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Reconfiguring Cardiac Rehabilitation to Achieve Panvascular Prevention:
New Care Models for a New World
Brief Title: Cardiac Rehabilitation - New Care Models
Pratik B. Sandesara, MDa; Devinder Dhindsa, MDa; Jay Khambhati, MDa , Suegene K. Lee, MDa; Tina Varghese, MDa;; Wesley T. O’Neal, MD, MPHa; Arash Harzand, MDa; Dan Gaita, FESCb; Kornelia Kotseva, MD, PhD, FESCc; Susan B. Connolly, MB, MRCPI, PhDc; Catriona
Jennings, PhDc; Sherry L. Grace, PhD, FCCSd; David A. Wood, MB, ChB, MSc, FRCPc; Laurence Sperling, MD, FACC, FAHA, FACP, FASPCa
aDivision of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GAbCardiac Rehabilitation Clinic, University of Medicine and Pharmacy, Timisoara, RomaniacDepartment of Cardiovascular Medicine, National Heart and Lung Institute, Imperial College London, London, UKdSchool of Kinesiology and Health Science, York University, Toronto, Canada; University Health Network, University of Toronto, Canada
Word Count:
Figures: 2 figures
Funding
PBS is supported by the Abraham J. & Phyllis Katz Foundation (Atlanta, GA)
Disclosures
Dr. Harzand reports consulting for, being a minor investor in, and participating in a speaker’s bureau with Moving Analytics, Inc.
None for the other co-authors
Address for correspondenceLaurence Sperling, MD, FACC, FAHA, FACP, FASPC1365 Clifton Road, NEBuilding A, Suite 2200Atlanta, GA 30322Tel: (404) 778-2746 Fax: (404) 778-2895E-mail: [email protected]
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Abstract
Atherosclerotic cardiovascular disease (ASCVD) and its associated economic burden is
increasing globally. Although cardiac rehabilitation (CR) is an important component of
secondary prevention with proven benefits, it is underutilized due to numerous barriers,
especially in resource-limited settings. New care models for delivery of comprehensive
prevention programs such as community-based, home-based, and “hybrid” models implementing
m-health, e-health, and telemedicine need to be adopted. Such new care models should be
offered to all patients with established ASCVD (coronary, cerebral and peripheral) and
additionally to those at high risk of developing ASCVD with multiple risk factors for
panvascular prevention.
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Introduction
The epidemic of atherosclerotic cardiovascular diseases (ASCVD) is growing globally,
with an estimated prevalence of more than 100 million and projected economic burden of
approximately $15 trillion over the next 20 years 1, 2. This increasing burden is due to the growth
of ASCVD in low- and middle-income countries (LMICs) together with demographic changes
and an increasing prevalence of obesity, metabolic syndrome and diabetes 3.
With regard to the former, the rates of major ASCVD events and ASCVD-related
mortality were found to be substantially higher in LMICs than in high-income countries (HICs),
despite a lower traditional cardiovascular risk factor burden in LMICs 4. Even more striking is
the low rate of secondary prevention, such as medication use (i.e., anti-platelet agents, beta-
blockers, angiotensin converting enzyme inhibitors [ACE-I] or angiotensin-II receptor blockers
[ARBs], and statins). In the poorest countries, 80% of the population with reported ASCVD is
not on any medical therapy, compared to 11% in HICs 5. Additionally, low rates of lifestyle
changes in individuals with ASCVD are particularly evident in the LMICs, namely non-
adherence to a heart-healthy diet, physical inactivity and suboptimal rates of smoking cessation 6.
Despite the improved efficacy of current therapeutic interventions, delivery to and
implementation of these in populations in need of them pose a major challenge. Comprehensive
prevention programs provide an avenue by which this barrier can be overcome. Cardiac
rehabilitation (CR) is a model of care that provides comprehensive service including medical
evaluation, prescriptive exercise, cardiac risk factor modification, education, and psychosocial
counseling; it is the cornerstone for secondary prevention of ASCVD and an essential component
to achieve global targets set by the WHO 25x25 initiative 1, 7.
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These prevention programs favorably influence underlying CV risk factors and associated
mortality, which are essential for stemming the growing global epidemic of ASCVD. However,
these programs continue to be under-utilized, particularly in resource-limited settings. Therefore,
in this review, we discuss the benefits of CR, current realities and barriers to CR utilization, and
highlight new care models for improved delivery of this impactful intervention for ASCVD
prevention.
