Kerstin 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.

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.

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.

Prognostic value of serial six-minute walk tests using tele-accelerometry in patients with chronic heart failure: A pre-specified sub-study of the TIM-HF-Trial

Background The six-minute walk test (6MWT) is an established functional test assessing exercise capacity and is used to predict clinical prognosis in patients with chronic heart failure (HF). Tele-accelerometry is a novel approach to activity monitoring using telemedical data transfer and allows a Tele-6MWT to be performed in an outpatient setting. It offers patients the option of performing simple serial follow-up tests in their own home. Aims The aim of this study was to investigate the prognostic value of serial Tele-6MWTs using tele-accelerometry in patients with HF. Design/methods In this proof-of-concept study, 155 patients with HF completed the Tele-6MWT in an outdoor setting once per month over a period of 0.25–21 months. We analysed the differences in the number of steps over time to predict hospitalization as a result of HF or death. Results Patients with at least one event (n = 31) recorded a lower number of steps and a shorter distance in Tele-6MWT at baseline compared with patients who remained event-free (n = 124) (540.1 ± 78.4 steps vs. 601.8 ± 76.7 steps, P < 0.001 respectively; 353.2 ± 82.4 m vs. 418.8 ± 95.6 m, P < 0.001). Patients (n = 19) who performed more than one Tele-6MWT prior to a clinical event showed no significant difference in the number of steps, regardless of whether the baseline test was compared with the last Tele-6MWT before the event or with the last two tests before the event. Conclusion Tele-6MWT has a high predictive value with respect to hospitalization as a result of HF or death from any cause and the results were comparable with the prognostic impact of a conventional 6MWT. Therefore Tele-6MWT may be used as alternative test method in the home environment. However, there is no added prognostic value of repeating Tele-6MWTs on a monthly basis.

Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial

BACKGROUND 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. METHODS 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. FINDINGS 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). INTERPRETATION 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. FUNDING German Federal Ministry of Education and Research.

Telemedical Interventional Management in Heart Failure II (TIM-HF2), a randomised, controlled trial investigating the impact of telemedicine on unplanned cardiovascular hospitalisations and mortality in heart failure patients: study design and description: TIM-HF2: study design

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.

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

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.