CAM 80308

Cardiac Rehabilitation in the Outpatient Setting

Category:Therapy   Last Reviewed:August 2021
Department(s):Medical Affairs   Next Review:August 2022
Original Date:August 2013    

Description
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. National organizations have specified core components to be included in cardiac rehabilitation programs.

Summary of Evidence
For individuals who have diagnosed heart disease who receive outpatient cardiac rehabilitation, the evidence includes multiple randomized controlled trials (RCTs) and systematic reviews of these trials. Relevant outcomes are overall survival (OS), disease-specific survival, symptoms, and morbid events. Meta-analyses of the available trials have found that cardiac rehabilitation improves health outcomes for select patients, particularly those with coronary heart disease, heart failure, and who have had cardiac surgical interventions. The available evidence has limitations, including lack of blinded outcome assessment, but for the survival-related outcomes of interest, this limitation is less critical. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have diagnosed heart disease without a second event who receive repeat outpatient cardiac rehabilitation, the evidence includes no trials. Relevant outcomes are OS , disease-specific survival, symptoms, and morbid events. No studies were identified evaluating the effectiveness of repeat participation in a cardiac rehabilitation program. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have diagnosed heart disease who receive intensive cardiac rehabilitation with the Ornish Program for Reversing Heart Disease, the evidence includes an RCT and uncontrolled studies. Relevant outcomes are OS , disease-specific survival, symptoms, and morbid events. No RCTs have compared the Ornish Program with a “standard” cardiac rehabilitation program; an RCT compared it with usual care. The trial included patients with coronary artery disease and no recent cardiac events and had mixed findings at 1 and 5 years. The trial had a small sample size for a cardiac trial (N=48), and only 35 patients were available for the 5-year follow-up. The Ornish Program is considered by the Centers for Medicare & Medicaid Services as an intensive cardiac rehabilitation program, but the program described in the RCT could meet criteria for standard cardiac rehabilitation. No studies were identified comparing the Ornish Program with any other cardiac rehabilitation program. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have diagnosed heart disease who receive intensive cardiac rehabilitation with the Pritikin Program, the evidence includes a case series. Relevant outcomes are OS , disease-specific survival, symptoms, and morbid events. Studies are needed that compare the impact of intensive cardiac rehabilitation using the Pritikin Program with standard outpatient cardiac rehabilitation programs. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have diagnosed heart disease who receive intensive cardiac rehabilitation with the Benson-Henry Institute Program, the evidence includes a case-control study and case series. Relevant outcomes are OS, disease-specific survival, symptoms, and morbid events. Studies are needed that compare the impact of intensive cardiac rehabilitation using the Benson-Henry Institute Program with standard outpatient cardiac rehabilitation programs. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Additional Information
Not applicable.

Background 
Cardiac Rehabilitation
In 1995, the U.S. Public Health Service defined cardiac rehabilitation services as, in part, “comprehensive, long-term programs involving medical evaluation, prescribed exercise, cardiac risk factor modification, education, and counseling … . (These programs) are designed to limit the physiologic and psychological effects of cardiac illness, reduce the risk for sudden death or reinfarction, control cardiac symptoms, stabilize or reverse the atherosclerotic process, and enhance the psychosocial and vocational status of selected patients.” The U.S. Public Health Service recommended cardiac rehabilitation services for patients with coronary heart disease and with heart failure, including those awaiting or following cardiac transplantation. A 2010 definition of cardiac rehabilitation from the European Association of Cardiovascular Prevention and Rehabilitation stated: “Cardiac rehabilitation can be viewed as the clinical application of preventive care by means of a professional multi-disciplinary integrated approach for comprehensive risk reduction and global long-term care of cardiac patients.”1, Since the 1995 release of the U.S. Public Health Service guidelines, other societies, including in 2005 the American Heart Association2, and in 2010 the Heart Failure Society of America 3, have developed guidelines on the role of cardiac rehabilitation in patient care. 

Regulatory Status
Not applicable.

Related Policies
None

Policy
Outpatient cardiac rehabilitation programs are considered MEDICALLY NECESSARY for patients with a history of the following conditions and procedures: 

  • acute myocardial infarction (heart attack) within the preceding 12 months; 
  • coronary artery bypass graft surgery; 
  • percutaneous transluminal coronary angioplasty or coronary stenting; 
  • heart valve surgery; 
  • heart or heart-lung transplantation; 
  • current stable angina pectoris; and 
  • compensated heart failure.

Repeat participation in an outpatient cardiac rehabilitation program in the absence of another qualifying cardiac event isinvestigational and/ or unproven and therefore considered NOT MEDICALLY NECESSARY. .

Intensive cardiac rehabilitation with the Ornish Program for Reversing Heart Disease, Pritikin Program, or Benson-Henry Institute Program is investigational and/or unproven and therefore considered NOT MEDICALLY NECESSARY.

Policy Guidelines
The following components must be included in cardiac rehabilitation programs:

  • Physician-prescribed exercise each day cardiac rehabilitation services are provided:
  • Cardiac risk factor modification:
  • Psychosocial assessment:
  • Outcomes assessment; and
  • Individualized treatment plan detailing how each of the above components are utilized.

A cardiac rehabilitation exercise program is eligible for coverage for 3 sessions per week up to a 12-week period (36 sessions). Programs should start within 90 days of the cardiac event and be completed within 6 months of the cardiac event.

A comprehensive evaluation may be performed prior to initiation of cardiac rehabilitation to evaluate the patient and determine an appropriate exercise program. In addition to a medical examination, an electrocardiogram (EKG) stress test may be performed. An additional stress test may be performed at the completion of the program.

Physical and/or occupational therapy are not medically necessary in conjunction with cardiac rehabilitation unless performed for an unrelated diagnosis.

Rationale  
Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function, including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and the quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Outpatient Cardiac Rehabilitation for Heart Disease
Clinical Context and Therapy Purpose
The purpose of cardiac rehabilitation in patients who have heart disease is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of cardiac rehabilitation in patients who have heart disease improve net health outcomes?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is patients with diagnosed heart disease.

Interventions
The treatment being considered is cardiac rehabilitation. Cardiac rehabilitation includes long-term programs that include medical evaluation, prescribed exercise, modification to reduce cardiac risks, education, and counseling.

Cardiac rehabilitation is administered by a cardiac rehabilitation specialist on an outpatient clinical basis. Some aspects of cardiac rehabilitation, such as exercise and nutrition changes, are performed by patients at home.

Comparators
The comparator of interest is standard management without cardiac rehabilitation. The following practices are currently being used to manage heart disease: medication, surgery, and medical devices.

Standard management of heart disease is administered by cardiologists in an outpatient clinical setting. Surgery for heart disease is performed by a cardiac surgeon in a tertiary care setting.

Outcomes
The general outcomes of interest are overall survival (OS), disease-specific survival, symptoms, and morbid events.

Once diagnosed with heart disease, a patient will require lifelong monitoring by a cardiologist.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:  

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.

