Cardiac Rehabilitation

Number: 0021

Policy

Aetna considers outpatient cardiac rehabilitation medically necessary as described below.

The following selection criteria represent implementation of guidelines established by the American College of Physicians, the American College of Cardiology, and the Agency for Healthcare Research and Quality (AHRQ) Health Technology Assessment.

Eligibility

Aetna considers a medically supervised outpatient Phase II cardiac rehabilitation program medically necessary for selected members when it is individually prescribed by a physician within a 12-month window after any of the following:

  1. Acute myocardial infarction within the preceding 12 months; or 
  2. Chronic stable angina pectoris unresponsive to medical therapy which prevents the member from functioning optimally to meet domestic or occupational needs (particularly with modifiable coronary risk factors or poor exercise tolerance); or 
  3. Coronary artery bypass grafting (coronary bypass surgery, CABG); or 
  4. Heart transplantation or heart-lung transplantation; or
  5. Major pulmonary surgery, great vessel surgery, or MAZE arrhythmia surgery; or 
  6. Percutaneous coronary vessel remodeling (i.e., angioplasty, atherectomy, stenting); or
  7. Placement of a ventricular assist device; or 
  8. Sustained ventricular tachycardia or fibrillation, or survivors of sudden cardiac death; or 
  9. Valve replacement or repair; or
  10. Stable congestive heart failure (CHF) with left ventricular ejection fraction (LVEF) of 35% or less and New York Heart Association (NYHA) class II to IV symptoms despite being on optimal heart failure therapy for at least 6 weeks; stable CHF is defined as CHF in persons who have not had recent (less than or equal to 6 weeks) or planned (less than or equal to 6 months) major cardiovascular hospitalizations or procedures.

Cardiac rehabilitation programs are not recommended and are considered experimental and investigational for individuals with coronary artery disease (CAD) who have the following conditions:

  • Acute pericarditis or myocarditis; or
  • Acute systemic illness or fever; or
  • Forced expiratory volume less than 1 liter; or
  • Moderate to severe aortic stenosis; or
  • New-onset atrial fibrillation; or
  • Progressive worsening of exercise tolerance or dyspnea at rest or on exertion over the previous 3 to 5 days; or
  • Recent embolism or thrombophlebitis; or
  • Significant ischemia at low work rates (less than 2 METs, or metabolic equivalents); or
  • Third-degree heart block without pacemaker; or
  • Uncontrolled diabetes. 

Aetna considers cardiac rehabilitation experimental and investigational for all other indications (e.g., atrial fibrillation (other than following the Maze procedure), following balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension, following repair of sinus venosus atrial septal defect, individuals who are too debilitated to exercise, postural tachycardia syndrome, and secondary prevention after transient ischemic attack or mild, non-disabling stroke) because of insufficient evidence in the peer-reviewed literature.

Frequency and Duration

The medically necessary frequency and duration of cardiac rehabilitation is determined by the member’s level of cardiac risk stratification:

  1. High-risk members have any of the following

    • Decrease in systolic blood pressure of 15 mm Hg or more with exercise; or
    • Exercise test limited to less than or equal to 5 METS; or
    • Marked exercise-induced ischemia, as indicated by either anginal pain or 2 mm or more ST depression by electrocardiography (ECG); or
    • Recent myocardial infarction (less than 6 months) which was complicated by serious ventricular arrhythmia, cardiogenic shock or CHF; or
    • Resting complex ventricular arrhythmia; or
    • Severely depressed left ventricular function (LVEF less than 30 %); or
    • Survivor of sudden cardiac arrest; or
    • Ventricular arrhythmia appearing or increasing with exercise or occurring in the recovery phase of stress testing.
    Program Description for High-Risk Members
    • 36 sessions (e.g., 3 times per week for 12 weeks) of supervised exercise with continuous telemetry monitoring
    • Create an individual out-patient exercise program that can be self-monitored and maintained
    • Educational program for risk factor/stress reduction
    • If no clinically significant arrhythmia is documented during the first 3 weeks of the program, the provider may have the member complete the remaining portion without telemetry monitoring.
  2. Intermediate-risk members have any of the following

    • Exercise test limited to 6 to 9 METS; or
    • Ischemic ECG response to exercise of less than 2 mm of ST depression; or
    • Uncomplicated myocardial infarction, coronary artery bypass surgery, or angioplasty and has a post-cardiac event maximal functional capacity of 8 METS or less on ECG exercise test.
    Program Description for Intermediate-Risk Members
    • 24 sessions or less of exercise training without continuous ECG monitoring (see exit criteria below, as some members may only require fewer than 3 weekly visits and/or less than 8 weeks)Footnotes*
    • Geared to define an ongoing exercise program that is "self-administered."
  3. Low-risk members have exercise test limited to greater than 9 METS

    Program Description for Low-Risk Members
    1. 6 1-hour sessions involving risk factor reduction education and supervised exercise to show safety and define a home program (e.g., 3 times per week for a total of 2 weeks or 2 sessions per week for 3 weeks).

