Elżbieta Gadula-Gacek

REmote SUpervision to Decrease HospitaLization RaTe. Unified and integrated platform for data collected from devices manufactured by different companies: Design and rationale of the RESULT study.

The number of patients with heart failure implantable cardiac electronic devices (CIEDs) is growing. Hospitalization rate in this group is very high and generates enormous costs. To avoid the need for hospital treatment, optimized monitoring and follow‐up is crucial. Remote monitoring (RM) has been widely put into practice in the management of CIEDs but it may be difficult due to the presence of differences in systems provided by device manufacturers and loss of gathered data in case of device reimplantation. Additionally, conclusions derived from studies about usefulness of RM in clinical practice apply to devices coming only from a single company. An integrated monitoring platform allows for more comprehensive data analysis and interpretation. Therefore, the primary objective of Remote Supervision to Decrease Hospitalization Rate (RESULT) study is to evaluate the impact of RM on the clinical status of patients with ICDs or CRT‐Ds using an integrated platform. Six hundred consecutive patients with ICDs or CRT‐Ds implanted will be prospectively randomized to either a traditional or RM‐based follow‐up model. The primary clinical endpoint will be a composite of all‐cause mortality or hospitalization for cardiovascular reasons within 12 months after randomization. The primary technical endpoint will be to construct and evaluate a unified and integrated platform for the data collected from RM devices manufactured by different companies. This manuscript describes the design and methodology of the prospective, randomized trial designed to determine whether remote monitoring using an integrated platform for different companies is safe, feasible, and efficacious (ClinicalTrials.gov Identifier: NCT02409225).

The impact of remote monitoring of implanted cardioverter-defibrillator (ICD) and cardiac resynchronization therapy device (CRT-D) patients on healthcare costs in the Silesian population: 3-year follow-up.

BACKGROUND The population of patients with implanted cardioverter-defibrillators (ICD) and cardiac resynchronisation therapy devices (CRT-D) is constantly growing. The use of remote-monitoring (RM) techniques in this group can significantly improve clinical outcomes, but there are limited data about the impact of RM on healthcare costs from a payers perspective. AIM The aim of the study was to assess the impact on costs for the healthcare system of RM in patients with ICD or CRT-D. METHODS We examined a cohort of 842 patients with ICD or CRT-D. The group was divided into two groups based on RM (or no RM [NRM]), matched according to important clinical characteristics. The subjects were followed for a maximum of three years after implantation (mean follow-up 2.11 ± 0.83 years). The overall costs for the healthcare provider in the follow-up were defined as the primary endpoint. The secondary endpoint was the use of different types of medical contact events: hospitalisation and number of in-clinic and general practitioner visits (without the number of remote transmissions). RESULTS In the three-year follow-up, the reduction in the costs of treatment for National Health Care in the RM group was 33.5% (median value, p < 0.001). In patients with implanted CRT-D, the reduction reached 42.7% (p = 0.011), and with ICD it was 31.3% (p = 0.007). We observed no significant reduction in the median hospitalisation costs in the three-year follow-up in the RM group (p = NS), despite a 25% drop in the mean value. The costs of outpatient visits were slightly higher in the RM group (p = NS). In the follow-up period, there was no reduction in the number of medical contact events (p = NS). CONCLUSIONS Remote monitoring in patients with implanted ICD or CRT-D devices reduces the cost for the national healthcare provider.

Telemonitoring pacjentów z niewydolnością serca Doświadczenia oddziału kardiologii uzyskane podczas realizacji projektu MONITEL-HF

In hereby publication the authors shall present the solution encompassing the combination of well-known and verified organisational and technological solutions in the new field of services, namely telemedical monitoring in patients with heart failure, on the example of the research and development project MONITEL-HF co-financed by the National Centre for Research and Development within STRATEGMED Programme. Dynamic development of modern medical devices with integrated electronics saving or supporting life has caused the increase of diagnostic data sent in a specific format and time regime to medical centres for the purpose of their verification. The decisions which may be made on their basis depend on the quality and speed of processing of these data to the form acceptable to the medical personnel as well as on the degree of an organisation preparation for the process of their analysis. MONITEL-HF uses the elements of the Information Technology Infrastructure Library (ITIL) for IT departments. ITIL constitutes the most widespread collection of the best practice applied in many enterprises and governmental organisations for the purpose of appropriate management of IT services. An application was developed, for which the basic premise of its implementation was the principle of minimalism in the approach to communication, understood as the ability to eliminate sources of useless information. Only those data that are needed to perform the work by the person concerned or that may influence the quality of life of the monitored patient (eg patient activity constituting a good indicator of his or her own health) are collected and processed. This selection has made it possible to reduce the burden on physicians, redirect the majority of activities to more nursing staff, and focus on the most urgent cases. Productivity has been enhanced and the foundation for providing the best possible relationship with the patient, regardless of the history of pacemaker implantation, cardioverter defibrillators or resynchronizing devices. Cardiology is one of the few areas where healthcare professionals can start medical intervention in a patient who may not be aware of the risk. Focusing on really important information is extremely important when medical data is slowly beginning to meet the definition of Big Data.