Telemedical cardiac risk assessment by implantable cardiac monitors in patients after myocardial infarction with autonomic dysfunction (SMART-MI-DZHK9): a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial.

BACKGROUND: Cardiac autonomic dysfunction after myocardial infarction identifies patients at high risk despite only moderately reduced left ventricular ejection fraction. We aimed to show that telemedical monitoring with implantable cardiac monitors in these patients can improve early detection of subclinical but prognostically relevant arrhythmic events. METHODS: We did a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial at 33 centres in Germany and Austria. Survivors of acute myocardial infarction with left ventricular ejection fraction of 36-50% had biosignal analysis for assessment of cardiac autonomic function. Patients with abnormal periodic repolarisation dynamics (≥5·75 deg2) or abnormal deceleration capacity (≤2·5 ms) were randomly assigned (1:1) to telemedical monitoring with implantable cardiac monitors or conventional follow-up. Primary endpoint was time to detection of serious arrhythmic events defined by atrial fibrillation 6 min or longer, atrioventricular block class IIb or higher and fast non-sustained (>187 beats per min; ≥40 beats) or sustained ventricular tachycardia or fibrillation. This study is registered with ClinicalTrials.gov, NCT02594488. FINDINGS: Between May 12, 2016, and July 20, 2020, 1305 individuals were screened and 400 patients at high risk were randomly assigned (median age 64 years [IQR 57-73]); left ventricular ejection fraction 45% [40-48]) to telemedical monitoring with implantable cardiac monitors (implantable cardiac monitor group; n=201) or conventional follow-up (control group; n=199). During median follow-up of 21 months, serious arrhythmic events were detected in 60 (30%) patients of the implantable cardiac monitor group and 12 (6%) patients of the control group (hazard ratio 6·33 [IQR 3·40-11·78]; p<0·001). An improved detection rate by implantable cardiac monitors was observed for all types of serious arrhythmic events: atrial fibrillation 6 min or longer (47 [23%] patients vs 11 [6%] patients; p<0·001), atrioventricular block class IIb or higher (14 [7%] vs 0; p<0·001) and ventricular tachycardia or ventricular fibrillation (nine [4%] patients vs two [1%] patients; p=0·054). INTERPRETATION: In patients at high risk after myocardial infarction and cardiac autonomic dysfunction but only moderately reduced left ventricular ejection fraction, telemedical monitoring with implantable cardiac monitors was highly effective in early detection of subclinical, prognostically relevant serious arrhythmic events. FUNDING: German Centre for Cardiovascular Research (DZHK) and Medtronic Bakken Research Center.

Efficacy of Lipid-Lowering Therapy during Cardiac Rehabilitation in Patients with Diabetes Mellitus and Coronary Heart Disease.

BACKGROUND: Cardiac rehabilitation (CR) in patients with coronary heart disease (CHD) increases adherence to a healthy lifestyle and to secondary preventive medication. A notable example of such medication is lipid-lowering therapy (LLT). LLT during CR improves quality of life and prognosis, and thus is particularly relevant for patients with diabetes mellitus, which is a major risk factor for CHD. DESIGN: A prospective, multicenter registry study with patients from six rehabilitation centers in Germany. METHODS: During CR, 1100 patients with a minimum age of 18 years and CHD documented by coronary angiography were included in a LLT registry. RESULTS: In 369 patients (33.9%), diabetes mellitus was diagnosed. Diabetic patients were older (65.5 ± 9.0 vs. 62.2 ± 10.9 years, p < 0.001) than nondiabetic patients and were more likely to be obese (BMI: 30.2 ± 5.2 kg/m2 vs. 27.8 ± 4.2 kg/m2, p < 0.001). Analysis indicated that diabetic patients were more likely to show LDL cholesterol levels below 55 mg/dL than patients without diabetes at the start of CR (Odds Ratio (OR) 1.9; 95% CI 1.3 to 2.9) until 3 months of follow-up (OR 1.9; 95% CI 1.2 to 2.9). During 12 months of follow-up, overall and LDL cholesterol levels decreased within the first 3 months and remained at the lower level thereafter (p < 0.001), irrespective of prevalent diabetes. At the end of the follow-up period, LDL cholesterol did not differ significantly between patients with or without diabetes mellitus (p = 0.413). CONCLUSION: Within 3 months after CR, total and LDL cholesterol were significantly reduced, irrespective of prevalent diabetes mellitus. In addition, CHD patients with diabetes responded faster to LTT than nondiabetic patients, suggesting that diabetic patients benefit more from LLT treatment during CR.

Lessons from the short- and mid-term outcome of medical rehabilitation in adults with congenital heart disease.

