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- Cardiac rehabilitation (8)
- Return to work (3)
- TAVI (3)
- Acute coronary syndrome (2)
- Frailty (2)
- Mortality (2)
- Randomized controlled trial (2)
- cardiac rehabilitation (2)
- genetics (2)
- hypertension (2)
Introduction: Remote telemonitoring (RTM) for patients with chronic heart failure (HF) holds promise to improve prognosis and well-being beyond the standard of care (SoC). The CardioBBEAT trial assessed the health economic and clinical impact of an interactive bidirectional RTM system (Motiva(R)) versus SoC for patients with HF and a reduced ejection fraction (HFrEF), in Germany.Methods: This multicenter, randomized controlled trial enrolled 621 patients with HFrEF (mean age 63.0 +/- 11.5 years, 88% men). The primary endpoint was the integrated effect of the intervention on total costs and nonhospitalized days alive after 12 months, reported as incremental cost-effectiveness ratio (ICER). Costs (in keuro) were based on actual charges of patients' statutory health insurance. Among secondary outcome measures were mortality and disease-specific quality of life.Results: We found a neutral effect on nonhospitalized days alive (RTM mean 341 +/- 59 days, SoC 346 +/- 45 days; p = 0.298) associated with increased total costs (RTM 18.5 +/- 39.5 keuro, SoC 12.8 +/- 22.0 keuro; p = 0.046). This yielded an ICER of -1.15 keuro/day. RTM did not impact mortality risk. All quality of life scales were consistently and meaningfully improved in the RTM group at 12 months compared to SoC (all p < 0.01).Conclusions: The first 12 months of RTM were not cost-effective compared to SoC in patients with HFrEF, but associated with a relevant improvement in disease-specific quality of life. The balanced assessment of the potential benefit of RTM requires integration of both the societal and patient perspective.ClinTrials.gov (NCT02293252).
Multicomponent cardiac rehabilitation in patients after transcatheter aortic valve implantation
(2017)
Background: In the last decade, transcatheter aortic valve implantation has become a promising treatment modality for patients with aortic stenosis and a high surgical risk. Little is known about influencing factors of function and quality of life during multicomponent cardiac rehabilitation. Methods: From October 2013 to July 2015, patients with elective transcatheter aortic valve implantation and a subsequent inpatient cardiac rehabilitation were enrolled in the prospective cohort multicentre study. Frailty-Index (including cognition, nutrition, autonomy and mobility), Short Form-12 (SF-12), six-minute walk distance (6MWD) and maximum work load in bicycle ergometry were performed at admission and discharge of cardiac rehabilitation. The relation between patient characteristics and improvements in 6MWD, maximum work load or SF-12 scales were studied univariately and multivariately using regression models. Results: One hundred and thirty-six patients (80.6 +/- 5.0 years, 47.8% male) were enrolled. 6MWD and maximum work load increased by 56.3 +/- 65.3 m (p < 0.001) and 8.0 +/- 14.9 watts (p < 0.001), respectively. An improvement in SF-12 (physical 2.5 +/- 8.7, p = 0.001, mental 3.4 +/- 10.2, p = 0.003) could be observed. In multivariate analysis, age and higher education were significantly associated with a reduced 6MWD, whereas cognition and obesity showed a positive predictive value. Higher cognition, nutrition and autonomy positively influenced the physical scale of SF-12. Additionally, the baseline values of SF-12 had an inverse impact on the change during cardiac rehabilitation. Conclusions: Cardiac rehabilitation can improve functional capacity as well as quality of life and reduce frailty in patients after transcatheter aortic valve implantation. An individually tailored therapy with special consideration of cognition and nutrition is needed to maintain autonomy and empower octogenarians in coping with challenges of everyday life.
The aim of the study was to determine pre-interventional predictors for all-cause mortality in patients after transcatheter aortic valve implantation (TAVI) with a 12-month follow-up. From 10/2013 to 07/2015, 344 patients (80.9 +/- 5.0 years, 44.5% male) with an elective TAVI were consecutively enrolled prospectively in a multicentre cohort study. Prior to the intervention, sociodemographic parameters, echocardiographic data and comorbidities were documented. All patients performed a 6-min walk test, Short Form 12 and a Frailty Index (score consisting of activities of daily living, cognition, nutrition and mobility). Peri-interventional complications were documented. Vital status was assessed over telephone 12 months after TAVI. Predictors for all-cause mortality were identified using a multivariate regression model. At discharge, 333 patients were alive (in-hospital mortality 3.2%; n = 11). During a follow-up of 381.0 +/- 41.9 days, 46 patients (13.8%) died. The non-survivors were older (82.3 +/- 5.0 vs. 80.6 +/- 5.1 years; p = 0.035), had a higher number of comorbidities (2.6 +/- 1.3 vs. 2.1 +/- 1.3; p = 0.026) and a lower left ventricular ejection fraction (51.0 +/- 13.6 vs. 54.6 +/- 10.6%; p = 0.048). Additionally, more suffered from diabetes mellitus (60.9 vs. 44.6%; p = 0.040). While the global Frailty Index had no predictive power, its individual components, particularly nutrition (OR 0.83 per 1 pt., CI 0.72-0.95; p = 0.006) and mobility (OR 5.12, CI 1.64-16.01; p = 0.005) had a prognostic impact. Likewise, diabetes mellitus (OR 2.18, CI 1.10-4.32; p = 0.026) and EuroSCORE (OR 1.21 per 5%, CI 1.07-1.36; p = 0.002) were associated with a higher risk of all-cause mortality. Besides EuroSCORE and diabetes mellitus, nutrition status and mobility of patients scheduled for TAVI offer prognostic information for 1-year all-cause mortality and should be advocated in the creation of contemporary TAVI risk scores.
