Prior Authorization Review Panel MCO Policy Submission...Cardiac Rehabilitation: Outpatient -...

Prior Authorization Review Panel MCO Policy Submission

A separate copy of this form must accompany each policy submitted for review. Policies submitted without this form will not be considered for review.

Plan: Aetna Better Health Submission Date:04/01/2020

Policy Number: 0021 Effective Date: Revision Date: 03/10/2020

Policy Name: Cardiac Rehabilitation: Outpatient

Type of Submission – Check all that apply:

New Policy Revised Policy*

Annual Review – No Revisions Statewide PDL

*All revisions to the policy must be highlighted using track changes throughout the document.

Please provide any clarifying information for the policy below:

CPB 0021 Cardiac Rehabilitation: Outpatient

This CPB has been revised to state that cardiac rehabilitation is considered experimental and investigational for individuals following pericardiectomy for calcified constrictive pericarditis.

Name of Authorized Individual (Please type or print):

Dr. Bernard Lewin, M.D.

Signature of Authorized Individual:

Proprietary Revised July 22, 2019

Proprietary

Cardiac Rehabilitation: Outpatient - Medical Clinical Policy Bulletins | Aetna

(https://www.aetna.com/)

Cardiac Rehabilitation: Outpatient

Number: 0021

Policy

*Please see amendment forPennsylvaniaMedicaid

at the end of this CPB.

Aetna considers outpatient (Phase II) cardiac rehabilitation medically

necessary when the eligibility and program description are met as

described below.

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 documented diagnoses:

Acute myocardial infarction within the preceding 12 months; or

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

Coronary artery bypass grafting (coronary bypass surgery, CABG);

or

Following surgical septal myectomy via thoracotomy; or

Heart transplantation or heart-lung transplantation; or

Major pulmonary surgery, great vessel surgery, or MAZE

arrhythmia surgery; or

Last Review

03/10/2020

Effective: 07/31/1995

Next Review: 01/14/2021

R eview History

Definitions

Additional Information

Clinical Policy Bulletin

Notes

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https://www.aetna.com/

Percutaneous coronary intervention (i.e., percutaneous

transluminal coronary angioplasty (PTCA), atherectomy, stenting);

or

Placement of a ventricular assist device; or

Sustained ventricular tachycardia or fibrillation, or survivors of

sudden cardiac death; or

Valve replacement or repair; or

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.

Program Description

Physician-prescribed exercise each day cardiac rehabilitation items

and services are furnished; and

Provides up to a maximum of two 1-hour sessions per day for up

to 36 sessions over a period of 36 weeks of supervised exercise

with continuous telemetry monitoring (frequency generally

consists of 2 to 3 sessions per week for 12 to 18 weeks); and

Program is under the direct supervision of a physician or other

qualified health care professional (e.g., nurse practitioner (NP),

physician's assistant (PA)) (Note: physician, NP or PA do not have

to be present in the room during the session; however, must

be immediately available and accessible for medical consultations

and emergencies at all times while services are being furnished

under the program); and

Facility is located in a physician's office, or outpatient hospital

setting, and has the necessary cardio-pulmonary, emergency,

diagnostic, and therapeutic life-saving equipment immediately

available (e.g., cardiopulmonary resuscitation equipment,

defibrillator); and

An individual out-patient exercise program has been created that

can be self-monitored and maintained; and

There has been a psychosocial assessment; and


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Cardiac risk factor modification, including education,

counseling and behavioral intervention is tailored to individual

needs; and

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

event for any of 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 le sions documented by c ardiac

catheterization.

Note: Up to an additional 36 sessions is considered medically necessary

for continuation (not to exceed a total of 72sessions).

Experimental and Investigational

Cardiac rehabilitation programs are not recommended and are

considered experimental and investigational for individuals with coronary

artery disease (CAD) who have the followingconditions:

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 than 1 liter; 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

Third-degree heart block without pacemaker; or

Unstable angina.