  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

  3. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

  4. Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
Oldridge (2012) identified 6 independent meta-analyses published since 2000 that reported outcomes from 71 RCTs ( N=13824 patients) following cardiac rehabilitation interventions.6, The RCTs included in the meta-analyses enrolled patients with myocardial infarction, coronary heart disease, angina, percutaneous coronary intervention, and/or coronary artery bypass graft (CABG). RCTs compared cardiac rehabilitation programs (exercise-only and/or comprehensive rehabilitation) with usual care. Cardiac rehabilitation was associated with a statistically significant (p<0.05) reduction in all-cause mortality in 4 of the 5 meta-analyses that reported this outcome. In the pooled analysis, cardiac rehabilitation was associated with an 18.5% mean reduction in all-cause mortality. Also, cardiac rehabilitation was associated with a statistically significant reduction in cardiac mortality in 3 of the 4 meta-analyses that reported disease-specific mortality as an outcome.

Two of the meta-analyses on cardiac rehabilitation were Cochrane reviews. One included patients with coronary heart disease.7, and the other focused on patients with systolic heart failure.8 Both addressed exercise-based cardiac rehabilitation programs (exercise alone or as part of a comprehensive program). Anderson et al. (2016) updated a 2011 Cochrane review addressing exercise-based cardiac rehabilitation for individuals with coronary heart disease.7,9 Reviewers included RCTs of exercise-based interventions with at least 6 months of follow-up compared with no-exercise controls in patients with myocardial infarction, CABG, or percutaneous coronary intervention, or with angina pectoris or coronary artery disease. The updated review included 63 RCTs ( N=14486 individuals), of which 16 trials had been published since the 2011 update. Reviewers reported that the overall risk of bias was unclear, although the quality of reporting improved with more recent trials. Due to the nature of the intervention, patients were not blinded to treatment group in any of the studies, but 16 (25%) of 62 studies reported details of blinded assessment of study outcomes. In the pooled analysis, cardiac rehabilitation was not significantly associated with overall mortality. However, among 27 studies, cardiac rehabilitation was significantly associated with reduced cardiovascular mortality (292/3850 for cardiac rehabilitation subjects vs. 375/3619 for control subjects; relative risk [RR], 0.74; 95% confidence interval [CI], 0.64 to 0.86). Rates of myocardial infarction, CABG, and percutaneous coronary intervention were not significantly associated with receiving cardiac rehabilitation.

Long et al. (2019) reported a Cochrane Review of studies assessing cardiac rehabilitation in patients with heart failure. A total of 44 RCTs were evaluated; 11 of which were new trials, for the effects of exercise-based cardiac rehabilitation on adults with heart failure (5,783 total participants).10 A single trial, Exercise Based Cardiac Rehabilitation for Adults With Heart Failure (HF-ACTION) contributed almost half of the patients (with results reported in 18 publications); most other studies were small and single-center. All studies had 6 months or longer follow-up and did not include a formal exercise training intervention as a comparator. The primary outcomes reported were mortality, hospital admission, and health-related quality of life (HRQoL). The overall risk of bias was assessed as being low or unclear, and results were downgraded using the GRADE tool for all outcomes except one. Results showed that cardiac rehabilitation had little effect on all-cause mortality over ≤1 year of follow-up (27 trials, 2,596 participants: cardiac rehabilitation 5.1% vs. control 5.8%; low-quality evidence). However, cardiac rehabilitation may make a difference in the long-term (>1 year of follow-up; 6 trials, 2,845 participants: cardiac rehabilitation 17.2% vs. control 19.6%; high-quality evidence). Mortality related to heart failure was not consistently reported in the studies. Chances of avoiding hospital admission for any cause within 12 months of follow-up were better with cardiac rehabilitation (21 trials, 2182 participants: cardiac rehabilitation 16.5% vs. control 23.7%; moderate-quality evidence). Cardiac rehabilitation may also reduce short-term heart failure-related hospital admission (14 trials, 1,114 participants: cardiac rehabilitation 7.1% vs. control 11.1%; RR 0.59, 95% CI, 0.42 to 0.84; p=.0003), but the evidence was rated low quality. HRQoL was reported by 29 trials, most of which used the Minnesota Living With Heart Failure questionnaire; however, other tools were also used among the 29 trials that reported validated HRQoL measures. For exercise-based cardiac rehabilitation, no trials reported lower HRQoL scores with cardiac rehabilitation than with control, and all but 1 reported on results at ≥6 months follow-up. The pooled results from all measures used showed a clinically important improvement (a 5-point difference on the Minnesota Living With Heart Failure with exercise at up to 12 months’ follow-up, but the evidence was of very low quality. Compared with the 2014 review, this version included more women, older patients, and participants with heart failure with preserved ejection fraction in recent trials, and with more trials of cardiac rehabilitation in a home-based setting, this version may be more valid and applicable.

Table 1. Systematic Review Characteristics 

StudyDatesTrialsParticipantsN (Range)Design
Davies et al. (2010)8 1995-2008 29 All adults with chronic systolic HF 3,647 (20 to 2,331) RCT
Oldridge (2012)6 2000-2011 71 Patients with MI, CHD, angina, PCI, and/or CABG 13,824 (6,111 to 10,794) RCT
Anderson et al. (2016)7 1975-2014 63 Patients with MI, angina pectoris, CAD, or who underwent CABG or PCI 14,486 (25 to 3,184) RCT
Long et al. (2016) 10 1995-2018 44 Patients with HF 5,783 (19 to 2,331) RCT

CABG: coronary artery bypass graft; CAD: coronary artery disease; CHD: coronary heart disease; HF: heart failure; MI: myocardial infarction; PCI: percutaneous coronary intervention; RCT: randomized controlled trial. 

Table 2. Systematic Review Results 

StudyAll-Cause MortalityCardiovascular Mortality
Davies et al. (2010)8 13 studies (≤12 mo) NR
Difference in pooled mortality, fixed-effect RR 1.02 NR
95% CI 0.70 to 1.51 NR
p-value 0.90 NR
Oldridge (2012)6 6 studies 6 studies
Reduction, mean % 18.50 29.4
p-value <0.05 NR
Range, % NR 20 to 43
Anderson et al. (2016)7 47 studies; N=12,455 participants 27 studies; N=7,469 participants
RR 0.96 0.74
95% CI 0.88 to 1.04 0.64 to 0.86
Long et al. (2019) 10 2,845 participants, 6 studies (Studies did not consistently report deaths due to heart failure.)
RR 0.88 NR
95 % (CI) 0.75 to 1.02 NR

CI: confidence interval; NR: not reported; RR: relative risk.

