This policy was originally developed in 1990 and has been updated with searches of scientific literature through January 2013. This section of the current policy has been substantially revised. The following is a summary of the key literature to date.
Many randomized controlled trials (RCTs) have been published comparing cardiac rehabilitation (CR) to usual care for patients with established heart disease, and several meta-analyses of RCTs have been performed. Two recent meta-analyses on cardiac rehabilitation were conducted by the Cochrane collaboration, one including patients with coronary heart disease (CHD) and the other focusing on patients with systolic heart failure.(3, 4) Both reviews addressed exercise-based cardiac rehabilitation programs (exercise-alone or as part of comprehensive program).
In 2011, Heran and colleagues identified 47 RCTs with 10,794 patients comparing cardiac rehabilitation to usual care in patients with CHD. (3) Seventeen of the studies used exercise-only interventions, and 29 used comprehensive rehabilitation (i.e., exercise plus psychosocial and/or educational interventions). The majority of studies (32 of 47, 68%) were conducted in Europe. Trial sample size ranged from 28 to 2,304. The median duration of rehabilitation interventions was 3 months, and there was a median follow-up duration of 24 months. The investigators reported that most studies had limited information available on methodologic quality. Due to the nature of the intervention, patients were not blinded to treatment group in any of the studies. Only 4 studies reported that there was blinded assessment of study outcomes. In a pooled analysis of data from 17 trials reporting all-cause mortality after at least 12 months of follow-up, cardiac rehabilitation resulted in a significantly lower mortality rate compared to usual care (relative risk [RR]: 0.87, 95% confidence interval [CI]: 0.75-0.99). Similarly, a pooled analysis of findings from 12 trials with at least 12 months follow-up found a significantly lower rate of cardiovascular mortality in the cardiac rehabilitation compared to the usual care group (RR: 0.74, 95% CI: 0.63-0.87). In sensitivity analyses of a priori defined variables, the investigators did not find a significant association between health outcomes and the type of cardiac rehabilitation (i.e., exercise-only versus comprehensive cardiac rehabilitation), length of the intervention or study publication date (i.e., published before 1995 or 1995 and later).
The 2010 Cochrane review by Davies and colleagues identified 19 trials with 3,647 heart failure patients; one large trial, HF-ACTION, contributed 2,331 (60%) patients. (4) The overall quality of the studies was judged poor; for example, only 3 studies adequately described their randomization process, and only 3 studies had blinded outcome assessment. A pooled analysis of the 13 studies reporting all-cause mortality with up to 12 months’ follow-up, did not find a statistically significant difference in mortality between groups (RR: 1.02, 95% CI: 0.70 to 1.51). Similarly, there was not a significant difference between groups in all-cause mortality in a pooled analysis of the 4 studies reporting more than 12 months’ follow-up (RR: 0.88, 95% CI: 0.73 to 1.07). No significant between-group differences were found for the other primary outcome variable, hospital admissions. For example, when findings from 5 studies reporting hospital admissions up to 12 months were pooled, the relative risk was 0.79 (95% CI: 0.58 to 1.07). The vast majority of the studies included in the Cochrane review, including the HF-ACTION trial, were exercise-only interventions; thus, conclusions cannot be drawn from this review regarding the impact of comprehensive cardiac rehabilitation programs on mortality or hospital admissions in patients with heart failure. The Cochrane review did not require that studies only include patients with compensated heart failure.
A 2011 meta-analysis by Lawler and colleagues addressed exercise-based cardiac rehabilitation programs for patients who had a recent myocardial infarction (MI). (5) To be included in the review, trials needed to include minimum intervention duration of 2 weeks and a minimum of 12 weeks of follow-up. Interventions could involve any form of exercise program, with or without other interventions. A total of 34 RCTs with 6,111 patients met the review’s inclusion criteria. In a pooled analysis of data from 18 trials, patients randomized to cardiac rehabilitation had a significantly lower risk of reinfarction than patients randomized to a control condition (odds ratio [OR]: 0.53, 95% CI: 0.38-0.76). There was also a lower risk of all-cause mortality (OR: 0.74, 95% CI: 0.58-0.95) and cardiovascular mortality (OR: 0.60, 95% CI: 0.40-0.76) in the group randomized to cardiac rehabilitation compared to a control intervention.
