Cardiac Rehabilitation: Outpatient - Medical Clinical Policy Bulletins (2024)

Number:0021

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

Policy

Scope of Policy

This Clinical Policy Bulletin addressesoutpatient cardiac rehabilitation.

1. Medical Necessity

   Aetna considers outpatient (Phase II) cardiac rehabilitation medically necessary whenthe eligibility and programdescription are metas described below.

   See Also

   Cardiopulmonary Exercise Testing - Medical Clinical Policy BulletinsCardiovascular Disease Risk Tests - Medical Clinical Policy BulletinsInvasive Prenatal Diagnosis of Genetic Diseases - Medical Clinical Policy BulletinsCardiology Non-emergent Outpatient Stress Testing (L35083)

   1. Eligibility

      Aetna considers a medically supervised outpatient Phase II cardiac rehabilitation program medically necessary for selected members when it is individually prescribed by a physicianwithin a 12-month window afteranyof the following documented diagnoses:

      1. Acute myocardial infarction within the preceding 12 months;or
      2. Any major open heart surgery, including the following:
         1. coronary artery bypass grafting (CABG)
         2. great vessel surgery
         3. heart transplantation or heart-lung transplantation
         4. major pulmonary surgery
         5. open MAZE arrhythmia surgery
         6. placement of a ventricular assist device
         7. removal of atrial myxoma
         8. surgical septal myectomy via thoracotomy
         9. thoracic aortic aneurysm repair
         10. transcatheter valve replacement or repair;or
      3. 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
      4. Percutaneous coronary intervention(i.e., percutaneous transluminal coronary angioplasty (PTCA), atherectomy, stenting);or
      5. Sustained ventricular tachycardia or fibrillation, or survivors of sudden cardiac death;or
      6. 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;stableCHF isdefined asCHF 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.

   2. Program Description

      1. Physician-prescribed exercise each day cardiac rehabilitation items and services are furnished;and
      2. Provides up toa maximum oftwo 1-hour sessions per day for up to 36 sessions over aperiod of 36weeksof medically supervised exercise with or without continuouselectrocardiogram (ECG) monitoring (frequency generally consists of 2 to 3 sessions per week for 12 to 18 weeks);and
      3. Program is underthe direct supervision of a physician or other qualified health care professional (e.g., nurse practitioner [NP], physician's assistant [PA])Note:physician, NP or PAdo not have to be present in the room during the session; however, must beimmediately available and accessible for medical consultations and emergenciesat all times while services are being furnished under the program;and
      4. Facility is located in a physician's office, or outpatient hospital setting, andhas the necessary cardio-pulmonary, emergency, diagnostic, and therapeutic life-saving equipmentimmediately available (e.g., cardiopulmonary resuscitation equipment, defibrillator);and
      5. An individual outpatient exercise program has been created that can be self-monitored and maintained;and
      6. There has been a psychosocial assessment;and
      7. Cardiac risk factor modification, including education, counselingand behavioral intervention is tailored to individual needs;and
      8. Entails an outcomes assessment (e.g., objective clinical measures of exercise performance).

   Aetna considers additional cardiac rehabilitation services medically necessary when the eligible member has an additional qualifying eventforanyof the following conditions:

   • Another cardiovascular surgery or percutaneous coronary intervention;or
   • Another documented myocardial infarction or extension of initial infarction;or
   • New clinically significant coronary lesions documented by cardiac catheterization.

   Note:Up to anadditional 36 sessions is considered medically necessary for continuation(not to exceed a total of 72 sessions).

   Aetna considers cardiac rehabilitation not medically necessary for individuals following pericardiectomy for calcified constrictive pericarditit*.

2. Experimental, Investigational, or Unproven

   1. Cardiac rehabilitation programs arenot recommended and are considered experimental, investigational, or unproven for individuals with coronary artery disease (CAD) who have the following conditions:
      • Acute pericarditis or myocarditis;or
      • Acute systemic illness or fever;or
      • Clinical signs of decompensated aortic stenosis (e.g., angina pectoris and dyspnea on exertion, or syncope);or
      • Forced expiratory volume less than1 liter;or
      • New-onset atrial fibrillation;or
      • Progressive worsening of exercise tolerance or dyspnea at rest or on exertion over the previous3 to5 days;or
      • Recent embolism or thrombophlebitis;or
      • Third-degree heart block without pacemaker;or
      • Unstable angina.

   2. Aetna considers cardiac rehabilitation experimental, investigational, or unproven for all other indications including the following (not an all-inclusive list) because of insufficient evidence in the peer-reviewed literature:

      • 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
      • Following thoracic aortic repair
      • Individuals who are too debilitated to exercise
      • Individuals who have hypertrophic cardiomyopathy
      • Individuals who have undergone atrial fibrillation ablation
      • Individuals who have undergone closure of patent foramen ovale
      • Individuals who have undergone placement of an implantable automated cardioverter-defibrillator
      • Individuals with a history of high degree atrio-ventricular block following implantation of a permanent pacemaker
      • Individuals with Takotsubo (stress) cardiomyopathy
      • Individuals with lymphoma undergoing autologous hematopoietic stem cell transplantation
      • Postural tachycardia syndrome (POTS)
      • Secondary prevention afterstroke
      • Secondary prevention after transient ischemic attack
      • Uncompensated heart failure
      • Uncontrolled arrhythmias.