Randomized Controlled Trials
Findings of a large, multicenter RCT from the United Kingdom, which evaluated the effectiveness of cardiac rehabilitation in a “real-life” setting, were published by West et al. (2012).11 Called the Rehabilitation After Myocardial Infarction Trial (RAMIT), the study included patients from 14 centers with established multifactorial cardiac rehabilitation programs (including exercise, education, and counseling), involved more than 1 discipline, and provided an intervention lasting a minimum of 10 hours. A total of 1,813 patients were randomized: 903 to cardiac rehabilitation and 910 to a control condition. Vital status was obtained at 2 years for 99.9% (all but 1 patient) and at 7 to 9 years for 99.4% of patients. By 2 years, 166 patients had died, 82 in the cardiac rehabilitation group and 84 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 to 9 years, 488 patients had died, 245 in the cardiac rehabilitation group and 243 in the control group (RR=0.99; 95% CI, 0.85 to 1.15). In addition, at 1 year, cardiovascular morbidity did not differ significantly between groups. For a combined endpoint including death, nonfatal myocardial infarction, stroke, or revascularization, the RR was 0.96 (95% CI, 0.88 to 1.07). In discussing the study’s negative findings, trialists noted that medical management of heart disease had improved over time, and patients in the control group might have had better outcomes than in earlier RCTs on this topic. Moreover, an editorial accompanying the publication of the trial’s findings emphasized that RAMIT was not an efficacy trial, but rather, a trial evaluating the effectiveness of actual cardiac rehabilitation programs in the United Kingdom. 12 Finally, these results might in part reflect the degree to which clinically based cardiac rehabilitation programs in the United Kingdom differ from the treatment protocols used in RCTs based in research settings.

A concern raised by the negative findings in the RAMIT trial is that most of the RCTs evaluating cardiac rehabilitation were conducted in an earlier era of heart disease management and might not be relevant to current care. However, RAMIT’s results, along with 15 additional RCTs reported since a 2011 Cochrane review, were included in the updated 2016 Cochrane review, which found improvements in cardiovascular mortality associated with exercise-based cardiac rehabilitation.

Pandey et al. (2017) evaluated endurance exercise training as part of a cardiac rehabilitation program in a population of heart failure patients stratified by ejection fraction.13 Participants had heart failure with preserved ejection fraction or reduced ejection fraction, were 65 years of age or older, and had participated in a 16-week exercise program that intensified from 40% to 50% of heart rate reserve in the first 2 weeks to 60% to 70% over the ensuing weeks as part of a previously published RCT.14 The primary outcome for assessing change in exercise capacity was the percentage change in peak oxygen uptake (mL/kg per minute) from baseline to end of exercise training (16-week follow-up). Data on testing from 48 patients (24 reduced ejection fraction, 24 heart failure with preserved ejection fraction) were assessed. Heart failure with preserved ejection fraction patients experienced greater improvement in exercise training patients (18.7%) than reduced ejection fraction patients (-0.3%; p<0.001) as measured by peak oxygen uptake. There was no information on subsequent hospitalization rates or clinical outcomes such as heart failure progression or mortality. This secondary analysis was used to assert the appropriateness of cardiac rehabilitation in heart failure with preserved ejection fraction patients.

Opotowsky et al. (2018) compared cardiac rehabilitation to the standard of care in 28 subjects (mean age: 41.1 years) with moderate to severe congenital heart disease.15 Cardiac rehabilitation was associated with a significant increase in peak oxygen consumption with no associated adverse events. There was also a nonsignificant improvement in peak work rate with cardiac rehabilitation as compared to standard of care (p=0.16) and a significant improvement in self-assessment of overall health (p<0.04). However, the study was limited by its small sample size and short-term follow-up.

Snoek et al. (2020) evaluated 6 months of home-based mobile guided cardiac rehabilitation versus standard of care in 179 elderly subjects (mean age: 72 years) with a recent diagnosis of cardiovascular disease.16 The primary outcome measure was peak oxygen uptake after 6 months. Results revealed that changes in peak oxygen uptake were greater in the cardiac rehabilitation group as compared to the control at both 6 and 12 months. The overall incidence of adverse events was low and did not differ between groups. A limitation of the study was that the authors used home-based mobile guided cardiac rehabilitation as an alternative to exercise-based cardiac rehabilitation and not for comprehensive cardiac rehabilitation, because the authors did not include all core components of cardiac rehabilitation in their intervention. Tables 2 and 3 provide a summary of key RCT characteristics and results. 

Table 3. Summary of Key Randomized Controlled Trial Characteristics 

TrialCountriesSitesDatesParticipantsInterventions
          Active Comparator
West et al. (2012); RAMIT11, United Kingdom 14 1997-2000 Patients diagnosed with acute MI (N=1813) Cardiac rehabilitation (n=903) Control (n=910)
Pandey et al. (2017)13 U.S. 1 NR Patients aged ≥ 65 with HFrEF (n=24) or HFpEF (n=24) (N=48) 16-week supervised moderate endurance exercise training (n=48) HRrEF (n=24) vs.
HFpEF (n=24)
Opotowsky et al. (2018)15 U.S. 1 NR Patients aged ≥ 16 with moderate to severe congenital heart disease (N=28) 12-week cardiac rehabilitation (n=13) Standard of care (n=15)
Snoek et al. (2020)16 5 European countries 6 2015-2018 Patients aged ≥ 65 with a recent diagnosis of acute coronary syndrome, coronary revascularization, surgical or percutaneous treatment for valvular disease, or documented coronary artery disease (N=179) 6-month mobile cardiac rehabilitation (n=89) Standard of care (n=90)

HF: heart failure; HFpEF: HF with preserved ejection fraction; HFrEF: HF with reduced ejection fraction; MI: myocardial infarction; NR: not reported; RCT: randomized controlled trial; RAMIT: Rehabilitation After Myocardial Infarction Trial. 

Table 4. Summary of Key Randomized Controlled Trial Results 

Study2-yr MortalityReadmission to Hospital for Any Cardiac Condition at 1 yTraining-Related Improvement in Vo2 Peak Change
West et al. (2012); RAMIT11 N=1813 participants N=1813 participants NR
CR 82 patients 222 (25%) NR
Control 84 patients 239 (26%) NR
RR 0.98 NR NR
95% CI 0.74 to 1.30 NR NR
Pandey et al. (2017)13 NR NR N=48 participants
HFrEF NR NR 18.7+/-17.6
HFpEF NR NR -0.3+/-15.4
p-value NR NR <0.001
Opotowsky et al. (2018)15     N=28 participants
CR NR NR +2.2 mL/kg/min (compared to standard of care)
95% CI; p value NR NR 0.7 to 3.7; p=0.002
Snoek et al. (2020)16     N=179 participants
CR [95% CI] NR NR At 6 months: 1.6 [0.9 to 2.4] mL/kg/min
At 12 months: 1.2 [0.4 to 2.0] mL/kg/min
Standard of care NR NR At 6 months: 0.2 [-0.4 to 0.8] mL/kg/min
At 12 months: 0.1 [-0.5 to 0.7] mL/kg/min

CI: confidence interval; CR: cardiac rehabilitation; HF: heart failure; HFpEF: HF with preserved ejection fraction; HFrEF: HF with reduced ejection fraction; NR: not reported; RCT: randomized controlled trial;  RR: relative risk; Vo2peak: peak oxygen uptake. RAMIT: Rehabilitation After Myocardial Infarction Trial. 

The purpose of the limitations tables (see Tables 5 and 6) is to display notable limitations identified in each study. This information is synthesized as a summary of the body of evidence following each table and provides the conclusions on the sufficiency of the evidence supporting the position statement.

