title: 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.
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).
authors.affiliation: 3rd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia, Katowice, Silesian Center for Heart Disease in Zabrze, Poland.
authors.forename: Mateusz
authors.initials: M
authors.lastname: Tajstra
authors.affiliation: Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Silesian Center for Heart Diseases, Medical University of Silesia, Zabrze, Poland.
authors.forename: Adam
authors.initials: A
authors.lastname: Sokal
authors.affiliation: WASKO SA, Gliwice, Poland.
authors.forename: Arkadiusz
authors.initials: A
authors.lastname: Gwóźdź
authors.affiliation: WASKO SA, Gliwice, Poland.
authors.forename: Marcin
authors.initials: M
authors.lastname: Wilczek
authors.affiliation: Institute of Medical Technology and Equipment, Zabrze, Poland.
authors.forename: Adam
authors.initials: A
authors.lastname: Gacek
authors.affiliation: Polish-Japanese Academy of Information Technology, Bytom, Poland.
authors.forename: Konrad
authors.initials: K
authors.lastname: Wojciechowski
authors.affiliation: 3rd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia, Katowice, Silesian Center for Heart Disease in Zabrze, Poland.
authors.forename: Elżbieta
authors.initials: E
authors.lastname: Gadula-Gacek
authors.affiliation: 3rd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia, Katowice, Silesian Center for Heart Disease in Zabrze, Poland.
authors.forename: Elżbieta
authors.initials: E
authors.lastname: Adamowicz-Czoch
authors.affiliation: WASKO SA, Gliwice, Poland.
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Chłosta-Niepiekło
authors.affiliation: Center for Cardiovascular Research and Development, American Heart of Poland SA, Katowice, Poland.
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Milewski
authors.affiliation: 3rd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia, Katowice, Silesian Center for Heart Disease in Zabrze, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Rozentryt
authors.affiliation: Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Silesian Center for Heart Diseases, Medical University of Silesia, Zabrze, Poland.
authors.forename: Zbigniew
authors.initials: Z
authors.lastname: Kalarus
authors.affiliation: 3rd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia, Katowice, Silesian Center for Heart Disease in Zabrze, Poland.
authors.forename: Mariusz
authors.initials: M
authors.lastname: Gąsior
authors.affiliation: 3rd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia, Katowice, Silesian Center for Heart Disease in Zabrze, Poland.
authors.forename: Lech
authors.initials: L
authors.lastname: Poloński
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017147:Defibrillators, Implantable / Q000706:statistics & numerical data*; D005260:Female; D006333:Heart Failure / Q000628:therapy*; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000706:statistics & numerical data*; D011446:Prospective Studies; D012107:Research Design; D017216:Telemedicine / Q000379:methods*; D055815:Young Adult
keywords: RESULT study; heart failure; integrated platform; remote monitoring