Indications and Benefits of Cardiac Rehabilitation
CR is a class IA indication and CR referral a quality of care metric following acute
coronary syndrome (ACS), chronic stable angina, coronary artery bypass graft surgery (CABG),
percutaneous coronary intervention (PCI), and systolic heart failure according to the American
Heart Association (AHA), American College of Cardiology (ACC) and European Society of
Cardiology guidelines 8-15, among others. CR is also indicated for patients following valve
procedures or cardiac transplantation 9, 16. More recently, for patients with peripheral artery
disease (PAD) and claudication, a supervised exercise program is classified as a class IA
recommendation by the ACC/AHA guidelines 17. Additionally, there has been evidence that CR
has shown benefit following stroke in reducing the risk of future cardiovascular events and
improving functional status 18, 19.
The benefits of CR for secondary prevention of coronary artery disease (CAD) are
compelling and well-established. A Cochrane systematic review and meta-analysis of
randomized controlled trials involving 14,486 patients with myocardial infarction (MI), angina,
or coronary revascularization demonstrated reductions in cardiovascular (CV) mortality by 26%
and hospital readmissions by 18%, as well as improvements in many quality of life measures in
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those that completed CR compared to usual care 20. CR is also shown to be cost-effective,
affordable, and to avert downstream healthcare utilization 21, 22.
Current Realities as well as Barriers to CR Referral and Delivery
Current CR delivery model
There is wide variation in CR delivery guidelines in countries around the world 23, though
there is broad consensus regarding the core components of CR as outlined in the International
Council of Cardiovascular Prevention and Rehabilitation (ICCPR) consensus guidelines
endorsed by 10 major national/international cardiac societies. These core components include
(1) assessment, (2) lifestyle risk factor management (i.e. physical activity, diet, tobacco and
mental health), (3) medical risk factor management (e.g. lipid control, blood pressure (BP)
control), (4) education for self-management and (5) return to work 24. Within these guidelines,
there is room for substantial variation in practice.
In the US for example, CR generally consists of up to 36 outpatient sessions over a span
of 8-12 weeks, delivered in electrocardiogram (ECG)-monitored settings 25. The dose varies
broadly however globally.26 Additionally, there is a variation in opinion regarding whether a
physician is required to lead a CR program. In some European countries, CR is delivered in
residential “spa” settings, and in the community in some low-resource settings. However,
globally most CR programs are delivered in supervised settings in tertiary care centers, which
likely contribute to the higher costs of these programs.
CR Under-Utilization
On a global basis, CR remains underutilized. A survey from EUROASPIRE III across 76
centers in 22 European countries also showed low referral (45%) and participation (37%) rates in
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patients with coronary heart disease 27. A recent study found that only 14-35% of patients who
had an MI and 31% of patients after CABG participate in CR 9. Of 58,269 patients eligible for
CR after an MI, only 62.4% were referred at the time of hospital discharge, with only 32.6% of
those referred attending at least 1 session within the next year and only 5.4% completing 36
sessions 28. Fewer than 50% of eligible patients are referred to CR globally 3. In particular, most
LMICs have a CR referral rate of <40% and the most commonly cited barrier was a lack of
physician referral 2. Recent meta-analyses suggest referral rates of 43% 29, enrolment rates of
42% 30, and overall adherence to 66% of sessions in those enrolling 31.
Barriers to CR are multi-level including physician/provider, patient and system related-
factors (Figure 1). With regard to the former, in the above study inpatient referral was a strong
predictor of eventual CR participation (odds ratio [OR] 12.16, 95% CI 5.50-26.89) but
physicians tend to under-refer certain sub-populations (women, ethnic minorities, heart failure
patients) despite clear indications 29, 32-35, highlighting the need for system-level interventions to
reduce inequity and referral barriers. CR referral rates are persistently sub-optimal, despite
guideline recommendations for referral based on the proven benefits (both summarized above).
Of the many barriers to participation in CR, lack of initial referral by physicians is a correctable
obstacle to subsequent enrollment of patients in CR.
Participation in CR is low even where patients are referred. Thus, the low participation
rate stems from not only low referral rates, but also low patient enrollment, and subsequent
program completion 7. Patient-specific barriers to CR participation include activity-limiting
comorbid conditions, low motivation / lack of awareness, geographic inaccessibility, competing
domestic or vocational responsibilities. Moreover, women are less likely to complete CR 36.
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Lower socioeconomic status and geography (i.e. rural populations) have also been shown to be
associated with decreased likelihood of completing a course of CR 37.
The current model of CR has significant obstacles to financial viability because it is not
reimbursed like other cardiac services-- pointing to a need for change on a systems-level. CR
payers are inconsistent around the globe 38, 39. Many patients pay out-of-pocket for CR and find it
financially difficult to afford. Furthermore, the revenues of traditional center-based CR programs
are often insufficient to meet their delivery costs 40.
