Therapeutic education of patients with coronary heart disease: Impact of digital platform monitoring in preventing major cardiovascular events in Tunisia: Study protocol.

BACKGROUND: Faced with the increase in the number of chronic diseases with the aging of the population, and with the observation of the insufficiency of therapeutic control, a new need has emerged, that of having a patient as a partner in care. METHODS: This study is a randomized controlled trial. Patients with coronary heart disease will be recruited from one clinical site and randomly assigned into two groups: the intervention group and the control group. All participants will be followed up for a total of one year (with three-time points for data collection). Patients who are assigned to the intervention group will receive therapeutic education at first. The digital platform will then allow healthcare providers to accompany them outside the hospital walls. The primary outcome is the incidence of major cardiovascular events within one year of discharge. Main secondary outcomes include changes in health behaviors, medication adherence, and quality of life score. The digital platform is a multi-professional telemonitoring platform that allows care teams to accompany the patient outside the hospital walls. It allows the collection and transmits information from the patient's home to the therapeutic education team. All data will be secured at a certified host. The patient application provides data on compliance, adherence to physical activity (number of steps taken per day), adequate diet (weight gain, food consumed during the meal, compliance with low-salt or salt-free diet, diabetic diet), smoking cessation, as well as medication adherence. Access to educational tools (digital media) is provided to all initial program participants. These tools will be updated annually by the rehabilitation team on the recommendations. The platform also offers the possibility of organizing an individual or group remote educational session (videoconference modules allowing group and individual sessions), a secure integrated caregiver-patient messaging system. The control group will receive the usual controls at the hospital. DISCUSSION: To offer a complete solution of care to our patients, we have thought of setting up a digital platform that aims to monitor the patient and strengthen their abilities to manage their condition daily. This pilot experience could be generalized to several services and disciplines. It could be used in several research works. TRIAL REGISTRATION: Trial registered with the Pan African Clinical Trial Registry (PACTR202307694422939). URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=24247.

E valuation of M aintained Physic A l Ca P acity 1-yr After Coronary Patient Cardiac Rehabilitation (EMAP) : A FRENCH MULTICENTER STUDY.

PURPOSE: Data are scarce concerning the sustainable effects of cardiac rehabilitation (CR), on cardiorespiratory fitness (CRF) of patients with coronary artery disease (CAD). This study, carried out using data from a French multicenter study, aimed to clarify the evolution of the CRF of patients with CAD 1 yr after the end of a CR stay. METHODS: Patients were included after an acute coronary syndrome (77%) and/or coronary revascularization, occurring <3 mo beforehand. All underwent a CR program with CRF evaluation by exercise testing (ET) on a cycle ergometer at the beginning of CR (ET1), at its end (ET2), and 1 yr later (ET3)-all ETs were performed with medication. RESULTS: Two hundred fifty-nine patients were included (age 60 ± 10 yr, 89% male) in 16 French CR centers. Left ventricular ejection fraction was 55.3 ± 9%. Revascularization was complete (82%). Maximal workloads were 110 ± 37 (ET1), 139 ± 43 (ET2), and 144 ± 46 W (ET3) ( P < .001). The estimated metabolic equivalents of the task (METs) were respectively 5.3 ± 1.4, 6.4 ± 1.6 ( P < .001), and 6.6 ± 1.7 ( P < .002). One year later, 163 patients (63%) improved or maintained their CRF (ET3 ≥ ET2), 73 (28%) decreased (ET1 < ET3 < ET2), and 23 (9%) lost the benefit of CR (ET3 ≤ ET1). CONCLUSION: Among completers who agreed to enroll in this study, most patients with CAD seem to maintain their CRF 1 yr after CR.

Evaluation of an Online Course in 5 Languages for Inpatient Cardiac Care Providers on Promoting Cardiac Rehabilitation: REACH, EFFECTS, AND SATISFACTION.

