Ljupco Hadzievski

A novel mobile transtelephonic system with synthesized 12-lead ECG

The problem of synthesizing the standard 12-lead electrocardiogram (ECG) from the signals recorded using three special ECG leads is studied in detail. The implementation of that concept into the design of a new mobile ECG transtelephonic system is presented. The system has two separate units: a stationary diagnostic-calibration center and a mobile ECG device with integrated electrodes. The patient records by himself three special leads with the mobile ECG recorder and sends data via cellular phone to the personal computer in the diagnostic center where standard 12-lead ECG is numerically reconstructed on the base of the patient transformation matrix previously calculated into the calibration process. The experimental study shows high accuracy of the reconstructed ECG.

Comparison of QTinno, a fully automated electrocardiographic analysis program, to semiautomated electrocardiographic analysis methods in a drug safety study in healthy subjects.

BACKGROUND Improved automated methods for electrocardiographic (ECG) analysis are needed, particularly for drug development purposes. OBJECTIVES This study compared a novel fully automated method for ECG analysis (QTinno; NewCardio, Santa Clara, CA) to 2 semiautomated digital methods: global measurement from the earliest QRS onset to the latest T-wave offset on representative superimposed beats (global) and tangent measurement on 3 consecutive beats in one lead (tangent). METHODS All 3 methods were used to determine uncorrected and rate-corrected QT interval duration (QT and QTcF) and related metrics in 1422 digital 12-lead ECGs from a phase 1 drug study. Global and tangent annotations were manually adjusted by the same 3 cardiologists wherever necessary. No adjustments were made in QTinno determinations. RESULTS QTinno returned QTcF change from time-matched baseline (DeltaQTcF) that differed minimally from both global and tangent methods (mean pairwise difference: 0.1 millisecond between QTinno and global, 1.1 milliseconds between QTinno and tangent). The average absolute QT and QTcF intervals by QTinno were approximately 5 milliseconds longer than global and 25 milliseconds longer than by tangent. QTinno had lower intrinsic variability for DeltaQTcF than either global or tangent (between-subject SD: QTinno 4.0 milliseconds, global 5.6 milliseconds, tangent 6.4 milliseconds; within-subject SD: QTinno 4.8 milliseconds, global 7.4 milliseconds, tangent 10.6 milliseconds). All methods were robust in detecting the largest placebo-adjusted mean time-matched DeltaQTcF (15-25 milliseconds) induced by study drug. CONCLUSIONS The methods show good agreement for drug-induced QTc prolongation. Lower intrinsic variability of DeltaQTcF by QTinno could facilitate smaller sample sizes or increase study power in thorough QTc studies.

Wireless remote monitoring of atrial fibrillation using reconstructed 12-lead ECGs

Remote surveillance is important for patients with atrial fibrillation (AF). Atrial signal recognition with conventional monitoring devices is difficult; remote AF detection is predominantly accomplished by R-R interval analysis. Twelve lead ECG (12L) displays atrial activity and remains the gold standard for AF diagnosis. CardioBip is a portable wireless patient-activated event monitor providing signal reconstruction of a 12L waveform (12CB) using 5 leads and patient-specific transformation matrices. We hypothesized that atrial signal analysis with 12CB can detect atrial activity and improve AF detection. METHODS: 18 patients with AF undergoing DC cardioversion (CV) were studied. Separate 12-lead P and QRS patient-specific transformation matrices were created at baseline AF. Multiple wireless 12CB transmissions were performed 3–7 days before and up to 2 weeks after CV. Rhythm was confirmed with 12-lead ECGs (12L). In SR the number of leads with visible P waves (atrial signal > 0.05 mV), and P wave polarity were analyzed. In AF, the number of leads with AF signal were compared (fibrillatory [f] waves >0.025 mV). RESULTS: Fourteen of 18 patients successfully cardioverted to SR and 4 failed; thus, 14 SR and 22 AF transmissions were analyzed. SR P wave was visible on 141/168 leads on 12L and 137/168 on 12CB (126 true pos [TP] and 11 false pos [FP] relative to 12L; p=0.26). In 126 leads with P waves in both 12L and 12CB, the methods agreed on P wave polarity in 125. In AF, F waves were visible in 178/264 leads on 12L and 189/264 leads on 12CB (144 TP, 45 FP; p=0.27). All 5 AF relapses were successfully detected by 12CB based on atrial activity. CONCLUSION: 12CB is not inferior to 12L in detecting atrial signal in SR and AF, and shows excellent potential for remote wireless monitoring of AF patients.