BACKGROUND: The number of adults with congenital heart disease (ACHD) is steadily increasing. Over their life-time, many of the affected patients require medical rehabilitation after interventional or surgical treatment of residua, sequels or complications of their congenital heart defect (CHD). However, up to now only scarce data exist about indication, performance and outcomes of cardiac rehabilitation in ACHD. METHODS: The course and outcome of rehabilitation after previous interventional or surgical treatment in ACHD was analyzed in a retrospective cohort study. RESULTS: Two hundred and five ACHD {54% female; mean age 34±12 [16-68] years} with mild (23.9%), moderate (35.1%) or severe CHD (41.0%), of whom 32% had complex CHD, 21% right-ventricular outflow tract obstructions, 20% pre-tricuspid shunts, 18% left heart or aortic anomalies, 9% post-tricuspid shunts and 2% other congenital cardiac anomalies were included into analysis. The main indications for rehabilitation were a preceding surgical (92%) or interventional (3%) treatment of the underlying CHD immediately before rehabilitation. During rehabilitation, no severe complications occurred. The number of patients in function class I/II increased from 189 to 200 and decreased in class III/IV from 16 to 5. Cardiac medication could be reduced or stopped after rehabilitation in 194 patients, with the exception of ACE-inhibitors. There was an improvement in cardiovascular risk factors. While before medical treatment 77% (n=157) patients were capable of working, the number increased to 82% [168] at the end of rehabilitation. Throughout a follow-up 9.3% (n=19) of patients needed further cardiac interventions. CONCLUSIONS: The current study provided for the first time comprehensive data on the course of rehabilitation in a large cohort of ACHD after surgical or interventional treatment. The overall outcome of ACHD after rehabilitation was uneventful and favorable. Further research is required to assess the clinical long-term outcome, the impact of rehabilitation on the quality of life, disease coping and employment. The results of this study can serve as a benchmark for the development of specific rehabilitation programs in ACHD.

Cardiac Rehabilitation in German Speaking Countries of Europe-Evidence-Based Guidelines from Germany, Austria and Switzerland LLKardReha-DACH-Part 1.

BACKGROUND: Although cardiovascular rehabilitation (CR) is well accepted in general, CR-attendance and delivery still considerably vary between the European countries. Moreover, clinical and prognostic effects of CR are not well established for a variety of cardiovascular diseases. METHODS: The guidelines address all aspects of CR including indications, contents and delivery. By processing the guidelines, every step was externally supervised and moderated by independent members of the "Association of the Scientific Medical Societies in Germany" (AWMF). Four meta-analyses were performed to evaluate the prognostic effect of CR after acute coronary syndrome (ACS), after coronary bypass grafting (CABG), in patients with severe chronic systolic heart failure (HFrEF), and to define the effect of psychological interventions during CR. All other indications for CR-delivery were based on a predefined semi-structured literature search and recommendations were established by a formal consenting process including all medical societies involved in guideline generation. RESULTS: Multidisciplinary CR is associated with a significant reduction in all-cause mortality in patients after ACS and after CABG, whereas HFrEF-patients (left ventricular ejection fraction <40%) especially benefit in terms of exercise capacity and health-related quality of life. Patients with other cardiovascular diseases also benefit from CR-participation, but the scientific evidence is less clear. There is increasing evidence that the beneficial effect of CR strongly depends on "treatment intensity" including medical supervision, treatment of cardiovascular risk factors, information and education, and a minimum of individually adapted exercise volume. Additional psychologic interventions should be performed on the basis of individual needs. CONCLUSIONS: These guidelines reinforce the substantial benefit of CR in specific clinical indications, but also describe remaining deficits in CR-delivery in clinical practice as well as in CR-science with respect to methodology and presentation.

Performance Measures for Short-Term Cardiac Rehabilitation in Patients of Working Age: Results of the Prospective Observational Multicenter Registry OutCaRe.

OBJECTIVE: To determine immediate performance measures for short-term, multicomponent cardiac rehabilitation (CR) in clinical routine in patients of working age, taking into account cardiovascular risk factors, physical performance, social medicine, and subjective health parameters and to explore the underlying dimensionality. DESIGN: Prospective observational multicenter register study in 12 rehabilitation centers throughout Germany. SETTING: Comprehensive 3-week CR. PARTICIPANTS: Patients (N=1586) ≤65 years of age (mean 53.8±7.3y, 77.1% men) in CR (May 2017-May 2018). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Feasibility, defined by data availability for ≥85% of patients (CR admission and discharge), and modifiability based on pre-post comparison (statistical significance, with P value<.01; standardized effect size≥.35; change by ≥5% points in categorical variables). In addition, latent factors were identified using an exploratory factor analysis (EFA). RESULTS: Based on feasibility and modifiability criteria, smoking behavior, lifestyle change behavior, blood pressure, endurance training load, depression in Patient Health Questionnaire-9 (PHQ-9), the 5-item World Health Organization Well-Being Index (WHO-5), physical and mental health and pain scale of the indicators of rehabilitation status-24 (IRES-24), and self-assessed health prognosis proved to be suitable performance measures. As a result of the EFA, 2 solid factors were identified: (1) subjective mental health including PHQ-9, WHO-5, mental health (IRES-24), mental quality of life, and anxiety and (2) physical health including physical quality of life, physical health and pain scale of IRES-24, and self-assessed occupational prognosis. A third factor represents the blood pressure. CONCLUSIONS: We provide a small set of performance measures, that are essentially based on 3 latent factors (subjective mental health, physical health, blood pressure). These performance measures can represent immediate success of comprehensive CR and be applied easily in clinical practice.

