Non-invasive telemedical care in heart failure patients and stroke: post hoc analysis of TIM-HF and TIM-HF2 trials.

AIMS: Patients with chronic heart failure (CHF) have an increased risk of ischaemic stroke. We aimed to identify the incidence rate and factors associated with ischaemic stroke or transient ischaemic attack (TIA) in CHF patients as well as the impact of non-invasive telemedical care (NITC) on acute stroke/TIA. METHODS AND RESULTS: We retrospectively analysed baseline characteristics of 2248 CHF patients enrolled to the prospective multicentre Telemedical Interventional Monitoring in Heart Failure study (TIM-HF) and Telemedical Interventional Management in Heart Failure II study (TIM-HF2), randomizing New York Heart Association (NYHA) II/III patients 1:1 to NITC or standard of care. Hospitalizations due to acute ischaemic stroke or TIA during a follow-up of 12 months were analysed. Old age, hyperlipidaemia, lower body mass index, and peripheral arterial occlusive disease (PAOD) were independently associated with present cerebrovascular disease on enrolment. The stroke/TIA rate was 1.5 per 100 patients-years within 12 months after randomization (n = 32, 1.4%). Rate of stroke/TIA within 12 months was in the intervention group similar compared with the control group (50.0% vs. 49.8%; P = 0.98) despite that the rate of newly detected atrial fibrillation (AF) was higher in the intervention group (14.1% vs. 1.6%; P < 0.001). A history of PAOD (OR 2.7, 95% CI 1.2-6.2; P = 0.02) and the highest tertile (OR 3.0, 95% CI 1.1-8.3) of N-terminal pro-brain natriuretic peptide (NT-proBNP) on enrolment were associated with stroke/TIA during follow-up. In patients who suffered acute stroke or TIA during follow-up, echocardiography was part of the diagnostic workup in only 56% after hospital admission. CONCLUSIONS: Annual rate of ischaemic stroke/TIA in NYHA II/III patients is low but higher in those with elevated NT-proBNP levels and history of PAOD at baseline. NITC showed no impact on the stroke rate during 1 year follow-up despite a significantly higher rate of newly detected AF. Irrespective of known CHF, echocardiography was often missing during in-hospital diagnostic workup after acute stroke/TIA.

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.

Tele-accelerometry as a novel technique for assessing functional status in patients with heart failure: feasibility, reliability and patient safety.

BACKGROUND: The six-minute walk test (6MWT) is an established measure of functional exercise capacity associated with clinical prognosis in Chronic Heart Failure (CHF). The aim of this study is to evaluate the employment of tele-accelerometry for the remote assessment of 6MWT in CHF. METHODS: 155 patients were subjected to tele-accelerometry in form of monthly 6MWTs in their home surroundings. Accelerometer output included steps/6 min and walking speed. Data was directly transferred via mobile network to the Telemedicine Centre subsequent to test completion. 6MWT distance was measured by hand wheel and steps were counted with a digital hand-counter at baseline (Test 1) and at 12 months follow-up (Test 2). RESULTS: Accelerometer accuracy was within the 99th percentile. There was a significant correlation between step count, walking speed and measured 6MWT distance (Test 1: steps: r=0.80, P<0.001; Test 2: steps: r=0.90, P<0.001 and Walking Speed Test 1: r=0.80, P<0.001; Walking Speed Test 2: r=0.86, P<0.001). The reproducibility of tele-accelerometry was within 95% margin for all performance parameters, which showed stronger associations to quality of life questionnaire (Short Form - 36) Physical Component Score (PCS) than New York Heart Association (NYHA) functional class. CONCLUSION: Tele-accelerometry is feasible in patients with CHF and output parameters are indicative of exercise capacity. The benefit of this approach lies in its simplicity under every day circumstances by enabling routine performance testing to assess patients' functional status.

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.

Telemedicine in heart failure: pre-specified and exploratory subgroup analyses from the TIM-HF trial.

BACKGROUND: Meta-analyses have suggested that remote telemedical management (RTM) positively affects clinical outcomes in chronic HF patients. The results of two recent randomised RTM trials do not corroborate these results. We aim to report prospectively defined and exploratory subgroup analyses for the TIM-HF trial and to identify a patient profile that could potentially benefit from RTM for further investigation in randomised clinical trials. METHODS: In TIM-HF, 710 stable chronic HF patients, in NYHA class II or III with a history of HF decompensation within 2 years previously or a LVEF ≤ 25% were randomly assigned (1:1) to RTM or usual care. The primary outcome was total death and secondary outcomes included days lost due to death or HF hospitalisation and a composite of cardiovascular death and HF hospitalisation. Twelve subgroups were prospectively defined and patient profiling was investigated for the subgroup with a prior history of HF decompensation, an LVEF ≥ 25% and a PHQ-9 score<10. RESULTS: The subgroup treatment effects were significant for total mortality for the PHQ-9 subgroup only (p for interaction<0.027). For the outcome 'number of days lost due to hospitalisation for HF or death', the subgroup treatment effects were significant (p for interaction<0.05) for patients with a prior HF decompensation or an ICD implant or a PHQ score of <10 and for the patient-profiling subgroup. CONCLUSIONS: Telemedicine management may not be appropriate for all HF patients. Future research needs to investigate which HF population may benefit from this intervention.

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.

AIMS: 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. Methods CHF patients [New York Heart Association (NYHA) II/III, left ventricular ejection fraction (LVEF)≤35%] with a history of cardiac decompensation with hospitalization in the past or therapy with intravenous diuretics in the prior 24 months (no decompensation required if LVEF≤25%) were randomized 1:1 to an intervention group of daily remote device monitoring (electrocardiogram, blood pressure, body weight) coupled with medical telephone support or to usual care led by the patients' local physician. In the intervention group, 24/7 physician-led medical support was provided by two central telemedical centres. A clinical event committee blinded to treatment allocation assessed cause of death and reason for hospitalization. The primary endpoint was total mortality. The first secondary endpoint was a composite of cardiovascular mortality or hospitalization due to heart failure. Other secondary endpoints included cardiovascular mortality, all-cause and cause-specific hospitalizations (all time to first event) as well as days lost due to heart failure hospitalization or cardiovascular death (in % of follow-up time), and changes in quality of life and NYHA class. Overall, 710 CHF patients were recruited. The mean follow-up was 21.5±7.2 months, with a minimum of 12 months. Perspective The study will provide important prospective outcome data on the impact of telemedical management in patients with CHF.