Effect of urban environment on cardiovascular health: a feasibility pilot study using machine learning to predict heart rate variability in patients with heart failure.

Aims: Urbanization is related to non-communicable diseases such as congestive heart failure (CHF). Understanding the influence of diverse living environments on physiological variables such as heart rate variability (HRV) in patients with chronic cardiac disease may contribute to more effective lifestyle advice and telerehabilitation strategies. This study explores how machine learning (ML) models can predict HRV metrics, which measure autonomic nervous system responses to environmental attributes in uncontrolled real-world settings. The goal is to validate whether this approach can ascertain and quantify the connection between environmental attributes and cardiac autonomic response in patients with CHF. Methods and results: A total of 20 participants (10 healthy individuals and 10 patients with CHF) wore smartwatches for 3 weeks, recording activities, locations, and heart rate (HR). Environmental attributes were extracted from Google Street View images. Machine learning models were trained and tested on the data to predict HRV metrics. The models were evaluated using Spearman's correlation, root mean square error, prediction intervals, and Bland-Altman analysis. Machine learning models predicted HRV metrics related to vagal activity well (R > 0.8 for HR; 0.8 > R > 0.5 for the root mean square of successive interbeat interval differences and the Poincaré plot standard deviation perpendicular to the line of identity; 0.5 > R > 0.4 for the high frequency power and the ratio of the absolute low- and high frequency power induced by environmental attributes. However, they struggled with metrics related to overall autonomic activity, due to the complex balance between sympathetic and parasympathetic modulation. Conclusion: This study highlights the potential of ML-based models to discern vagal dynamics influenced by living environments in healthy individuals and patients diagnosed with CHF. Ultimately, this strategy could offer rehabilitation and tailored lifestyle advice, leading to improved prognosis and enhanced overall patient well-being in CHF.

Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee: Developed in collaboration with the European Heart Rhythm Association (EHRA), the Association of Cardiovascular Nursing & Allied Professions (ACNAP) of the ESC, the Heart Failure Association (HFA) of the ESC, the ESC Young Community, the ESC Working Group on e-Cardiology, the ESC Council for Cardiology Practice, the ESC Council of Cardio-Oncology, the ESC Council on Hypertension, the ESC Patient Forum, the ESC Digital Health Committee, and the European Association of Preventive Cardiology (EAPC).

Mobile health (mHealth) solutions have the potential to improve self-management and clinical care. For successful integration into routine clinical practice, healthcare professionals (HCPs) need accepted criteria helping the mHealth solutions' selection, while patients require transparency to trust their use. Information about their evidence, safety and security may be hard to obtain and consensus is lacking on the level of required evidence. The new Medical Device Regulation is more stringent than its predecessor, yet its scope does not span all intended uses and several difficulties remain. The European Society of Cardiology Regulatory Affairs Committee set up a Task Force to explore existing assessment frameworks and clinical and cost-effectiveness evidence. This knowledge was used to propose criteria with which HCPs could evaluate mHealth solutions spanning diagnostic support, therapeutics, remote follow-up and education, specifically for cardiac rhythm management, heart failure and preventive cardiology. While curated national libraries of health apps may be helpful, their requirements and rigour in initial and follow-up assessments may vary significantly. The recently developed CEN-ISO/TS 82304-2 health app quality assessment framework has the potential to address this issue and to become a widely used and efficient tool to help drive decision-making internationally. The Task Force would like to stress the importance of co-development of solutions with relevant stakeholders, and maintenance of health information in apps to ensure these remain evidence-based and consistent with best practice. Several general and domain-specific criteria are advised to assist HCPs in their assessment of clinical evidence to provide informed advice to patients about mHealth utilization.

Modifiable risk factors and motivation for lifestyle change of CVD patients starting cardiac rehabilitation: The BENEFIT study.