Findings of a large, multicenter RCT from the United Kingdom (U.K.) that evaluated the effectiveness of cardiac rehabilitation in a ‘real-life’ setting were published by West and colleagues in 2012. (6) Called the Rehabilitation After Myocardial Infarction Trial (RAMIT), the study included patients from centers with established cardiac rehabilitation programs that were multifactorial (including exercise, education and counseling), involved more than one discipline, and provided an intervention lasting a minimum of 10 hours. A total of 1,813 patients from 14 centers were randomized, 903 to cardiac rehabilitation and 910 to a control condition. Vital status was obtained at 2 years for 99.9% of participants (all but one patient) and at 7-9 years for 99.4% of participants. By 2 years, 166 patients had died, 82 (9.1%) in the cardiac rehabilitation group and 84 (9.2%) in the control group. The between-group difference in mortality at 2 years (the primary study outcome) was not statistically significant (RR: 0.98, 95% CI: 0.74 to 1.30). After 7-9 years, 488 patients had died, 245 (27%) in the cardiac rehabilitation group and 243 (26.7%) in the control group (RR: 0.99, 95% CI: 0.85-1.15). In addition, at 2 years, cardiovascular morbidity did not differ significantly between groups. For a combined endpoint including death, non-fatal MI, stroke or revascularization, the RR was 0.96 (95% CI: 0.88-1.07). In discussing the study’s negative findings, the trial authors noted that medical management of heart disease has improved over time, and patients in the control group may have had better outcomes than in earlier RCTs on this topic. Moreover, an editorial accompanying publication of study findings emphasized that RAMIT was not an efficacy trial but instead a trial evaluating the effectiveness of actual cardiac rehabilitation programs in the U.K. (7) Finally, these results may in part reflect the degree to which clinically based cardiac rehabilitation programs in the U.K. differ from the treatment protocols used in RCTs that were based in research settings.
Repeat Cardiac Rehabilitation
No studies were identified that evaluated the effectiveness of repeat participation in a cardiac rehabilitation program.
Cardiac rehabilitation refers to comprehensive medically supervised programs in the outpatient setting that aim to improve the function of patients with heart disease and prevent future cardiac events. A joint national U.S. guideline has specified core components of cardiac rehabilitation programs. Numerous RCTs have been performed, and meta-analyses of randomized controlled trials have found that cardiac rehabilitation improves health outcomes for selected patients. The evidence is insufficient to support repeat participation in cardiac rehabilitation programs.
Practice Guidelines and Position Statements
In 2007, the American Heart Association (AHA) and American Association of Cardiovascular and Pulmonary Rehabilitation (AACPR) issued an updated consensus statement on the core components of cardiac rehabilitation programs. (8) The 10 core components are: patient assessment prior to beginning the program, nutritional counseling, weight management, blood pressure management, lipid management, diabetes management, tobacco cessation, psychosocial management, physical activity counseling, and exercise training. Programs that only offer supervised exercise training are not considered to be cardiac rehabilitation. The updated guidelines specify the assessment, interventions, and expected outcomes for each of the core components. For example, symptom-limited exercise testing prior to exercise training is strongly recommended. The national guideline does not specify the optimal overall length of programs or number or duration of sessions.
In 2010, Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation published a position paper on cardiac rehabilitation. (2) Recommendations were based on a review of national guidelines from the U.S. and Europe. They stated that core components of cardiac rehabilitation are patient assessment, physical activity counseling, exercise training, diet/nutritional counseling, weight-control management, lipid management, blood pressure monitoring, smoking cessation, and psychosocial management. The recommended criteria for adequate exercise training are:
- Mode: Continuous endurance e.g., walking, jogging, cycling, swimming, etc.
- Duration: At least 20-30 minutes (preferably 45-60 minutes)
- Frequency: Most days (at least 3 days per week and preferably 6-7 days per week)
- Intensity: 50-80% of peak oxygen consumption or of peak heart rate or 40-60% of heart rate reserve.
The position paper did not address repeat participation in cardiac rehabilitation programs.
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