ABSTRACT
Objective@#Remote cardiac implantable electronic device (CIED) interrogators, originally developed for home use, have been proven to be efficacious in clinical settings, especially emergency departments. Concern exists that attempting to interrogate a CIED with the remote interrogator of a different brand, i.e., a brand-mismatched interrogator, may cause device malfunction. The aim of this study was to determine if intentionally attempting to interrogate a CIED with a brand-mismatched remote interrogator resulted in device malfunction. @*Methods@#A total of 75 ex vivo CIEDs manufactured by various companies underwent attempted interrogation by a brand-mismatched remote interrogator. CIED settings were compared before and after attempted mismatch interrogation. A total of 30 in vivo CIEDs were then randomized for an attempted 2-minute mismatched remote interrogation by one of the two possible mismatched remote interrogators. CIED settings were compared before and after attempted mismatch interrogation. @*Results@#Of 150 ex vivo brand-mismatched interrogations, no device setting changes or malfunctions occurred; no remote interrogators connected to a mismatched CIED, and no devices were turned off. In the 30 patients undergoing brand-mismatched interrogations, the mean (standard deviation) age was 71.6 ( ± 14.7) years, 16 (53%) were male, with 24 pacemakers (80%), four pacemaker/implantable cardioverter defibrillators (13%), and two implantable cardioverter defibrillators (7%). Of the 30 mismatched interrogations performed, no device setting changes or malfunctions occurred; no remote interrogators connected to a mismatched CIED, and no devices turned off. @*Conclusion@#In a total 180 attempted brand-mismatched CIED interrogations, no CIED malfunctions occurred. This suggests that the use of remote CIED interrogators when device manufacturer is unknown is unlikely to result in adverse CIED-related events.
ABSTRACT
BACKGROUND: We aimed to compare the diagnostic accuracy of the Alere Triage Cardio3 Tropinin I (TnI) assay (Alere, Inc., USA) and the PathFast cTnI-II (Mitsubishi Chemical Medience Corporation, Japan) against the central laboratory assay Singulex Erenna TnI assay (Singulex, USA). METHODS: Using the Markers in the Diagnosis of Acute Coronary Syndromes (MIDAS) study population, we evaluated the ability of three different assays to identify patients with acute myocardial infarction (AMI). The MIDAS dataset, described elsewhere, is a prospective multicenter dataset of emergency department (ED) patients with suspected acute coronary syndrome (ACS) and a planned objective myocardial perfusion evaluation. Myocardial infarction (MI) was diagnosed by central adjudication. RESULTS: The C-statistic with 95% confidence intervals (CI) for diagnosing MI by using a common population (n=241) was 0.95 (0.91-0.99), 0.95 (0.91-0.99), and 0.93 (0.89-0.97) for the Triage, Singulex, and PathFast assays, respectively. Of samples with detectable troponin, the absolute values had high Pearson (R(P)) and Spearman (R(S)) correlations and were R(P)=0.94 and R(S)=0.94 for Triage vs Singulex, R(P)=0.93 and R(S)=0.85 for Triage vs PathFast, and R(P)=0.89 and R(S)=0.73 for PathFast vs Singulex. CONCLUSIONS: In a single comparative population of ED patients with suspected ACS, the Triage Cardio3 TnI, PathFast, and Singulex TnI assays provided similar diagnostic performance for MI.