This document describes the design and implementation of the Cardiac Implantable Electronic Devices Adverse Events Reporting System (CIEDAERS). CIEDAERS is a web-based platform designed to facilitate the prospective collection and management of adverse event data from a multicenter registry of over 1,300 cardiac implantable electronic device procedures. The platform integrates data from electronic health records, a research data capture system, and a business process management software to provide a user-friendly interface for reporting adverse events according to regulatory standards. Analysis of data collected through CIEDAERS found that 4.5% of patients experienced complications before discharge from the hospital and 4.1% experienced complications within the first 6 months. The authors conclude that

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Abstract ID: 280
Primary Contact: Katia Silva, University of Sao Paulo, katia.research@gmail.com (mailto:katia.research@gmail.com)
All Authors: Katia Silva, University of Sao Paulo, katia.research@gmail.com (mailto:katia.research@gmail.com) (Presenter)
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References: "Silva KR, Costa R, Crevelari ES, Lacerda MS, Albertini CMM, Martinelli Filho M, Santana JE, Vissoci JRN, Pietrobon
R, Barros JV. Glocal Clinical Registries: Pacemaker Registry Design and Implementation for Global and Local
Integration ? Methodology and Case Study. PLOS One 2013;8(7):e71090. Gliklich RE, Dreyer NA, editors (2010)
Registries for Evaluating Patient Outcomes: A User's Guide. 2nd edition. Rockville (MD): Agency for Healthcare
Research and Quality (US)."
General topics: Health technology assessments (including new and emerging technologies)
Title: Cardiac Implantable Electronic Devices Adverse Events Reporting System (CIEDAERS): design and implementation
of a remote tool for prospective multicenter studies
Background:
The reporting of serious adverse events is a requirement for clinical studies necessary to ensure the protection of
human subjects. The reporting process is a multi­step procedure, involving a number of individuals from initiation
to final review, and must be completed in a timely fashion.
Objectives:
To effectively satisfy these requirements, we developed an electronic Adverse Events Reporting System (AERS)
web platform designed for cardiac implantable electronic devices (CIED) patients denominated as CIED_AERS.
Methods:
Prospective and multicenter registry of all CIED procedures performed at 13 cardiology centers. Outcome
measures included: complications, mortality, re­operations, re­hospitalizations and costs over 12­months of follow­
up. The CIED_AERS platform was designed according to the requirements of regulatory agencies and the adverse
events vocabulary was based on validated international medical terminology (MedDRA, AHA/ACC). CIED_AERS
combines three different data sources: electronic health records, REDCap (Research Electronic Data Capture) and a
Business Process Management (BPM) software in order to provide a simple and user­friendly interface for data
collection and management.
Results:
Data from 1,334 consecutive CIED procedures performed between January 2014 and January 2015 were collected
by using the CIED_AERS platform. The majority of patients (53.1%) underwent new CIED implants. Median age
was 68 years (range: 1 day to 99 years old). A total of 55 patients (4.5%) experienced at least one complication
before the discharge and 48 (4.1%) within the first 6 months. A total of 15 (1.6%) patients died. Three patients
died from infection related to the CIED procedure. According to the Adverse Events Committee there was no
indication that any other patients died from procedure­related complications.
Conclusions:

2. CIED_AERS is a flexible and suitable solution to perform the reporting and monitoring of adverse events in
multicenter research settings. Such approach has the potential to facilitate data integration between health care
and research settings, also being an useful framework to be used in other biomedical registries.
Health Technology Assessment international
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