Aetna considers additional cardiac rehabilitation services medically necessary based on the above-listed criteria when the member has any of the following conditions:

  1. Another cardiovascular surgery or angioplasty; or
  2. Another documented myocardial infarction or extension of initial infarction; or
  3. New clinically significant coronary lesions documented by cardiac catheterization; or
  4. New evidence of ischemia on an exercise test, including thallium scan.

Footnotes* Supervision by a physician or other qualified health care professional is of no proven value for non-EKG monitored cardiac rehabilitation and is therefore considered experimental and investigational because of insufficient evidence in the peer-reviewed literature.

Note: Phase III and Phase IV cardiac rehabilitation programs (see background section) are not covered under standard Aetna benefit plans as these programs are considered educational and training in nature.  Education and training programs are generally not covered under most Aetna benefit plans.  Please check benefit plan descriptions.

Background

Patients who have cardiovascular events are often functional in society and employed prior to a cardiac event, and frequently require only re-entry into their former life pattern.  Cardiac rehabilitation serves this purpose by providing a supervised program in the outpatient setting that involves medical evaluation, an ECG-monitored physical exercise program, cardiac risk factor modification, education, and counseling.  .

Cardiac rehabilitation is designed to help individuals with conditions such as heart or vascular disease return to a healthier and more productive life. This includes individuals who have had heart attacks, open heart surgery, stable angina, vascular disease or other cardiac related health problems.

Traditionally, cardiac rehabilitation programs have been classified into 4 phases, phase I to IV, representing a progression from the hospital (phase I) to a medically supervised out-patient program (phases II and III) to a community or home-based setting (phase IV).  Phase I cardiac rehabilitation begins in the hospital (inpatient) after experiencing a heart attack or other major heart event. During this phase, individuals receive education and nutritional counseling to prepare them for discharge. Phase II outpatient cardiac rehabilitation begins after leaving the hospital. As described by the U.S. Public Health Service, it is a comprehensive, long-term program including medical evaluation, prescribed exercise, cardiac risk factor modification, education and counseling. Phase II refers to medically supervised programs that typically begin one to three weeks after discharge and provide appropriate electrocardiographic monitoring. Phase III cardiac rehabilitation utilizes a supervised program that encourages exercise and healthy lifestyle and is usually performed at home or in a fitness center with the goal of continuing the risk factor modification and exercise program learned in phase II. Phase IV cardiac rehabilitation is based on an indefinite exercise maintenance program. These programs encourage a commitment to regular exercise and healthy habits for risk factor modification to establish lifelong cardiovascular fitness. Some programs combine phases III and IV. 

Due to changes in hospital and health care practices, and the need to accommodate patients at various stages of disease risk, some have argued that the need for phase designation becomes inappropriate, and that cardiac rehabilitation programs can be more appropriately distinguished as inpatient, outpatient or community/home-based programs.  Participation within these programs is determined by appropriate risk stratification in order to maximize health care resources and patient benefit.  Irrespective of the program, there should be regular communication, in the form of progress reports, between the program staff and the patient’s attending physician (Ignaszewski and Lear, 1998).

Entry into such programs is based on the demonstrated limitation of functional capacity on exercise stress testing, and the expectation that medically supervised exercise training will improve functional capacity to a clinically significant degree.  The exercise test in cardiac rehabilitation is a vital component of the overall rehabilitative process as it provides continuous follow-up in a noninvasive manner and adds information to the overall physical evaluation.  In general, testing is performed before entering the cardiac rehabilitation exercise program, and sequentially during the program to provide information on the changes in cardiac status, prognosis, functional capacity, and evidence of training effect.  The central component of cardiac rehabilitation is a prescribed regimen of physical exercises intended to improve functional work capacity and to increase the patient's confidence and well-being.  Depending on the degree of debilitation, cardiac patients may or may not require a full or supervised rehabilitation program.

The scientific literature documents that some of the benefits of participation in a cardiac rehabilitation program include decreased symptoms of angina pectoris, dyspnea, and fatigue, and improvement in exercise tolerance, blood lipid levels, and psychosocial well-being, as well as a reduction in weight, cigarette smoking and stress.  The efficacy of modification of risk factors in reducing the progression of coronary artery disease and future morbidity and mortality has been established.  Meta-analysis of data from random controlled studies indicates a 20 % to 25 % reduction in mortality in patients participating in cardiac rehabilitation following myocardial infarction as compared to controls.

The typical model for delivering outpatient cardiac rehabilitation in the United States is for patients to attend sessions 2 to 3 times per week for up to 12 to 18 weeks (36 total sessions) (CMS, 2006).  A session typically lasts for approximately 1 hour and includes aerobic and/or resistance exercises with continuous electro-cardiographic monitoring.  There are alternative approaches to this typical model.  Patients can be classified as low-, moderate- or high-risk for participating in exercise based on a combination of clinical and functional data.  The number of recommended supervised exercise sessions varies by risk level: low-risk patients receive 6 to 18 exercise sessions over 30 days or less from the date of the cardiac event/procedure; moderate-risk 12 to 24 sessions over 60 days; and high-risk 18 to 36 sessions over 90 days (Hamm, 2008; AACVPR, 2004).