PURPOSE: Evidence proves that health care providers should promote cardiac rehabilitation (CR) to patients face-to-face to increase CR enrollment. An online course was designed to promote this at the bedside; it is evaluated herein in terms of reach, effect on knowledge, attitudes, discussion self-efficacy and practices, and satisfaction. METHODS: Design was observational, one-group pre- and post-test. Some demographics were requested from learners taking all language versions of the 20-min course: English, Portuguese, French, Spanish, and simplified Chinese, available at: https://globalcardiacrehab.com/CR-Utilization. Investigator-generated items in the pre- and post-test and evaluation survey administered using Google Forms were based on Kirkpatrick's training evaluation model. RESULTS: The course was initiated by 522 learners from 33 of 203 (16%) countries; most commonly female (n = 341, 65%) nurses (n = 180, 34%) from high-income countries (n = 259, 57%) completing the English (n = 296, 57%) and Chinese (n = 108, 21%) versions. A total of 414 (79%) learners completed the post-test and 302 (58%) completed the evaluation. Median CR attitudes were 5 of 5 on the Likert scale at pre-test, suggesting some selection bias. Mean CR knowledge ([7.22 ± 2.14]/10), discussion self-efficacy ([3.86 ± 0.85]/5), and practice ([4.13 ± 1.11]/5) significantly improved after completion of the course (all P < .001). Satisfaction was high regardless of language version ([4.44 ± 0.64]/5; P = .593). CONCLUSIONS: This free, open-access course is effective in increasing CR knowledge, self-efficacy, and encouragement practices among participating inpatient cardiac providers, with high satisfaction. While testing impact on actual CR use is needed, it should be more broadly disseminated to increase reach, in an effort to increase patient enrollment in CR, to reduce morbidity and mortality.

MEdical TReatment Optimization in cardiac rehabilitation (METRO study) : a French multicenter study.

BACKGROUND: Cardiac rehabilitation (CR) is the right place to optimize the medical treatment in coronary artery disease (CAD) patients. AIMS: To report the medical management in CAD patients during CR and evaluate the consequences. METHODS: CAD patients who attended a CR program within less than three months of an acute coronary syndrome (ACS), a percutaneous coronary intervention (PCI), or a coronary artery bypass graft (CABG) were included in a prospective multicenter study. Medical treatments were analyzed at the beginning and at discharge of the CR stay. Results of exercise tests were compared between 4 groups. G1: unchanged medication, n=443, G2: beta-blockers or bradycardic agents adaptation n=199, G3: renin-angiotensin system (RAS) inhibitors adaptation, n=194, G4: both medications adaptation, n=164. RESULTS: One thousand consecutive patients were included in 23 French CR centers (85.3% males; mean age 59.9 ± 11 years). The index event was ACS (68.5%), PCI (62.6%) and CABG (36.3%). During CR, we noted an adaptation for beta-blockers in 32.1%, in other bradycardic agents (ivabradine, verapamil, diltiazem, amiodarone) in 9.5%, and in RAS inhibitors in 36.3%. Patients of group 1 had an initial resting heart rate lower than in group 2 and 4, but at the final exercise testing, the range of the decrease was more important in group 2 and 4. The combination of physical training and therapeutic modifications resulted in similar exercise capacities in the four groups, from 5.2, 5.3, 5.4 and 5.2 MET (p=0.68), to 6.3, 6.5, 6.5 and 6.1 MET (p=0.44), respectively. CONCLUSION: The METRO study showed that significant alteration in medical treatment during cardiac rehabilitation programs could take part in improving physical capacity.

Delphi consensus recommendations on how to provide cardiovascular rehabilitation in the COVID-19 era.

This Delphi consensus by 28 experts from the European Association of Preventive Cardiology (EAPC) provides initial recommendations on how cardiovascular rehabilitation (CR) facilities should modulate their activities in view of the ongoing coronavirus disease 2019 (COVID-19) pandemic. A total number of 150 statements were selected and graded by Likert scale [from -5 (strongly disagree) to +5 (strongly agree)], starting from six open-ended questions on (i) referral criteria, (ii) optimal timing and setting, (iii) core components, (iv) structure-based metrics, (v) process-based metrics, and (vi) quality indicators. Consensus was reached on 58 (39%) statements, 48 'for' and 10 'against' respectively, mainly in the field of referral, core components, and structure of CR activities, in a comprehensive way suitable for managing cardiac COVID-19 patients. Panelists oriented consensus towards maintaining usual activities on traditional patient groups referred to CR, without significant downgrading of intervention in case of COVID-19 as a comorbidity. Moreover, it has been suggested to consider COVID-19 patients as a referral group to CR per se when the viral disease is complicated by acute cardiovascular (CV) events; in these patients, the potential development of COVID-related CV sequelae, as well as of pulmonary arterial hypertension, needs to be focused. This framework might be used to orient organization and operational of CR programmes during the COVID-19 crisis.