BACKGROUND: To improve lifestyle guidance within cardiac rehabilitation (CR), a comprehensive understanding of the motivation and lifestyle-supporting needs of patients with cardiovascular disease (CVD) is required. OBJECTIVES: This study's purpose is to evaluate patients' lifestyle and their motivation, self-efficacy and social support for change when starting CR. METHODS: 1782 CVD patients (69 % male, mean age 62 years) from 7 Dutch outpatient CR centers participated between 2020 and 2022. Modifiable risk factors were assessed with a survey and interviews by healthcare professionals during CR intake. RESULTS: Most patients exhibited an elevated risk in 3-4 domains. Elevated risks were most prominent in domains of (1) waist circumference and BMI (2) physical exercise (3) healthy foods intake and (4) sleep duration. Most patients chose to focus on increasing physical exercise, but about 20 % also wanted to focus on a healthy diet and/or decrease stress levels. Generally, motivation, self-efficacy and social support to reach new lifestyle goals were high. However, patients with an unfavorable risk profile had lower motivation and self-efficacy to work on lifestyle changes, while patients with lower social support had a higher chance to quit the program prematurely. CONCLUSIONS: Our results underscore the need to begin CR with a comprehensive lifestyle assessment and highlight the importance of offering lifestyle interventions tailored to patients' specific modifiable risk factors and lifestyle-supporting needs, targeting multiple lifestyle domains. Expanding the current scope of CR programs to address diverse patient needs and strengthening support may enhance motivation and adherence and lead to significant long-term benefits for cardiovascular health. CLINICAL TRIAL REGISTRATION NUMBER: Netherlands Trial Register; registration number NL8443.

Prevention and Rehabilitation After Heart Transplantation: A Clinical Consensus Statement of the European Association of Preventive Cardiology, Heart Failure Association of the ESC, and the European Cardio Thoracic Transplant Association, a Section of ESOT.

Little is known either about either physical activity patterns, or other lifestyle-related prevention measures in heart transplantation (HTx) recipients. The history of HTx started more than 50 years ago but there are still no guidelines or position papers highlighting the features of prevention and rehabilitation after HTx. The aims of this scientific statement are (i) to explain the importance of prevention and rehabilitation after HTx, and (ii) to promote the factors (modifiable/non-modifiable) that should be addressed after HTx to improve patients' physical capacity, quality of life and survival. All HTx team members have their role to play in the care of these patients and multidisciplinary prevention and rehabilitation programmes designed for transplant recipients. HTx recipients are clearly not healthy disease-free subjects yet they also significantly differ from heart failure patients or those who are supported with mechanical circulatory support. Therefore, prevention and rehabilitation after HTx both need to be specifically tailored to this patient population and be multidisciplinary in nature. Prevention and rehabilitation programmes should be initiated early after HTx and continued during the entire post-transplant journey. This clinical consensus statement focuses on the importance and the characteristics of prevention and rehabilitation designed for HTx recipients.

Prevention and rehabilitation after heart transplantation: A clinical consensus statement of the European Association of Preventive Cardiology, Heart Failure Association of the ESC, and the European Cardio Thoracic Transplant Association, a section of ESOT.

Little is known either about either physical activity patterns, or other lifestyle-related prevention measures in heart transplantation (HTx) recipients. The history of HTx started more than 50 years ago but there are still no guidelines or position papers highlighting the features of prevention and rehabilitation after HTx. The aims of this scientific statement are (i) to explain the importance of prevention and rehabilitation after HTx, and (ii) to promote the factors (modifiable/non-modifiable) that should be addressed after HTx to improve patients' physical capacity, quality of life and survival. All HTx team members have their role to play in the care of these patients and multidisciplinary prevention and rehabilitation programmes designed for transplant recipients. HTx recipients are clearly not healthy disease-free subjects yet they also significantly differ from heart failure patients or those who are supported with mechanical circulatory support. Therefore, prevention and rehabilitation after HTx both need to be specifically tailored to this patient population and be multidisciplinary in nature. Prevention and rehabilitation programmes should be initiated early after HTx and continued during the entire post-transplant journey. This clinical consensus statement focuses on the importance and the characteristics of prevention and rehabilitation designed for HTx recipients.

Prevention and rehabilitation after heart transplantation: A clinical consensus statement of the European Association of Preventive Cardiology, Heart Failure Association of the ESC, and the European Cardio Thoracic Transplant Association, a section of ESOT.