The limited number of CR programs is also a key system-level barrier globally. To date,
only 38.8% of the countries worldwide have any CR programs3, despite its proven benefits as an
essential mechanism for secondary prevention. The Carinex Survey and the European Cardiac
Rehabilitation Inventory Survey found that of the 75 HICs, only 51 (68%) had CR services
available 3, 41, 42. Of greater concern is the lower availability of CR in middle-income (28.2%) and
low-income (8.3%) countries where >80% of ASCVD deaths occur 3, 39, 43.The density of CR
programs (number of CR programs per inhabitant) is low globally, but is also significantly lower
in LMICs. The US has the highest CR program density in the world with one program per
102,000 inhabitants, whereas some LMICs have as few as one program per 160 million
inhabitants 3.
Roadblocks and care gaps in low and middle-income countries specifically
The discrepancy between best evidence-based clinical practice and the actual care
provided is referred to as the “care gap.” Although care gaps can be seen in all countries, they are
most severe in LMICs and rural settings due to limited resources 1. The Population Urban Rural
Epidemiology (PURE) cohort study reported that ASCVD patients in LMICs had the lowest
rates of lifestyle changes, including adherence to a heart-healthy diet, physical activity, and
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tobacco cessation 5, 6. The more pronounced care gaps in these countries are secondary to lower
rates of preventive care, lower healthcare, inadequate care of patients with acute CV events
(often due to lack of coverage and availability of public services), and poor chronic management
of people with ASCVD 22. Limited access to care, including health services and medications,
and low health literacy are possible contributing factors as well. Thus, use of CR worldwide,
including in HICs, is suboptimal due to numerous barriers outlined herein, and new care models
are needed to overcome these barriers.
New Care Models / Settings
As outlined above, most CR is delivered in supervised settings, and we have grossly
insufficient reach. To address the issue of CR underutilization, alternative models have been
established to improve patient uptake, choice, and access 44. When asked about barriers to
accepting a referral, patients often cite concerns such as accessibility and transportation, a
reluctance to participate in a group setting, and work or domestic commitments 45-47. Moreover,
delivery of CR in alternative settings could greatly increase capacity. CR should increasingly be
offered in the home and community and exploit existing primary care services and information
and communications technologies.
Home-based programs
One model that addresses these issues directly is a regimen in which patients can
participate from their home on a more flexible schedule without having to travel to a dedicated
CR center. The home-based model also consists of all core CR components, but they are
delivered through regular contact with staff through telephone calls and/or other technology, as
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well as self-monitoring diaries for heart-healthy behaviors 48. It may also include remote
monitoring. An example of an evidence-based standardized model is the Heart Manual 49.
Home-based CR has been shown to be safe, cost-effective, and as effective as a center-
based rehabilitation program, making it an attractive option for enhancing CR utilization,
particularly for low to intermediate-risk patients 50, 51. A meta-analysis of available studies on
home- vs. center-based CR demonstrated not only the efficacy, but also a comparable, if not
higher completion rate as compared to center-based CR 52.
Community-based programs
Community-based CR programs are effective alternatives to traditional center-based
models of CR delivery 50. Community-based programs utilize alternative care models including
multifactorial individualized telehealth, an internet-based regimen, and home-based therapies 50.
Importantly, these modalities, namely multifactorial individualized telehealth and home-based
CR have shown comparable risk factor reductions as compared to hospital-based CR regimens 53,
54.
The MyAction Program developed in Europe offers an innovative, community-based
prevention program 55. MyAction represents an evolution of EUROACTION, a cluster
randomized-controlled trial of a nurse-coordinated multidisciplinary, family-based ASCVD
prevention program that was conducted in hospitals and general practice across eight European
countries 56. The program used a behavioral approach to address lifestyle, together with medical
risk factor management and the use of cardio-protective medications. At one year, the program
demonstrated healthier lifestyle changes and improvements in other risk factors for patients with
coronary heart disease and those at high risk of ASCVD and their partners than those in usual
care. The program subsequently evolved in the United Kingdom (UK) through integration of
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secondary and primary prevention in one community-based ASCVD panvascular prevention
program called MyAction. The feasibility of this approach has now been demonstrated in 2
different healthcare settings – both in London in a socioeconomically and ethnically diverse
population and also in Galway in the West of Ireland with outcomes that are similar, or even
better than the EUROACTION trial 55, 57.
This model involves integrative secondary prevention for patients with ASCVD and
high-risk primary prevention for patients with multiple ASCVD risk factors by focusing on
comprehensive lifestyle modifications and medical therapy to achieve optimal risk factor control.
