[Telemedicine in cardiology - what is new?] / Telemedizin in der Kardiologie ­ was ist neu?

There is robust evidence for the clinical efficacy of telemedicine in heart failure (HF) patients to reduce mortality and morbidity. For the first time, the Federal Joint Committee (G-BA) has approved telemedicine for HF patients as a digital method of care for a well-defined heart failure population. Patients with HF and a reduced left ventricular ejection fraction (LVEF ) < 40 % are now eligible for telemonitoring in a real-world settings of out-patient care in Germany. The implementation of telemedicine in the German health care system is a complex process including the introduction of telemedical technologies, educational programs for the patients as well as the implementation of standard operating procedures (SOPs) for the staff of telemedical centers. The ongoing research in telemedicine in HF patients is focusing on three issues: a) research to extend the suitable HF-population for telemonitoring; b) research on new telemedical sensor technologies, e.g. a new pulmonary pressure measurement system (Cordella) and a system for wireless measurement of left atrial pressure (V-LAP); c) the introduction of methods of artifical intelligence (AI), e.g. the AI-based speech analysis using a smart phone to characterize the pulmonary fluid status.

Pulmonary artery sensor system pressure monitoring to improve heart failure outcomes (PASSPORT-HF): rationale and design of the PASSPORT-HF multicenter randomized clinical trial.

BACKGROUND: Remote monitoring of patients with New York Heart Association (NYHA) functional class III heart failure (HF) using daily transmission of pulmonary artery (PA) pressure values has shown a reduction in HF-related hospitalizations and improved quality of life in patients. OBJECTIVES: PASSPORT-HF is a prospective, randomized, open, multicenter trial evaluating the effects of a hemodynamic-guided, HF nurse-led care approach using the CardioMEMS™ HF-System on clinical end points. METHODS AND RESULTS: The PASSPORT-HF trial has been commissioned by the German Federal Joint Committee (G-BA) to ascertain the efficacy of PA pressure-guided remote care in the German health-care system. PASSPORT-HF includes adult HF patients in NYHA functional class III, who experienced an HF-related hospitalization within the last 12 months. Patients with reduced ejection fraction must be on stable guideline-directed pharmacotherapy. Patients will be randomized centrally 1:1 to implantation of a CardioMEMS™ sensor or control. All patients will receive post-discharge support facilitated by trained HF nurses providing structured telephone-based care. The trial will enroll 554 patients at about 50 study sites. The primary end point is a composite of the number of unplanned HF-related rehospitalizations or all-cause death after 12 months of follow-up, and all events will be adjudicated centrally. Secondary end points include device/system-related complications, components of the primary end point, days alive and out of hospital, disease-specific and generic health-related quality of life including their sub-scales, and laboratory parameters of organ damage and disease progression. CONCLUSIONS: PASSPORT-HF will define the efficacy of implementing hemodynamic monitoring as a novel disease management tool in routine outpatient care. TRIAL REGISTRATION: ClinicalTrials.gov; NCT04398654, 13-MAY-2020.

[Telemedicine in chronic heart failure-From clinical studies to standard care]. / Telemedizin bei chronischer Herzinsuffizienz ­ von klinischen Studien zur Regelversorgung.

Telemedicine has the potential to solve many current and especially future challenges in medical care. Using the example of heart failure (HF), the transition of telemedicine from clinical studies to standard care is presented. In patients with chronic HF, randomized controlled trials have shown that telemedicine-based care leads to a reduction in mortality and cardiovascular morbidity. Based on these data, the Federal Joint Committee (G-BA) decided that for the first time a digital method should be introduced into standard care for high-risk patients with reduced left ventricular ejection fraction. In the future, this group of patients will be entitled to telemedical care using active rhythm devices or noninvasive measuring devices. The indications are assessed by the primary treating physician (PBA), who works together with a telemedicine center (TMZ) managed through cardiology that receives daily telemetric data and notifies the PBA of abnormal findings. Alternatively, a cardiologist PBA with an associated TMZ infrastructure can also provide telemedical care. In the future, advanced technologies such as artificial intelligence or mobile communication standard 5G will help to make telemedicine both widely available and usable for alternative sensor technology.

A support programme for secondary prevention in patients with transient ischaemic attack and minor stroke (INSPiRE-TMS): an open-label, randomised controlled trial.