Table 5. Study Relevance Limitations  

StudyPopulationaInterventionbComparatorcOutcomesdFollow-Upe
West et al. (2012); RAMIT11         1,2. Trial was closed prematurely
Pandey et al. (2017)13     2. No comparator used   1,2. Only 16 weeks follow-up
Opotowsky et al. (2018)15       1. Key health outcomes such as
mortality or readmission not addressed
1,2. Only 12 weeks follow-up
Snoek et al. (2020)16   2. Intervention was an alternative for exercise-based cardiac rehabilitation and not for comprehensive cardiac rehabilitation; authors did not include all core components of cardiac rehabilitation in the intervention   1. Key health outcomes such as
mortality or readmission not addressed
 

 The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.
RAMIT: Rehabilitation After Myocardial Infarction Trial.

Table 6. Study Design and Conduct Limitations 

StudyAllocationaBlindingbSelective ReportingcFollow-UpdPowereStatisticalf
West et al. (2012); RAMIT11 3. Allocation concealment unclear 1,2. Not blinded        
Pandey et al. (2017)13 1. Participants not randomly allocated 1,2. Not blinded        
Opotowsky et al. (2018)15   1,2. Not blinded     1. Power calculations not reported  
Snoek et al. (2020)16,   2. Not blinded to outcome assessment     3. Not powered to detect a difference in hard outcomes or more rare adverse events  

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps s assessment.
a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
d Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.
RAMIT: Rehabilitation After Myocardial Infarction Trial.

Observational Studies
Sumner et al. (2017) published a systematic review of controlled observational studies evaluating cardiac rehabilitation in patients diagnosed with acute myocardial infarction.17 Cardiac rehabilitation interventions consisted of structured multicomponent programs that included exercise and at least 1 of the following: education, information, health behavior change, and psychological or social support. Usual care interventions, generally supervised medical interventions, were the control conditions. Ten studies met reviewers’ eligibility criteria. In a meta-analysis of 5 studies reporting all-cause mortality (an unadjusted outcome), there was a significantly lower risk of death in the group that received cardiac rehabilitation (odds ratio, 0.25; 95% CI, 0.16 to 0.40). Three studies that reported an adjusted analysis of all-cause mortality also found a significant benefit from cardiac rehabilitation (odds ratio, 0.47; 95% CI, 0.38 to 0.59). Similarly, a meta-analysis of 3 studies reporting cardiac-related mortality (an unadjusted analysis) found a significant benefit from cardiac rehabilitation (odds ratio, 0.21; 95% CI, 0.12 to 0.37). Only 1 study reported an adjusted analysis of cardiac-related mortality, so data could not be pooled.

Nilsson et al. (2018) investigated the effect of a 12-week cardiac rehabilitation program with a high-intensity interval exercise component using participant peak oxygen uptake as a measure of improved exercise capacity.18, Increased exercise capacity has been shown to improve survival among persons with coronary heart disease. The objective of the study was to assess whether this addition to a cardiac rehabilitation program yielded improved long-term results. One hundred thirty-three coronary patients participated in this prospective cohort study and were evaluated at baseline, at the end of the 12-week program, and again at a 15-month follow-up. Additional test measurements included a cardiopulmonary exercise test, body mass index, blood pressure tests, and a quality of life questionnaire. Of the 133 patients, 86 patients had complete information for the 15-month follow-up. Mean peak oxygen uptake improved from a baseline of 31.9 mL/kg/min to 35.9 mL/kg/min (p<0.001) at the end of the 12-week program, and to 36.8 mL/kg/min (CI not reported) at 15-month follow-up. Most of the 86 patients reported maintaining an exercise routine. Study limitations included the small sample size, a relatively low-risk male population at baseline, and lack of information on the qualifying event for cardiac rehabilitation. The authors concluded that the cardiac rehabilitation program intervention potentially fostered consistent and beneficial exercise habits as demonstrated by improved peak oxygen uptake.

Section Summary: Outpatient Cardiac Rehabilitation for Heart Disease
Overall, the evidence from RCTs reviewed in well-structured systematic reviews suggests that cardiac rehabilitation is associated with reduced cardiovascular mortality in patients with coronary heart disease. Additional RCTs, systematic reviews, and observational studies have evaluated outpatient cardiac rehabilitation in patients with heart failure or in the postintervention setting. An overview of 6 meta-analyses found a statistically significant association between cardiac rehabilitation and all-cause mortality and/or cardiac mortality. The available evidence has limitations, including lack of blinded outcome assessment, but, for the survival-related outcomes of interest, this limitation is less critical.

Repeat Outpatient Cardiac Rehabilitation
Clinical Context and Therapy Purpose
The purpose of repeat cardiac rehabilitation in patients who have heart disease without a second event is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of repeat cardiac rehabilitation in patients who have heart disease without a second event improve net health outcomes?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is patients with diagnosed heart disease who have had cardiac rehabilitation before but who have not had a second cardiac event.

Interventions
The treatment being considered is repeat cardiac rehabilitation. Cardiac rehabilitation includes long-term programs that include medical evaluation, prescribed exercise, modification to reduce cardiac risks, education, and counseling.

Cardiac rehabilitation is administered by a cardiac rehabilitation specialist on an outpatient clinical basis. Some aspects of cardiac rehabilitation, such as exercise and nutrition changes, are performed by patients at home.

Comparators
The comparator of interest is standard management with a single course of cardiac rehabilitation. Cardiac rehabilitation includes long-term programs that include medical evaluation, prescribed exercise, modification to reduce cardiac risks, education, and counseling.

Cardiac rehabilitation is administered by a cardiac rehabilitation specialist on an outpatient clinical basis. Some aspects of cardiac rehabilitation, such as exercise and nutrition changes, are performed by patients at home.

Outcomes
The general outcomes of interest are OS, disease-specific survival, symptoms, and morbid events.

Once diagnosed with heart disease, a patient will require lifelong monitoring by a cardiologist.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:  

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.

  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

  3. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

  4. Studies with duplicative or overlapping populations were excluded.

Review of Evidence
No studies were identified that evaluated the effectiveness of repeat participation in a cardiac rehabilitation program.

Intensive Cardiac Rehabilitation for Heart Disease
There is no standard definition of an intensive cardiac rehabilitation program and, thus, specific programs are reviewed individually. Three programs have been evaluated by the Centers for Medicare & Medicaid Services, and the published evidence supporting these programs is reviewed. The ideal trial design would be an RCT comparing the impact of intensive cardiac rehabilitation with standard cardiac rehabilitation on health outcomes.

Ornish Program for Reversing Heart Disease
Clinical Context and Therapy Purpose
The purpose of the Ornish Program for Reversing Heart Disease in patients who have diagnosed heart disease is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of the Ornish Program for Reversing Heart Disease in patients who have heart disease improve net health outcomes?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is patients with diagnosed heart disease.

Interventions
The treatment being considered is the Ornish Program for Reversing Heart Disease.

The Ornish Program for Reversing Heart Disease is an intensive cardiac rehabilitation program that focuses on exercise, diet, stress management, and support from others.

