Friedrich Koehler

Impact of Remote Telemedical Management on Mortality and Hospitalizations in Ambulatory Patients With Chronic Heart Failure The Telemedical Interventional Monitoring in Heart Failure Study

Background— This study was designed to determine whether physician-led remote telemedical management (RTM) compared with usual care would result in reduced mortality in ambulatory patients with chronic heart failure (HF). Methods and Results— We enrolled 710 stable chronic HF patients in New York Heart Association functional class II or III with a left ventricular ejection fraction ⩽35% and a history of HF decompensation within the previous 2 years or with a left ventricular ejection fraction ⩽25%. Patients were randomly assigned (1:1) to RTM or usual care. Remote telemedical management used portable devices for ECG, blood pressure, and body weight measurements connected to a personal digital assistant that sent automated encrypted transmission via cell phones to the telemedical centers. The primary end point was death from any cause. The first secondary end point was a composite of cardiovascular death and hospitalization for HF. Baseline characteristics were similar between the RTM (n=354) and control (n=356) groups. Of the patients assigned to RTM, 287 (81%) were at least 70% compliant with daily data transfers and no break for >30 days (except during hospitalizations). The median follow-up was 26 months (minimum 12), and was 99.9% complete. Compared with usual care, RTM had no significant effect on all-cause mortality (hazard ratio, 0.97; 95% confidence interval, 0.67 to 1.41; P=0.87) or on cardiovascular death or HF hospitalization (hazard ratio, 0.89; 95% confidence interval, 0.67 to 1.19; P=0.44). Conclusions— In ambulatory patients with chronic HF, RTM compared with usual care was not associated with a reduction in all-cause mortality. Clinical Trial Registration:— URL: http://www.ClinicalTrials.gov. Unique identifier: NCT00543881.

Telemedicine and remote management of patients with heart failure

Advances in telecommunication technologies have created new opportunities to provide telemedical care as an adjunct to medical management of patients with heart failure. Meta-analyses suggest that telemedicine can reduce morbidity and mortality in such patients; however, two prospective clinical trials not included in the analyses do not support these findings. Therefore, the effectiveness of telemedicine in heart failure is not established. Telemedicine approaches range from computer-based support systems to programmes led by nurses and physicians. Standardisation and appropriate classification of telemedical systems are needed to enable accurate interpretation of clinical trials. Here we propose a classification of four generations of telemedicine in heart failure. Not all approaches are the same and not every patient with heart failure will need telemedicine. Crisis prevention and treatment, and stabilisation and self-empowerment of patients are focuses of telemedicine in heart failure. The profile of patients who can potentially benefit from telemedicine is unknown and should be investigated in adequately powered randomised clinical trials. We are optimistic that telemedicine is an efficient approach and will become an important feature of management in heart failure.

Telemedical Interventional Monitoring in Heart Failure (TIM‐HF), a randomized, controlled intervention trial investigating the impact of telemedicine on mortality in ambulatory patients with heart failure: study design

Remote patient management (telemonitoring) may help to detect early signs of cardiac decompensation, allowing optimization of and adherence to treatments in chronic heart failure (CHF). Two meta‐analyses have suggested that telemedicine in CHF can reduce mortality by 30–35%. The aim of the TIM‐HF study was to investigate the impact of telemedical management on mortality in ambulatory CHF patients.

Accelerometer-based quantification of 6-minute walk test performance in patients with chronic heart failure : applicability in telemedicine

BACKGROUND Distance walked in the 6-minute walk test (6MWT) is an important prognostic parameter used clinically to assess functional status in patients with chronic heart failure (CHF). In this study, we investigated if alternative performance parameters with similar prognostic value can be gained from accelerometers. METHODS AND RESULTS Fifty CHF patients (age, 60.9 +/- 14.0 years) were asked to perform a 6MWT while wearing 2 accelerometers and 1 pedometer. Total 6MWT step frequency (SF) and activity counts (VMU) were correlated to 6MWT distance. The accelerometer was highly accurate at quantifying SF (detected vs. observed: r = 0.99; P < .001), whereas the pedometer was unreliable below 50 m/min. VMU increased linearly with walking speed (r = 0.99), and both SF and VMU correlated strongly with 6MWT distance (VMU: r = 0.91; SF: r = 0.87, respectively; P < .001) and each other (r = 0.80, P < .001). CONCLUSIONS Accelerometers are reliable in measuring physical performance during the 6MWT in CHF patients. Besides the simple acquisition of 6MWT distance currently used for patient assessment, accelerometers provide new data that might be useful to evaluate exercise performance during the 6MWT. This allows for routine assessment of exercise capacity in a home-based setting in the context of telemedicine.