There is limited evidence on the appropriate duration of cardiac rehabilitation.  Hammill et al (2010) stated that for patients with coronary heart disease, exercise-based cardiac rehabilitation improves survival rate and has beneficial effects on risk factors for coronary artery disease.  However, the relationship between the number of sessions attended and long-term outcomes is unknown.  In a national 5 % sample of Medicare beneficiaries, these investigators identified 30,161 elderly patients who attended at least 1 cardiac rehabilitation session between January 1, 2000, and December 31, 2005.  They used a Cox proportional hazards model to estimate the relationship between the number of sessions attended and death and myocardial infarction (MI) at 4 years.  The cumulative number of sessions was a time-dependent co-variate.  After adjustment for demographical characteristics, co-morbid conditions, and subsequent hospitalization, patients who attended 36 sessions had a 14 % lower risk of death (hazard ratio [HR], 0.86; 95 % confidence interval [CI]: 0.77 to 0.97) and a 12 % lower risk of MI (HR, 0.88; 95 % CI: 0.83 to 0.93) than those who attended 24 sessions; a 22 % lower risk of death (HR, 0.78; 95 % CI: 0.71 to 0.87) and a 23 % lower risk of MI (HR, 0.77; 95 % CI: 0.69 to 0.87) than those who attended 12 sessions; and a 47 % lower risk of death (HR, 0.53; 95 % CI: 0.48 to 0.59) and a 31 % lower risk of MI (HR, 0.69; 95 % CI: 0.58 to 0.81) than those who attended 1 session.  The authors concluded that among Medicare beneficiaries, a strong dose-response relationship existed between the number of cardiac rehabilitation sessions and long-term outcomes.  Attending all 36 sessions reimbursed by Medicare was associated with lower risks of death and MI at 4 years compared with attending fewer sessions.

Prior and colleagues (2011) tested feasibility and effectiveness of 6-month outpatient comprehensive cardiac rehabilitation (CCR) for secondary prevention after transient ischemic attack or mild, non-disabling stroke.  Consecutive consenting subjects having sustained a transient ischemic attack or mild, non-disabling stroke within the previous 12 months (mean of 11.5 weeks; event-to-CCR entry) with greater than or equal to 1 vascular risk factor, were recruited from a stroke prevention clinic providing usual care.  These researchers measured 6-month CCR outcomes following a prospective cohort design.  Of 110 subjects recruited from January 2005 to April 2006, 100 subjects (mean age of 64.9 years; 46 women) entered and 80 subjects completed CCR.  These investigators obtained favorable, significant intake-to-exit changes in: aerobic capacity (+31.4 %; p < 0.001), total cholesterol (-0.30 mmol/L; p = 0.008), total cholesterol/high-density lipoprotein (-11.6 %; p < 0.001), triglycerides (-0.27 mmol/L; p = 0.003), waist circumference (-2.44 cm; p < 0.001), body mass index (-0.53 kg/m(2); p = 0.003), and body weight (-1.43 kg; p = 0.001).  Low-density lipoprotein (-0.24 mmol/L), high-density lipoprotein (+0.06 mmol/L), systolic (-3.21 mm Hg) and diastolic (-2.34 mm Hg) blood pressure changed favorably, but non-significantly.  A significant shift toward non-smoking occurred (p = 0.008).  Compared with intake, 11 more individuals (25.6 % increase) finished CCR in the lowest-mortality risk category of the Duke Treadmill Score (p < 0.001).  The authors concluded that CCR is feasible and effective for secondary prevention after transient ischemic attack or mild, non-disabling stroke, offering a promising model for vascular protection across chronic disease entities.  The authors stated that they know of no similar previous investigation, and are now conducting a randomized trial.

Pack et al (2013) noted that outpatient CR decreases mortality rates but is under-utilized.  Current median time from hospital discharge to enrollment is 35 days.  These researchers hypothesized that an appointment within 10 days would improve attendance at CR orientation.  At hospital discharge, 148 patients with a non-surgical qualifying diagnosis for CR were randomized to receive a CR orientation appointment either within 10 days (early) or at 35 days (standard).  The primary end-point was attendance at CR orientation. Secondary outcome measures were attendance at greater than or equal to 1 exercise session, the total number of exercise sessions attended, completion of CR, and change in exercise training work-load while in CR.  Average age was 60 ± 12 years; 56 % of participants were male and 49 % were black, with balanced baseline characteristics between groups.  Median time (95 % CI) to orientation was 8.5 (7 to 13) versus 42 (35 to NA [not applicable]) days for the early and standard appointment groups, respectively (p < 0.001).  Attendance rates at the orientation session were 77 % (57/74) versus 59%  (44/74) in the early and standard appointment groups, respectively, which demonstrated a significant 18 % absolute and 56 % relative improvement (relative risk, 1.56; 95 % CI: 1.03 to 2.37; p = 0.022).  The number needed to treat was 5.7.  There was no difference (p > 0.05) in any of the secondary outcome measures, but statistical power for these end points was low.  Safety analysis demonstrated no difference between groups in CR-related adverse events.  The authors concluded that early appointments for CR significantly improved attendance at orientation.  This simple technique could potentially increase initial CR participation nationwide.

