Avaliação remota dos dispositivos cardíacos eletrônicos implantáveis - nova metodologia de uso em Manaus

Abstract

BACKGROUND: Remote interrogation of implantable electronic cardiac devices (DCEIs) is an important tool for tracking patients with these devices, especially in places where access to the reference medical center is hampered by the geographical distances and their costs. These difficulties are most evident in Amazonas, the largest state in Brazil, possessing continental dimensions and unique topography, in which the main transportation route is the river, and which has only one reference center for face-to- face assessment of the DCEI, in the State Capital. OBJECTIVE: To demonstrate that the remote interrogation of DCEI is as effective as the in-person interrogation in the diagnosis of the proper functioning of the devices. METHODS: Eighty-eight patients with DCEI manufactured by BiotronikR who were already assisted by the Pacemaker and Electrophysiology Service of the Francisca Mendes University Hospital (HUFM) were selected. Patients were randomized into two groups of 44 patients, one for in- person evaluation (Group P - questioned by the investigating physician) and one for remote interrogation (Group R - questioned by a non-medical professional) after applying the inclusion and exclusion criteria. The two groups had their DCEIs evaluated monthly over a period of four months. The parameters, obtained with the adjusted HUFM’s DCEI self-assessment protocol, as battery status, leads impedance, sense and stimulations thresholds, and also DCEI’s alerts, were transcribed in a data collection form for the two groups, as well as sent by the "ReportShare" system to manufacturer’s data center, such as in a telemedicine system. The collected data remained secretly guarded in the cloud and were later reanalyzed by an auditor who was blinded to which group the information came from. The information, recorded in the instrument of data collection, as well as those stored in the data center, were tabulated for statistical treatment. RESULTS: There were 349 evaluations for the in- person and remote interrogation groups, and 344 evaluations registered in the manufacturer’s database. The self-evaluation protocol was able to obtain all the necessary parameters for DCEI’s evaluation in 86.82% of the cases and the "ReportShare" system properly sent the data to the manufacturer's database in 98.57% of them, allowing the DCEI’s function diagnosis in 93.6% of the evaluations. CONCLUSION: The self-assessment protocol, obtaining the necessary parameters for DCEI’s diagnostic functioning, and the programmer’s ReportShare system, transmitting the self-assessment protocol acquired information to the manufacturer’s database, were found to be useful in the DCEI follow-up. They conferred an earlier time-response to critical events than that of the in-person conventional evaluation, without presenting a statistically significant difference between the obtained values for the evaluated parameters and allowed a diagnosis of critical DCEI dysfunctions.