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Background: Evidence that home telemonitoring for patients with chronic heart failure (CHF) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage.
Methods: Between January 2010 and June 2013, patients with a confirmed diagnosis of CHF were enrolled and randomly assigned to 2 study groups comprising usual care with and without an interactive bi-directional remote monitoring system (Motiva (R)). The primary endpoint in CardioBBEAT is the Incremental Cost-Effectiveness Ratio (ICER) established by the groups' difference in total cost and in the combined clinical endpoint "days alive and not in hospital nor inpatient care per potential days in study" within the follow-up of 12 months.
Results: A total of 621 predominantly male patients were enrolled, whereof 302 patients were assigned to the intervention group and 319 to the control group. Ischemic cardiomyopathy was the leading cause of heart failure. Despite randomization, subjects of the control group were more often in NYHA functional class III-IV, and exhibited peripheral edema and renal dysfunction more often. Additionally, the control and intervention groups differed in heart rhythm disorders. No differences existed regarding risk factor profile, comorbidities, echocardiographic parameters, especially left ventricular and diastolic diameter and ejection fraction, as well as functional test results, medication and quality of life. While the observed baseline differences may well be a play of chance, they are of clinical relevance. Therefore, the statistical analysis plan was extended to include adjusted analyses with respect to the baseline imbalances.
Conclusions: CardioBBEAT provides prospective outcome data on both, clinical and health economic impact of home telemonitoring in CHF. The study differs by the use of a high evidence level randomized controlled trial (RCT) design along with actual cost data obtained from health insurance companies. Its results are conducive to informed political and economic decision-making with regard to home telemonitoring solutions as an option for health care. Overall, it contributes to developing advanced health economic evaluation instruments to be deployed within the specific context of the German Health Care System.
Background: Melatonin exerts multiple biological effects with potential impact on human diseases. This is underscored by genetic studies that demonstrated associations between melatonin receptor type 2 gene (MTNR1B) polymorphisms and characteristics of type 2 diabetes. We set out to test the hypothesis whether genetic variants at MTNR1B are also relevant for other disease phenotypes within the cardiovascular continuum. We thus investigated single nucleotide polymorphisms (SNPs) of MTNR1B in relation to blood pressure (BP) and cardiac parameters in hypertensive patients.
Methods: Patients (n = 605, mean age 56.2 +/- 9.4 years, 82.3% male) with arterial hypertension and cardiac ejection fraction (EF) >= 40% were studied. Cardiac parameters were assessed by echocardiography.
Results: The cohort comprised subjects with coronary heart disease (73.1%) and myocardial infarction (48.1%) with a mean EF of 63.7 +/- 8.9%. Analysis of SNPs rs10830962, rs4753426, rs12804291, rs10830963, and rs3781638 revealed two haplotypes 1 and 2 with frequencies of 0.402 and 0.277, respectively. Carriers with haplotype 1 (CTCCC) showed compared to non-carriers a higher mean 24-hour systolic BP (difference BP: 2.4 mm Hg, 95% confidence interval (CI): 0.3 to 4.5 mm Hg, p = 0.023). Haplotype 2 (GCCGA) was significantly related to EF with an absolute increase of 1.8% (CI: 0.45 to 3.14%) in carriers versus non-carriers (p = 0.009).
Conclusion: Genetics of MTNR1B point to impact of the melatonin signalling pathway for BP and left ventricular function. This may support the importance of the melatonin system as a potential therapeutic target.
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
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 Cardiac rehabilitation (CR) seeks to simultaneously improve several outcome parameters related to patient risk factors, exercise capacity and subjective health. A single score, the multiple outcome criterion (MOC), comprised of alterations in 13 outcome variables was used to measure the overall success of CR in an older population. As this success depends on the older patient's characteristics at the time of admission to CR, we attempted to determine the most important influences.
Methods The impact of baseline characteristics on the success of CR, measured by MOC, was analysed using a mixed model for 1,220 older patients (70.9 +/- A 7.0 years, 78.3 % men) who enrolled in 12 CR clinics. A multitude of potentially influential baseline patient characteristics was considered including sociodemographic variables, comorbidity, duration of hospital stay, exercise capacity, cardiovascular risk factors, emotional status, and laboratory and echocardiographic data.
Results Overall, CR was successful, as indicated by the mean value of the MOC (0.6 +/- A 0.45; min -1.0, max 2.0; positive values denoting improvement, negative ones deterioration). Examples of association with negative MOC values included smoking (MOC -0.15, p < 0.001), female gender (MOC -0.07, p = 0.049), and a longer hospital stay (MOC -0.03, p = 0.03). An example of association with positive MOC value was depression score (MOC 0.06, p = 0.003). Further associations included maximal exercise capacity, blood pressure, heart rate and the rehabilitation centre attended.
Conclusion Our results emphasize the necessity to take into consideration baseline characteristics when evaluating the success of CR and setting treatment targets for older 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.