A novel personalized approach to cardiovascular prevention: The VIVOPTIM programme.

BACKGROUND: Cardiovascular diseases are a leading cause of mortality, but a substantial proportion are preventable. AIMS: The Mutuelle générale de l'éducation nationale (MGEN), a provider of private health insurance in France, has developed the VIVOPTIM programme, a novel digital approach to healthcare based on individualized, multiprofessional, ranked management of cardiovascular risk factors. METHODS: Between November 2015 and June 2016, eligible individuals (age 30-70 years) from two regions of France were invited to participate. Volunteers completed a questionnaire based on the Framingham Heart Study Risk Score and were assigned to one of three cardiovascular risk levels. VIVOPTIM comprises four components: cardiovascular risk assessment, instruction on cardiovascular diseases and associated risk factors, personalized coaching (telephone sessions with a specially trained healthcare professional to provide information on risk factors and disease management, set individual health targets, monitor progress and motivate participants), and e-Health monitoring. RESULTS: Data from 2240 participants were analysed. Significant benefits were observed on mean systolic blood pressure (-3.4mmHg), weight (-1.5kg), smoking (-2.2 cigarettes/day) and daily steps (+1726 steps/day (all P<0.0001)), though not on weekly duration of exercise (-0.2hours/week, P=0.619). CONCLUSION: As a result of the positive mid-to-long-term results of the pilot programme on weight, smoking, blood pressure, and uptake of physical activity, the VIVOPTIM programme was extend to the whole of France in 2018 and has the potential to have a genuine impact on patient care and organization of the healthcare system in France.

Cardiac rehabilitation availability and delivery in Europe: How does it differ by region and compare with other high-income countries?: Endorsed by the European Association of Preventive Cardiology.

AIMS: The aims of this study were to establish cardiac rehabilitation availability and density, as well as the nature of programmes, and to compare these by European region (geoscheme) and with other high-income countries. METHODS: A survey was administered to cardiac rehabilitation programmes globally. Cardiac associations were engaged to facilitate programme identification. Density was computed using global burden of disease study ischaemic heart disease incidence estimates. Four high-income countries were selected for comparison (N = 790 programmes) to European data, and multilevel analyses were performed. RESULTS: Cardiac rehabilitation was available in 40/44 (90.9%) European countries. Data were collected in 37 (94.8% country response rate). A total of 455/1538 (29.6% response rate) programme respondents initiated the survey. Programme volumes (median 300) were greatest in western European countries, but overall were higher than in other high-income countries (P < 0.001). Across all Europe, there was on average only 1 CR spot per 7 IHD patients, with an unmet regional need of 3,449,460 spots annually. Most programmes were funded by social security (n = 25, 59.5%; with significant regional variation, P < 0.001), but in 72 (16.0%) patients paid some or all of the programme costs (or ∼18.5% of the ∼€150.0/programme) out of pocket. Guideline-indicated conditions were accepted in 70% or more of programmes (lower for stable coronary disease), with no regional variation. Programmes had a multidisciplinary team of 6.5 ± 3.0 staff (number and type varied regionally; and European programmes had more staff than other high-income countries), offering 8.5 ± 1.5/10 core components (consistent with other high-income countries) over 24.8 ± 26.0 hours (regional differences, P < 0.05). CONCLUSION: European cardiac rehabilitation capacity must be augmented. Where available, services were consistent with guidelines, but varied regionally.

French Society of Cardiology guidelines on exercise tests (part 2): Indications for exercise tests in cardiac diseases.

