Cardiac Implantable Electronic Devices Adverse Events Repor7ng System ( CIED AERS): Design and Implementa7on of a Remote Tool for Prospec7ve Mul7center Studies Ka#a R. Silva 1 , Lucas Bassolli 1 , Ta#ana Kawauchi 1 , Caio Alber#ni 1 , Jacson Barros 2 , Isabela Maurino 1 , Giovanna Melo 1 , Mar#no Mar#nelli 1 , Roberto Costa 1 1 Heart Ins#tute (InCor) – Clinics Hospital of the University of Sao Paulo Medical School, 2 Clinics Hospital of the University of Sao Paulo Medical School (NETI) – São Paulo, Brazil BACKGROUND OBJETIVE METHODS Cardiac implantable electronic devices (CIED) More than 4 million people worldwide have a pacemaker (PM) or an implantable cardioverter defibrillator (ICD) More than 730.000 new procedures are performed each year LiXle is known regarding safety and adverse events rates Adverse Events* Inhospital mortality= 0.5 to 1.4% Procedure associated complica#ons= 0.5 to 3.6% *Data derived from randomized trials Mo7va7on for specific AE documenta7on and repor7ng Repor#ng of serious AE is a requirement in clinical inves#ga#ons Ensures human subject safety AE should be precisely and uniformly documented Facilitates accurate analysis of effects and costs of medical interven#ons We describe an electronic Adverse Events Repor#ng System (AERS) designed at our ins#tu#on to enhance efficiency, completeness and consistency of repor#ng adverse events in pa#ents submiXed to CIED procedures, in both the hospital and outpa#ent seengs. In addi#on, we integrate the CIED AERS with REDCap and Electronic Health Records. SeNngs Mul#center study 12 cardiology centers IRB – University of São Paulo Medical School Study Popula7on Subjects submiXed to PM or ICD procedures CIED AERS Data Sources REDCap Electronic Health Records Business Process Management (BPM) sofware CIED AERS Data Terminology MedDRA and AHA/ACC vocabulary Severity Grade No AE (or within normal limits) 0 Mild= asymptoma#c or mild symptoms; clinical or diagnos#c observa#ons only; interven#on not indicated. 1 Moderate= minimal, local, or noninvasive interven#on indicated; limi#ng ageappropriate instrumental ac#vi#es of daily living (ADL). 2 Severe= hospitaliza#on or prolonga#on of hospitaliza#on indicated; disabling; limi#ng selfcare ADL. 3 Lifethreatening consequences; urgent interven#on indicated. 4 Death related to AE. 5 Adverse Event Severity is defined by a grading scale Rela7onship APribu7on Descrip7on Unrelated to inves#ga#onal agent/ interven#on Unrelated The AE is clearly NOT related to the interven#on Unlikely The AE is doubjully related to the interven#on Related to inves#ga#onal agent/ interven#on Possible The AE may be related to the interven#on Probable The AE is likely related to the interven#on Definite The AE is clearly related to the interven#on Defining CIED AERS A8ribu:on Standards Funding: CNPq/ REBRATS (Brazil Government Agency) – Grant Proposal # 401317/20137 Intellectual Property Rights (under registra#on process) Adverse Event Study Workflow Yes No Yes Adverse Event (AE) 2 MDs Review the AE The case is sent for the CommiXee Review Adjudicated data goes into the study database (1) Is it serious (Grade ≥ 3)? (2) Do the 2 MDs agree? (3) Is the required documenta#on present and cri#cal variables clean? Automa7c email to the site responsible for AE repor7ng CIED AERS Diagram Process According to Severity