Telemonitoring of outpatients with heart failure: a search for the holy grail?
ABSTRACT Heart failure (HF) remains a large medical problem, and prevention of decompensation and HF-related hospitalizations is important, not only for the patient, but also from an economic point of view. Close monitoring is crucial, and can be done through a whole spectrum of modalities. This ranges from a (nurse-based) disease management program, to structured telephone support, to remote or telemonitoring with or without the use of an implantable device(1-3). (SELECT FULL TEXT TO CONTINUE).
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ABSTRACT: Remote monitoring (RM) in patients with advanced heart failure and cardiac resynchronization therapy defibrillators (CRT-D) may reduce delays in clinical decisions by transmitting automatic alerts. However, this strategy has never been tested specifically in this patient population, with alerts for lung fluid overload, and in a European setting. The main objective of Phase 1 (presented here) is to evaluate if RM strategy is able to reduce time from device-detected events to clinical decisions. In this multicenter randomized controlled trial, patients with moderate to severe heart failure implanted with CRT-D devices were randomized to a Remote group (with remote follow-up and wireless automatic alerts) or to a Control group (with standard follow-up without alerts). The primary endpoint of Phase 1 was the delay between an alert event and clinical decisions related to the event in the first 154 enrolled patients followed for 1 year. The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group: 2 (25(th)-75(th) percentile, 1-4) days vs 29 (25(th)-75(th) percentile, 3-51) days respectively, P=.004. In-hospital visits were reduced in the Remote group (2.0 visits/patient/year vs 3.2 visits/patient/year in the Control group, 37.5% relative reduction, P<.001). Automatic alerts were successfully transmitted in 93% of events occurring outside the hospital in the Remote group. The annual rate of all-cause hospitalizations per patient did not differ between the two groups (P=.65). RM in CRT-D patients with advanced heart failure allows physicians to promptly react to clinically relevant automatic alerts and significantly reduces the burden of in-hospital visits. Clinicaltrials.gov NCT00885677; http://clinicaltrials.gov/show/NCT00885677 (Archived by WebCite at http://www.webcitation.org/6IkcCJ7NF).Journal of Medical Internet Research 01/2013; 15(8):e167. · 3.77 Impact Factor
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ABSTRACT: Heart failure patients with implantable defibrillators place a significant burden on health care systems. Remote monitoring allows assessment of device function and heart failure parameters, and may represent a safe, effective, and cost-saving method compared to conventional in-office follow-up. We hypothesized that remote device monitoring represents a cost-effective approach. This paper summarizes the economic evaluation of the Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators (EVOLVO) study, a multicenter clinical trial aimed at measuring the benefits of remote monitoring for heart failure patients with implantable defibrillators. Two hundred patients implanted with a wireless transmission-enabled implantable defibrillator were randomized to receive either remote monitoring or the conventional method of in-person evaluations. Patients were followed for 16 months with a protocol of scheduled in-office and remote follow-ups. The economic evaluation of the intervention was conducted from the perspectives of the health care system and the patient. A cost-utility analysis was performed to measure whether the intervention was cost-effective in terms of cost per quality-adjusted life year (QALY) gained. Overall, remote monitoring did not show significant annual cost savings for the health care system (€1962.78 versus €2130.01; P=.80). There was a significant reduction of the annual cost for the patients in the remote arm in comparison to the standard arm (€291.36 versus €381.34; P=.01). Cost-utility analysis was performed for 180 patients for whom QALYs were available. The patients in the remote arm gained 0.065 QALYs more than those in the standard arm over 16 months, with a cost savings of €888.10 per patient. Results from the cost-utility analysis of the EVOLVO study show that remote monitoring is a cost-effective and dominant solution. Remote management of heart failure patients with implantable defibrillators appears to be cost-effective compared to the conventional method of in-person evaluations. ClinicalTrials.gov NCT00873899; http://clinicaltrials.gov/show/NCT00873899 (Archived by WebCite at http://www.webcitation.org/6H0BOA29f).Journal of Medical Internet Research 01/2013; 15(5):e106. · 3.77 Impact Factor
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ABSTRACT: Abstract Introduction: Telemedicine systems consist of collection, transmission, and analysis of biometric data essentially based on instrumental measures. Our goal was to evaluate if information collected from patients has an incremental informative value in automatically rating the patient's health status. Materials and Methods: We present preliminary results of a new telemedicine system (ASCOLTA) obtained by observation of 12 heart failure patients (New York Heart Association Class IIb-III). Instrumental data (electrocardiogram, oxygen saturation level, and respiration rate) were wirelessly collected daily together with clinical data (weight, heart rate, and blood pressure values) and patients' information obtained through a Web-based questionnaire, simulating a virtual medical visit. Health status was independently judged by two blinded cardiologists and by the patient's cardiologist on the basis of 348 daily clinical reports. Random forest classification analysis was applied to 240 complete clinical report variables in order to estimate the judged health status. Results: The use of "patient's information" led to a better predictive ability in comparison with using only physiological parameters assessed by instruments. The complete set of variables (Patient+Instrumental) achieved 84% concordance, compared with 72% for the instrumental-only variables and 69% for the patient-only variables. The receiver operator characteristics curves graphically confirmed the described results. Conclusions: Patients have an active role in home monitoring, and their information appears relevant for a new telemedicine approach integrating subjective and objective vital signs. Combining patient information with instrumental parameters, it is possible to achieve a more correct automatic classification of health status of heart failure patients.Telemedicine and e-Health 04/2014; 20(6):508-521. · 1.40 Impact Factor