BACKGROUND: Patients with recent stroke or transient ischaemic attack are at high risk for a further vascular event, possibly leading to permanent disability or death. Although evidence-based treatments for secondary prevention are available, many patients do not achieve recommended behavioural modifications and pharmaceutical prevention targets in the long-term. We aimed to investigate whether a support programme for enhanced secondary prevention can reduce the frequency of recurrent vascular events. METHODS: INSPiRE-TMS was an open-label, multicentre, international randomised controlled trial done at seven German hospitals with acute stroke units and a Danish stroke centre. Patients with non-disabling stroke or transient ischaemic attack within 2 weeks from study enrolment and at least one modifiable risk factor (ie, arterial hypertension, diabetes, atrial fibrillation, or smoking) were included. Computerised randomisation was used to allocate patients (1:1) either to the support programme in addition to conventional care or to conventional care alone. The support programme used feedback and motivational interviewing strategies with eight outpatient visits over 2 years aiming to improve adherence to secondary prevention targets. The primary outcome was the composite of major vascular events consisting of stroke, acute coronary syndrome, and vascular death, assessed in the intention-to-treat population (all patients who underwent randomisation, did not withdraw study participation, and had at least one follow-up). Outcomes were assessed at annual follow-ups using time-to-first-event analysis. All-cause death was monitored as a safety outcome. This trial is registered with ClinicalTrials.gov, NCT01586702. FINDINGS: From Aug 22, 2011, to Oct 30, 2017, we enrolled 2098 patients. Of those, 1048 (50·0%) were randomly assigned to the support programme group and 1050 (50·0%) patients were assigned to the conventional care group. 1030 (98·3%) patients in the support group and 1042 (99·2%) patients in the conventional care group were included in the intention-to-treat analysis. The mean age of analysed participants was 67·4 years and 700 (34%) were women. After a mean follow-up of 3·6 years, the primary outcome of major vascular events had occurred in 163 (15·8%) of 1030 patients of the support programme group and in 175 (16·8%) of 1042 patients of the conventional care group (hazard ratio [HR] 0·92, 95% CI 0·75-1·14). Total major vascular event numbers were 209 for the support programme group and 225 for the conventional care group (incidence rate ratio 0·93, 95% CI 0·77-1·12; p=0·46) and all-cause death occurred in 73 (7·1%) patients in the support programme group and 85 (8·2%) patients in the conventional care group (HR 0·85, 0·62-1·17). More patients in the support programme group achieved secondary prevention targets (eg, in 1-year-follow-up 52% vs 42% [p<0·0001] for blood pressure, 62% vs 54% [p=0·0010] for LDL, 33% vs 19% [p<0·0001] for physical activity, and 51% vs 34% [p=0·0010] for smoking cessation). INTERPRETATION: Provision of an intensified secondary prevention programme in patients with non-disabling stroke or transient ischaemic attack was associated with improved achievement of secondary prevention targets but did not lead to a significantly lower rate of major vascular events. Further research is needed to investigate the effects of support programmes in selected patients who do not achieve secondary prevention targets soon after discharge. FUNDING: German Federal Ministry of Education and Research, Pfizer, and German Stroke Foundation.

A Novel Wireless Left Atrial Pressure Monitoring System for Patients with Heart Failure, First Ex-Vivo and Animal Experience.

The V-LAP™ measures left atrial pressure (LAP) and enables bi-directional communications with an external unit, designed to monitor heart failure patients. We hereby describe the pre-clinical experience. Following an ex vivo phase, the system was implanted at the interatrial septum of 10 ovine subjects. LAP readouts were compared with pulmonary capillary wedge pressure (PCWP) at index procedure and 1, 2 and 3-6 months after the implantation, at rest and after volume loading. Histopathology assessment (n = 8) was performed up to 50 weeks post procedure. Procedural success was 100%. Measurements showed a mean difference of 0.19 ± 2.51 mmHg. During this period, correlation of V-LAP™ with PCWP was excellent (R2 = 0.95, for 119 total measurements). There were no major adverse events related to the V-LAP™ system. In an animal model, the implantation of the novel wireless left atrial pressure sensor V-LAP™ was feasible, safe, and showed good accuracy and precision.

Safety and feasibility of pulmonary artery pressure-guided heart failure therapy: rationale and design of the prospective CardioMEMS Monitoring Study for Heart Failure (MEMS-HF).