Little is known either about either physical activity patterns, or other lifestyle-related prevention measures in heart transplantation (HTx) recipients. The history of HTx started more than 50 years ago but there are still no guidelines or position papers highlighting the features of prevention and rehabilitation after HTx. The aims of this scientific statement are (i) to explain the importance of prevention and rehabilitation after HTx, and (ii) to promote the factors (modifiable/non-modifiable) that should be addressed after HTx to improve patients' physical capacity, quality of life and survival. All HTx team members have their role to play in the care of these patients and multidisciplinary prevention and rehabilitation programmes designed for transplant recipients. HTx recipients are clearly not healthy disease-free subjects yet they also significantly differ from heart failure patients or those who are supported with mechanical circulatory support. Therefore, prevention and rehabilitation after HTx both need to be specifically tailored to this patient population and be multidisciplinary in nature. Prevention and rehabilitation programmes should be initiated early after HTx and continued during the entire post-transplant journey. This clinical consensus.

Cardiac telerehabilitation: current status and future perspectives.

Multidisciplinary cardiac rehabilitation (CR) improves the prognosis and quality of life of patients with cardiovascular disease and has therefore received strong recommendations in international guidelines for the treatment of patients with chronic coronary syndromes and chronic heart failure. Aiming to both resolve several barriers that impede participation in CR and to improve the effectiveness of CR, cardiac telerehabilitation (CTR) has emerged as a cost-effective alternative to traditional, centre-based CR. Although the body of evidence for the feasibility and effectiveness of CTR is large and still growing, real-life implementations are scarce, which may be due to insufficient knowledge about CTR interventions and due to the challenges its implementation comes with. Up to now, mainly exercise-related core components of CR and e­coaching have been investigated in the setting of CTR. Translation of research findings to clinical practice may be hampered by methodological limitations present in most CTR studies, being selection bias of participants, lack of long-term follow-up, heterogeneity of studied interventions and the lack of robust outcome measures. Besides conducting highly needed implementation studies for CTR interventions, their implementation could be facilitated by the development of guideline-based, multidisciplinary and personalised CTR programmes and widespread reimbursement for CTR.

Evaluation of an application for the self-assessment of lifestyle behaviour in cardiac patients.

BACKGROUND: Currently, no uniform, well-validated and comprehensive lifestyle behaviour self-assessment instrument exists for patients with cardiovascular disease. PURPOSE: To evaluate the usability of a novel mobile application (LifeStyleScore) based on validated instruments for the assessment of cardiovascular risk behaviours. Secondly, the application's acceptance by healthcare professionals (HCPs) and its association with improved patient activation and lifestyle behaviour was evaluated. METHODS: In this single-centre, non-randomised observational pilot study, patients with coronary artery disease or atrial fibrillation entering cardiac rehabilitation (CR) completed the LifeStyleScore application, the Patient Activation Measure (PAM-13®), and the System Usability Scale (SUS) during the CR intake and after CR completion. A focus group interview was performed with the HCPs involved. RESULTS: We analysed 20 participants, 3 of whom were women, with a mean age of 61.9 ± 6.7 years. The LifeStyleScore application was rated with a SUS score above average (> 68) before (69.6 ± 13.4) and after CR (68.6 ± 15.1). All HCPs (n = 8) found the application usable. Patient activation did not increase significantly after CR compared with baseline (62.0 ± 8.6 versus 59.2 ± 9.5, respectively, p = 0.28) and only physical activity levels improved significantly (2.4 ± 0.7 (standardised score) at baseline, 2.8 ± 0.4 after CR, p = 0.04). CONCLUSION: The LifeStyleScore application was found to be usable for patients receiving CR. Its use did not result in increased patient activation, and of the lifestyle behaviours only physical activity levels improved. Further research is needed to evaluate how such applications can be optimally incorporated in CR programmes.

Exercise-based cardiac rehabilitation in stable angina pectoris: a narrative review on current evidence and underlying physiological mechanisms.

