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.

OBJECTIVE: Patients with implanted cardiac devices may wait extended periods for interrogation in emergency departments (EDs). Our purpose was to determine if device interrogation could be done safely and faster by ED staff. METHODS: Prospective randomized, standard therapy controlled, trial of ED staff device interrogation vs. standard process (SP), with 30-day follow-up. Eligibility criteria: ED presentation with a self-report of a potential device related complaint, with signed informed consent. SP interrogation was by company representative or hospital employee. RESULTS: Of 60 patients, 42 (70%) were male, all were white, with a median (interquartile range) age of 71 (64 to 82) years. No patient was lost to follow up. Of all patients, 32 (53%) were enrolled during business hours. The overall median (interquartile range) ED vs. SP time to interrogation was 98.5 (40 to 260) vs. 166.5 (64 to 412) minutes (P=0.013). While ED and SP interrogation times were similar during business hours, 102 (59 to 138) vs. 105 (64 to 172) minutes (P=0.62), ED interrogation times were shorter vs. SP during non-business hours; 97 (60 to 126) vs. 225 (144 to 412) minutes, P=0.002, respectively. There was no difference in ED length of stay between the ED and SP interrogation, 249 (153 to 390) vs. 246 (143 to 333) minutes (P=0.71), regardless of time of presentation. No patient in any cohort suffered an unplanned medical contact or post-discharge adverse device related event. CONCLUSION: ED staff cardiac device interrogations are faster, and with similar 30-day outcomes, as compared to SP.
Cohort Studies ; Commerce ; Defibrillators, Implantable ; Emergencies* ; Emergency Medicine ; Emergency Service, Hospital* ; Follow-Up Studies ; Humans ; Informed Consent ; Length of Stay ; Lost to Follow-Up ; Male ; Prospective Studies

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.
Acute Coronary Syndrome/*diagnosis ; Biomarkers/analysis ; Emergency Service, Hospital ; Humans ; Laboratories/standards ; Myocardial Infarction/diagnosis ; *Point-of-Care Systems ; Prospective Studies ; Reagent Kits, Diagnostic ; Sensitivity and Specificity ; Troponin I/*analysis