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Aetna considers cardiac rehabilitation experimental and investigational 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

Individuals who are too debilitated to exercise

Individuals with lymphoma undergoing autologous hematopoietic

stem cell transplantation

Postural tachycardia syndrome

Secondary prevention after stroke

Secondary prevention after transient ischemic attack

Uncompensated heart failure

Uncontrolled arrhythmias.

Aetna considers cardiac rehabilitation not medically necessary for

individuals following pericardiectomy for calcified constrictive pericarditits.

* Supervision by a physician or other qualified healthcare professional of

cardiac rehabilitation program without continuous electrocardiographic

(ECG) monitoring is considered experimental and investigational; clinician

supervision of such non-monitored programs has no proven value.

Note: Phase III and Phase IV cardiac rehabilitation programs are not

covered under 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

generally not covered under most Aetna benefit plans. Please check

benefit plan descriptions.

See

C PB 0267 - Intensive Cardiac Rehabilitation Programs

(../200_299/0267.html)

.

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http://aetnet.aetna.com/mpa/cpb/200_299/0267.html

http://aetnet.aetna.com/mpa/cpb/200_299/0267.html


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, 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) 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 electrocardiographic (ECG) monitoring. Phase III and

phase IV cardiac rehabilitation programs encourage exercise and healthy

lifestyle performed at an outpatient medical 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 continuous ECG 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).

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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 that for cardiac rehabilitation

sessions "the physician does not need to be in the rehab suite but must

be immediately available and interruptible".

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

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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

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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 =

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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

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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 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. 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).

Shibata e t 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 (i) circulatory

control during exercise is normal in POTS; and (ii) t hat 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

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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

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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),

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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 c ohort 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

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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 scientificevaluation.

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

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(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.

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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: (i) it lacked

randomization during group assignment, although it was

prospectively designed with a control group. Thus, they could not

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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, (ii) 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, (iii) 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

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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.

Cardiac Rehabilitation Following Septal Myectomy

Septal myectomy is one treatment option that is perfomed surgically via

open-heart in order to reduce the muscle thickening that occurs in

symptomatic patients with hypertrophic cardiomyopathy (HCM) refractory

to medications, or with left ventricular outlow tract (LVOT) obstruction

severely restricting blood ejection from the heart. Surgical spetal

myectomy relieves LVOT obstruction by directly removing the thickened

septal wall. The surgical septal myectomy involves performing a

thoractomy, with individual being placed on cardiopulmonary bypass.

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Surgical septal myectomy results in resolution of the LVOT gradient and

improvmeent in heart failure symptoms in most individuals. Long-term

outcomes also includes reductions in implantable cardioverter-defibrillator

(ICD) discharges and improvment in left atrial volumes and pulmonary

hypertension (Maron, 2019).

Redwood et al (1979) noted that the effect of left ventriculomyotomy and

myectomy on exercise capacity and cardiac function in patients with

obstructive hypertrophic cardiomyopathy has not previously been

determined. In this study, a total of 29 patients were evaluated during

graded treadmill exercise before and after operation. Post-operatively, 27

of 29 patients reported symptomatic improvement and had greatly

reduced left ventricular outflow gradient; 25 of 28 patients (89 %) attained

higher exercise levels after operation, and this was accompanied by an

increase in total body oxygen consumption from 16 to 21 ml/min per kg (p

< 0.005). A significant increase in cardiac index during maximal exercise

also accompanied this improved exercise performance (5.0 to 5.7

L/min/m2, p < 0.05). The increase in maximal cardiac index was

associated with greater desaturation of mixed venous blood (34 to 24 %,

p < 0.02) in patients with pre-operative angina. At a given level of mixed

venous oxygen saturation (30 %), overall mean cardiac index was higher

post-operatively (4.6 to 5.2 L/min/m2, p < 0.05). The authors concluded

that these findings suggested that, although several mechanisms

probably contributed to symptomatic improvement after myotomy and

myectomy, enhanced cardiac performance played an important role in the

majority of patients.