Patient-reported outcomes predict return to work and health-related quality of life six months after cardiac rehabilitation: Results from a German multi-centre registry (OutCaRe).

BACKGROUND: Multi-component cardiac rehabilitation (CR) is performed to achieve an improved prognosis, superior health-related quality of life (HRQL) and occupational resumption through the management of cardiovascular risk factors, as well as improvement of physical performance and patients' subjective health. Out of a multitude of variables gathered at CR admission and discharge, we aimed to identify predictors of returning to work (RTW) and HRQL 6 months after CR. DESIGN: Prospective observational multi-centre study, enrolment in CR between 05/2017 and 05/2018. METHOD: Besides general data (e.g. age, sex, diagnoses), parameters of risk factor management (e.g. smoking, hypertension), physical performance (e.g. maximum exercise capacity, endurance training load, 6-min walking distance) and patient-reported outcome measures (e.g. depression, anxiety, HRQL, subjective well-being, somatic and mental health, pain, lifestyle change motivation, general self-efficacy, pension desire and self-assessment of the occupational prognosis using several questionnaires) were documented at CR admission and discharge. These variables (at both measurement times and as changes during CR) were analysed using multiple linear regression models regarding their predictive value for RTW status and HRQL (SF-12) six months after CR. RESULTS: Out of 1262 patients (54±7 years, 77% men), 864 patients (69%) returned to work. Predictors of failed RTW were primarily the desire to receive pension (OR = 0.33, 95% CI: 0.22-0.50) and negative self-assessed occupational prognosis (OR = 0.34, 95% CI: 0.24-0.48) at CR discharge, acute coronary syndrome (OR = 0.64, 95% CI: 0.47-0.88) and comorbid heart failure (OR = 0.51, 95% CI: 0.30-0.87). High educational level, stress at work and physical and mental HRQL were associated with successful RTW. HRQL was determined predominantly by patient-reported outcome measures (e.g. pension desire, self-assessed health prognosis, anxiety, physical/mental HRQL/health, stress, well-being and self-efficacy) rather than by clinical parameters or physical performance. CONCLUSION: Patient-reported outcome measures predominantly influenced return to work and HRQL in patients with heart disease. Therefore, the multi-component CR approach focussing on psychosocial support is crucial for subjective health prognosis and occupational resumption. TRIAL REGISTRATION: The study was registered at the German Clinical Trial Registry and the International Clinical Trials Registry Platform (ICTRP) of the World Health Organization (DRKS00011418; http://www.drks.de/DRKS00011418, http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00011418).

The Efficacy of Goal Setting in Cardiac Rehabilitation-a Gender-Specific Randomized Controlled Trial.

BACKGROUND: Patients with coronary heart disease undergo cardiac rehabilitation in order to reduce their cardiovascular risk factors. Often, however, the benefit of rehabilitation is lost over time. It is unclear whether this happens in the same way to men and women. We studied whether the setting of gender-specific behavior goals with an agreement between the doctor and the patient at the end of rehabilitation can prolong its positive effects. METHODS: This study was performed with a mixed-method design. It consisted of qualitative interviews and group discussions with patients, doctors and other treating personnel, and researchers, as well as a quantitative, randomized, controlled intervention trial in which data were acquired at four time points (the beginning and end of rehabilitation and then 6 and 12 months later). 545 patients, 262 of them women (48.1%), were included. The patients were assigned to a goal checking group (n = 132), a goal setting group (n = 143), and a control group (n = 270). The primary endpoints were health-related behavior (exercise, diet, tobacco consumption), subjective state of health, and medication adherence. The secondary endpoints included physiological protection and risk factors such as blood pressure, cholesterol (HDL, LDL, and total), blood sugar, HbA1c, and body-mass index. RESULTS: The intervention had no demonstrable effect on the primary or secondary endpoints. The percentage of smokers declined to a similar extent in all groups from the beginning of rehabilitation to 12 months after its end (overall figures: 12.4% to 8.6%, p <0.05). The patients' exercise behavior, diet, and subjective state of health also improved over the entire course of the study. Women had a healthier diet than men. Subgroup analyses indicated a possible effect of the intervention on exercise behavior in women who were employed and in men who were not (p<0.01). CONCLUSION: The efficacy of goal setting was not demonstrated. Therefore, no indication for its routine provision can be derived from the study results.