A new telemonitoring system intended for chronic heart failure patients using mobile telephone technology — Feasibility study

BACKGROUND Remote monitoring is one modality of structured care in chronic heart failure. The purpose of this study was to evaluate the feasibility of a new wireless telemonitoring system via a mobile phone network. METHODS Portable home devices for electrocardiogram, blood pressure, body weight and self-assessment measurements were connected (via Bluetooth) to a personal digital assistant (PDA) that performs automated encrypted transmission via mobile phone. Two telemedical centres were set-up. RESULTS 30 healthy volunteers were enrolled and followed for 26 days. A total of 4002 single measurements were taken, 133 ± 37 per person. No data was lost or incorrectly allocated. 880 of 937 (94%) of the ECG recordings had sufficient diagnostic quality for rhythm analysis and single beat measurements. 50 continuous ECG-streams (312 min) without disruption were performed. Total system availability was 96.6%, including that of the mobile phone network. CONCLUSIONS Mobile phone technology is suitable for continuous and secure medical data transmission. To evaluate the clinical use in chronic heart failure patients, a large multicentre randomized controlled trial (ClinicalTrials.gov Identifier: NCT00543881) was started.

Daily walking performance as an independent predictor of advanced heart failure : Prediction of exercise capacity in chronic heart failure

PURPOSE The purpose of this study was to use an accelerometer to measure daily walking performance in patients with chronic heart failure (CHF) to investigate if this parameter is a determinant of New York Heart Association class and indicative of maximal and functional exercise capacity. METHODS Fifty patients with CHF were instructed to wear an accelerometer for 7 consecutive days while going about their daily business. Maximal and functional exercise capacity was assessed by cardiopulmonary (VO(2peak)) and 6-minute walk testing, respectively. RESULTS Patients in New York Heart Association I, II, and III reached an average total walking time (TWT) of 160.6 +/- 35.8 minutes, 133.9 +/- 59.0 minutes, and 76.1 +/- 22.5 minutes per day of which 19%, 19%, and 9% where spent in the fast walking mode (>83 m/minute), respectively. The TWT correlated strongly with VO(2peak) (r = 0.72; P <.001) and 6-minute walk testing distance (r = 0.68; P <.001). The TWT and time spent in fast walking mode were the strongest determinants in discriminating moderate CHF. CONCLUSION Daily walking performance is a clear determinant of maximal and functional exercise capacities in patients with CHF. Walking intensity in particular is an independent predictor in discriminating patients with advanced heart failure. Monitoring of daily walking performance might aid in detecting disease progression and improve clinical outcome.

e-Health: a position statement of the European Society of Cardiology

e-Health encompasses the use of information and communication technologies (ICTs) in the support of health and health-related activity.1 It can be subdivided into several domains, listed in Table 1 .2 View this table: Table 1 The domains of e-health, involving healthcare administration and support, education, healthcare delivery, and research e-Health has the potential to provide innovate solutions to health issues, and is often viewed by politicians and healthcare professionals as a key ‘enabling’ technology to improve care and the experience of care for the those living with chronic conditions, particularly at a time of constrained healthcare funding. Behind all of this stands the individual/citizen/patient/customer, who is increasingly familiar with ICT and expects to find it supporting modern healthcare delivery, facilitating more personalized and person-centred care at the right time and in the right place. In theory, technological innovation should bring better inter-professional co-operation, information sharing, decision support, and flexibility to the healthcare system. However, there are important societal and professional constraints that reduce the impact of such innovation, including legal, ethical, and data protection issues. Healthcare professionals may be resistant to such innovation, particularly if the technologies are considered to be ‘solutions seeking a problem’ and where the evidence for the impact on quality of care is seen as less than robust. Indeed, ensuring proper integration of new technologies into the healthcare system is often difficult, requiring process redesign or ‘disruption’.6 Regulatory bodies, reimbursement authorities, and national and international political bodies often find it difficult to react quickly, or consistently, to this rapidly changing area. The European Union has an e-health action plan for 2012–2020, which states that the promise of ICT to increase efficiency, improve quality …