BACKGROUND: Wireless monitoring of pulmonary artery (PA) pressures with the CardioMEMS HF™ system is indicated in patients with New York Heart Association (NYHA) class III heart failure (HF). Randomized and observational trials have shown a reduction in HF-related hospitalizations and improved quality of life in patients using this device in the United States. OBJECTIVE: MEMS-HF is a prospective, non-randomized, open-label, multicenter study to characterize safety and feasibility of using remote PA pressure monitoring in a real-world setting in Germany, The Netherlands and Ireland. METHODS AND RESULTS: After informed consent, adult patients with NYHA class III HF and a recent HF-related hospitalization are evaluated for suitability for permanent implantation of a CardioMEMS™ sensor. Participation in MEMS-HF is open to qualifying subjects regardless of left ventricular ejection fraction (LVEF). Patients with reduced ejection fraction must be on stable guideline-directed pharmacotherapy as tolerated. The study will enroll 230 patients in approximately 35 centers. Expected duration is 36 months (24-month enrolment plus ≥ 12-month follow-up). Primary endpoints are freedom from device/system-related complications and freedom from pressure sensor failure at 12-month post-implant. Secondary endpoints include the annualized rate of HF-related hospitalization at 12 months versus the rate over the 12 months preceding implant, and health-related quality of life. Endpoints will be evaluated using data obtained after each subject's 12-month visit. CONCLUSIONS: The MEMS-HF study will provide robust evidence on the clinical safety and feasibility of implementing haemodynamic monitoring as a novel disease management tool in routine out-patient care in selected European healthcare systems. TRIAL REGISTRATION: ClinicalTrials.gov; NCT02693691.

Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS): a protocol for a randomised controlled trial.

BACKGROUND: Patients with recent stroke or TIA are at high risk for new vascular events. Several evidence based strategies in secondary prevention of stroke are available but frequently underused. Support programs with multifactorial risk factor modifications after stroke or TIA have not been investigated in large-scale prospective controlled trials so far. INSPiRE-TMS is a prospective, multi-center, randomized open intervention trial for intensified secondary prevention after minor stroke and TIA. METHODS/DESIGN: Patients with acute TIA or minor stroke admitted to the participating stroke centers are screened and recruited during in-hospital stay. Patients are randomised in a 1:1 ratio to intervention (support program) and control (usual care) arms. Inclusion of 2.082 patients is planned. The support program includes cardiovascular risk factor measurement and feedback, monitoring of medication adherence, coaching in lifestyle modifications, and active involvement of relatives. Standardized motivational interviewing is used to assess and enhance patients' motivation. Primary objective is a reduction of new major vascular events defined as nonfatal stroke and myocardial infarction or vascular death. Recruitment time is planned for 3.5 years, follow up time is at least 2 years for every patient resulting in a total study time of 5 years (first patient in to last patient out). DISCUSSION: Given the high risk for vascular re-events in acute stroke and the available effective strategies in secondary prevention, the INSPIRE-TMS support program has the potential to lead to a relevant reduction of recurrent events and a prolongation of the event-free survival time. The trial will provide the basis for the decision whether an intensified secondary prevention program after stroke should be implemented into regular care. A cost-effectiveness evaluation will be performed. TRIAL REGISTRATION: clinicaltrials.gov: 01586702.

[Remote telemedical management in chronic heart failure--hitches and opportunities]. / Telemedizinische Betreuung bei chronischer Herzinsuffizienz--Möglichkeiten und Probleme.

Prognosis of chronic heart failure has improved but remains severe. Modern disease management for ambulatory patients includes telemedical approaches, which have shown positive effects on morbidity and mortality both for device-assisted monitoring and for nurse telephone support. Current technology is feasible for comfortable and extensive real-time transmission of patient data. Daily monitoring of symptoms, vital signs, and information from cardiac implants should enable the health care specialist to detect early worsening of the disease and initiate treatment. Appropriate clinical application of telemedicine to the individual patient and local health care structure is a challenge.

A network against failing hearts--introducing the German "Competence Network Heart Failure".

Heart failure (HF) has been identified as one of the most threatening diseases for the western civilisation, posing a risk to health for a rising number of patients. Acknowledging the medical problem of HF to be both economically and socially threatening the German Federal Ministry of Research and Education (BMBF) initiated a nationwide research network aiming to find new ways in prevention, alleviation and treatment of the widespread disease. The "Competence Network Heart Failure" (CNHF), initiated in 2003, bundles the scientific expertise in a large-scale research network; its aims are the coordination of basic and applied clinical research as well as dissemination of findings into clinical practice in order to consolidate and perpetuate the achieved improvements. The scope of this paper is to introduce the CNHF and to provide an overview of the tasks and hitherto attained achievements to a broad spectrum of health care providers.

Gastrointestinal failure in intensive care: a retrospective clinical study in three different intensive care units in Germany and Estonia.