In a retrospective cohort study, Beauchamp et al (2013) examined if attendance at CR independently predicts all-cause mortality over 14 years and whether there is a dose-response relationship between the proportion of CR sessions attended and long-term mortality.  The sample comprised 544 men and women eligible for CR following MI, coronary artery bypass surgery or percutaneous interventions.  Participants were tracked 4 months after hospital discharge to ascertain CR attendance status.  Main outcome measure was all-cause mortality at 14 years ascertained through linkage to the Australian National Death Index.  In total, 281 (52 %) men and women attended at least 1 CR session.  There were few significant differences between non-attenders and attenders.  After adjustment for age, sex, diagnosis, employment, diabetes and family history, the mortality risk for non-attenders was 58 % greater than for attenders (HR = 1.58, 95 % CI: 1.16 to 2.15).  Participants who attended less than 25 % of sessions had a mortality risk more than twice that of participants attending greater than or equal to 75 % of sessions (odds ratio [OR] = 2.57, 95 % CI: 1.04 to 6.38).  This association was attenuated after adjusting for current smoking (OR = 2.06, 95 % CI: 0.80 to 5.29).  The authors concluded that this study provided further evidence for the long-term benefits of CR in a contemporary, heterogeneous population.  While a dose-response relationship may exist between the number of sessions attended and long-term mortality, this relationship does not occur independently of smoking differences.  They stated that CR practitioners should encourage smokers to attend CR and provide support for smoking cessation.

The Centers for Medicare & Medicaid Services (CMS, 2014) has determined that the evidence is sufficient to expand coverage for cardiac rehabilitation services to beneficiaries with stable, chronic heart failure defined as patients with left ventricular ejection fraction of 35 % or less and New York Heart Association (NYHA) class II to IV symptoms despite being on optimal heart failure therapy for at least 6 weeks. Stable patients are defined as patients who have not had recent (less than or equal to 6 weeks) or planned (less than or equal to 6 months) major cardiovascular hospitalizations or procedures.

Shibata et al (2012) stated that recent studies have suggested the presence of cardiac atrophy as a key component of the pathogenesis of the postural orthostatic tachycardia syndrome (POTS), similar to physical deconditioning.  It has also been shown that exercise intolerance is associated with a reduced stroke volume (SV) in POTS, and that the high heart rate observed at rest and during exercise in these patients is due to this low SV.  These researchers tested the hypotheses that
  1. circulatory control during exercise is normal in POTS; and
  2. that physical “reconditioning” with exercise training improves exercise performance in patients with POTS.


A total of 19 (18 women) POTS patients completed a 3 month training program.  Cardiovascular responses during maximal exercise testing were assessed in the upright position before and after training.  Resting left ventricular diastolic function was evaluated by Doppler echocardiography.  Results were compared with those of 10 well-matched healthy sedentary controls.  A lower SV resulted in a higher heart rate in POTS at any given oxygen uptake (V(O(2))) during exercise while the cardiac output (Q(c))-V(O(2)) relationship was normal.  V(O(2peak)) was lower in POTS than controls (26.1 ± 1.0 (SEM) versus 36.3 ± 0.9 ml kg-1 min-1; p < 0.001) due to a lower peak SV (65 ± 3 versus 80 ± 5 ml; p = 0.009).  V(O(2peak)) increased by 11 % (p < 0.001) due to increased peak SV (p = 0.021) and was proportional to total blood volume.  Peak heart rate was similar, but heart rate recovery from exercise was faster after training than before training (p = 0.036 for training and 0.009 for interaction).  Resting diastolic function was mostly normal in POTS before training, though diastolic suction was impaired (p = 0.023).  There were no changes in any Doppler index after training.  The authors concluded that these results suggested that short-term exercise training improves physical fitness and cardiovascular responses during exercise in patients with POTS. 

Benarroch (2012) noted that management of POTS includes avoidance of precipitating factors, volume expansion, physical counter-maneuvers, exercise training, pharmacotherapy (fludrocortisone, midodrine, beta-blockers, and/or pyridostigmine), and behavioral-cognitive therapy.

Although it can be argued that a structured exercise program for physical reconditioning may be beneficial for patients with POTS, it is unclear there is a need for a supervised cardiac rehabilitation program.  Furthermore, an UpToDate review on “Postural tachycardia syndrome” (Freeman and Kaufman, 2014) does not mention cardiac rehabilitation as a management tool.

Gaalema et al (2015) noted that continued smoking after a cardiac event greatly increases mortality risk.  Smoking cessation and participation in CR are effective in reducing morbidity and mortality.  However, these 2 behaviors may interact; those who smoke may be less likely to access or complete CR.  These researchers explored the association between smoking status and CR referral, attendance, and adherence.  They carried out a systematic literature search examining associations between smoking status and CR referral, attendance and completion in peer-reviewed studies published through July 1, 2014.  For inclusion, studies had to report data on outpatient CR referral, attendance or completion rates and smoking status had to be considered as a variable associated with these outcomes.  A total of 56 studies met inclusion criteria.  A history of smoking was associated with an increased likelihood of referral to CR.  However, smoking status also predicted not attending CR and was a strong predictor of CR drop-out.  The authors concluded that continued smoking after a cardiac event predicts lack of attendance in, and completion of CR.  The issue of smoking following a coronary event deserves renewed attention.