Impact of Remote Telemedical Management on Mortality and Hospitalizations in Ambulatory Patients With Chronic Heart Failure

Background— This study was designed to determine whether physician-led remote telemedical management (RTM) compared with usual care would result in reduced mortality in ambulatory patients with chronic heart failure (HF). Methods and Results— We enrolled 710 stable chronic HF patients in New York Heart Association functional class II or III with a left ventricular ejection fraction ⩽35% and a history of HF decompensation within the previous 2 years or with a left ventricular ejection fraction ⩽25%. Patients were randomly assigned (1:1) to RTM or usual care. Remote telemedical management used portable devices for ECG, blood pressure, and body weight measurements connected to a personal digital assistant that sent automated encrypted transmission via cell phones to the telemedical centers. The primary end point was death from any cause. The first secondary end point was a composite of cardiovascular death and hospitalization for HF. Baseline characteristics were similar between the RTM (n=354) and control (n=356) groups. Of the patients assigned to RTM, 287 (81%) were at least 70% compliant with daily data transfers and no break for >30 days (except during hospitalizations). The median follow-up was 26 months (minimum 12), and was 99.9% complete. Compared with usual care, RTM had no significant effect on all-cause mortality (hazard ratio, 0.97; 95% confidence interval, 0.67 to 1.41; P=0.87) or on cardiovascular death or HF hospitalization (hazard ratio, 0.89; 95% confidence interval, 0.67 to 1.19; P=0.44). Conclusions— In ambulatory patients with chronic HF, RTM compared with usual care was not associated with a reduction in all-cause mortality. Clinical Trial Registration:— URL: http://www.ClinicalTrials.gov. Unique identifier: NCT00543881.

Telemedical care: feasibility and perception of the patients and physicians: a survey-based acceptance analysis of the Telemedical Interventional Monitoring in Heart Failure (TIM-HF) trial

Background The randomized Telemedical Interventional Monitoring in Heart Failure (TIM-HF) trial (NCT00543881) was performed during 2008 and 2010 to determine whether physician-led remote patient management (RPM) compared with usual care would result in reduced mortality and morbidity in stable out-patient heart failure (HF) patients. However, besides results of clinical benefit, the acceptance by patients and primary physicians is necessary for the implementation of RPM as part of the upcoming out-patient HF-care programs. Methods Two months after finishing of the trial, a survey based analysis of the perception of telemedical care with patients (n = 288) and primary physicians (n = 102) was carried out. The survey included questions regarding self-management, usability and physician-patient communication. Results The concept of RPM was perceived positively by patients and physicians. The devices were assessed as easy to use (98.6%, n = 224) and robust (88.8%, n = 202). Through trial participation and daily measurements most of the patients (85.5%, n = 195) felt more confident in dealing with their disease than before. The perception of the nurses and physicians of the telemedical centers was professional (92.1%, n = 210 and 89.9%, n = 205) and committed (94.3%, n = 215 and 91.7%, n = 209). Also more than half of the patients noticed an improvement in the contact with their primary physician (52.6%, n = 120); and for 46.1% (n = 105) the contact has not been changed. Conclusions RPM will be a medical care concept for recently hospitalized HF- patients in the near future but the optimal telemedical setting of RPM and the duration of this intervention have to be defined in further clinical trials.

Embedded fall and activity monitoring for a wearable ambient assisted living solution for older adults

With the rapidly increasing over 60 and over 80 age groups in society, greater emphasis will be put on technology to detect emergency situations, such as falls, in order to promote independent living. This paper describes the development and deployment of fall-detection, activity classification and energy expenditure algorithms, deployed in a tele-monitoring system. These algorithms were successfully tested in an end-user trial involving 9 elderly volunteers using the system for 28 days.