Aim We aimed to identify patient characteristics and comorbidities that correlate with the initial exercise capacity of cardiac rehabilitation (CR) patients and to study the significance of patient characteristics, comorbidities and training methods for training achievements and final fitness of CR patients. Methods We studied 557 consecutive patients (51.76.9 years; 87.9% men) admitted to a three-week in-patient CR. Cardiopulmonary exercise testing (CPX) was performed at discharge. Exercise capacity (watts) at entry, gain in training volume and final physical fitness (assessed by peak O-2 utilization (VO2peak) were analysed using analysis of covariance (ANCOVA) models. Results Mean training intensity was 90.7 +/- 9.7% of maximum heart rate (81% continuous/19% interval training, 64% additional strength training). A total of 12.2 +/- 2.6 bicycle exercise training sessions were performed. Increase of training volume by an average of more than 100% was achieved (difference end/beginning of CR: 784 +/- 623 wattsxmin). In the multivariate model the gain in training volume was significantly associated with smoking, age and exercise capacity at entry of CR. The physical fitness level achieved at discharge from CR as assessed by VO2peak was mainly dependent on age, but also on various factors related to training, namely exercise capacity at entry, increase of training volume and training method. Conclusion CR patients were trained in line with current guidelines with moderate-to-high intensity and reached a considerable increase of their training volume. The physical fitness level achieved at discharge from CR depended on various factors associated with training, which supports the recommendation that CR should be offered to all cardiac patients.
Aim: We aimed to identify patient characteristics and comorbidities that correlate with the initial exercise capacity of
cardiac rehabilitation (CR) patients and to study the significance of patient characteristics, comorbidities and training
methods for training achievements and final fitness of CR patients.
Methods: We studied 557 consecutive patients (51.7 Æ 6.9 years; 87.9% men) admitted to a three-week in-patient CR.
Cardiopulmonary exercise testing (CPX) was performed at discharge. Exercise capacity (watts) at entry, gain in training
volume and final physical fitness (assessed by peak O 2 utilization (VO 2peak ) were analysed using analysis of covariance
(ANCOVA) models.
Results: Mean training intensity was 90.7 Æ 9.7% of maximum heart rate (81% continuous/19% interval training, 64%
additional strength training). A total of 12.2 Æ 2.6 bicycle exercise training sessions were performed. Increase of training
volume by an average of more than 100% was achieved (difference end/beginning of CR: 784 Æ 623 watts  min). In the
multivariate model the gain in training volume was significantly associated with smoking, age and exercise capacity at
entry of CR. The physical fitness level achieved at discharge from CR as assessed by VO 2peak was mainly dependent on
age, but also on various factors related to training, namely exercise capacity at entry, increase of training volume and
training method.
Conclusion: CR patients were trained in line with current guidelines with moderate-to-high intensity and reached a
considerable increase of their training volume. The physical fitness level achieved at discharge from CR depended on
various factors associated with training, which supports the recommendation that CR should be offered to all cardiac
patients.
BACKGROUND: Reduced left ventricular ejection fraction (LVEF) ≤30% is the most powerful prognostic indicator for sudden cardiac death (SCD) in patients after myocardial infarction (MI), but there are little data about long-term changes of LVEF after revascularization and the following implantation of a cardioverter defibrillator (ICD).
METHODS: We performed a retrospective analysis of 277 patients with reduced LVEF at least 1month after MI and complete revascularization. Patients (median time post-MI 23.4months; 74.3% after PCI, 25.7% after CABG were assigned either to group 1 (LVEF<30%) or group 2 (LVEF 30-40%). Biplane echocardiography was redone after a mean follow-up of 441±220days.
RESULTS: LVEF increased significantly in both two groups (group 1: 26.2±4.8% to 32.4±8.5%; p<0.001; group 2: 38.2±2.5% to 44.4±9.6%; p<0.001). However, statistical analysis of first and second LVEF measurement by means of a LOWESS regression and with an appropriate correction of the regression towards the mean effect revealed only a moderate increase of the mean LVEF from 35 to 37% (p<0.001) with a large interindividual variation.
CONCLUSIONS: The impact of early revascularization on LVEF appears to be low in the majority of post-MI heart failure patients. Owing to the high variability, a single measurement may not be reliable enough to justify a decision on ICD indication.
Objective. We evaluated the long-term effect of a smoking intervention embedded in an adherence program in patients with an increased risk for cardiovascular disease.
Method. Secondary analysis of a randomized controlled trial: In 2002-2004,8108 patients with hypercholesterolemia were enrolled from general practices in Germany. Patients received a 12-month adherence program and statin medication (intervention) or statin medication only (control). The program aimed to improve adherence to medication and lifestyle by educational material, mailings, and phone calls. Smoking was self-reported at baseline and every 6 months during the 3-year follow-up.
Results. In total, 7640 patients were analyzed. At baseline, smoking prevalence was 21.7% in the intervention and 21.5% in the control group. Prevalence decreased in both groups to 16.6% vs. 19.5%, 153% vs. 16.8%, and 14.2% vs. 15.6% at the 12-, 24-, and 36-month follow-up. The intervention had a beneficial effect on smoking differing over time (group x time: P = 0.005). The effect was largest after 6 and 12 months [odds ratios (95% confidence intervals): 0.67 (0.54-0.82) and 0.63 (0.51-0.78)]. The effect decreased until the 18-month follow-up [0.72 (0.58-0.90)] and was not significant after 24 months.
Conclusion. A low-intensity smoking intervention embedded in an adherence program can contribute to smoking cessation although the intervention effect diminished over time. (C) 2015 Elsevier Inc. All rights reserved.