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

Mateusz Tajstra, Adam Sokal, Arkadiusz Gwóźdź, Marcin Wilczek, Adam Gacek, Konrad Wojciechowski, Elżbieta Gadula-Gacek, Elżbieta Adamowicz-Czoch, Katarzyna Chłosta-Niepiekło, Krzysztof Milewski, Piotr Rozentryt, Zbigniew Kalarus, Mariusz Gąsior, Lech Poloński, Mateusz Tajstra, Adam Sokal, Arkadiusz Gwóźdź, Marcin Wilczek, Adam Gacek, Konrad Wojciechowski, Elżbieta Gadula-Gacek, Elżbieta Adamowicz-Czoch, Katarzyna Chłosta-Niepiekło, Krzysztof Milewski, Piotr Rozentryt, Zbigniew Kalarus, Mariusz Gąsior, Lech Poloński

Abstract

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).

Keywords: RESULT study; heart failure; integrated platform; remote monitoring.