Diagnostic accuracy of a new detection algorithm for atrial fibrillation in cardiac telemonitoring with portable electrocardiogram devices.

BACKGROUND: Telemedical approaches targeting cardiac outpatients try to include electrocardiogram (ECG) analysis. Increasing numbers of monitored patients require automated preanalysis of the ECG to prioritize the evaluation for the clinical professional to enable an efficient intervention. METHODS: ECGs were recorded from 60 patients, both with a standard 12-lead ECG and with a new handheld ECG device having dry electrodes for direct skin contact. Recordings of the handheld device were automatically analyzed by a new algorithm. The 12-lead recordings were evaluated by a blinded cardiologist and then compared to the automated analysis of the handheld ECG. Sensitivity and specificity of the algorithm for the detection of atrial fibrillation (AF) were calculated. RESULTS: A total of 60 ECG strips having 122 ± 36 beats were registered. One hundred percent of the ECG strips were sufficient for automated heart rate count; 96.6%, for automated AF analysis; and 80%, for PQ, QRS, and QTc time measurements. AF detection had a sensitivity of 92.9% and a specificity of 90.9%. There was no difference in heart rate count between automated and manual analysis (median, 71 vs 70 beats per minute; P = .51). Automated measurements of a summary complex showed no difference for PQ time (165 vs 161 milliseconds, P = .50) but overestimated QRS (119 vs 90 milliseconds, P = .001) and QTc (489 vs 417 milliseconds, P < .001) times as compared to the 12-lead recordings analyzed manually. CONCLUSION: The new algorithm is suitable for automated preanalysis of the ECG data with regard to AF. It could be used for rapid selection of ECGs with relevant rhythm abnormalities from a large pool. Electrocardiographic data remain to be evaluated by health care professionals for exact diagnosis.

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 of the intervention.

BACKGROUND: 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. OBJECTIVE: The objective of the present article is to describe the design of a new trial investigating the impact of RPM on unplanned cardiovascular hospitalisations and mortality in HF patients. METHODS: The TIM-HF2 trial is designed as a prospective, randomised, controlled, parallel group, open (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection. Eligible patients with HF are randomised (1:1) to either RPM + usual care or to usual care only and are followed for 12 months. The primary outcome is the percentage of days lost due to unplanned cardiovascular hospitalisations or all-cause death. The main secondary outcomes are all-cause and cardiovascular mortality. CONCLUSION: The TIM-HF2 trial will provide important prospective data on the potential beneficial effect of telemedical monitoring and RPM on unplanned cardiovascular hospitalisations and mortality in HF patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01878630.

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.