Franz et al (2008) stated that infective endocarditis due to viridans

streptococci is associated with a mortality of 5 to 10 %. Even today, it

remains difficult to diagnose it at an early stage, to select a sufficient

antibiotic therapy and to choose the right time for surgical intervention.

These investigators reported on the case of a 37-year old man who

presented with anemia, fever, adynamia and a loud systolic murmur over

the base of the heart. Blood culture data were positive for Streptococcus

mitis. Trans-thoracic echocardiography (TTE) revealed an endocarditis of

the aortic and mitral valve with regurgitations as well as a hypertrophic

obstructive cardiomyopathy. The hemodynamically stable patient was

treated with penicillin G, gentamicin and verapamil. Because of an

extension of valve vegetations and a decline in the hemodynamic

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situation with an incipient sepsis, the patient was surgically treated

urgently by replacement of the aortic and mitral valve as well as a Morrow

septal myectomy. A post-operative sepsis required the application of high

catecholamine doses. Because of a respiratory insufficiency, a prolonged

mechanical ventilation was required. Finally, the patient could be

discharged for in-hospital rehabilitation. The authors concluded that the

indication for surgical therapy in patients with endocarditis of the aortic

and mitral valve as well as hypertrophic obstructive cardiomyopathy

should be critically discussed with regard to the patient's age, the aims of

conservative therapy, and the consequences of a surgical intervention. If

there were any indices of a disease progress in spite of antibiotic therapy,

patients should be subjected to cardiac surgery immediately.

Although there is insuffient evidence via randomized controlled clinical

trials to support cardiac rehabilitation specifically for surgical septal

myectomy, cardiac rehabilitation programs' efficacy has been established

in other open-heart surgical indications (e.g. CABG, heart transplant).

Individuals With Lymphoma Undergoing Autologous Hematopoietic Stem Cell Transplantation

Rothe and colleagues (2018) noted that worldwide more than 50,000

hematopoietic stem cell transplants (HSCTs) are performed annually; and

HSCT patients receive multiple cardiotoxic therapies (chemotherapy and

radiation therapy) in addition to severe physical deconditioning during

hospital admission. These researchers hypothesized that guided

exercise in a CR program following autologous HSCT is a safe and

feasible intervention. This was a pilot project to assess for safety,

feasibility and impact of 8 weeks of CR in HSCT patients following

transplant. Consecutive patients with lymphoma underwent standard

activity protocol testing before HSCT, at 6 weeks following HSCT (prior to

CR), and at 14 weeks following HSCT (at completion of CR), consisting of

grip strength (GS), gait speed (GtS), timed up-and-go (TUG), and 6

minute walk test (6MWT); CR consisted of 8 weekly visits for guided

exercise. Activity tolerance protocol data of 30 patients (24 male, 6

female) from December 2014 to December 2016 were analyzed using

repeated measures (analysis of variance [ANOVA]) to observe for

changes in GS, GtS, TUG, and 6MWT. Statistically significant

improvements were found in GS (p < 0.005), GtS (p = 0.02), and 6MWT

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(p = 0.001). These improvements showed that guided CR-based

exercise may assist HSCT survivors to meet or even surpass baseline

exercise levels and improve physical functioning. There were no AEs

(i.e., death or injury) during the study period; 57 % of referred patients

participated in CR, exceeding documented CR adherence in cardiac

populations. The authors concluded that the addition of CR-based

exercise programming in HSCT survivorship care of patients with

lymphoma was a safe and feasible intervention to assist in recovery

following transplant. These preliminary findings need to be validated by

well-designed studies.