Stable angina pectoris (SAP) is a prevalent condition characterised by a high disease burden. Based on recent evidence, the need for revascularisation in addition to optimal medical treatment to reduce mortality and re-events is heavily debated. These observations may be explained by the fact that revascularisation is targeted at the local flow-limiting coronary artery lesion, while the aetiology of SAP relates to the systemic, inflammatory process of atherosclerosis, causing generalised vascular dysfunction throughout the entire vascular system. Moreover, cardiovascular events are not solely caused by obstructive plaques but are also associated with plaque burden and high-risk plaque features. Therefore, to reduce the risk of cardiovascular events and angina, and thereby improve quality of life, alternative therapeutic approaches to revascularisation should be considered, preferably targeting the cardiovascular system as a whole with a physiological approach. Exercise-based cardiac rehabilitation fits this description and is a promising strategy as a first-line treatment in addition to optimal medical treatment. In this review, we discuss the role of exercise-based cardiac rehabilitation in SAP in relation to the underlying physiological mechanisms, we summarise the existing evidence and highlight future directions.

Less stick more carrot? Increasing the uptake of deposit contract financial incentives for physical activity: A randomized controlled trial.

BACKGROUND: Financial incentives are a promising tool to help people increase their physical activity, but they are expensive to provide. Deposit contracts are a type of financial incentive in which participants pledge their own money. However, low uptake is a crucial obstacle to the large-scale implementation of deposit contracts. Therefore, we investigated whether (1) matching the deposit 1:1 (doubling what is deposited) and (2) allowing for customizable deposit amounts increased the uptake and short term effectiveness of a deposit contract for physical activity. METHODS: In this randomized controlled trial, 137 healthy students (age M = 21.6 years) downloaded a smartphone app that provided them with a tailored step goal and then randomized them to one of four experimental conditions. The deposit contract required either a €10 fixed deposit or a customizable deposit with any amount between €1 and €20 upfront. Furthermore, the deposit was either not matched or 1:1 matched (doubled) with a reward provided by the experiment. During 20 intervention days, daily feedback on goal progress and incentive earnings was provided by the app. We investigated effects on the uptake (measured as agreeing to participate and paying the deposit) and effectiveness of behavioral adoption (measured as participant days goal achieved). FINDINGS: Overall, the uptake of deposit contracts was 83.2%, and participants (n = 113) achieved 14.9 out of 20 daily step goals. A binary logistic regression showed that uptake odds were 4.08 times higher when a deposit was matched (p = .010) compared to when it was not matched. Furthermore, uptake odds were 3.53 times higher when a deposit was customizable (p = .022) compared to when it was fixed. Two-way ANCOVA showed that matching (p = .752) and customization (p = .143) did not impact intervention effectiveness. However, we did find a marginally significant interaction effect of deposit matching X deposit customization (p = .063, ηp2 = 0.032). Customization decreased effectiveness when deposits were not matched (p = .033, ηp2 = 0.089), but had no effect when deposits were matched (p = .776, ηp2 = 0.001). CONCLUSIONS: We provide the first experimental evidence that both matching and customization increase the uptake of a deposit contract for physical activity. We recommend considering both matching and customization to overcome lack of uptake, with a preference for customization since matching a deposit imposes significant additional costs. However, since we found indications that customizable deposits might reduce effectiveness (when the deposits are not matched), we urge for more research on the effectiveness of customizable deposit contracts. Finally, future research should investigate which participant characteristics are predictive of deposit contract uptake and effectiveness. PRE-REGISTRATION: OSF Registries, https://osf.io/cgq48.

The Utility of a Novel Electrocardiogram Patch Using Dry Electrodes Technology for Arrhythmia Detection During Exercise and Prolonged Monitoring: Proof-of-Concept Study.