BACKGROUND: While gastrointestinal problems are common in ICU patients with multiple organ failure, gastrointestinal failure has not been given the consideration other organ systems receive. The aim of this study was to evaluate the incidence of gastrointestinal failure (GIF), to identify its risk factors, and to determine its association with ICU mortality. METHODS: A retrospective analysis of adult patients (n = 2588) admitted to three different ICUs (two ICUs at the university hospital Charité-Universitätsmedizin Berlin, Germany and one at Tartu University Clinics, Estonia) during the year 2002 was performed. Data recorded in a computerized database were used in Berlin. In Tartu, the data documented in the patients' charts was retrospectively transferred into a similar database. GIF was defined as documented gastrointestinal problems (food intolerance, gastrointestinal haemorrhage, and/or ileus) in the patient data at any period of their ICU stay. ICU mortality, length of stay, and duration of mechanical ventilation were assessed as outcome parameters. RESULTS: GIF was identified in 252 patients (9.7% of all patients). Only 20% of GIF patients were identifiable at admission. GIF was related to significantly higher mortality (43.7% vs. 5.3% in patients without GIF), as well as prolonged length of ICU stay (10 vs. 2 days) and mechanical ventilation (8 vs. 1 day), p < 0.001, respectively. Patients' profile (emergency surgical or medical), APACHE II and SOFA scores and the use of catecholamines at admission were identified as independent risk factors for the development of GIF. Development of GIF during ICU stay was an independent predictor for death. CONCLUSION: Gastrointestinal failure represents a relevant clinical problem accompanied by an increased mortality, longer ICU stay and mechanical ventilation.

Partnership for the heart. German-Estonian health project for the treatment of congenital heart defects in Estonia.

Congenital heart defects (CHD) occur in 8 per 1000 live births. If they remain untreated, 70-80% of these patients die in early childhood. With modern diagnostic and treatment procedures, 90% of these patients reach adulthood. Within 8 years following reunification of Germany, it was possible to improve treatment for CHD in former East Germany to West German standards. Based on the experience gained in this process, a plan for improvement of care of Estonian patients with CHD was developed and implemented in the German-Estonian project, "Partnership for the Heart". The main elements of the project were (1) the training of Estonian physicians in Germany, (2) training courses conducted by German and Estonian specialists in Estonia and (3) use of telemedicine for consultation on a continuous basis. During the project 15 Estonian patients underwent cardiac surgery and/or catheter interventions performed by a joint team of German and Estonian specialists. The infant mortality due to CHD in Estonia fell by 28% during the project period. Key techniques of cardiac surgery are now being employed in Estonia without outside support, indicating the success of the training program and the long-term improvements to cardiac health care in Estonia. The total project costs were 314,252 Euro (euro), which is 50% lower than the estimated cost of treating the 15 patients abroad in Western Europe. The structure of "Partnership for the Heart" and the modified self-sufficiency model of medical care have not only produced results for Estonia but can be taken as a template for future bilateral health projects with other transition countries and for other fields of medical specialisation, and thus might aid a European health policy.

Determinants of the quality of life of patients with congenital heart disease.

OBJECTIVE: The improvement of the quality of life of chronically ill patients has become an important goal in treatment. However, it is seldom taken into account that many other factors, in addition to somatic factors, have an influence on the quality of life of patients. Using patients with congenital heart defects as an example, we examined the relative significance of biological factors, compared to psychological and social factors, for the various quality of life dimensions. RESEARCH DESIGN AND METHODS: One hundred and eleven patients (aged 33+/-12 years) with different degrees of cardiac dysfunction were examined (NYHA 0: 2 I: 56, II: 38, III: 13, IV: 2). All patients for whom there was no contra-indication underwent a treadmill ergometry in order to determine their level of cardiopulmonary functioning (peak oxygen consumption: VO2max). All patients were asked to fill out questionnaires concerning their quality of life (WHOQOL-Bref), their cardiac complaints (Giessener Complaint Questionnaire GBB), their personality traits (Giessen Test GTS), and the social support they experience (Social Support Questionnaire SOZU-k22). The data were analyzed using a linear structural equation model (SEM). RESULTS: In all aspects but the social domain, the HRQL of CgHD patients was significantly diminished compared to the normal population. The SEM proposed was valid, showing good indices of fit (chi2 = 1.18; p = 0.55; AGFI = 0.92). The level of cardiopulmonary functioning was most significant for the reporting of specific cardiac complaints (beta = -28) and for the physical component of the general HRQL (beta = 32), although the former was also influenced by a depressed disposition (beta = -0.20) and the extent of social support experienced (beta = 0.18). The objective findings, however, had virtually no individual significance for the psychological (beta = 0.09) and social domains (beta = -0.02). These HRQL domains are primarily influenced by depressive personality traits (beta= -26/-0.16) and the social support experienced (beta = 0.51/0.51). CONCLUSIONS: The patient's organic dysfunction primarily determines illness-specific complaints but has little relevance for the psychological and social aspects of the HRQL. These aspects are predominantly determined by the patient's depressive disposition and by the experienced social support. A successful therapy should therefore take biological as well as psycho-social determinants of the quality of life into account.