The exercise test is performed routinely in cardiology; its main indication is the diagnosis of myocardial ischemia, evaluated along with the subject's pretest probability and cardiovascular risk level. Other criteria, such as analysis of repolarization, must be taken into consideration during the interpretation of an exercise test, to improve its predictive value. An exercise test is also indicated for many other cardiac diseases (e.g. rhythm and conduction disorders, severe asymptomatic aortic stenosis, hypertrophic cardiomyopathy, peripheral artery disease, hypertension). Moreover, an exercise test may be indicated for specific populations (women, the elderly, patients with diabetes mellitus, patients in a preoperative context, asymptomatic patients and patients with congenital heart defects). Some cardiac diseases (such as chronic heart failure or arterial pulmonary hypertension) require a cardiopulmonary exercise test. Finally, an exercise test or a cardiopulmonary exercise test is indicated to prescribe a cardiac rehabilitation programme, adapted to the patient.

French Society of Cardiology guidelines on exercise tests (part 1): Methods and interpretation.

The exercise test is still a key examination in cardiology, used for the diagnosis of myocardial ischemia, as well as for the clinical evaluation of other heart diseases. The cardiopulmonary exercise test can further define functional capacity and prognosis for any given cardiac pathology. These new guidelines focus on methods, interpretation and indications for an exercise test or cardiopulmonary exercise test, as summarized below. The safety rules associated with the exercise test must be strictly observed. Interpretation of exercise tests and cardiopulmonary exercise tests must be multivariable. Functional capacity is a strong predictor of all-cause mortality and cardiovascular events. Chest pain, ST-segment changes and an abnormal ST/heart rate index constitute the first findings in favor of myocardial ischemia, mostly related to significant coronary artery disease. Chronotropic incompetence, abnormal heart rate recovery, QRS changes (such as enlargement or axial deviations) and the use of scores (based on the presence of various risk factors) must also be considered in exercise test interpretation for a coronary artery disease diagnosis. Arrhythmias or conduction disorders arising during the exercise test must be considered in the assessment of prognosis, in addition to a decrease or low increase in blood pressure during the exercise phase. When performing a cardiopulmonary exercise test, peak oxygen uptake and the volume of expired gas/carbon dioxide output slope are the two main variables used to evaluate prognosis.

Effects of combined exercise training and electromyostimulation treatments in chronic heart failure: A prospective multicentre study.

Background Exercise training as part of a comprehensive cardiac rehabilitation is recommended for patients with cardiac heart failure. It is a valuable method for the improvement of exercise tolerance. Some studies reported a similar improvement with quadricipital electrical myostimulation, but the effect of combined exercise training and electrical myostimulation in cardiac heart failure has not been yet evaluated in a large prospective multicentre study. Purpose The aim of this study was to determine whether the addition of low frequency electrical myostimulation to exercise training may improve exercise capacity and/or muscular strength in cardiac heart failure patients. Methods Ninety-one patients were included (mean age: 58 ± 9 years; New York Heart Association II/III: 52/48%, left ventricular ejection fraction: 30 ± 7%) in a prospective French study. The patients were randomised into two groups: 41 patients in exercise training and 50 in exercise training + electrical myostimulation. All patients underwent 20 exercise training sessions. In addition, in the exercise training + electrical myostimulation group, patients underwent 20 low frequency (10 Hz) quadricipital electrical myostimulation sessions. Each patient underwent a cardiopulmonary exercise test, a six-minute walk test, a muscular function evaluation and a quality of life questionnaire, before and at the end of the study. Results A significant improvement of exercise capacity (Δ peak oxygen uptake+15% in exercise training group and +14% in exercise training + electrical myostimulation group) and of quality of life was observed in both groups without statistically significant differences between the two groups. Mean creatine kinase level increased in the exercise training group whereas it remained stable in the combined group. Conclusions This prospective multicentre study shows that electrical myostimulation on top of exercise training does not demonstrate any significant additional improvement in exercise capacity in cardiac heart failure patients.

Validation of the French version of the MacNew heart disease health-related quality of life questionnaire.