Symptomatic Individuals with Non-Obstructive Coronary Artery Disease

Kissel and colleagues (2018) stated that non-obstructive coronary artery

disease (NOCAD) on coronary angiography is a common finding in

patients with stable angina. Angina in NOCAD patients is thought to be

caused by endothelial dysfunction of the epicardial coronary arteries

and/or the microvasculature. Treatment is empiric, and 30 % of patients

remain symptomatic in spite of therapy. It is well known that physical

exercise can improve endothelial function. These investigators evaluated

the evidence on effects of physical exercise in NOCAD patients with

angina. They performed a literature search (up to March 13, 2018) using

the following search terms: syndrome X, microvascular angina, non-

obstructive coronary artery disease and exercise training, cardiac

rehabilitation, endothelial function. All original publications which

examined the effect of a CR program or exercise training (ET) on patients

with angina and NOCAD. A total of 8 studies, of which 4 were RCTs,

examined 218 participants, 162 in an intervention and 56 in control

groups. Most patients were women (97.7 %). Exercise programs varied

from 8 weeks to 4 months at moderate intensity and some included

relaxation therapy. The studies examined the effect of CR on exercise

capacity, QOL, and perfusion defects. CR increased exercise capacity,

oxygen uptake, symptom severity, and QOL; myocardial perfusion

improved. The authors concluded that CR appeared to be beneficial in

symptomatic patients with NOCAD, improving exercise capacity and QOL

and reducing severity of symptoms and myocardial perfusion defects.

Moreover, these researchers stated that data were limited to a small

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number of predominantly female patients. They stated that further larger

trials with inclusion of men are needed to determine the optimal

rehabilitation protocols and define its long-term benefits.

The authors stated that this study had several drawbacks. First, the

included studies were all small with low patient numbers in each

treatment group, thus limiting statistical power. In addition, not all of the

studies were randomized. Second, the majority of studies included only

women (97.7 %). Although cardiac syndrome X is more common in

women, it is well established that it also occurs in men, with up to 30 % of

men with SA presenting for coronary angiogram, have NOCAD. Given

that the studies were limited to women, these investigators could only

speculate whether ET has the same positive effect in men. Outcome

measures in the reported trials consisted mostly of parameters for

exercise capacity, easily measurable physical values, and QOL assessed

by questionnaires. All outcomes were evaluated in the short-term,

directly after completion of the CR program. No data were available on

the long-term effects of CR programs in NOCAD, and whether the

beneficial effect was sustained over time. Furthermore, it would be

interesting to find out whether this transferred into hard end-points like

less frequent hospitalization, lower treatment costs, and possibly an

improved outcome. For a long time, symptomatic patients with NOCAD

were assured of the benign nature of their condition. However, recent

data pointed towards an adverse outcome of these patients in regard to

MI, cardiovascular, and all-cause mortality. Thus, it would be intriguing to

examine if CR also led to an improved cardiovascular outcome in this

patient population. These researchers stated that current studies on the

effect of ET in symptomatic patients with NOCAD are promising but

larger, randomized studies with inclusion of men are needed to evaluate

the benefit of ET on hard end-points and the long-term effect of ET.

Furthermore, a study protocol should include randomized groups to

determine the optimal training protocol in regard to training intensity,

duration, and inclusion of relaxation techniques. Furthermore, it would be

of interest to include vascular function studies to gain further insight into

the pathophysiological mechanisms.

Diabetes Mellitus

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Cardiac rehabilitation (CR) programs include interventions aimed at

improving diabetes mellitus (DM) control (e.g., education, blood glucose

monitoring, supervised exercise, and ECG monitoring for phase II

sessions). One of the core components of CR/secondary prevention

program includes diabetes management. CR programs monitor blood

glucose (BG) levels before/after exercise sessions and instruct patients

regarding identification and treatment of post-exercise hypoglycemia.

Because the AACVPR recommends avoiding vigorous exercise before

blood glucose has been adequately controlled, CR programs follow

protocols/guidelines that monitor and check diabetic patients before and

after exercise, and will prohibit patients from exercise if blood glucose

level is outside of set parameters (Balady et al, 2000; McCulloch, 2019).

According to AACVPR, “monitoring BG levels is vital for the long-term

maintenance of glycemic control and is especially important during

exercise given that beta-blocker therapy can mask the onset of an

impending insulin reaction. Monitoring BG levels during exercise may also

provide positive feedback regarding the regulation or progression of the

exercise prescription, which may result in subsequent long-term

adherence to exercise. This is particularly important since exercise is a

cornerstone of treatment for diabetes” (Human Kinetics, 2019).