Huang et al (2015) examined the effectiveness of telehealth intervention-delivered CR compared with center-based supervised CR.  Medline, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library and the Chinese BioMedical Literature Database (CBM), were searched to April 2014, without language restriction.  Existing randomized controlled trials (RCTs), reviews, relevant conference lists and gray literature were checked.  Randomized controlled trials that compared telehealth intervention delivered CR with traditional center-based supervised CR in adults with coronary artery disease (CAD) were included.  Two reviewers selected studies and extracted data independently.  Main clinical outcomes including clinical events, modifiable risk factors or other end-points were measured.  A total of 15 articles reporting 9 trials were reviewed, most of which recruited patients with MI or re-vascularization.  No statistically significant difference was found between telehealth interventions delivered and center-based supervised CR in exercise capacity (standardized mean difference (SMD) -0.01; 95 % CI: -0.12 to 0.10), weight (SMD -0.13; 95 % CI: -0.30 to 0.05), systolic and diastolic blood pressure (SBP and DBP) (mean difference (MD) -1.27; 95 % CI: -3.67 to 1.13 and MD 1.00; 95 % CI: -0.42 to 2.43, respectively), lipid profile, smoking (risk ratio (RR) 1.03; 95 % CI: 0.78 to 1.38), mortality (RR 1.15; 95 % CI: 0.61 to 2.19), quality of life and psychosocial state.  The authors concluded that telehealth intervention-delivered CR does not have significantly inferior outcomes compared to center-based supervised program in low-to-moderate risk CAD patients.  Telehealth intervention offers an alternative deliver model of CR for individuals less able to access center-based CR.  Choices should reflect preferences, anticipation, risk profile, funding, and accessibility to health service.

In a Cochrane review, Taylor et al (2015) compared the effect of home-based and supervised center-based CR on mortality and morbidity, health-related quality of life, and modifiable cardiac risk factors in patients with heart disease.  To update searches from the previous Cochrane review, these investigators searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 9, 2014), MEDLINE (Ovid, 1946 to Week 1 of October, 2014), EMBASE (Ovid, 1980 to Week 41 of 2014), PsycINFO (Ovid,  to Week 2 of October, 2014), and CINAHL (EBSCO, to October 2014).  They checked reference lists of included trials and recent systematic reviews.  No language restrictions were applied.  The authors concluded that this updated review supports the conclusions of the previous version of this review that home- and center-based forms of CR seem to be equally effective for improving the clinical and health-related quality of life outcomes in low risk patients after MI or re-vascularization, or with heart failure (HF).  This finding, together with the absence of evidence of important differences in healthcare costs between the 2 approaches, supports the continued expansion of evidence-based, home-based CR programs.  The choice of participating in a more traditional and supervised center-based program or a home-based program should reflect the preference of the individual patient.  They stated that further data are needed to determine whether the effects of home- and center-based CR reported in these short-term trials can be confirmed in the longer term.  A number of studies failed to give sufficient detail to assess their risk of bias.

Acute Coronary Syndrome:

Rauch and colleagues (2016) noted that the prognostic effect of multi-component CR in the modern era of statins and acute re-vascularization remains controversial.  These investigators evaluated the effect of CR on total mortality and other clinical end-points after an acute coronary event.  Randomized controlled trials, retrospective controlled cohort studies (rCCSs) and prospective controlled cohort studies (pCCSs) evaluating patients after acute coronary syndrome (ACS), coronary artery bypass grafting (CABG) or mixed populations with CAD were included, provided the index event was in 1995 or later.  Out of 18,534 abstracts, 25 studies were identified for final evaluation (RCT: n = 1; pCCS: n = 7; rCCS: n = 17), including n = 219,702 patients (after ACS: n = 46,338; after CABG: n = 14,583; mixed populations: n = 158,781; mean follow-up of 40 months).  Heterogeneity in design, biometrical assessment of results and potential confounders was evident; CCSs evaluating ACS patients showed a significantly reduced mortality for CR participants (pCCS: HR 0.37, 95 % CI: 0.20 to 0.69; rCCS: HR 0.64, 95 % CI: 0.49 to 0.84; OR 0.20, 95 % CI: 0.08 to 0.48), but the single RCT fulfilling Cardiac Rehabilitation Outcome Study (CROS) inclusion criteria showed neutral results.  These investigators noted that CR participation was also associated with reduced mortality after CABG (rCCS: HR 0.62, 95 % CI: 0.54 to 0.70) and in mixed CAD populations.  The authors concluded that CR participation after ACS and CABG was associated with reduced mortality even in the modern era of CAD treatment.  However, the heterogeneity of study designs and CR programs highlighted the need for defining internationally accepted standards in CR delivery and scientific evaluation.

