Remote patient management in patients with heart failure might help to detect early signs and symptoms of cardiac decompensation, thus enabling a prompt initiation of the appropriate treatment and ...care before a full manifestation of a heart failure decompensation. We aimed to investigate the efficacy of our remote patient management intervention on mortality and morbidity in a well defined heart failure population.
The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial was a prospective, randomised, controlled, parallel-group, unmasked (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection. The trial was done in Germany, and patients were recruited from hospitals and cardiology practices. Eligible patients had heart failure, were in New York Heart Association class II or III, had been admitted to hospital for heart failure within 12 months before randomisation, and had a left ventricular ejection fraction (LVEF) of 45% or lower (or if higher than 45%, oral diuretics were being prescribed). Patients with major depression were excluded. Patients were randomly assigned (1:1) using a secure web-based system to either remote patient management plus usual care or to usual care only and were followed up for a maximum of 393 days. The primary outcome was percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death, analysed in the full analysis set. Key secondary outcomes were all-cause and cardiovascular mortality. This study is registered with ClinicalTrials.gov, number NCT01878630, and has now been completed.
Between Aug 13, 2013, and May 12, 2017, 1571 patients were randomly assigned to remote patient management (n=796) or usual care (n=775). Of these 1571 patients, 765 in the remote patient management group and 773 in the usual care group started their assigned care, and were included in the full analysis set. The percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause death was 4·88% (95% CI 4·55–5·23) in the remote patient management group and 6·64% (6·19–7·13) in the usual care group (ratio 0·80, 95% CI 0·65–1·00; p=0·0460). Patients assigned to remote patient management lost a mean of 17·8 days (95% CI 16·6–19·1) per year compared with 24·2 days (22·6–26·0) per year for patients assigned to usual care. The all-cause death rate was 7·86 (95% CI 6·14–10·10) per 100 person-years of follow-up in the remote patient management group compared with 11·34 (9·21–13·95) per 100 person-years of follow-up in the usual care group (hazard ratio HR 0·70, 95% CI 0·50–0·96; p=0·0280). Cardiovascular mortality was not significantly different between the two groups (HR 0·671, 95% CI 0·45–1·01; p=0·0560).
The TIM-HF2 trial suggests that a structured remote patient management intervention, when used in a well defined heart failure population, could reduce the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality.
German Federal Ministry of Education and Research.
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: ΔPCS 0.3, 95% CI − 1.9 to 2.5;
P
= 0.77;
n
= 177; ΔMCS 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.
To determine the physician's perspective and perception on walking exercise as well as barriers in guideline-directed best medical treatment of patients with lower extremity peripheral arterial ...disease (PAD).
All members of the German Society for Vascular Surgery and Vascular Medicine and of the German Society for Angiology - Society for Vascular Medicine with valid email address were invited to participate in an electronic survey on walking exercise for treatment of intermittent claudication that was developed by the authors.
Amongst 3910 invited participants, 743 (19%) provided valid responses (33% females, 84% vascular surgery, 15% angiology). Thereof, 65% were employed by non-university hospitals, 16% by university institutions, and 18% by outpatient facilities. A mean of 14 minutes were spent per patient to counsel and educate, while only 53% responded they had enough time in everyday clinical practice. While 98% were aware of the beneficial impact of structured exercise training (SET) on pain free walking distance and 90% advise their patients to adhere to SET, only 44% provided useful guidance to patients to find local SET programmes and merely 42% knew how to prescribe SET as service that can be reimbursed by medical insurances. Approximately 35% knew a local SET programme and appropriate contact person. Health-related quality of life was assessed in a structured way by only 11%. Forty-seven percent responded that medical insurances should be responsible to implement and maintain SET programmes, while only 4% held hospital physicians responsible to achieve this task.