An UpToDate review of the “Effects of exercise in adults with diabetes

mellitus” (McCulloch, 2019) state that in the absence of contraindications

(e.g., moderate to severe proliferative retinopathy), people with type 1

and 2 diabetes should be encouraged to perform resistance training

(exercise with free weights or weight machines) at least twice per week;

however, vigorous exercise should be avoided in the presence of

substantial hyperglycemia (≥250 mg/dL [13.9 mmol/L]) or ketosis. The

authors state that it is not necessary to defer exercise based on milder

hyperglycemia, as long as the patient feels well and there is no ketonemia

or ketonuria. It should be noted that patients can be at risk of late

hypoglycemia (i.e., 4-8 hours after the termination of exercise); however,

this can usually be avoid by ingesting slowly absorbed carbohydrates

immediately after exercise. “Inadequate replacement of carbohydrate

before, during, and after exercise is the most common cause of exercise-

associated hy poglycemia in patients taking insulin.”

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Jimenez-Navarro et al. (2017) state that cardiac rehabilitation (CR)

participation after percutaneous coronary intervention (PCI) is associated

with lower all‐cause mortality rates in patients with DM, to a similar

degree as for those without DM. The authors note that CR participation

has been lower in patients with DM, suggesting the need to identify and

correct the barriers to CR participation for this higher‐risk group of

patients. The authors conducted a retrospective analysis of patients

(n=700) with DM who underwent percutaneous coronary intervention in a

single center facility between 1994 and 2010, assessing the impact of CR

participation on clinical outcomes. The endpoints of their study were to

evaluate the impact of CR on cardiovascular events and mortality after

PCI in patients with DM, and to compare the relative impact of CR on

these outcomes in patients with and without DM. The authors found that

CR participation was significantly lower in patients with DM (38%,

263/700) compared with those who did not have DM (45%, 1071/2379;

p=0.004). Using propensity score adjustment, the authors found that in

patients with DM, CR participation was associated with significantly

reduced all‐cause mortality (p=0.002) and composite end point of

mortality, myocardial infarction, or revascularization (p=0.037), during a

median follow‐up of 8.1 years. In patients without DM, CR participation

was associated with a significant reduction in all‐cause mortality

(p<0.001) and cardiac mortality (p=0.024). This study is limited by the

retrospective nature of the data, and was conducted in a single-center

facility. In addition, the study cohort was primarily white, non‐Hispanic

individuals, and, therefore, may not be representative of other

populations. However, the authors note that data from the study location

was identified as being a representative community‐based sample of

data, with characteristics that are similar to those of other primarily white

populations within the United States. The authors concluded that these

findings highlight the benefits of CR, while supporting efforts, including

the development and dissemination of clinical practice guidelines,

performance measures, and policy initiatives, that are aimed at increasing

CR participation after PCI. Methods to improve delivery of CR after PCI to

patients with DM appear to be warranted.

Cardiac Rehabilitation Following Pericardiectomy for Calcified Constrictive Pericarditis

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Drahosova (1989) noted that between 1967 to 1986 in the Czechoslovak

State spa Sliac, a total of 961 (48.15 %) men and 1,035 (51.85 %) women

after surgical operations on the heart were followed-up during the 2nd

rehabilitation stage. The operations were made because of the following

indications: acquired rheumatic valvular defects (n = 1,208; 60.52 %),

congenital heart disease (n = 461; 23.10 %), ischemic heart disease (n =

260; 13.03 %), myxomas and thrombi of the left atrium (n = 31; 1.55 %),

pericardiectomy (n = 36; 1.80 %). As to surgical operations,

commissurotomy and commissurolysis were performed in 724 (36.27 %);

an artificial prosthesis was implanted in 330 (16.53 %), homo-transplants

in 151 (7.57 %) auto-transplants in 3 (0.15 %), aorto-coronary by-pass/re

vascularization in 260 (13.03), surgical operations on account of

congenital heart disease, thrombi and myxomas of the left atrium were

performed in 492 (24.65 %) of the patients. Rehabilitation care

comprised in addition to remedial exercise a therapeutic regime, clinical

and laboratory examinations, diet therapy, medicamentous and physical

therapy and carbon dioxide (CO2) baths. After rehabilitation care

objective improvement was recorded in 850 (42.59 %), subjective

improvement in 953 (47.74 %), no change in 143 (7.16 %), deterioration

in 47 (2.35 %), and 3 patients (0.15 %) died.