BACKGROUND: Accurate detection of myocardial ischemia and arrhythmias during free-living exercise could play a pivotal role in screening and monitoring for the prevention of exercise-related cardiovascular events in high-risk populations. Although remote electrocardiogram (ECG) solutions are emerging rapidly, existing technology is neither designed nor validated for continuous use during vigorous exercise. OBJECTIVE: In this proof-of-concept study, we evaluated the usability, signal quality, and accuracy for arrhythmia detection of a single-lead ECG patch platform featuring self-adhesive dry electrode technology in individuals with chronic coronary syndrome. This sensor was evaluated during exercise and for prolonged, continuous monitoring. METHODS: We recruited a total of 6 consecutive patients with chronic coronary syndrome scheduled for an exercise stress test (EST) as part of routine cardiac follow-up. Traditional 12-lead ECG recording was combined with monitoring with the ECG patch. Following the EST, the participants continuously wore the sensor for 5 days. Intraclass correlation coefficients (ICC) and Wilcoxon signed rank tests were used to assess the utility of detecting arrhythmias with the patch by comparing the evaluations of 2 blinded assessors. Signal quality during EST and prolonged monitoring was evaluated by using a signal quality indicator. Additionally, connection time was calculated for prolonged ECG monitoring. The comfort and usability of the patch were evaluated by a web-based self-assessment questionnaire. RESULTS: A total of 6 male patients with chronic coronary syndrome (mean age 69.8, SD 6.2 years) completed the study protocol. The patch was worn for a mean of 118.3 (SD 5.6) hours. The level of agreement between the patch and 12-lead ECG was excellent for the detection of premature atrial contractions and premature ventricular contractions during the whole test (ICC=0.998, ICC=1.000). No significant differences in the total number of premature atrial contractions and premature ventricular contractions were detected neither during the entire exercise test (P=.79 and P=.18, respectively) nor during the exercise and recovery stages separately (P=.41, P=.66, P=.18, and P=.66). A total of 1 episode of atrial fibrillation was detected by both methods. Total connection time during recording was between 88% and 100% for all participants. There were no reports of skin irritation, erythema, or pain while wearing the patch. CONCLUSIONS: This proof-of-concept study showed that this innovative ECG patch based on self-adhesive dry electrode technology can potentially be used for arrhythmia detection during vigorous exercise. The results suggest that the wearable patch is also usable for prolonged continuous ECG monitoring in free-living conditions and can therefore be of potential use in cardiac rehabilitation and tele-monitoring for the prevention of exercise-related cardiovascular events. Future efforts will focus on optimizing signal quality over time and conducting a larger-scale validation study focusing on both arrhythmia and ischemia detection.

The kinocardiograph for assessment of fluid status in patients with acute decompensated heart failure.

AIMS: To improve telemonitoring strategies in heart failure patients, there is a need for novel non-obtrusive sensors that monitor parameters closely related to intracardiac filling pressures. This proof-of-concept study aims to evaluate the responsiveness of cardiac kinetic energy (KE) measured with the Kinocardiograph (KCG), consisting of a seismocardiographic (SCG) sensor and a ballistocardiographic (BCG) sensor, during treatment of patients with acute decompensated heart failure. METHODS AND RESULTS: Eleven patients with acute decompensated heart failure who were hospitalized for treatment with intravenous diuretics received daily KCG measurements. The KCG measurements were compared with the diameter of the inferior vena cava (IVC) and body weight. Follow-up stopped at discharge, that is, in the recompensated state. Median (interquartile range) weight and IVC diameter decreased significantly after diuretic treatment [weight 74.5 (67.6-98.7) to 73.3 (66.7-95.6) kg, P = 0.003; IVC diameter 2.47 (2.33-2.99) to 1.78 (1.65-2.47) cm, P = 0.03]. In contrast with BCG measurements, significant changes in median KE measured with SCG were observed during the passive filling phase of the diastole [SGG: 0.48 (0.39-0.60) to 0.69 (0.56-0.84), P = 0.026; BCG: 0.68 (0.46-0.73) to 0.68 (0.59-0.82), P = 0.062], the active filling phase of the diastole [SCG: 0.38 (0.30-0.61) to 0.31 (0.09-0.47), P = 0.016; BCG: 0.29 (0.17-0.39) to 0.26 (0.20-0.34), P = 0.248], and the ratio between the passive and active filling phases [SCG: 2.76 (1.68-5.30) to 5.02 (3.13-10.17), P = 0.006; BCG: 5.87 (3.57-7.55) to 5.27 (3.95-9.43), P = 0.790]. The correlations between changes in KE during the passive and active filling phases, using SCG, and changes in weight or IVC were non-significant. Systolic KE did not show significant changes. CONCLUSION: KE measured with the KCG using SCG is highly responsive to changes in fluid status. Future research is needed to confirm its accuracy in a larger study population and specifically its application for detection of clinical deterioration in the home-environment.