This community-based, nurse-led, physician supervised 12-week program is delivered by a
multi-disciplinary team including nurses, dietitians, physical activity specialists, and clinical
psychologists. Patients and their partners undergo initial assessment of their lifestyle and risk
factors which informs an individualized care plan incorporating behavioral change strategies,
education and exercise. The comprehensive approach includes support for smoking cessation,
healthy eating, physical activity in everyday living, weight management, risk factor control, and
prescribing cardio-protective drugs .The efficacy of the MyAction program was demonstrated in
a study of 3232 patients 55. Significant improvements in healthy living, such as adherence to a
cardio-protective diet and increased physical activity were observed and maintained over a one-
year follow-up. Improvements in medical risk factors (blood pressure and lipids), prescription of,
and adherence to cardioprotective medications were also seen. Patient-reported outcomes such as
depression and quality of life improved as well.
Furthermore, the RESPONSE 2 (Randomized Evaluation of Secondary Prevention by
Outpatient Nurse Specialists 2) trial showed that community-based lifestyle programs are
effective in improving lifestyle risk factors (weight loss, physical activity and smoking cessation)
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in patients with CAD compared to usual care alone 58. These types of community-based
programs could be successfully adopted and implemented as an alternative to traditional, center-
based CR, as a multi-faceted approach to primary and secondary ASCVD prevention. Going
forward, however, more data is needed regarding the cost-effectiveness of these models.
Consideration also is needed for liability and coverage for the healthcare providers delivering the
care.
eCR programs
Efforts to augment this home-based care with information and communication
technologies, often termed telehealth CR, has provided enhanced, additional opportunity for
counselling, education, and feedback 51. For example, one phone call every four weeks using
telephonic coaching in the ‘Hartcoach’ Trial in the Netherlands, demonstrated a modest impact
on body composition, physical activity and vegetable intake in patients with ASCVD over the 6-
month study period 59. In their review, Rawstorn et al. noted an improvement in physical activity,
diastolic blood pressure, and lipids with telehealth CR as compared to a center-based program 51.
This “hybrid” model of telehealth serves to augment usual home-based CR, and functions as an
attractive option going forward for increased reach of CR.
The increasing use of mobile technology in developing countries, serves as an
opportunity to reduce gaps in access for CR, through so-called mobile health or “M-health”. The
penetrance of mobile technology is increasing globally, and already the penetration rate is 90%
in LMICs, increased from 45% of the population in LICs in 2011, and 75% in LMICs during that
time 56, 60. In the U.S., approximately 95% of adults own a cellphone of some kind, with
smartphone ownership estimated to be at 77%, an increase from 35% in 2011. This rise in
smartphone adoption provides an opportunity to leverage additional advances in mobile
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computing such as task automation, higher fidelity data regarding patient behaviors and physical
activity, and enhanced two-way communication. Early research suggests “mCR” may be
associated with greater utilization. Specifically, post-MI patients assigned to a smartphone-based
CR program were shown to have greater uptake (80% vs 62%), adherence (94% vs 68%), and
completion (80% vs 47%) compared to those assigned to traditional, center-based CR 61.
Importantly, both groups showed significant and comparable improvements in physiological and
psychological outcomes. This suggests equivalent benefits may be achieved, and potential
reductions in mortality and morbidity commensurate with those observed with center-based
programs, but with much greater reach.
Furthermore, the utility of m-health also extends to text-message reminders supporting
the promotion of healthy behavior modification 62, 63. Data supporting the efficacy of this low-
cost intervention is demonstrated in a study in which patients enrolled in an outpatient CR
program were to receive three to five text message reminders per week reminding them of heart-
healthy tips, medication adherence, as well as assessment and reporting of body weight, minutes
of exercise, and blood pressure. With just the addition of these text message reminders, there
was a significant difference in attendance of sessions and completion of the program 64.
Similarly, the randomized controlled Tobacco, Exercise and Diet Messages (TEXT ME) trial
showed that the use of lifestyle-focused text messaging resulted in significant reduction in low
density lipoprotein cholesterol, systolic blood pressure, body mass index, smoking rates and an
increase in physical activity compared to usual care in patients with ASCVD 65.
In general, systematic reviews of the literature do indicate a benefit of digital health
interventions (telemedicine, web-based strategies, e-mail, mobile applications, text messages,
remote monitoring) on attenuating ASCVD risk. These may provide an important low-cost and
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readily available tool for addressing the global burden of ASCVD 66. An important area of future
investigation will be exploring opportunities to optimize other emerging technologies (i.e.
smartphone applications), to improve access, reach and effectiveness of CR.