Background Heart failure (HF) is a complex, chronic condition that is associated with debilitating symptoms, all of which necessitate close follow-up by health care providers. Lack of disease monitoring may result in increased mortality and more frequent hospital readmissions for decompensated HF. Remote patient management (RPM) in this patient population may help to detect early signs and symptoms of cardiac decompensation, thus enabling a prompt initiation of the appropriate treatment and care before a manifestation of HF decompensation. Objective The objective of the present article is to describe the design of a new trial investigating the impact of RPM on unplanned cardiovascular hospitalisations and mortality in HF patients. Methods The TIM-HF2 trial is designed as a prospective, randomised, controlled, parallel group, open (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection. Eligible patients with HF are randomised (1:1) to either RPM + usual care or to usual care only and are followed for 12 months. The primary outcome is the percentage of days lost due to unplanned cardiovascular hospitalisations or all-cause death. The main secondary outcomes are all-cause and cardiovascular mortality. Conclusion The TIM-HF2 trial will provide important prospective data on the potential beneficial effect of telemedical monitoring and RPM on unplanned cardiovascular hospitalisations and mortality in HF patients.
Background
Although associations between cardiovascular diseases and cognitive impairment are well known, the impact of cognitive performance on the success of patient education as a core component of cardiac rehabilitation remains insufficiently investigated so far.
Design
Prospective observational study in two inpatient cardiac rehabilitation centres between September 2014 and August 2015 with a follow-up six months after cardiac rehabilitation.
Method
At admission to and discharge from cardiac rehabilitation, the cognitive performance of 401 patients (54.5 ± 6.3 years, 80% men) following an acute coronary syndrome and/or coronary artery bypass graft was tested using the Montreal Cognitive Assessment. Patients’ disease-related knowledge was determined using a quiz (22 items for medical knowledge and 12 items for healthy lifestyle and behaviour) at both times and at follow-up. The change in knowledge after cardiac rehabilitation was analysed in multivariable regression models. Potentially influencing parameters (e.g. level of education, medication, cardiovascular risk factors, coronary artery bypass graft, comorbidities, exercise capacity) were considered.
Results
During cardiac rehabilitation, disease-related knowledge was significantly enhanced in both scales. At follow-up, the average level of medical knowledge was significantly reduced, while lifestyle knowledge remained at a stable level. The maintenance of knowledge after cardiac rehabilitation was predominantly predicted by prior knowledge, cognitive performance at discharge from cardiac rehabilitation and, in the case of medical knowledge, by coronary artery bypass graft.
Conclusion
Patient education in cardiac rehabilitation led to enhanced disease-related knowledge, but the maintenance of this essentially depended on patients’ cognitive performance, especially after coronary artery bypass graft. Therefore, patient education concepts in cardiac rehabilitation should be reconsidered and adjusted as needed.
Objectives To examine the effectiveness of extensive social therapy intervention during inpatient multi-component cardiac rehabilitation (CR) on return to work and quality of life in patients with low probability of work resumption after an acute cardiac event. Methods Patients after acute cardiac event with negative subjective expectations about return to work or unemployment (n = 354) were included and randomized in clusters of 3-6 study participants. Clusters were randomized for social counseling and therapy led by a social worker, six sessions of 60 min each in 3 weeks, or control group (usual care: individual counseling meeting by request). The return to work (RTW) status and change in quality of life (QoL, short form 12: Physical and Mental Component Summary PCS and MCS) 12 months after discharge from inpatient CR were outcome measures. Results The regression model for RTW showed no impact of the intervention (OR 1.1, 95% CI 0.6-2.1, P = 0.79; n = 263). Predictors were unemployment prior to CR as well as higher anxiety values at discharge from CR. Likewise, QoL was not improved by social therapy (linear mixed model: Delta PCS 0.3, 95% CI - 1.9 to 2.5; P = 0.77; n = 177; Delta MCS 0.7, 95% CI - 1.9 to 3.3; P = 0.58; n = 215). Conclusions In comparison to usual care, an intensive program of social support for patients during inpatient cardiac rehabilitation after an acute cardiac event had no additional impact on either the rate of resuming work or quality of life.