Wireless remote monitoring of reconstructed 12-lead ECGs after ablation for atrial fibrillation using a hand-held device

OBJECTIVE Atrial fibrillation (AF) surveillance using a wireless handheld monitor capable of 12-lead electrocardiogram reconstruction was performed, and arrhythmia detection rate was compared with serial Holter monitoring. METHODS Twenty-five patients were monitored after an AF ablation procedure using the hand-held monitor for 2 months immediately after and then for 1 month approximately 6 months postablation. All patients underwent 12-lead 24-hour Holter monitoring at 1, 2, and 6 months postablation. RESULTS During months 1-2, 425 of 2942 hand-held monitor transmissions from 21 of 25 patients showed AF/atrial flutter (Afl). The frequency of detected arrhythmias decreased by month 6 to 85/1128 (P < .01) in 15 of 23 patients. Holter monitoring diagnosed AF/Afl in 8 of 25 and 7 of 23 patients at months 1-2 and month 6, respectively (P < .01 compared with wireless hand-held monitor). Af/Afl diagnosis by wireless monitoring preceded Holter detection by an average of 24 days. CONCLUSIONS Wireless monitoring with 12-lead electrocardiogram reconstruction demonstrated reliable AF/Afl detection that was more sensitive than serial 12-lead 24-hour Holter monitoring.

Cardiac-induced localized thoracic motion detected by a fiber optic sensing scheme.

Abstract. The cardiovascular health of the human population is a major concern for medical clinicians, with cardiovascular diseases responsible for 48% of all deaths worldwide, according to the World Health Organization. The development of new diagnostic tools that are practicable and economical to scrutinize the cardiovascular health of humans is a major driver for clinicians. We offer a new technique to obtain seismocardiographic signals up to 54 Hz covering both ballistocardiography (below 20 Hz) and audible heart sounds (20 Hz upward), using a system based on curvature sensors formed from fiber optic long period gratings. This system can visualize the real-time three-dimensional (3-D) mechanical motion of the heart by using the data from the sensing array in conjunction with a bespoke 3-D shape reconstruction algorithm. Visualization is demonstrated by adhering three to four sensors on the outside of the thorax and in close proximity to the apex of the heart; the sensing scheme revealed a complex motion of the heart wall next to the apex region of the heart. The detection scheme is low-cost, portable, easily operated and has the potential for ambulatory applications.

Visual 3Dx: Algorithms for quantitative 3-dimensional analysis of ECG signals

Introduction: The 12-lead ECG is useful for cardiac diagnosis but has limited sensitivity and specificity. To address this, we developed the Visual3Dx, a comprehensive method for describing cardiac electrical activity in time and space. The Visual3Dx transforms the ECG input into a time-variable heart vector, and normalizes each lead input to assure equal representation from all cardiac regions. Methods: We compared the Visual3Dx to the standard 12-lead ECG for detection of acute myocardial ischemia (AMI) in 2 clinical models. Model 1 was AMI after 90 s of balloon coronary occlusion in 117 cases. Model 2 was 122 consecutive patients who: (1) presented to an urban emergency department with chest pain; (2) were admitted to coronary care and developed elevated cardiac troponin levels; and (3) had coronary arteriography within 6 hrs. Results: In Model 1, the 12 lead ECG developed ST segment deviation diagnostic of AMI in 78/117 occlusions (67%), whereas using the same input ECG data, the Visual3Dx was diagnostic of AMI in 105/117 occlusions (90%; p<0.001). In Model 2, the first 12 lead ECG was diagnostic of AMI in 80/122 (66%), whereas the Visual3Dx was diagnostic in 103/122 (84%). In both Models, the largest sensitivity gains were seen in left circumflex and right coronary artery occlusions. Conclusions: The Visual3Dx is a promising tool for 3D quantitative analysis of cardiac electrical activity that may improve diagnosis of AMI, especially in electrically remote regions of the heart. Additional studies will define diagnostic specificity and further improve 3D biomarkers of AMI.

Rib-cage-movement measurements as a potential new trigger signal in non-invasive mechanical ventilation.

Non-invasive ventilation performed through an oronasal mask is a standard in clinical and homecare mechanical ventilation. Besides all its advantages, inevitable leaks through the mask cause errors in the feedback information provided by the airflow sensor and, hence, patient-ventilator asynchrony with multiple negative consequences. Here we investigate a new way to provide a trigger to the ventilator. The method is based on the measurement of rib cage movement at the onset of inspiration and during breathing by fibre-optic sensors. In a series of simultaneous measurements by a long-period fibre grating sensor and pneumotachograph we provide the statistical evidence of the 200 ms lag of the pneumo with respect the fibre-optic signal. The lag is registered consistently across three independent delay metrics. Further, we discuss exceptions from this trend and identify the needed improvements to the proposed fibre-sensing scheme.