Model for low-resource settings
Overall, as an alternative to traditional center-based CR programs, these new care
prevention and rehabilitation models / settings can be adopted in both HICs and LMICs to
improve suboptimal utilization rates and overcome barriers. LMICs face unique barriers due to
scarcity of resources and therefore, new care models for secondary prevention programs tailored
specifically for low-resource settings (i.e., LMIC and under-resource areas in HICs) have been
proposed by an International Council of Cardiovascular Prevention and Rehabilitation (ICCPR)
consensus statement. This statement proposes strategies to deliver each of the core CR
components (i.e., risk assessment, lifestyle risk factor management, medical risk factor
management, education, and return to work) using the fewest resources possible 67. This model is
based on a nurse/allied health or community health worker led program, delivered in non-clinical
settings to minimize cost. As emphasized in the consensus statement, consideration of health
literacy, gender, religion and cultural context in the care delivery model is imperative. Limited
equipment for exercise and monitoring adds to the challenge of providing CR services in low-
resource settings and therefore, exercise programs requiring no equipment, such as walking,
provide a practical alternative. When possible, low-cost options such as resistance bands,
pedometers, and “home-made” weights can be utilized. These services can be delivered in the
community at places such as schools, places of worship or local meeting places to minimize
costs. This model can also be adopted in under-resourced areas in HICs to expand CR delivery
and overcome barriers related to cost.
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Risk assessment and stratification should be the starting point for selection of appropriate
level of supervision needed in order to tailor CR programs to meet individual patient needs and
risk factor interventions 68. Figure 2 provides a framework for CR delivery where resource
intensity is tailored to individual risk level. Hybrid models could be used, where high-risk
patients commence in supervised settings, and transition to unsupervised settings (potentially
including new technologies) once safety has been established.
Future Directions
Panvascular Prevention – The Case for Change
Patients with established ASCVD are at increased risk for recurrent CV events. This not
only applies to coronary patients but also to those with cerebrovascular disease and PAD. Yet,
the care of these patients is frequently delivered in silos by neurology, cardiology and vascular
services. While such a disease-specific approach may be appropriate for acute treatment, it is less
so for prevention as many patients have overlapping risk factors and diffuse overt vascular
disease occurs in at least 20% of patients 69. Furthermore, the REduction of Atherothrombosis for
Continued Health (REACH) registry has shown that those with cerebrovascular disease and PAD
have an even higher hard ASCVD event rate (MI/cerebrovascular accident (CVA)/death) at 3
years than those with coronary heart disease. Patients with cerebrovascular disease and PAD will
likely benefit from the same comprehensive CV risk reduction approaches while the exercise
prescription could be tailored to accommodate physical limitations and disabilities 70.
There is a large treatment gap, particularly for patients with PAD, where studies have
consistently demonstrated concerning underuse of preventive therapies such as statins and anti-
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platelet drugs, with only a minority receiving lifestyle counselling 71, 72. All patients with
established ASCVD merit access to a professional lifestyle and risk factor intervention program
to reduce their risk of a recurrent CV event and improve their quality of life.
Furthermore, asymptomatic patients with multiple risk factors are often at higher risk for
ASCVD. Therefore, we need to address a continuum of risk from secondary through primary
prevention and deliver these comprehensive prevention programs to those at increased risk. The
definition of panvascular prevention should include those with CAD, cerebrovascular disease,
PAD and the asymptomatic high-risk population. These patients could be managed within a
multi-faceted preventive cardiology program.
Conclusion
The growing burden of ASCVD in LMICs together with the increasing prevalence of
obesity, metabolic syndrome, and diabetes in HICs pose a significant threat to CV health
globally. The implementation of effective prevention strategies for individuals with ASCVD is
needed to reduce morbidity and mortality. New care models for comprehensive risk reduction
programs including community-based, home-based, and “hybrid” models utilizing m-health, e-
health, and telemedicine need to be implemented. These programs should be implemented not
only for patients with established ASCVD, but also for patients with multiple risk factors who
are at high ASCVD risk, embracing panvascular prevention.
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Figure Legends
Figure 1: Strategies to Overcome Cardiac Rehabilitation Referral, Enrollment and
Adherence/Completion Barriers
Patient, provider and health systems related barriers contribute to inadequate utilization of CR.
The table on the right provides potential solutions to overcome these barriers to referral,
enrollment and adherence/completion of CR programs. EMR=electronic medical record; CR =
Cardiac Rehabilitation
Figure 2: Three Levels of Resource Intensity Based on Patient Risk Level
This figure provides a framework for CR delivery and resource intensity based on individual risk
level. CR = Cardiac Rehabilitation
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Figure 1
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Figure 2
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