Objectives: To explore predictors of return to work in patients after acute coronary syndrome and coronary artery bypass grafting, taking into account cognitive performance, depression, physical capacity, and self-assessment of the occupational prognosis. Design: Observational, prospective, bicentric. Setting: Postacute 3-week inpatient cardiac rehabilitation (CR). Participants: Patients (N=401) <65 years of age (mean 54.5 +/- 6.3y), 80% men. Interventions: Not applicable. Main Outcome Measures: Status of return to work (RTW) 6 months after discharge from CR. Results: The regression model for RTW showed negative associations for depression (odds ratio 0.52 per SD, 95% confidence interval 0.36-0.76, P=.001), age (odds ratio 0.72, 95% confidence interval 0.52-1.00, P=.047), and in particular for a negative subjective occupational prognosis (expected incapacity for work odds ratio 0.19, 95% confidence interval 0.06-0.59, P=.004; unemployment odds ratio 0.08, 95% confidence interval 0.01-0.72, P=.024; retirement odds ratio 0.07, 95% confidence interval 0.01-0.067, P=.021). Positive predictors were employment before the cardiac event (odds ratio 9.66, 95% confidence interval 3.10-30.12, P<.001), capacity to work (fit vs unfit) at discharge from CR (odds ratio 3.15, 95% confidence interval 1.35-7.35, P=.008), and maximum exercise capacity (odds ratio 1.49, 95% confidence interval 1.06-2.11, P=.022). Cognitive performance had no effect.
Background
Aim of the study was to find predictors of allocating patients after transcatheter aortic valve implantation (TAVI) to geriatric (GR) or cardiac rehabilitation (CR) and describe this new patient group based on a differentiated characterization.
Methods
From 10/2013 to 07/2015, 344 patients with an elective TAVI were consecutively enrolled in this prospective multicentric cohort study. Before intervention, sociodemographic parameters, echocardiographic data, comorbidities, 6-min walk distance (6MWD), quality of life and frailty (score indexing activities of daily living [ADL], cognition, nutrition and mobility) were documented. Out of these, predictors for assignment to CR or GR after TAVI were identified using a multivariable regression model.
Results
After TAVI, 249 patients (80.7 ± 5.1 years, 59.0% female) underwent CR (n = 198) or GR (n = 51). GR patients were older, less physically active and more often had a level of care, peripheral artery disease as well as a lower left ventricular ejection fraction. The groups also varied in 6MWD. Furthermore, individual components of frailty revealed prognostic impact: higher values in instrumental ADL reduced the probability for referral to GR (OR:0.49, p < 0.001), while an impaired mobility was positively associated with referral to GR (OR:3.97, p = 0.046). Clinical parameters like stroke (OR:0.19 of GR, p = 0.038) and the EuroSCORE (OR:1.04 of GR, p = 0.026) were also predictive.
Conclusion
Advanced age patients after TAVI referred to CR or GR differ in several parameters and seem to be different patient groups with specific needs, e.g. regarding activities of daily living and mobility. Thus, our data prove the eligibility of both CR and GR settings.
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.
Background: Total hip or knee replacement is one of the most frequently performed surgical procedures. Physical rehabilitation following total hip or knee replacement is an essential part of the therapy to improve functional outcomes and quality of life. After discharge from inpatient rehabilitation, a subsequent postoperative exercise therapy is needed to maintain functional mobility. Telerehabilitation may be a potential innovative treatment approach. We aim to investigate the superiority of an interactive telerehabilitation intervention for patients after total hip or knee replacement, in comparison to usual care, regarding physical performance, functional mobility, quality of life and pain. Methods/design: This is an open, randomized controlled, multicenter superiority study with two prospective arms. One hundred and ten eligible and consenting participants with total knee or hip replacement will be recruited at admission to subsequent inpatient rehabilitation. After comprehensive, 3-week, inpatient rehabilitation, the intervention group performs a 3-month, interactive, home-based exercise training with a telerehabilitation system. For this purpose, the physiotherapist creates an individual training plan out of 38 different strength and balance exercises which were implemented in the system. Data about the quality and frequency of training are transmitted to the physiotherapist for further adjustment. Communication between patient and physiotherapist is possible with the system. The control group receives voluntary, usual aftercare programs. Baseline assessments are investigated after discharge from rehabilitation; final assessments 3 months later. The primary outcome is the difference in improvement between intervention and control group in 6-minute walk distance after 3 months. Secondary outcomes include differences in the Timed Up and Go Test, the Five-Times-Sit-to-Stand Test, the Stair Ascend Test, the Short-Form 36, the Western Ontario and McMaster Universities Osteoarthritis Index, the International Physical Activity Questionnaire, and postural control as well as gait and kinematic parameters of the lower limbs. Baseline-adjusted analysis of covariance models will be used to test for group differences in the primary and secondary endpoints. Discussion: We expect the intervention group to benefit from the interactive, home-based exercise training in many respects represented by the study endpoints. If successful, this approach could be used to enhance the access to aftercare programs, especially in structurally weak areas.