Atrial Fibrillation:

In a Cochrane review, Risom and colleagues (2017) evaluated the benefits and harms of exercise-based CR programs, alone or with another intervention, compared with no-exercise training controls in adults who currently have atrial fibrillation (AF), or have been treated for AF.  These investigators searched the following electronic databases; CENTRAL and the Database of Abstracts of Reviews of Effectiveness (DARE) in the Cochrane Library, Medline Ovid, Embase Ovid, PsycINFO Ovid, Web of Science Core Collection Thomson Reuters, CINAHL EBSCO, LILACS Bireme, and 3 clinical trial registers on July 14, 2016.  They also checked the bibliographies of relevant systematic reviews identified by the searches.  They imposed no language restrictions.  These researchers included RCTs that examined exercise-based interventions compared with any type of no-exercise control.  They included trials with adults aged 18 years or older with AF, or post-treatment for AF.  Two authors independently extracted data.  They assessed the risk of bias using the domains outlined in the Cochrane Handbook for Systematic Reviews of Interventions.  They assessed clinical and statistical heterogeneity by visual inspection of the forest plots, and by using standard Chi² and I² statistics.  These researchers performed meta-analyses using fixed-effect and random-effects models; they used SMDs where different scales were used for the same outcome.  They assessed the risk of random errors with trial sequential analysis (TSA) and used the GRADE methodology to rate the quality of evidence, reporting it in the “Summary of findings” table.  A total of 6 RCTs with 421 patients with various types of AF were included in this review.  All trials were conducted between 2006 and 2016, and had short follow-up (8 weeks to 6 months).  Risks of bias ranged from high risk to low risk.  The exercise-based CR programs in 4 trials consisted of both aerobic exercise and resistance training, in 1 trial consisted of Qi-gong (slow and graceful movements), and in another trial, consisted of inspiratory muscle training.  For mortality, very low-quality evidence from 6 trials suggested no clear difference in deaths between the exercise and no-exercise groups (RR 1.00, 95 % CI: 0.06 to 15.78; participants = 421; I² = 0 %; deaths = 2).  Very low-quality evidence from 5 trials suggested no clear difference between groups for serious adverse events (AEs) (RR 1.01, 95 % CI: 0.98 to 1.05; participants = 381; I² = 0 %; events = 8).  Low-quality evidence from 2 trials suggested no clear difference in health-related quality of life (QOL) for the Short Form-36 (SF-36) physical component summary measure (MD 1.96, 95 % CI: -2.50 to 6.42; participants = 224; I² = 69 %), or the SF-36 mental component summary measure (MD 1.99, 95 % CI: -0.48 to 4.46; participants = 224; I² = 0 %).  Exercise capacity was assessed by cumulated work, or maximal power (Watt), obtained by cycle ergometer, or by 6-minute walking test (6MWT), or ergo-spirometry testing measuring VO2 peak.  These researchers found moderate-quality evidence from 2 studies that exercise-based CR increased exercise capacity, measured by VO2 peak, more than no exercise (MD 3.76, 95 % CI: 1.37 to 6.15; participants = 208; I² = 0 %); and very low-quality evidence from 4 studies that exercise-based rehabilitation increased exercise capacity more than no exercise, measured by the 6MWT (MD 75.76, 95 % CI: 14.00 to 137.53; participants = 272; I² = 85 %).  When these investigators combined the different assessment tools for exercise capacity, they found very low-quality evidence from 6 trials that exercise-based rehabilitation increased exercise capacity more than no exercise (SMD 0.86, 95 % CI: 0.46 to 1.26; participants = 359; I² = 65 %).  Overall, the quality of the evidence for the outcomes ranged from moderate to very-low.  The authors concluded that due to few randomized patients and outcomes, they could not evaluate the real impact of exercise-based CR on mortality or serious AEs.  The evidence showed no clinically relevant effect on health-related QOL.  Pooled data showed a positive effect on the surrogate outcome of physical exercise capacity, but due to the low number of patients and the moderate to very low-quality of the underpinning evidence, the authors could not be certain of the magnitude of the effect.  Moreover, they stated that future high-quality randomized trials are needed to evaluate the benefits and harms of exercise-based CR for adults with AF on patient-relevant outcomes.

Following Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension:

Fukui and co-workers (2016) determined the safety and effectiveness of CR initiated immediately following balloon pulmonary angioplasty (BPA) in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who presented with continuing exercise intolerance and symptoms on effort even after a course of BPA; 2 to 8 sessions/patient.  A total of 41 consecutive patients with inoperable CTEPH who underwent their final BPA with improved resting mean pulmonary arterial pressure (PAP) of 24.7±5.5 mm Hg and who suffered remaining exercise intolerance were prospectively studied.  Participants were divided into 2 groups just after the final BPA (6.8 ± 2.3 days): (i) patients with (CR group, n = 17) or without (non-CR group, n = 24) participation in a 12-week CR of 1-week in-hospital training followed by an 11-week out-patient program.  Cardiopulmonary exercise testing (CPET), hemodynamics, and quality of life (QOL) were assessed before and after CR.  No significant between-group differences were found for any baseline characteristics.  At week 12, peak oxygen uptake (VO2), per cent predicted peak VO2 (70.7 ± 9.4 % to 78.2 ± 12.8 %, p < 0.01), peak work-load, and oxygen pulse significantly improved in the CR group compared with the non-CR group, with a tendency towards improvement in mental health-related QOL.  Quadriceps strength and heart failure (HF) symptoms (WHO functional class, 2.2 to 1.8, p = 0.01) significantly improved within the CR group.  During the CR, no patient experienced adverse events (AEs) or deterioration of right-sided HF or hemodynamics as confirmed via right heart catheterization.  The authors concluded that the combination of BPAs and subsequent CR for inoperable CTEPH additively ameliorated exercise intolerance to near-normal levels and improved HF symptoms, with a tendency towards improvement in mental health-related QOL.  They stated that this promising new treatment strategy did not require a prolonged hospital stay for initial in-hospital training and did not lower patient compliance; however, further large, randomized, multi-center studies are needed to confirm the present findings.

