safe and effective CR program.

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Authors' roles & responsibilities

AKFS: Analysis and/or interpretation of data; final approval of the manuscript; conception and design of the study; implementation of operations and/or experiments; writing of the manuscript or revising it critically for content

MPCRB: Analysis and/or interpretation of data; implementation of operations and/or experiments; writing of the manuscript or revising it critically for content

AFBB: Analysis and/or interpretation of data; implementation of operations and/or experiments; writing of the manuscript or revising it critically for content

FMV: Analysis and/or interpretation of data; conception and design of the study; implementation of operations and/or experiments; writing of the manuscript or revising it critically for content

FLP: Analysis and/or interpretation of data; conception and design of the study; implementation of operations and/or experiments; writing of the manuscript or revising it critically for content

LCMV: Analysis and/or interpretation of data; final approval of the manuscript; conception and design of the study; implementation of operations and/or experiments; writing of the manuscript or revising it critically for content

 

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