3. Policy Limitations and Exclusions

   Note:Phase III and Phase IV cardiac rehabilitation programs are not coveredunder standard Aetna benefit plans as these programs do not require direct supervision by a physician or advanced practitioner (NP or PA), or continuous ECG monitoring. These programs are considered educational and training in nature. Education and training programs are generallynot covered under mostAetna benefit plans. Please check benefit plan descriptions.

4. Related Policies

   • CPB 0267 - Intensive Cardiac Rehabilitation Programs

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 (CR) serves this purpose by providing a supervised program in the outpatient setting that involves medical evaluation, aphysical exercise program with electrocardiogram (ECG) monitored and non-ECG monitored sessions, 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 into4 phases, phase I to IV, representing a progression from the hospital (phase I) to a medically supervised outpatient program (phases II) to maintenance programs that are structured for community or home-based settings (phase III or 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 ECGmonitoring. Phase III and phase IV cardiac rehabilitation programs encourage exercise and healthy lifestyle performed at an outpatientmedical facility,home or in a fitness center with the goal of continuing the risk factor modification and exercise program learned in phase II.Phase III and IV do not require direct physician supervision or continuousECG monitoring. 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 (CMS, 2006).

Cardiac rehabiliation phase II sessions can take place in an outpatient hospital setting or a physician's office (CGS, 2018). Per the Centers for Medicare & Medicaid Services (CMS, 2010) and the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR, 2019), cardiac rehabilitation sessions require direct physician supervision. Although the physician does not have to be present in the room during the CR sessions, all CR settings must have a physician immediately available and accessible for medical consultations and emergencies at all times when items and services are being furnished under the program. This provision is satisfied if the physician meets the requirements for supervision for physician office services, at section 410.26; and for hospital outpatient services at section 410.27. For pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac rehabilitation services, direct supervision must be furnished by a doctor of medicine or osteopathy, as specified in §§410.47 and 410.49, respectively (CGS, 2018).AACVPR website (2018) also state thatfor cardiac rehabilitation sessions"the physician does not need to be in the rehab suite but must be immediately available and interruptible".

The AACVPR recommends "adjusting levels or intensities of ECGmonitoring of patients during the outpatient training phase of CRbased on clinical need and patient safety. Procedures includegraduated processes with an initial intensive phase of continuousECG monitoring followed by intermittent monitoring over the courseof the program, or basing the level of monitoring on the patient’srisk of cardiac events during exercise; low risk patients would bemonitored less frequently than high risk patients". Furthermore, "research indicates that “modified” CR programs that limitECG monitoring are both cost-effective and safe, while potentiallyimproving patient adherence (Carlson, 2000). Current Medicareregulations do not mandate that CR sessions be ECG-monitored.Per American Medical Association definitions of CR CPT codes,sessions may be with ECG-monitoring (93798) or without ECGmonitoring (93797) (CPT Manual). Both procedure codes arereimbursed by Medicare at the same rate in a hospital outpatientsetting" (AACVPR, 2024).

Due to changes in hospital and health care practices, and the need to accommodate patients at various stages of disease risk, some have argued thatthe need for phase designation becomes inappropriate, and thatcardiac 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 (Ignaszewskiand 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 outpatientcardiac rehabilitationin the United States is for patients to attend sessions2 to3 times per week for up to 12 to 18 weeks (36 total sessions) (CMS, 2006). A session typically lasts for approximately1 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 investigatorsidentified 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.

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, 2010) state that cardiac rehabilitation (CR)programs must include a medical evaluation, a program to modify cardiac risk factors, with prescribed exercise, education and counseling. CMS allows for physicians to determine the time period over with CR services are provided as long as it falls within the covered time period identified in the CMS regulation. The regulation allows for coverage of up to 36 1-hour sessions over up to 36 weeks.

In 2014, CMS determined that the evidence was sufficient to expand coverage for cardiac rehabilitation servicesto 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.Per CMS,CR sessions are limted to a maximum of two 1-hour session per day for up to 36 sessions over a period of 36 weeks. Furthermore, and additional 36 sessions may be warranted and approved by the Medicare contractor under section 1862(a)(1)(A) of the Social Security Act (CMS, 2014).

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 randomized study (the CopenHeartRFA Trial), Risom and colleagues (2016) examined the effects of comprehensive CR compared with usual care on physical activity and mental health for patients treated with catheter ablation for AF. The patients were randomized 1:1 stratified by paroxysmal or persistent AF and sex to CR consisting of 12 weeks physical exercise and 4 psycho-educational consultations plus usual care (CR group) versus usual care. The primary outcome was peak oxygen uptake (Vo2 peak). The secondary outcome was self-rated mental health measured by the Short Form-36 questionnaire. Exploratory outcomes were collected. A total of 210 patients were included (mean age of 59 years, 74 % men), 72 % had paroxysmal AF prior to ablation. Compared with usual care, the CR group had a beneficial effect on Vo2 peak at 4 months (24.3 ml/kg/min versus 20.7 ml/kg/min, p of main effect = 0.003, p of interaction between time and intervention = 0.020). No significant difference between groups on Short Form-36 was found (53.8 versus 51.9 points, p = 0.20); 2 serious AEs (AF in relation to physical exercise and death unrelated to rehabilitation) occurred in the CR group versus 1 in the usual care group (death unrelated to intervention) (p = 0.56). In the CR group 16 patients versus 7 in the usual care group reported non-serious AEs (p = 0.047). The authors concluded that comprehensive CR had a positive effect on physical capacity compared with usual care, but not on mental health. Moreover, CR caused more non-serious AEs.

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 (A