Wachter and Hasenfuss (2010) presented the case of a 46-year old man

with progressive dyspnea on exertion and severe headache while having

the head lowered. Clinically, the patient showed left-sided pleural

effusion, jugular venous distension, and a congested liver. During

cardiologic work-up, echocardiography, combined left/right heart

catheterization and magnetic resonance imaging (MRI) established the

diagnosis of constrictive pericarditis. Under conservative medical

treatment, the patient again developed cardiac decompensation and,

thus, a pericardectomy was performed. Immediately after surgery,

symptoms diminished and exercise tolerance increased. The patient was

currently in CR. The authors concluded that constrictive pericarditis is a

rare differential diagnosis of right heart failure. Especially in patients with

congested inferior vena cava, but normal systolic left ventricular function

and normal function of the cardiac valves, constrictive pericarditis should

be considered as a differential diagnosis.

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Ponomarev et al (2018) stated that constrictive pericarditis (CP) is the

final stage of a chronic inflammatory process characterized by fibrous

thickening and calcification of the pericardium that impairs diastolic filling,

reduces cardiac output, and ultimately leads to HF. These researchers

presented a clinical case of CP in a patient with rare inherited bleeding

disorder -- factor VII deficiency. Heart failure due to CP was suspected

based on clinical symptoms, results of ultrasonic and radiological

investigations. The diagnosis was verified by the results of cardiac MRI.

Pericardectomy was performed resulting in significant improvement in the

patient's condition. Cardiac rehabilitation was not mentioned and was not

listed as one of the keywords for this study.

Cardiac Rehabilitation Following Stroke

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,

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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.

Jeffares and colleagues (2019) stated that the CR model has potential as

an approach to providing rehabilitation following stroke. These

researchers provided evidence for the participation of stroke patients in

cardiac/cardiovascular rehabilitation programs internationally, whether or

not such programs offer a cognitive intervention as part of treatment, and

the impact of rehabilitation on post-stroke cognitive function. A total of 5

electronic databases were searched from inception to May 1, 2019,

namely: Medline, PsycINFO, the Cumulative Index to Nursing and Allied

Health Literature, the Cochrane Central Register of Controlled Trials, and

the Web of Science. Eligible studies included both randomized and non-

randomized studies of CR-type interventions that measured cognitive

function in patients with transient ischemic attack (TIA) or stroke. Of

14,153 records reviewed, 9 studies that delivered CR-type interventions

to stroke patients were finally included. Only 3 of these studies delivered

cognitive rehabilitation as part of the intervention. Cardiac rehabilitation

had no statistically significant effect on cognitive function in 5 RCTs (SMD

= 0.28, 95 % CI: -0.16 to 0.73) or in 3 one-group pre-post studies (SMD =

0.15, 95 % CI: -0.03 to 0.33). The authors concluded that this review

highlighted that there were very few studies of delivery of CR to stroke

patients and that the inclusion of cognitive interventions was even less

common, despite the high prevalence of post-stroke cognitive

impairment. These investigators noted that the CR model has the

potential to be expanded to include patients post-stroke given the

commonality of secondary prevention needs, thereby becoming a

cardiovascular rehabilitation model. Up to 50 % of patients experience

cognitive impairment following stroke; suggesting that a post-stroke

cardiovascular rehabilitation model should incorporate specific cognitive

strategies for patients. This systematic review identified 3 cardiovascular

rehabilitation programs which delivered cognitive rehabilitation as part of

treatment; however, evidence for efficacy was weak.