BACKGROUND: Assessment of health-related quality of life is widely recommended by European health agencies in relevant research studies as well as in clinical care. AIMS: To validate the French version of the MacNew heart disease health-related quality of life questionnaire. METHODS: As part of the International HeartQoL Project, 323 French-speaking patients with ischaemic heart disease (angina, n=76; myocardial infarction [MI], n=155; heart failure, n=91; mean age 58.6±11.3 years) were recruited at seven cardiac rehabilitation centres. All patients completed the French versions of the MacNew questionnaire, the Short Form-36 Health Survey (SF-36) and the Hospital Anxiety and Depression Scale, to evaluate the psychometric properties of the French version of the MacNew instrument. RESULTS: The mean MacNew global scale scores were 4.6±0.8, 5.0±1.0 and 4.8±0.9 in patients with angina, MI and heart failure, respectively (P<0.05, MI versus angina). We observed minimal missing items and ceiling effects and no floor effects. Factor analysis confirmed a three factorial structure explaining 55.9% of the observed variance. Internal consistency reliability (Cronbach's α) ranged from 0.86 to 0.94 and test-retest reliability ranged from 0.68 to 0.73 Convergent validity was confirmed in the total group and each diagnosis, although the correlations between the MacNew physical subscale and the SF-36 mental component summary were higher than expected. Discriminative validity was partially confirmed with the SF-36 health transition item and fully confirmed with anxiety and depression as predictor variables. CONCLUSION: The French version of MacNew questionnaire is recommended for assessing health-related quality of life in French-speaking patients with ischaemic heart disease.

Exercise training is safe after coronary stenting: a prospective multicentre study.

BACKGROUND: Data on the safety of exercise training after coronary stenting are scarce. DESIGN: This is a prospective cohort study of 3132 patients with coronary stenting within the last 12 months, recruited by 44 cardiac rehabilitation centres; patients were included in a cardiac rehabilitation programme with training sessions 3-5 days a week. Cardiac rehabilitation was defined as early rehabilitation when starting <1 month after coronary stenting and as late rehabilitation when starting later. METHODS: Rate of acute coronary syndrome (ACS) after coronary stenting was estimated according to time to training session. ACS was defined as related to exercise when it occurs during or within the hour after an exercise stress test or a training session. All ACS were documented by an angiographic control. RESULTS: Overall 5016 stents (41.4% drug-eluting stents) were implanted in 3132 patients aged 56.5 ± 12.9 years (84.7% men) with a median of 1 stent (range 1-8) per patient. Indication of coronary senting was ACS (86.4%), angina pectoris (8.6%), and silent ischaemia (5%). Combined antiplatelet treatment was used in 97.2% of the patients. Overall rate of ACS after coronary stenting was 2.9/1000 patients, corresponding to 1.7 complications out of 10(6) patient-hours of exercise. There were four stent thromboses related to exercise (1.2/1000 patients, 0.8/10(6) patient-hours of exercise): two in the early rehabilitation group (days 9 and 11), and two in the late rehabilitation group (days 77 and 228). CONCLUSIONS: Exercise training seems safe and there is no justification to delay cardiac rehabilitation after coronary stenting.

Therapeutic education in coronary heart disease: position paper from the Working Group of Exercise Rehabilitation and Sport (GERS) and the Therapeutic Education Commission of the French Society of Cardiology.

Cardiovascular mortality has decreased over the past 25 years, largely because of acute coronary syndrome care and preventive actions. Nevertheless, the rate of coronary heart disease remains high, with an annual risk of 4.7% (cardiac mortality, myocardial infarction, stroke). Cardiovascular risk factor management must be a priority in primary and secondary prevention, to improve the prognosis of this severe disease, in which absence of symptoms does not mean benignity. The current goals of therapeutic patient education are smoking cessation, regular physical activity, a cardioprotective (Mediterranean) diet, management of stress, good treatment adherence (which improves compliance), judicious use of the care system and help with occupational reintegration. Current and future programmes must be in accordance with the Haute Autorité de Santé recommendations published in 2007.

Is the use of cholesterol-lowering drugs for the prevention of cardiovascular complications in type 2 diabetics evidence-based? A systematic review.

