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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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
Cardiac Rehabilitation: Outpatient - Medical Clinical Policy Bulletins | Aetna
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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).
Cardiac Rehabilitation: Outpatient - Medical Clinical Policy Bulletins | Aetna
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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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
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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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Code Code Description
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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Code Code Description
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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Code Code Description
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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Code Code Description
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]
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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
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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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