Cardiac Rehabilitation Following Surgery to Correct Anomalous Coronary Artery

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Lee et al (2016) examined physiological and clinical relevance of an

anomalous right coronary artery originating from left sinus of Valsalva

(right ACAOS) with inter-arterial course in adults. For physiological

assessment, fractional flow reserve (FFR) during dobutamine challenge

was measured in 37 consecutive adult patients with lone right ACAOS

with inter-arterial course. At baseline, mean FFR was 0.91 ± 0.06,

declining to 0.89 ± 0.06 upon dobutamine infusion (p < 0.001).

Dobutamine stress FFR was significant (≤ 0.8) in 3 patients (8.1 %), 2 of

whom were surgically treated. Following surgery, dobutamine stress FFR

rose from 0.76 to 0.94 and 0.76 to 0.98. Re-modelling index (r = 0.583, p

= 0.002), minimal lumen area (diastole: r = 0.580, p = 0.002; systole: r =

0.0618, p < 0.001) and per cent area stenosis (r = -0.550, p = 0.004),

measured by intravascular ultrasound (IVUS), correlated with dobutamine

stress FFR. To assess the c linical relevance, follow-up data of 119

patients with lone right ACAOS with inter-arterial course were analyzed

retrospectively; 2 deaths occurred during a median follow-up period of 4

years, for a mortality rate of 0.34 per 100 person-year. No instances of

MI were recorded and 1 patient did undergo surgical re-vascularization in

the course follow-up. The authors concluded that most instances of lone

right ACAOS with inter-arterial course discovered in adults were

physiologically insignificant and ran benign clinical courses. Conservative

management may thus suffice in this setting if no definitive signs of

myocardial ischemia w ere evident.

Furthermore, recent consensus guidelines on anomalous coronary artery

implantation (Brothers et al, 2017) discussed certain exercise restrictions

following surgery, but did not address whether they need monitored CR.

Cardiac Rehabilitation for Individuals with an Implantable Cardioverter Defibrillator

Nielsen and colleagues (2019) stated that an effective way of preventing

sudden cardiac death (SCD) is the use of an implantable cardioverter

defibrillator (ICD). In spite of the potential mortality benefits of receiving

an ICD device, psychological problems experienced by patients after

receiving an ICD may negatively impact their health-related QOL, and

lead to increased re-admission to hospital and healthcare needs, loss of

productivity and employment earnings, and increased morbidity and

mortality. Evidence from other heart conditions suggested that CR should

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consist of both exercise training and psycho-educational interventions;

such rehabilitation may benefit patients with an ICD. Prior systematic

reviews of CR have excluded participants with an ICD. These

researchers carried out a systematic review to examine the evidence for

the use of exercise-based intervention programs following implantation of

an ICD. To assess the benefits and harms of exercise-based CR

programs (exercise-based interventions alone or in combination with

psycho-educational components) compared with control (group of no

intervention, treatment as usual or another rehabilitation program with no

physical exercise element) in adults with an ICD. These investigators

searched CENTRAL, Medline, Embase and 4 other databases on August

30, 2018 and 3 trials registers on November 14, 2017. They also

undertook reference checking, citation searching and contacted study

authors for missing data. These researchers included RCTs if they

examined exercise-based CR interventions compared with no

intervention, treatment as usual or another rehabilitation program.

Subjects were adults (aged 18 years or older), who had been treated with

an ICD regardless of type or indication. Two review authors

independently extracted data and assessed risk of bias. The primary

outcomes were all-cause mortality, serious AEs and health-related QOL.