The multiple 4-hour sessions are administered by an Ornish-certified physician, cardiac therapist, or other certified health care provider.

Comparators
The comparator of interest is standard outpatient cardiac rehabilitation. Cardiac rehabilitation includes long-term programs that include medical evaluation, prescribed exercise, modification to reduce cardiac risks, education, and counseling.

Cardiac rehabilitation is administered by a cardiac rehabilitation specialist on an outpatient clinical basis. Some aspects of cardiac rehabilitation, such as exercise and nutrition changes, are performed by patients at home.

Outcomes
The general outcomes of interest are OS, disease-specific survival, symptoms, and morbid events.

Once diagnosed with heart disease, a patient will require lifelong monitoring by a cardiologist.

Study Selection Criteria
Methodologically credible studies were selected using the following principles: 

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.

  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

  3. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

  4. Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Randomized Controlled Trials
Ornish et al. (1990) conducted an RCT, called the Lifestyle Heart Trial, comparing a version of the Ornish Program for Reversing Heart Disease with usual care. Initial results were reported in 1990, and 5-year results in 1998.19,20 Eligibility for the trial included diagnosed coronary artery disease, left ventricular ejection fraction greater than 25%, no myocardial infarction during the previous 6 weeks, not scheduled for CABG, and not taking lipid-lowering medication. Ninety-four eligible patients were randomized to an intervention group (n=53) or a usual care control group (n=43). Final consenting was done after randomization; 28 (53%) of patients assigned to the intervention group and 20 (43%) assigned to the control group agreed to participate in the trial.

The lifestyle intervention consisted of recommending a low-fat vegetarian diet and an individualized exercise regimen. Also, patients were taught stress management techniques and were taught to practice them at home for at least an hour a day. Also, twice-weekly group discussions were offered to provide social support. It is not clear how long patients attended these group discussions (ie, the number of weeks or months). As reported by Ornish et al. (1990), the mean percentage diameter stenosis decreased from 40% at baseline to 37.8% at 1 year in the intervention group and increased from 42.7% to 46.1% in the control group (p=0.001). The frequency and duration of chest pain did not differ between groups. However, during chest pain episodes, at 1 year, the intervention group reported mean chest pain severity of 1.7 (on a 7-point scale) whereas the mean score in the control group was 2.5 (p<0.001).

Twenty (71%) of 28 patients in the intervention group and 15 (75%) of 20 in the control group completed the 5-year follow-up. The intervention and control groups did not differ significantly in the number of myocardial infarction events (2 vs. 4), CABGs (2 vs. 5), or deaths (2 vs. 1). However, compared with the control group, the intervention group had significantly fewer percutaneous transluminal coronary angioplasties (8 vs. 14, p<0.050) and cardiac hospitalizations (23 vs. 44, p<0.001).

Section Summary: Ornish Program for Reversing Heart Disease
One RCT was identified that evaluated the Ornish Program in patients diagnosed with heart disease and compared it with usual care. This RCT, which included patients with coronary artery disease but no recent cardiac event, had mixed findings at 1 and 5 years. The trial had a small sample size for a cardiac trial (N=48), and only 35 patients were available for the 5-year follow-up. The Ornish Program is considered by the Centers for Medicare & Medicaid Services to be an intensive cardiac rehabilitation program, but the program described in this RCT might meet the criteria for standard cardiac rehabilitation. No studies were identified that compared the Ornish Program with any other cardiac rehabilitation program.

Pritikin Program
Clinical Context and Therapy Purpose
The purpose of the Pritikin Program in patients who have diagnosed heart disease is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of the Pritikin Program in patients who have heart disease improve net health outcomes?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is patients with diagnosed heart disease.

Interventions
The treatment being considered is the Pritikin Program.

The Pritikin Program is an intensive cardiac rehabilitation program based on effective exercise, a healthy diet, and a healthy mindset. The Pritikin Program is administered by cardiologists, cardiac therapists, and other health care providers.

Comparators
The comparator of interest is standard outpatient cardiac rehabilitation. Cardiac rehabilitation includes long-term programs that include medical evaluation, prescribed exercise, modification to reduce cardiac risks, education, and counseling.

Cardiac rehabilitation is administered by a cardiac rehabilitation specialist on an outpatient clinical basis. Some aspects of cardiac rehabilitation, such as exercise and nutrition changes, are performed by patients at home.

Outcomes
The general outcomes of interest are OS , disease-specific survival, symptoms, and morbid events.

Once diagnosed with heart disease, a patient will require lifelong monitoring by a cardiologist.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:  

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.

  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

  3. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

  4. Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Case Series
No RCTs evaluating the Pritikin Program were identified. The published evidence on this program consists of case series, and only 1 included patients with heart disease.21 (Other case series included patients without heart failure, e.g., those with high cholesterol levels.) Sixty-four patients with documented coronary artery disease attended a 26-day residential treatment program between 1976 and 1977. During the program, patients were encouraged to walk for 30 to 45 minutes twice a day, learned how to prepare foods consistent with the Pritikin diet, and attended over 60 hours of group education classes. Serum samples were taken at baseline and at the end of the program. Patients were called in March 1980 for a follow-up interview and asked to send in serum samples. At the 3- to 4-year follow-up, 12 (19%) of 64 patients had had bypass surgery, and 4 patients had died. Fifty (81%) patients provided serum samples at follow-up, and the mean cholesterol level (166 mg/dL) was significantly lower than the baseline value (220 mg/dL). The trial was limited in the lack of a control group, especially a group receiving “standard” outpatient cardiac rehabilitation, and long-term mortality outcomes were not reported.

Section Summary: Pritikin Program
No RCTs have evaluated the Pritikin Program; a single case series in patients with heart disease was identified. Conclusions cannot be drawn from this series on the impact of intensive cardiac rehabilitation with the Pritikin Program compared with standard outpatient cardiac rehabilitation.

Benson-Henry Institute Program
Clinical Context and Therapy Purpose
The purpose of the Benson-Henry Institute Program in patients who have diagnosed heart disease is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of the Benson-Henry Institute Program in patients who have heart disease improve net health outcomes?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is patients with diagnosed heart disease.

Interventions
The treatment being considered is the Benson-Henry Institute Program.

The Benson-Henry Institute Program is an intensive cardiac rehabilitation program based on effective exercise, a healthy diet, and a healthy mindset. The Benson-Henry Institute Program is administered by cardiologists, cardiac therapists, and other health care providers.

Comparators
The comparator of interest is standard outpatient cardiac rehabilitation. Cardiac rehabilitation includes long-term programs that include medical evaluation, prescribed exercise, modification to reduce cardiac risks, education, and counseling.

Cardiac rehabilitation is administered by a cardiac rehabilitation specialist on an outpatient clinical basis. Some aspects of cardiac rehabilitation, such as exercise and nutrition changes, are performed by patients at home.

Outcomes
The general outcomes of interest are OS, disease-specific survival, symptoms, and morbid events.

Once diagnosed with heart disease, a patient will require lifelong monitoring by a cardiologist.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:  

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.

