An annotated ventricular tachycardia (VT) alarm database: Toward a uniform standard for optimizing automated VT identification in hospitalized patients.

BACKGROUND: False ventricular tachycardia (VT) alarms are common during in-hospital electrocardiographic (ECG) monitoring. Prior research shows that the majority of false VT can be attributed to algorithm deficiencies. PURPOSE: The purpose of this study was: (1) to describe the creation of a VT database annotated by ECG experts and (2) to determine true vs. false VT using a new VT algorithm created by our group. METHODS: The VT algorithm was processed in 5320 consecutive ICU patients with 572,574 h of ECG and physiologic monitoring. A search algorithm identified potential VT, defined as: heart rate >100 beats/min, QRSs > 120 ms, and change in QRS morphology in >6 consecutive beats compared to the preceding native rhythm. Seven ECG channels, SpO2 , and arterial blood pressure waveforms were processed and loaded into a web-based annotation software program. Five PhD-prepared nurse scientists performed the annotations. RESULTS: Of the 5320 ICU patients, 858 (16.13%) had 22,325 VTs. After three levels of iterative annotations, a total of 11,970 (53.62%) were adjudicated as true, 6485 (29.05%) as false, and 3870 (17.33%) were unresolved. The unresolved VTs were concentrated in 17 patients (1.98%). Of the 3870 unresolved VTs, 85.7% (n = 3281) were confounded by ventricular paced rhythm, 10.8% (n = 414) by underlying BBB, and 3.5% (n = 133) had a combination of both. CONCLUSIONS: The database described here represents the single largest human-annotated database to date. The database includes consecutive ICU patients, with true, false, and challenging VTs (unresolved) and could serve as a gold standard database to develop and test new VT algorithms.

PDF-ECG in clinical practice: A model for long-term preservation of digital 12-lead ECG data.

BACKGROUND: In clinical practice, data archiving of resting 12-lead electrocardiograms (ECGs) is mainly achieved by storing a PDF report in the hospital electronic health record (EHR). When available, digital ECG source data (raw samples) are only retained within the ECG management system. OBJECTIVE: The widespread availability of the ECG source data would undoubtedly permit successive analysis and facilitate longitudinal studies, with both scientific and diagnostic benefits. METHODS & RESULTS: PDF-ECG is a hybrid archival format which allows to store in the same file both the standard graphical report of an ECG together with its source ECG data (waveforms). Using PDF-ECG as a model to address the challenge of ECG data portability, long-term archiving and documentation, a real-world proof-of-concept test was conducted in a northern Italy hospital. A set of volunteers undertook a basic ECG using routine hospital equipment and the source data captured. Using dedicated web services, PDF-ECG documents were then generated and seamlessly uploaded in the hospital EHR, replacing the standard PDF reports automatically generated at the time of acquisition. Finally, the PDF-ECG files could be successfully retrieved and re-analyzed. CONCLUSION: Adding PDF-ECG to an existing EHR had a minimal impact on the hospital's workflow, while preserving the ECG digital data.

Quantitative performance of E-Scribe warehouse in detecting quality issues with digital annotated ECG data from healthy subjects.

The US Food and Drug Administration recommends submission of digital electrocardiograms in the standard HL7 XML format into the electrocardiogram warehouse to support preapproval review of new drug applications. The Food and Drug Administration scrutinizes electrocardiogram quality by viewing the annotated waveforms and scoring electrocardiogram quality by the warehouse algorithms. Part of the Food and Drug Administration warehouse is commercially available to sponsors as the E-Scribe Warehouse. The authors tested the performance of E-Scribe Warehouse algorithms by quantifying electrocardiogram acquisition quality, adherence to QT annotation protocol, and T-wave signal strength in 2 data sets: "reference" (104 digital electrocardiograms from a phase I study with sotalol in 26 healthy subjects with QT annotations by computer-assisted manual adjustment) and "test" (the same electrocardiograms with an intentionally introduced predefined number of quality issues). The E-Scribe Warehouse correctly detected differences between the 2 sets expected from the number and pattern of errors in the "test" set (except for 1 subject with QT misannotated in different leads of serial electrocardiograms) and confirmed the absence of differences where none was expected. E-Scribe Warehouse scores below the threshold value identified individual electrocardiograms with questionable T-wave signal strength. The E-Scribe Warehouse showed satisfactory performance in detecting electrocardiogram quality issues that may impair reliability of QTc assessment in clinical trials in healthy subjects.