The secondary outcomes were exercise capacity, anti-tachycardia pacing,

shock, non-serious AEs, employment or loss of employment and costs

and cost-effectiveness. Risk of systematic errors (bias) was assessed by

evaluation of pre-defined bias risk domains. Clinical and statistical

heterogeneity were assessed. Meta-analyses were undertaken using

both fixed-effect and random-effects models. These investigators used

the GRADE approach to assess the quality of evidence. They identified 8

trials published from 2004 to 2017 randomizing a total of 1,730 subjects,

with mean intervention duration of 12 weeks. All 8 trials were judged to

be at overall high risk of bias and effect estimates were reported at the

end of the intervention with a follow-up range of 8 to 24 weeks; 7 trials

reported all-cause mortality, but deaths only occurred in 1 trial with no

evidence of a difference between exercise-based CR and control (RR

1.96, 95 % CI: 0.18 to 21.26; subjects = 196; trials = 1; quality of

evidence: low). There was also no evidence of a difference in serious

AEs between exercise-based CR and control (RR 1.05, 95 % CI: 0.77 to

1.44; subjects = 356; trials = 2; quality of evidence: low). Due to the

variation in reporting of health-related QOL outcomes, it was not possible

to pool data. However, the 5 trials reporting health-related QOL at the

Proprietary 29/48


end of the intervention, each showed little or no evidence of a difference

between exercise-based CR and control. For secondary outcomes, there

was evidence of a higher pooled exercise capacity (peak VO2) at the end

of the intervention (MD 0.91 ml/kg/min, 95 % CI: 0.60 to 1.21; subjects =

1,485; trials = 7; quality of evidence: very low) favoring exercise-based

CR, albeit there was evidence of substantial statistical heterogeneity (I2 =

78 %). There was no evidence of a difference in the risk of requiring anti-

tachycardia pacing (RR 1.26, 95 % CI: 0.84 to 1.90; subjects = 356; trials

= 2; quality of evidence: moderate), appropriate shock (RR 0.56, 95 % CI:

0.20 to 1.58; subjects = 428; studies = 3; quality of evidence: low) or

inappropriate shock (RR 0.60, 95 % CI: 0.10 to 3.51; subjects = 160;

studies = 1; quality of evidence: moderate). The authors concluded that

due to a lack of evidence, they were unable to definitively assess the

impact of exercise-based CR on all-cause mortality, serious AEs and

health-related QOL in adults with an ICD. However, these findings

provided very low-quality evidence that patients following exercise-based

CR experienced a higher exercise capacity compared with the no

exercise control. These researchers stated that further high-quality

randomized trials are needed in order to examine the impact of exercise-

based CR in this population on all-cause mortality, serious AEs, health-

related QOL, anti-tachycardia pacing and shock.

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, d yspnea or anginal pain.

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Class IV (severe) – Inability to carry on any physical activity without

discomfort; symptoms of cardiac insufficiency may be present

even a t rest. If any physical activity is undertaken, discomfort

increases.

CPT Codes / HCPCS Codes / ICD-10 Codes

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

Code Code Description

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:

33030 Pericardiectomy, subtotal or complete; without

cardiopulmonary by pass

33031 with cardiopulmonary bypass


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http://aetnet.aetna.com/mpa/cpb/1_99/0021.html#dummyLink2



93015-

93024

Cardiovascular stress test using maximal or submaximal

treadmill or bicycle exercise, continuous

electrocardiographicmonitoring,and/orpharmacological

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

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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

I42.2 Other hypertrophic cardiomyopathy [asymmetric septal

hypertrophy]

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 [compensated or stable]

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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):

I06.0 Rheumatic aortic stenosis [moderate to severe]

I20.0 Unstable angina

I27.24 Chronic thromboembolic pulmonary hypertension

I30.0 - I30.9 Acute pericarditis

I31.1 Chronic constrictive pericarditis [following

pericardiectomy for calcified constrictive pericarditis]

I35.0 - I35.9 Nonrheumatic aortic valve disorder [moderate to severe

stenosis]

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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 pr evious 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]

Proprietary 35/48


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and

constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or

program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any

results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna

or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be

updated and therefore is subject to change.

Copyright © 2001-2020 Aetna Inc.

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AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number: 0021

Cardiac Rehabilitation: Outpatient

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania revised 03/10/2020

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http://www.aetnabetterhealth.com/pennsylvania

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