This nationwide survey study amongst vascular specialists illustrates the current insufficient utilisation of SET as an evidence-based therapeutic cornerstone in patients with lower extremity PAD in Germany. The study also identified several barriers and flaws from the physician's perspectives which should be addressed collectively by all health care providers aiming to increase the SET use and eventually its' impact on patients with PAD.
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.
Background: Scientific guidelines have been developed to update and harmonize exercise based cardiac rehabilitation (ebCR) in German speaking countries. Key recommendations for ebCR indications have ...recently been published in part 1 of this journal. The present part 2 updates the evidence with respect to contents and delivery of ebCR in clinical practice, focusing on exercise training (ET), psychological interventions (PI), patient education (PE). In addition, special patients’ groups and new developments, such as telemedical (Tele) or home-based ebCR, are discussed as well. Methods: Generation of evidence and search of literature have been described in part 1. Results: Well documented evidence confirms the prognostic significance of ET in patients with coronary artery disease. Positive clinical effects of ET are described in patients with congestive heart failure, heart valve surgery or intervention, adults with congenital heart disease, and peripheral arterial disease. Specific recommendations for risk stratification and adequate exercise prescription for continuous-, interval-, and strength training are given in detail. PI when added to ebCR did not show significant positive effects in general. There was a positive trend towards reduction in depressive symptoms for “distress management” and “lifestyle changes”. PE is able to increase patients’ knowledge and motivation, as well as behavior changes, regarding physical activity, dietary habits, and smoking cessation. The evidence for distinct ebCR programs in special patients’ groups is less clear. Studies on Tele-CR predominantly included low-risk patients. Hence, it is questionable, whether clinical results derived from studies in conventional ebCR may be transferred to Tele-CR. Conclusions: ET is the cornerstone of ebCR. Additional PI should be included, adjusted to the needs of the individual patient. PE is able to promote patients self-management, empowerment, and motivation. Diversity-sensitive structures should be established to interact with the needs of special patient groups and gender issues. Tele-CR should be further investigated as a valuable tool to implement ebCR more widely and effectively.
Glycoprotein IIb/IIIa blockade by abciximab and tirofiban, non-peptidergic inhibitors, leads to sustained clinical benefits in the treatment of acute coronary syndromes. The purpose of this study was ...to clarify the functional effects of abciximab and tirofiban on vascular vitronectin receptors, αvβ3- and αvβ5-integrins. Integrin expression and 7E3 binding in human umbilical venous endothelial cells, human umbilical venous smooth muscle cells, and human iliac arterial smooth muscle cells were observed in the following intensity: αvβ3 — human umbilical venous endothelial cells>human umbilical venous smooth muscle cells>human iliac arterial smooth muscle cells/αvβ5 — human iliac arterial smooth muscle cells>human umbilical venous smooth muscle cells>human umbilical venous endothelial cells. 7E3 binding correlated with αvβ3-expression in all cell types. Integrin-mediated cell functions were analysed with adhesion and spreading assays on vitronectin. In human umbilical venous endothelial cells, these functions were mediated by αvβ3 and in human iliac arterial smooth muscle cells by αvβ5. In human umbilical venous smooth muscle cells, both vitronectin receptors were involved. Abciximab potently inhibited αvβ3-mediated cell adhesion and spreading. With tirofiban, no significant inhibition of vascular cell functions was observed. The present data demonstrate that vitronectin–cell interactions in vascular cells are mediated via two distinct integrin-receptors, αvβ3 and αvβ5. Abciximab, which solely inhibits αvβ3-mediated cell functions, may be particularly effective in human endothelium and in β3-integrin expressing vascular smooth muscle cells.
Forced expression of proneural transcription factors has been shown to direct neuronal conversion of fibroblasts. Because neurons are postmitotic, conversion efficiencies are an important parameter ...for this process. We present a minimalist approach combining two-factor neuronal programming with small molecule-based inhibition of glycogen synthase kinase-3β and SMAD signaling, which converts postnatal human fibroblasts into functional neuron-like cells with yields up to >200% and neuronal purities up to >80%.
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