The authors stated that this study had several drawbacks:
  1. it lacked randomization during group assignment, although it was prospectively designed with a control group.  Thus, they could not exclude the possibility that selection bias affected the present results.  However, no significant between-group differences were found in any baseline characteristics, which might strengthen the value of the present results,
  2. this study was implemented in a single center, although the center is one of the largest pulmonary hypertension centers in Japan with experienced rehabilitation centers.  These results should be confirmed in a large, randomized, multi-center study,
  3. the increase in 6-minute walk distance (6MWD) in the CR group did not reach statistical significance -- this was inconsistent with previous studies with patients with CTEPH. 

It was possible that these patients with CR walked much better in the baseline 6MWD examination (498 ± 96 m) than the patients with CTEPH in previous studies (353 to 453 m), because these patients had already undergone BPAs before group assignment, in addition to PH-specific therapies.  This was also supported by the findings that exercise training might be more effective in patients with a lower 6MWD, rather than those who have a near-normal 6MWD (greater than 550 m) and that 6MWD was less sensitive to increases in peak VO2 at distances greater than 500 m, (iv) VO2 at anaerobic threshold (AT) did not significantly improve after CR, consistent with the findings of Yuan et al who conducted a systematic review and meta-analysis on exercise training for PH.  In addition, these researchers could not accurately determine the AT level in the pre-interventional and/or post-interventional CPET in 5 of 17 patients in the CR group due to ventilatory oscillation-like changes or increased ventilatory drives even at rest, implying that the AT level was unreliable in this population, and (v) physical-related QOL scores were unchanged after CR, which was inconsistent with previous studies.  The authors could explain this discrepancy by their preliminary data that physical-related QOL scores in their patients had already improved to a certain degree before CR via BPA alone (data not shown), as well as hemodynamics and functional capacity.

Following Heart Valve Surgery:

Sibilitz and colleagues (2016) stated that the evidence for CR after valve surgery remains sparse.  Thus, current recommendations are based on patients with ischemic heart disease.  In a randomized clinical trial, these researchers examined the effects of CR versus usual care after heart valve surgery.  The trial was an investigator-initiated, randomized superiority trial (The CopenHeartVR trial, VR; valve replacement or repair).  They randomized 147 patients after heart valve surgery 1:1 to 12 weeks of CR consisting of physical exercise and monthly psycho-educational consultations (intervention) versus usual care without structured physical exercise or psycho-educational consultations (control).  Primary outcome was physical capacity measured by VO2 peak and secondary outcome was self-reported mental health measured by Short Form-36.  A total of 76 % of participants were men, mean age of 62 years, with aortic (62 %), mitral (36 %) or tricuspid/pulmonary valve surgery (2 %).  Cardiac rehabilitation compared with control had a beneficial effect on VO2 peak at 4 months (24.8 mL/kg/min versus 22.5 mL/kg/min, p = 0.045); but did not affect Short Form-36 Mental Component Scale at 6 months (53.7 versus 55.2 points, p = 0.40) or the exploratory physical and mental outcomes.  Cardiac rehabilitation increased the occurrence of self-reported non-serious AEs (11/72 versus 3/75, p = 0.02).  The authors concluded that CR following heart valve surgery significantly improved VO2 peak at 4 months but had no effect on mental health and other measures of exercise capacity and self-reported outcomes.  Moreover, they stated that further research is needed to justify CR in this patient group.

Following Repair of Sinus Venosus Atrial Septal Defects:

A Medscape review on “Sinus venosus atrial septal defects” (Satou, 2015) did not mention CR.  Furthermore, an UpToDate review on “Surgical and percutaneous closure of atrial septal defects in adults” (Connolly, 2017) does not mention CR as a management tool.

Appendix

Note on Exit Criteria

The following clinical exit criteria have been identified as acceptable (CMS, 1989):

  • Symptoms of angina or dyspnea are stable at the patients maximum exercise level; and
  • The patient has achieved a stable level of exercise tolerance without ischemia or dysrhythmia; and
  • The patient's resting blood pressure and heart rate are within normal limits; and
  • The stress test is not positive during exercise (A positive stress test in this context implies an ECG with a junctional depression of 2 mm or more associated with slowly rising, horizontal, or down sloping ST segment).

