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Cardiac Implantable Electronic Devices Adverse Events Repor7ng System (CIEDAERS): Design and Implementa7on of a Remote Tool for Prospec7ve Mul7center Studies
Ka#a R. Silva1, Lucas Bassolli1, Ta#ana Kawauchi1, Caio Alber#ni1, Jacson Barros2, Isabela Maurino1, Giovanna Melo1, Mar#no Mar#nelli1, Roberto Costa1
1 Heart Ins#tute (InCor) – Clinics Hospital of the University of Sao Paulo Medical School, 2Clinics Hospital of the University of Sao Paulo Medical School (NETI) – São Paulo, Brazil
BACKGROUND
OBJETIVE
METHODS
Ø 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
Ø Adverse Events* § In-‐hospital mortality= 0.5 to 1.4% § Procedure associated complica#ons= 0.5 to 3.6% *Data derived from randomized trials
Ø 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 CIEDAERS with REDCap and Electronic Health Records.
Ø SeNngs § Mul#center study § 12 cardiology centers § IRB – University of São Paulo Medical School
Ø Study Popula7on § Subjects submiXed to PM or ICD procedures
Ø CIEDAERS Data Sources § REDCap § Electronic Health Records § Business Process Management (BPM) sofware
Ø CIEDAERS 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 age-‐appropriate instrumental ac#vi#es of daily living (ADL).
2
Severe= hospitaliza#on or prolonga#on of hospitaliza#on indicated; disabling; limi#ng self-‐care ADL.
3
Life-‐threatening 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 CIEDAERS A8ribu:on Standards
Funding: CNPq/ REBRATS (Brazil Government Agency) – Grant Proposal # 401317/2013-‐7 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
CIEDAERS Diagram Process According to Severity
CONCLUSIONS
RESULTS
Cardiac Implantable Electronic Devices Adverse Events Repor7ng System (CIEDAERS): Design and Implementa7on of a Remote Tool for Prospec7ve Mul7center Studies
Ka#a R. Silva1, Lucas Bassolli1, Ta#ana Kawauchi1, Caio Alber#ni1, Jacson Barros2, Isabela Maurino1, Giovanna Melo1, Mar#no Mar#nelli1, Roberto Costa1
1 Heart Ins#tute (InCor) – Clinics Hospital of the University of Sao Paulo Medical School, 2Clinics Hospital of the University of Sao Paulo Medical School (NETI) – São Paulo, Brazil
Ø User-‐friendly dashboard interface Ø Report builder tools Ø Mul#-‐site access Ø User defined hierarchies Ø Sta#s#cs on the performance of each processes steps
§ AE No#fica#on § AE Descrip#on § Quality Control § MDs Reviewers § AE Adjudica#on
Ø Time-‐sensi#ve reports Ø Step-‐by-‐step wizard guides users through the detailed process of collec#ng the necessary informa#on
Ø AE Dic#onary (drop-‐down lists) Ø Grading scale for each AE Ø Cri#cal AE Documents (file upload) Ø Tracking process is performed by the AE CommiXee
CIEDAERS Features Home
AE Repor:ng
Surgical Characteris7cs
Demographics (N= 2,548 pa7ents)
Baseline Clinical Characteris7cs
Adverse Events (n=427)
Male 52%
Female 48%
27 23 66 80 171
315
584 678
518
86
0
200
400
600
800
1a 2a 3a 4a 5a 6a 7a 8a 9a 10a
Pa7e
nts (n)
Decade of Life
Distribu7on by age Distribu7on by gender
Mean= 66.6±17.6 Min= 1 day Max= 99.9 y
I 49%
II 28%
III 20%
IV 3%
Func7onal Class (NYHA)
AV block 41%
Ischemic cardiom. 14%
Nonischemic 20%
Chagas 16%
CHD 4%
Others 5%
Underlying heart disease
PM 72%
ICD 14%
CRT-‐P 8%
CRT-‐D 6%
Distribu7on by CIED type Procedure Performed
First implant 55%
Reopera7on 45%
Ø CIEDAERS is a flexible and suitable solution to perform the reporting and monitoring of AE in multicenter research settings.
Ø Future Enhancements § Improvements in CIEDAERS and REDCap and EHR integration (flag AE)
Ø Potential uses § CIEDAERS can be easily customized in order to be used in different medical specialties and patient conditions.
Intraop 8%
Discharge 33%
Follow-‐up 1m 32%
Follow-‐up 6m 21%
Follow-‐up 12m 6%
22
57 40
23 4
8
17
16
7 4
33
46
34
6
38 33
28
17
0
20
40
60
80
100
120
140
160
Intra Discharge 1 month 6 month 12 month Definite Probable Unrelated Unlikely
12 8 5 1 11
45 69
30
7
12
57
50
39
13 7
5 1
9
1 2
26 11
9
5
0
20
40
60
80
100
120
140
160
Intra Discharge 1 month 6 month 12 month Mild Moderate Severe Life=threatening Death
AE by Study Period Adverse Event vs Procedure Adverse Event Severity
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