Cholesterol-lowering drugs are often prescribed to patients with type 2 diabetes mellitus despite uncertainty about the benefits of this treatment in the prevention of cardiovascular complications. We here systematically review (PRISMA guidelines) the results of high-quality double blind trials testing whether cholesterol-lowering drugs (statins and fibrates) reduce mortality and cardiovascular complications specifically in type 2 diabetics. Trials with premature termination without pertinent medical justification or using nonrandomized subgroups of diabetics were excluded from the review. Only four trials met our predefined inclusion criteria. Among the 3 statin trials, CARDS was discontinued 2 years before the anticipated end and in the absence of significant effect on both overall and cardiovascular mortality, suggesting that the trial should not have been prematurely stopped. The two other statin trials showed no significant effect on the primary endpoint (relative risk 0.92, 95% CI 0.77 to 1.10 in 4D and 0.90, 95% CI 0.73 to 1.12 in ASPEN) and on both cardiovascular and overall mortality. Finally, the fibrate trial (FIELD) showed no significant benefit on the primary endpoint (relative risk 0.89, 95% CI 0.75 to 1.05) and mortality (relative risk 1.11, 95% CI 0.95 to 1.29). Because of a huge medical heterogeneity between patients in the selected trials, it was consensually decided to stop the analysis at this stage. This review does not support the use of cholesterol-lowering drugs (such as statin and fibrate) to reduce mortality and cardiovascular complications in type 2 diabetics. Official guidelines should be re-examined and reformulated by experts independent from the pharmaceutical industry.

Cholesterol lowering, cardiovascular diseases, and the rosuvastatin-JUPITER controversy: a critical reappraisal.

BACKGROUND: Among the recently reported cholesterol-lowering drug trials, the JUPITER (Justification for the Use of Statins in Primary Prevention) trial is unique: it reports a substantial decrease in the risk of cardiovascular diseases among patients without coronary heart disease and with normal or low cholesterol levels. METHODS: Careful review of both results and methods used in the trial and comparison with expected data. RESULTS: The trial was flawed. It was discontinued (according to prespecified rules) after fewer than 2 years of follow-up, with no differences between the 2 groups on the most objective criteria. Clinical data showed a major discrepancy between significant reduction of nonfatal stroke and myocardial infarction but no effect on mortality from stroke and myocardial infarction. Cardiovascular mortality was surprisingly low compared with total mortality-between 5% and 18%-whereas the expected rate would have been close to 40%. Finally, there was a very low case-fatality rate of myocardial infarction, far from the expected number of close to 50%. The possibility that bias entered the trial is particularly concerning because of the strong commercial interest in the study. CONCLUSION: The results of the trial do not support the use of statin treatment for primary prevention of cardiovascular diseases and raise troubling questions concerning the role of commercial sponsors.

Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation.

BACKGROUND: Cardiac rehabilitation is widely recognized as a medical management procedure that reduces mortality, but the cardiovascular safety of exercise training has not been clearly established. Published data are retrospective or outdated, as patient management has substantially progressed in recent years. The aim of this prospective registry was to determine the current complication rate during exercise performed in the course of cardiac rehabilitation. METHODS: This study was conducted by the Functional Evaluation and Cardiac Rehabilitation Working Group of the French Society of Cardiology. During a 1-year period, 65 cardiac rehabilitation centers reported that serious events had occurred during or 1 hour after an exercise stress test or a training session. Severe cardiovascular events were validated by a scientific committee. RESULTS: A total of 25,420 patients (78% men; mean age, 61.3 years) were included in the study. Initial indications for cardiac rehabilitation were post-cardiac surgery (coronary bypass, 34.3%; valvular surgery, 18.4%); recent percutaneous coronary intervention (21.6%); and other coronary (13.2%) and noncoronary (12.5%) conditions. The study population underwent 42,419 exercise stress tests and 743,471 patient-hours of exercise training. Twenty severe cardiac events were reported: 5 were related to exercise testing and 15 were related to exercise training. The event rate was 1 per 8484 exercise stress tests and 1 per 49,565 patient-hours of exercise training; the cardiac arrest rate was 1.3 per million patient-hours of exercise. Neither fatal complications nor emergency defibrillations were reported. CONCLUSION: The frequency of major cardiovascular complications during supervised exercise training in France is quite low.