  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

  3. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

  4. Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Case-Control Studies
Zeng et al. (2013) reported outcomes of a Medicare-sponsored demonstration of 2 intensive lifestyle modification programs in patients with symptomatic coronary heart disease: the Cardiac Wellness Program of the Benson-Henry Mind Body Institute and the Dr. Dean Ornish Program for Reversing Heart Disease.22 This analysis included 461 participants and 1795 matched controls using Medicare claims data from 1998 to 2008. Four matched controls were sought for each participant from Medicare claims data, 2 of whom had received traditional cardiac rehabilitation within 12 months following their cardiac events (cardiac rehabilitation controls) and 2 of whom had not (non-cardiac rehabilitation controls). Outcomes included mortality rates during the 3 post-enrollment years, total hospitalizations, hospitalizations with a cardiac-related principal discharge diagnosis, and Medicare-paid costs of care. Of the 324 participants in the Benson-Henry Mind Body Medical Institute program analysis, the authors concluded that during the active intervention and follow-up years, total, cardiac, and non-cardiac hospitalizations were lower in the Benson-Henry program participants than their controls for each comparison (p<0.001). The investigators further reported that after year 1, the mortality rate was 1.5% in the Benson-Henry program participants compared with 2.5% and 4.2%, respectively, in cardiac rehabilitation and non-cardiac rehabilitation controls. After year 3, comparable figures were 6.2% in Benson-Henry program participants, 10.5% in cardiac rehabilitation controls, and 11.0% in non-cardiac rehabilitation controls. These mortality differences for the Benson-Henry program participants reached borderline significance (p=0.08).

Case Series
Casey et al. (2009) reported the results of a case series that evaluated the effects of an intensive cardiac rehabilitation program, incorporating components of the Benson-Henry Institute Cardiac Wellness Program at a single center.23 From 1997 to 2005, 637 patients with coronary artery disease were enrolled and completed the program, which consisted of 13 weekly 3 hour sessions with supervised exercise, relaxation techniques, stress management, and behavioral interventions. The mean age of participants was 63 years (range 27 to 92 years); men comprised 72% of the study population. Results revealed significant improvements in clinical (blood pressure, lipids, weight, exercise conditioning, frequency of symptoms of chest pain, and shortness of breath) and psychological outcomes (general severity index, depression, anxiety, and hostility) (p<0.0001) with the program.

Section Summary: Benson-Henry Institute Program
No RCTs have evaluated the Benson-Henry Institute Program; a case-control study found the program participants to have lower total, cardiac, and non-cardiac hospitalizations during the active intervention and follow-up years as compared to controls for each comparison. Additionally, program participants had lower mortality rates compared to controls; however, the mortality differences were borderline significant at year 3. A case series also demonstrated that the implementation of components of the Benson-Henry Institute program resulted in an improvement in clinical and psychological outcomes. Conclusions cannot be drawn from these data on the impact of intensive cardiac rehabilitation with the Benson Henry Institute program compared with standard outpatient cardiac rehabilitation.

Summary of Evidence
For individuals who have diagnosed heart disease who receive outpatient cardiac rehabilitation, the evidence includes multiple RCTs and systematic reviews of these trials. Relevant outcomes are OS, disease-specific survival, symptoms, and morbid events. Meta-analyses of the available trials have found that cardiac rehabilitation improves health outcomes for select patients, particularly those with coronary heart disease, heart failure, and who have had cardiac surgical interventions. The available evidence has limitations, including lack of blinded outcome assessment, but for the survival-related outcomes of interest, this limitation is less critical. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have diagnosed heart disease without a second event who receive repeat outpatient cardiac rehabilitation, the evidence includes no trials. Relevant outcomes are OS, disease-specific survival, symptoms, and morbid events. No studies were identified evaluating the effectiveness of repeat participation in a cardiac rehabilitation program. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have diagnosed heart disease who receive intensive cardiac rehabilitation with the Ornish Program for Reversing Heart Disease, the evidence includes an RCT and uncontrolled studies. Relevant outcomes are OS , disease-specific survival, symptoms, and morbid events. No RCTs have compared the Ornish Program with a “standard” cardiac rehabilitation program; an RCT compared it with usual care. The trial included patients with coronary artery disease and no recent cardiac events and had mixed findings at 1 and 5 years. The trial had a small sample size for a cardiac trial (N=48), and only 35 patients were available for the 5-year follow-up. The Ornish Program is considered by the Centers for Medicare & Medicaid Services as an intensive cardiac rehabilitation program, but the program described in the RCT could meet criteria for standard cardiac rehabilitation. No studies were identified comparing the Ornish Program with any other cardiac rehabilitation program. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have diagnosed heart disease who receive intensive cardiac rehabilitation with the Pritikin Program, the evidence includes a case series. Relevant outcomes are OS , disease-specific survival, symptoms, and morbid events. Studies are needed that compare the impact of intensive cardiac rehabilitation using the Pritikin Program with standard outpatient cardiac rehabilitation programs. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have diagnosed heart disease who receive intensive cardiac rehabilitation with the Benson-Henry Institute Program, the evidence includes a case-control study and case series. Relevant outcomes are OS, disease-specific survival, symptoms, and morbid events. Studies are needed that compare the impact of intensive cardiac rehabilitation using the Benson-Henry Institute Program with standard outpatient cardiac rehabilitation programs. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in ‘Supplemental Information’ if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American College of Cardiology Foundation et al.
In 2013, the American College of Cardiology Foundation and the American Heart Association updated their joint guidelines on the management of heart failure.24 These guidelines included the following class IIA recommendation on cardiac rehabilitation (level of evidence: B): “Cardiac rehabilitation can be useful in clinically stable patients with heart failure to improve functional capacity, exercise duration, health-related quality of life, and mortality.” The 2017 focused update of the guideline did not include additional information on cardiac rehabilitation.25,

American College of Physicians
In 2012, the American College of Physicians and 6 other cardiology associations published joint guidelines on the management of stable ischemic heart disease.26 The guidelines included the following statement on cardiac rehabilitation: “Medically supervised exercise programs (cardiac rehabilitation) and physician-directed, home-based programs are recommended for at-risk patients at first diagnosis.” The 2014 update to the guideline did not include additional information on cardiac rehabilitation.27

American Heart Association et al.
In 2007, the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation issued a consensus statement on the core components of cardiac rehabilitation programs.2, The core components included patient assessment before 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 offered supervised exercise training were not considered cardiac rehabilitation. The guidelines specified the assessment, interventions, and expected outcomes for each of the core components. For example, symptom-limited exercise testing before exercise training was strongly recommended. The guidelines did not specify the optimal overall length of programs or number or duration of sessions.

In 2019, the American Heart Association, with the American Association of Cardiovascular and Pulmonary Rehabilitation and the American College of Cardiology, released a scientific statement on home-based cardiac rehabilitation.28 They make the following suggestions for health care providers:  

  • Recommend center-based cardiac rehabilitation (CBCR) to all eligible patients.

  • As an alternative, recommend home-based cardiac rehabilitation (HBCR) to clinically stable low- and moderate-risk patients who cannot attend CBCR.