Telerehabilitation in patients with recent hospitalisation due to acute decompensated heart failure: protocol for the Tele-ADHF randomised controlled trial.

BACKGROUND: Cardiac rehabilitation in patients with chronic heart failure (CHF) has favourable effects on exercise capacity, the risk at hospital (re-)admission and quality of life. Although cardiac rehabilitation is generally recommended it is still under-utilised in daily clinical practice, particularly in frail elderly patients after hospital admission, mainly due to low referral and patient-related barriers. Cardiac telerehabilitation (CTR) has the potential to partially solve these barriers. The purpose of this study is to evaluate the effects of CTR as compared to standard remote care after hospital admission on physical functional capacity in CHF patients. METHODS: In this randomised controlled trial, 64 CHF patients will be recruited during hospitalisation for acute decompensated heart failure, and randomised to CTR combined with remote patient management (RPM) or RPM alone (1:1). All participants will start with RPM after hospital discharge for early detection of deterioration, and will be up titrated to optimal medical therapy before being randomised. CTR will start after randomisation and consists of an 18-week multidisciplinary programme with exercise training by physical and occupational therapists, supported by a (remote) technology-assisted dietary intervention and mental health guiding by a physiologist. The training programme consists of three centre-based and two home-based video exercise training sessions followed by weekly video coaching. The mental health and dietary programme are executed using individual and group video sessions. A wrist-worn device enables remote coaching by the physical therapist. The web application is used for promoting self-management by the following modules: 1) goal setting, 2) progress tracking, 3) education, and 4) video and chat communication. The primary outcome measure is physical functional capacity evaluated by the Short Physical Performance Battery (SPPB) score. Secondary outcome measures include frailty scoring, recovery after submaximal exercise, subjective health status, compliance and acceptance to the rehabilitation programme, and readmission rate. DISCUSSION: The Tele-ADHF trial is the first prospective randomised controlled trial designed for evaluating the effects of a comprehensive combined RPM and CTR programme in recently hospitalised CHF patients. We hypothesize that this intervention has superior effects on physical functional capacity than RPM alone. TRIAL REGISTRATION: Netherlands Trial Registry (NTR) NL9619, registered 21 July 2021.

Corrigendum to 'Put your money where your feet are: The real-world effects of StepBet gamified deposit contracts for physical activity' [Internet Interv., volume 31, March 2023, 100610].

[This corrects the article DOI: 10.1016/j.invent.2023.100610.].

Effects of a Dedicated Cardiac Rehabilitation Program for Patients With Obesity on Body Weight, Physical Activity, Sedentary Behavior, and Physical Fitness: The OPTICARE XL Randomized Controlled Trial.

OBJECTIVE: Previously published results of the OPTICARE XL open label randomized controlled trial showed no added value of OPTICARE XL CR, a dedicated cardiac rehabilitation (CR) program for patients with obesity, with respect to health-related quality of life (primary outcome). This clinical trial studied the effects of OPTICARE XL CR on several secondary outcomes, which included body weight, physical activity, sedentary behavior, and physical fitness. METHODS: Patients with coronary artery disease or atrial fibrillation and body mass index ≥ 30 were randomized to OPTICARE XL CR (n = 102) or standard CR (n = 99). OPTICARE XL CR was a 1-year group intervention, specifically designed for patients with obesity that included aerobic and strength exercise, behavioral coaching, and an aftercare program. Standard CR consisted of a 6- to 12-week group aerobic exercise program, supplemented with cardiovascular lifestyle education. Study end points included body weight, physical activity, sedentary behavior (accelerometer), and physical fitness (6-Minute Walk Test and handgrip strength), which were evaluated 6 months after the end of CR (primary endpoint) and 3 months after the start of CR. RESULTS: Six months after completion of either program, improvements in body weight, physical activity, sedentary behavior, and physical fitness were similar between the groups. Three months after CR start, patients randomized to OPTICARE XL CR showed greater weight loss (mean change = -3.6 vs -1.8 kg) and a larger improvement in physical activity (+880 vs +481 steps per day) than patients randomized to standard CR. CONCLUSION: Patients allocated to OPTICARE XL CR lost significantly more body weight and showed promising results with respect to physical activity 3 months after the start of CR; however, these short-term results were not expanded or sustained in the longer term. IMPACT: Patients with obesity do not benefit from standard CR programs. The new OPTICARE XL CR program showed its effects in the short term on weight loss and physical activity, and, therefore, redesign of the aftercare phase is recommended.