A new method for respiratory-volume monitoring based on long-period fibre gratings

Respiratory-volume monitoring is an indispensable part of mechanical ventilation. Here we present a new method of the respiratory-volume measurement based on a single fibre-optical long-period sensor of bending and the correlation between torso curvature and lung volume. Unlike the commonly used air-flow based measurement methods the proposed sensor is drift-free and immune to air-leaks. In the paper, we explain the working principle of sensors, a two-step calibration-test measurement procedure and present results that establish a linear correlation between the change in the local thorax curvature and the change of the lung volume. We also discuss the advantages and limitations of these sensors with respect to the current standards.

Wireless monitoring of reconstructed 12-lead ECG in atrial fibrillation patients enables differential diagnosis of recurrent arrhythmias

Differential diagnosis of symptomatic events in post-ablation atrial fibrillation (AF) patients (pts) is important; in particular, accurate, reliable detection of AF or atrial flutter (AFL) is essential. However, existing remote monitoring devices usually require attached leads and are not suitable for prolonged monitoring; moreover, most do not provide sufficient information to assess atrial activity, since they generally monitor only 1–3 ECG leads and rely on RR interval variability for AF diagnosis. A new hand-held, wireless, symptom-activated event monitor (CardioBip; CB) does not require attached leads and hence can be conveniently used for extended periods. Moreover, CB provides data that enables remote reconstruction of full 12-lead ECG data including atrial signal information. We hypothesized that these CB features would enable accurate remote differential diagnosis of symptomatic arrhythmias in post-ablation AF pts. Methods: 21 pts who underwent catheter ablation for AF were instructed to make a CB transmission (TX) whenever palpitations, lightheadedness, or similar symptoms occurred, and at multiple times daily when asymptomatic, during a 60 day post-ablation time period. CB transmissions (TXs) were analyzed blindly by 2 expert readers, with differences adjudicated by consensus. Results: 7 pts had no symptomatic episodes during the monitoring period. 14 of 21 pts had symptomatic events and made a total of 1699 TX, 164 of which were during symptoms. TX quality was acceptable for rhythm diagnosis and atrial activity in 96%. 118 TX from 10 symptomatic pts showed AF (96 TX from 10 pts) or AFL (22 TX from 3 pts), and 46 TX from 9 pts showed frequent PACs or PVCs. No other arrhythmias were detected. Five pts made symptomatic TX during AF/AFL and also during PACs/PVCs. Conclusions: Use of CB during symptomatic episodes enabled detection and differential diagnosis of symptomatic arrhythmias. The ability of CB to provide accurate reconstruction of 12 L ECGs including atrial activity, combined with its ease of use, makes it suitable for long-term surveillance for recurrent AF in post-ablation patients.

Algorithm for quantitative 3 dimensional analysis of ECG signals improves myocardial diagnosis over cardiologists in diabetic patients

Acute myocardial infarction (AMI) diagnosis in type II diabetes (DM2) patients is difficult and ECG findings are often non-diagnostic or inconclusive. We developed computer algorithms to process standard 12-lead ECG input data for quantitative 3-dimensional (3D) analysis (my3KGTM), and hypothesized that use of the my3KGTMs array of over 100 3D-based AMI diagnostic markers may improve diagnostic accuracy for AMI in DM2 patients. Methods: We identified 155 consecutive DM2 patients age >25 yrs with chest discomfort or shortness of breath who were evaluated at an urban emergency department (130 patients (pts)) or the cardiac catheterization laboratory (25 pts) for possible AMI. The first digital 12-lead ECG for each patient, obtained within 30 min of presentation, was evaluated by (1) 2 blinded expert cardiologists, and (2) my3KGTM. In each case, the ECG was classified as either likely AMI or likely non-AMI. “Gold standard” was the final clinical diagnosis. Statistical analysis was McNemars test with continuity correction. Results: The 155 DM2 patients were 50% male, mean age 56.8 ± 12.0 yrs; 44 pts had a final clinical diagnosis of AMI (17 ST Elevation Myocardial Infarctions (STEMI), 27 Non-ST Elevation Myocardial Infarctions (NSTEMI)) and 111 had no AMI. Conclusions: Relative to standard 12L ECG read by cardiologists, quantitative 3D ECG analysis showed significant and substantial gains in sensitivity for AMI diagnosis in DM2 patients, without loss in specificity. Sensitivity gains were particularly high in patients exhibiting NSTEMI, the most common form of AMI in DM2.