  • Design and test HBCR “using effective processes of care for CVD secondary prevention.”

  • For health care organizations, develop and support the following:

    • Maximization of CR referrals

    • High-quality CBCR and HBCR programs “using evidence-based standards and guidelines, strategies to maximize patient adherence both in the shorter and longer-term, and outcome tracking methods to help promote continuous quality improvement.”

    • “Testing and implementation of an evidence-based hybrid approach to CR" that are optimized for each patient and that "promote long-term adherence and favorable behavior change.”

  • For CR professionals, “work with other healthcare professionals and policymakers to implement additional research and ... expand the evidence base for HBCR.”

U.S. Preventive Services Task Force Recommendations
Not applicable.

Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that might influence this review are listed in Table 7.

Table 7. Summary of Key Trials  

NCT No. Trial Name Planned Enrollment Completion Date
Ongoing      
NCT02762825 Novel Cardiac Rehabilitation in Patients With Heart Failure and Preserved Ejection Fraction 66 Sep 2021
NCT04245813 Effectiveness of a Cardiac Rehabilitation Program in Patients With Heart Failure 144 Dec 2021
NCT03218891 Cardiac Rehabilitation in Patients With Refractory Angina 72 Mar 2023
NCT02984449 Preventive Heart Rehabilitation in Patients Undergoing Elective Open Heart Surgery to Prevent Complications and to Improve Quality of Life (Heart-ROCQ) - A Prospective Randomized Open Controlled Trial, Blinded End-point (PROBE) 350 Aug 2025
Unpublished      
NCT03385837 Activity Level and Barriers to Participate of Cardiac Rehabilitation in Advanced Heart Failure Patients 50 Dec 2018
(unknown; last updated 03/09/20 )
NCT02619422 Multicenter, Prospective, Randomized, Open, Blinded for the End Point Evaluator to Compare Compliance to Secondary Prevention Measures After Acute Coronary Syndrome and Intensive Cardiac Rehabilitation Program vs. Standard Program 509 Feb 2018
(last updated 06/06/18)

NCT: national clinical trial.

References 

  1. Virani SS, Alonso A, Benjamin EJ, et al. Heart Disease and Stroke Statistics-2020 Update: A Report From the American Heart Association. Circulation. Mar 03 2020; 141(9): e139-e596. PMID 31992061
  2. Balady GJ, Williams MA, Ades PA, et al. Core components of cardiac rehabilitation/secondary prevention programs: 2007 update: a scientific statement from the American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; the Councils on Cardiovascular Nursing, Epidemiology and Prevention, and Nutrition, Physical Activity, and Metabolism; and the American Association of Cardiovascular and Pulmonary Rehabilitation. Circulation. May 22 2007; 115(20): 2675-82. PMID 17513578
  3. Corra U, Piepoli MF, Carre F, et al. Secondary prevention through cardiac rehabilitation: physical activity counselling and exercise training: key components of the position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur Heart J. Aug 2010; 31(16): 1967-74. PMID 20643803
  4. Leon AS, Franklin BA, Costa F, et al. Cardiac rehabilitation and secondary prevention of coronary heart disease: an American Heart Association scientific statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity), in collaboration with the American association of Cardiovascular and Pulmonary Rehabilitation. Circulation. Jan 25 2005; 111(3): 369-76. PMID 15668354
  5. Lindenfeld J, Albert NM, Boehmer JP, et al. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail. Jun 2010; 16(6): e1-194. PMID 20610207
  6. Oldridge N. Exercise-based cardiac rehabilitation in patients with coronary heart disease: meta-analysis outcomes revisited. Future Cardiol. Sep 2012; 8(5): 729-51. PMID 23013125
  7. Anderson L, Thompson DR, Oldridge N, et al. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. Jan 05 2016; (1): CD001800. PMID 26730878
  8. Davies EJ, Moxham T, Rees K, et al. Exercise based rehabilitation for heart failure. Cochrane Database Syst Rev. Apr 14 2010; (4): CD003331. PMID 20393935
  9. Heran BS, Chen JM, Ebrahim S, et al. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. Jul 06 2011; (7): CD001800. PMID 21735386
  10. Long L, Mordi IR, Bridges C, et al. Exercise-based cardiac rehabilitation for adults with heart failure. Cochrane Database Syst Rev. Jan 29 2019; 1: CD003331. PMID 30695817
  11. West RR, Jones DA, Henderson AH. Rehabilitation after myocardial infarction trial (RAMIT): multi-centre randomised controlled trial of comprehensive cardiac rehabilitation in patients following acute myocardial infarction. Heart. Apr 2012; 98(8): 637-44. PMID 22194152
  12. Doherty P, Lewin R. The RAMIT trial, a pragmatic RCT of cardiac rehabilitation versus usual care: what does it tell us?. Heart. Apr 2012; 98(8): 605-6. PMID 22505460
  13. Pandey A, Kitzman DW, Brubaker P, et al. Response to Endurance Exercise Training in Older Adults with Heart Failure with Preserved or Reduced Ejection Fraction. J Am Geriatr Soc. Aug 2017; 65(8): 1698-1704. PMID 28338229
  14. Kitzman DW, Brubaker PH, Morgan TM, et al. Exercise training in older patients with heart failure and preserved ejection fraction: a randomized, controlled, single-blind trial. Circ Heart Fail. Nov 2010; 3(6): 659-67. PMID 20852060
  15. Opotowsky AR, Rhodes J, Landzberg MJ, et al. A Randomized Trial Comparing Cardiac Rehabilitation to Standard of Care for Adults With Congenital Heart Disease. World J Pediatr Congenit Heart Surg. Mar 2018; 9(2): 185-193. PMID 29544423
  16. Snoek JA, Prescott EI, van der Velde AE, et al. Effectiveness of Home-Based Mobile Guided Cardiac Rehabilitation as Alternative Strategy for Nonparticipation in Clinic-Based Cardiac Rehabilitation Among Elderly Patients in Europe: A Randomized Clinical Trial. JAMA Cardiol. Oct 28 2020. PMID 33112363
  17. Sumner J, Harrison A, Doherty P. The effectiveness of modern cardiac rehabilitation: A systematic review of recent observational studies in non-attenders versus attenders. PLoS One. 2017; 12(5): e0177658. PMID 28498869
  18. Nilsson BB, Lunde P, Grogaard HK, et al. Long-Term Results of High-Intensity Exercise-Based Cardiac Rehabilitation in Revascularized Patients for Symptomatic Coronary Artery Disease. Am J Cardiol. Jan 01 2018; 121(1): 21-26. PMID 29096886
  19. Ornish D, Brown SE, Scherwitz LW, et al. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. Jul 21 1990; 336(8708): 129-33. PMID 1973470
  20. Ornish D, Scherwitz LW, Billings JH, et al. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. Dec 16 1998; 280(23): 2001-7. PMID 9863851
  21. Barnard RJ, Guzy PM, Rosenberg JM, et al. Effects of an intensive exercise and nutrition program on patients with coronary artery disease: five-year follow-up. J Cardiac Rehabil 1983;3:183-190.
  22. Zeng W, Stason WB, Fournier S, et al. Benefits and costs of intensive lifestyle modification programs for symptomatic coronary disease in Medicare beneficiaries. Am Heart J. May 2013; 165(5): 785-92. PMID 23622916
  23. Casey A, Chang BH, Huddleston J, et al. A model for integrating a mind/body approach to cardiac rehabilitation: outcomes and correlators. J Cardiopulm Rehabil Prev. Jul-Aug 2009; 29(4): 230-8; quiz 239-40. PMID 19451830
  24. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. Oct 15 2013; 128(16): 1810-52. PMID 23741057
  25. Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. Aug 08 2017; 136(6): e137-e161. PMID 28455343
  26. Qaseem A, Fihn SD, Dallas P, et al. Management of stable ischemic heart disease: summary of a clinical practice guideline from the American College of Physicians/American College of Cardiology Foundation/American Heart Association/American Association for Thoracic Surgery/Preventive Cardiovascular Nurses Association/Society of Thoracic Surgeons. Ann Intern Med. Nov 20 2012; 157(10): 735-43. PMID 23165665
  27. Lanza GA, Grea F. Stable Ischemic Heart Disease: The Update to the 2012 Guideline. https://www.acc.org/latest-in-cardiology/articles/2015/01/30/12/26/stable-ischemic-heart-disease-the-update-to-the-2012-guideline. Accessed January 19, 2021.
  28. Thomas RJ, Beatty AL, Beckie TM, et al. Home-Based Cardiac Rehabilitation: A Scientific Statement From the American Association of Cardiovascular and Pulmonary Rehabilitation, the American Heart Association, and the American College of Cardiology. J Am Coll Cardiol. Jul 09 2019; 74(1): 133-153. PMID 31097258
  29. Centers for Medicare % Medicaid Services (CMS). National Coverage Determination (NCD) for Intensive Cardiac Rehabilitation Programs (20.31). 2010; http://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=339&ncdver=1&CoverageSelection=National&KeyWord=intensive+cardiac&KeyWordLook Up=Title&KeyWordSearchType=And&clickon=search&bc=gAAAABAAAAAA&. Accessed January 19, 2021.
  30. Centers for Medicare & Medicaid Services (CMS). CMS Manual System: Pub 100-03 Medicare National Coverage Determinations. Cardiac Rehabilitation Programs for Chronic Heart Failure. 2014; https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=359&ncdVer=1. Accessed January 19, 2021.
  31. Centers for Medicare & Medicaid Services (CMS). Decision Memo for Intensive Cardiac Rehabilitation (ICR) Program - Dr. Ornish's Program for Reversing Heart Disease (CAG-00419N). 2010; https://www.cms.gov/medicare-coverage-database/details/nca-decision- memo.aspx?NCAId=240&NCDId=339&ncdver=1&CoverageSelection=National&KeyWord=intensive+cardiac&K eyWordLookUp=Title&KeyWordSearchType=And&clickon=search&IsPopup=y&bc=AAAAAAAACAAAAA%3d%3 d&. Accessed January 23, 2021.
  32. Centers for Medicare & Medicaid Services (CMS). Decision Memo for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N). 2010; https://www.cms.gov/medicare-coverage- database/details/nca-decision- memo.aspx?NCAId=239&NCDId=339&ncdver=1&CoverageSelection=National&KeyWord=intensive+cardiac&K eyWordLookUp=Title&KeyWordSearchType=And&clickon=search&IsPopup=y&bc=AAAAAAAACAAAAA%3d%3 d&. Accessed January 22, 2021.
  33. Centers for Medicare and Medicaid Services. Decision memo for intensive cardiac rehabilitation (ICR) program - Benson-Henry Institute Cardiac Wellness Program (CAG-00434N). May 6, 2014. https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=271. Accessed January 21, 2021.