Impact of a comprehensive cardiac rehabilitation programme versus coronary revascularisation in patients with stable angina pectoris: study protocol for the PRO-FIT randomised controlled trial.

BACKGROUND: Currently, in the majority of patients with stable angina pectoris (SAP) treatment consists of optimal medical treatment, potentially followed by coronary angiography and subsequent coronary revascularisation if necessary". Recent work questioned the effectiveness of these invasive procedures in reducing re-events and improving prognosis. The potential of exercise-based cardiac rehabilitation on clinical outcomes in patients with coronary artery disease is well-known. However, in the modern era, no studies compared the effects of cardiac rehabilitation versus coronary revascularisation in patients with SAP. METHODS: In this multicentre randomised controlled trial, 216 patients with stable angina pectoris and residual anginal complaints under optimal medical treatment will be randomised to: 1) usual care (i.e., coronary revascularisation), or 2) a 12-month cardiac rehabilitation (CR) programme. CR consists of a multidisciplinary intervention, including education, exercise training, lifestyle coaching and a dietary intervention with a stepped decline in supervision. The primary outcome will be anginal complaints (Seattle Angina Questionnaire-7) following the 12-month intervention. Secondary outcomes include cost-effectiveness, ischemic threshold during exercise, cardiovascular events, exercise capacity, quality of life and psychosocial wellbeing. DISCUSSION: In this study, we will examine the hypothesis that multidisciplinary CR is at least equally effective in reducing anginal complaints as the contemporary invasive approach at 12-months follow-up for patients with SAP. If proven successful, this study will have significant impact on the treatment of patients with SAP as multidisciplinary CR is a less invasive and potentially less costly and better sustainable treatment than coronary revascularisations. TRIAL REGISTRATION: Netherlands Trial Register, NL9537. Registered 14 June 2021.

The prognostic value of quality of life in atrial fibrillation on patient value.

BACKGROUND: In this study, the prognostic value of AF-related quality of life (AFEQT) at baseline on Major Adverse Cardiovascular Events (MACE) and improvement of perceived symptoms (EHRA) was assessed. Furthermore, the relationship between QoL and AF-related hospitalizations was assessed. METHODS: A cohort of AF-patients diagnosed between November 2014 and October 2019 in four hospitals embedded within the Netherlands Heart Network were prospectively followed for 12 months. MACE was defined as stroke, myocardial infarction, heart failure and/or mortality. Subsequently, MACE, EHRA score improvement and AF-related hospitalizations between baseline and 12 months of follow-up were recorded. RESULTS: In total, 970 AF-patients were available for analysis. In analyses with patients with complete information on the confounder subset 36/687 (5.2%) AF-patients developed MACE, 190/432 (44.0%) improved in EHRA score and 189/510(37.1%) were hospitalized during 12 months of follow-up. Patients with a low AFEQT score at baseline more often developed MACE (OR(95%CI): 2.42(1.16-5.06)), more often improved in EHRA score (OR(95%CI): 4.55(2.45-8.44) and were more often hospitalized (OR(95%CI): 4.04(2.22-7.01)) during 12 months post diagnosis, compared to patients with a high AFEQT score at baseline. CONCLUSIONS: AF-patients with a lower quality of life at diagnosis more often develop MACE, more often improve on their symptoms and also were more often hospitalized, compared to AF-patients with a higher quality of life. This study highlights that the integration of patient-reported outcomes, such as quality of life, has the potential to be used as a prognostic indicator of the expected disease course for AF.