New York Heart Association (NYHA) Functional Classification System – Designed to classify heart failure according to severity of symptoms:

  • Class I (mild) – No limitations on physical activity; ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath) or anginal pain.
  • Class II (mild) – Slight limitation of physical activity; comfortable at rest; ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.
  • Class III (moderate) – Marked limitation of physical activity; comfortable at rest; less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.
  • Class IV (severe) – Inability to carry on any physical activity without discomfort; symptoms of cardiac insufficiency may be present even at rest. If any physical activity is undertaken, discomfort increases.
Table: CPT Codes / HCPCS Codes / ICD-10 Codes
Code Code Description

Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":

CPT codes covered if selection criteria are met:

93798 Physician or other qualified health care professional services for outpatient cardiac rehabilitation; with continuous ECG monitoring (per session) [not covered for Phase III or Phase IV]

CPT codes not covered for indications listed in the CPB:

92997 Percutaneous transluminal pulmonary artery balloon angioplasty; single vessel.
92998 Percutaneous transluminal pulmonary artery balloon angioplasty; each additional vessel
93797 Physician or other qualified health care professional services for outpatient cardiac rehabilitation; without continuous ECG monitoring (per session)

Other CPT codes related to the CPB:

93015- 93024 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, or physician supervision only, without interpretation and report, or tracing only, without interpretation and report, or interpretation and report only

HCPCS codes covered if selection criteria are met:

G0422 Intensive cardiac rehabilitation; with or without continuous ECG monitoring with exercise, per session [Ornish Cardiac Rehab Program] [not covered for Phase III or Phase IV]
G0423 Intensive cardiac rehabilitation; with or without continuous ECG monitoring; without exercise, per session [not covered for Phase III or Phase IV]
S9472 Cardiac rehabilitation program, non-physician provider, per diem [not covered for Phase III or Phase IV]

Other HCPCS codes related to the CPB:

S9449 Weight management classes, non-physician provider, per session
S9451 Exercise classes, non-physician provider, per session
S9452 Nutrition classes, non-physician provider, per session
S9453 Smoking cessation classes, non-physician provider, per session
S9454 Stress management classes, non-physician provider, per session
S9470 Nutritional counseling, dietitian visit

ICD-10 codes covered if selection criteria are met:

I02.0 Rheumatic chorea with heart involvement
I05.0 - I05.9, I06.1 - I08.9 Rheumatic mitral, aortic, tricuspid, and multiple valve diseases
I09.81 Rheumatic heart failure (congestive)
I11.0 Hypertensive heart disease with heart failure
I13.0 Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4, chronic kidney disease, or unspecified chronic kidney disease
I13.2 Hypertensive heart and chronic kidney disease with heart failure and stage 5 chronic kidney disease or end stage renal disease
I20.9 Angina pectoris, unspecified [stable]
I21.01 - I25.9 Ischemic heart disease
I21.A1 Myocardial infarction type 2
I21.A9 Other myocardial infarction type
I34.0 - I34.9, I36.0 - I37.9 Nonrheumatic mitral, tricuspid and pulmonary valve disorders
I42.3 - I42.7 Cardiomyopathy
I46.2 - I46.9 Cardiac arrest
I47.2 Ventricular tachycardia
I47.9 Paroxysmal tachycardia, unspecified
I49.01 Ventricular fibrillation
I49.02 Ventricular flutter
I50.1 - I50.9 Heart failure
I97.0, I97.110, I97.130, I97.190 Postprocedural cardiac functional disturbances
Z51.89 Encounter for other specified aftercare
Z94.1 Heart transplant status
Z94.2 Lung transplant status
Z95.1 Presence of aortocoronary bypass graft
Z95.2 Presence of prosthetic heart valve
Z95.3 Presence of xenogenic heart valve
Z95.4 Presence of other heart-valve replacement
Z95.5 Presence of coronary angioplasty implant and graft
Z95.811 Presence of heart assist device
Z95.812 Presence of fully implantable artificial heart
Z98.61 Coronary angioplasty status
Z98.890 Other specified postprocedural status [surgery to heart and great vessels]

ICD-10 codes not covered for indications listed in the CPB (not all-inclusive):

E08.00 - E13.9 Diabetes [uncontrolled]
I06.0 Rheumatic aortic stenosis [moderate to severe]
I27.24 Chronic thromboembolic pulmonary hypertension
I30.0 - I30.9 Acute pericarditis
I35.0 - I35.9 Nonrheumatic aortic valve disorder [moderate to severe stenosis]
I40.1 - I40.9 Acute myocarditis
I44.2 Atrioventricular block, complete [without pacemaker]
I48.0 - I48.2, I48.91 Atrial fibrillation [new onset]
I49.8 Other specified cardiac arrhythmias [postural tachycardia syndrome]
I74.01 - I74.9 Arterial embolism and thrombosis [recent]
I80.0 - I80.9 Phlebitis and thrombophlebitis [recent]
Q21.1 Atrial septal defect [sinus venosus atrial septal defect]
Q23.0 Congenital stenosis of aortic valve [moderate to severe]
Q23.3 Supravalvular aortic stenosis [moderate to severe]
R00.0 Tachycardia [postural]
R06.00 - R06.09 Dyspnea [progressive worsening at rest or on exertion over the previous three to five days]
R06.89 Other abnormalities of breathing [forced expiratory volume of less than one liter]
R50.81 Fever presenting with conditions classified elsewhere [systemic]
R50.9 Fever, unspecified [systemic]
Z86.73 Personal history of transient ischemic attack [TIA], and cerebral infarction without residual deficits [not covered when used to report secondary prevention after transient ischemic attack or mild, non-disabling stroke]

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