Coding Section

 Codes Number  Description 
CPT 93015 

Cardiovascular stress test using maximal or submaximal treadmill or bicycle exercise, continuous electrocardiographic monitoring, and/or pharmacological stress; with physician supervision, with interpretation and report 

  93016

Same as 93015, but with physician supervision only, and without interpretation and report 

  93797

Physician or other qualified health care professional services for outpatient cardiac rehab; without continuous ECG monitoring (per session) 

  93798

; with continuous ECG monitoring (per session) 

  99215

Physician office visit for comprehensive examination, established patient 

ICD-9 Procedure   89.44 

Other cardiovascular stress test (includes EKG stress test) 

  89.7

General physical examination 

  93.36 

Cardiac retraining (cardiac rehabilitation regimen following myocardial infarction or coronary bypass graft procedure) 

ICD-9 Diagnosis   410.00-410.92 

Acute myocardial infarction code range

  412

History of, or “old,” myocardial infarction (MI is healed, presenting no symptoms, and greater than 8 weeks since MI) 

  413.9 

Angina pectoris (includes stable) 

  428.0 

Congestive heart failure, unspecified (includes compensated) 

  V42.0 

Organ or tissue replaced by transplant; heart 

  V45.81 

Other postprocedural status: aortocoronary bypass status 

  V45.82 

Other postprocedural status; percutaneous transluminal coronary angioplasty status 

HCPCS  S9472 

Cardiac rehabilitation program, nonphysician provider, per diem 

ICD-10-CM (effective 10/01/15) I20.8-I20.9 

Angina pectoris, other/unspecified code range

 

I21.01-I21.4 

ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction code range 

 

I50.1-I50.9 

Heart failure code range 

 

Z94.1 

Heart transplant status 

 

Z94.3 

Heart and lungs transplant status 

 

Z95.1 

Presence of aortocoronary bypass graft 

 

Z95.2-Z95.4 

Presence of heart valve code range 

 

Z95.5 

Presence of coronary angioplasty implant and graft 

 

Z98.61 

Coronary angioplasty status 

ICD-10-PCS (effective 10/01/15)   

Not applicable. Policy is only for outpatient services.

Type of Service 

Medical  

Place of Service 

Outpatient 

 

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association.  All Rights Reserved" 

History From 2014 Forward     

08/06/2021 

Annual review, adding Benson-Henry Institute Program to the list of not medically necessary rehabilitation programs. No other changes to policy intent. Also updating description, background, rationale and references. 

08/04/2020 

Annual review, no change to policy intent. Updating background, rationale and references. 

08/06/2019 

Annual review, no change to policy intent. Updating rationale and references. 

08/13/2018 

Annual review, no change to policy intent. Updating rationale and references. 

08/28/2017 

Annual review, adding verbiage to indicate intensive cardiac rehabiliataion with the Ornish Program for reversing heart disease or Pritikin Program is investigational. Also updating background, description, rationale and references. 

08/11/2016 

Annual review, no change to policy intent. Updating background, description, rationale and references. 

08/11/2015 

Annual review, no change to policy intent. Updated background, description, rationale and references. Added coding. 

08/04/2014

Annual review. Added two additional diagnoses in the medical necessity area: current stable angina pectoris and compensated heart failure. Updated description, background, rationale and references.


Go Back