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Device and method for monitoring and optimising a temporal trigger stability (WO2023094554A1)
(2023)
The present invention relates to devices for monitoring and optimising a temporal trigger stability of an extracorporeal circulatory support means, and to open-loop and closed-loop control units for the extracorporeal circulatory support means comprising such a device, and to corresponding methods. A device (10) for monitoring a temporal trigger stability of an extracorporeal circulatory support means is accordingly proposed, which device is designed to receive a first dataset (14) of a measurement of an ECG signal of a supported patient over a predefined period of time. The device (10) comprises an evaluation unit (16), which is designed to determine or identify a plurality of R triggers (26) from the first dataset (14), wherein the evaluation unit (16) is also designed to receive or provide a second dataset (20) having evaluated ECG signals and a plurality of R triggers (28) and to selectively map the second dataset (20) on the first dataset (14). The device is also designed to emit a signal (22) that characterises a temporal gap between successive R triggers (26) from the first dataset (14) and successive R triggers (28) from the second dataset (20) which are mapped on the first dataset.
Termination of atrial flutter (AFL) is not possible in all AFL patients (P) with transesophageal left atrial pacing (TLAP) with undirected electrical pacing field (EPF) and high atrial pacing threshold. Purpose of the study was to evaluate bipo-lar transesophageal left atrial electrocardiography (TLAE) and TLAP with directed EPF for evaluation and termination of AFL with and without simultaneous transesophageal echocardiography (TEE).
Methods: AFL P were analysed using either a TO electrode with one cylindrical (CE) and three or seven hemispherical electrodes (HE) or TEE electrode with four HE (Osypka, Rheinfelden, Germany). Burst TLAP cycle length was between 200msand 50ms.
Results: AFL cycle length was 233±30 ms with mean ventricular cycle length of 540±149 ms. AFL could be terminated by rapid bipolar TLAP with directed EPF using HE-HE and CE-HE with induction of atrial fibrillation (AF), induction of AF and spontaneous conversion to sinus rhythm and direct conversion to sinus rhythm. Directed EPF was simulated with finite element method.
Conclusions: AFL can be evaluated by bipolar TLAE. AFL can be terminated with rapid TLAP with directed EPF with and without simultaneous TEE. Bipolar TLAE with rapid TLAP is a safe, simple and useful method for evaluation and termination of AFL.
Cardiac resynchronisation therapy (CRT) with biventricular pacing (BV) is an established therapy for heart failure (HF) patients with interventricular conduction delay (IVCD). The aim of the study was to evaluate transesophageal IVCD and left ventricular (LV) pacing with directed electrical pacing field (EPF) in HF patients.
Methods: HF patients were analysed with bipolar transesophageal LV electrocardiogram recording and LV pacing with constant voltage stimulus output, 4 ms stimulus duration, distal cylindrical electrode (CE) and seven 6 mm hemispherical electrodes (HE) with 15 mm electrode distance (TO, Dr. Osypka, Rheinfelden, Germany).
Results: LV electrocardiogram recording with HE-HE and CE-HE evaluated a mean IVCD of 79.9 ± 36.7 ms. Directed EPF with CE-HE and HE-HE allowed LV VAT (n=12) and LV D00 pacing (n=5) with a mean effective capture output of 97.35 ± 6.64 V. In 15 responders with IVCD of 87 ± 33 ms arterial pulse pressure (PP) increased from 65 ± 24 mmHg to 79 ± 27 mmHg (p < 0.001). EPF was simulated with finite element method.
Conclusions: Transesophageal LV electrocardiography and directed EPF pacing with CE and HE allowed the evaluation of IVCD and PP to select patients for BV pacing.
Cardiac resynchronization therapy (CRT) with biventricular pacing (BV) is an established therapy for heart failure (HF) patients with inter- and intraventricular conduction delay. The aim of this pilot study was to test the feasibility of both transesophageal measurement of left ventricular (LV) electrical delay and transesophageal LV pacing prior to implantation, to better select patients for CRT.
Introduction: Cardiac resynchronization therapy (CRT) with biventricular pacing (BV) is an established therapy for heart failure (HF) patients (P) with ventricular desynchronisation, but not all patients improved clinically. Aim of this study was to evaluate electrical intra-left ventricular conduction delay (LVCD) and interventricular conduction delay (IVCD), to better select patients for CRT.
Methods: 65 HF patients (age 63.4 ± 10.6 years; 7 females, 58 males) with New York Heart Association (NYHA) class 3 ± 0.2, 24.4 ± 6.7 % left ventricular (LV) ejection fraction and 167.4 ± 35.6 ms QRSD were included. Esophageal TO Osypka focused hemispherical electrodes catheter was perorally applied in position of maximum LV deflection to measure LVCD between onset and offset of LV deflection and IVCD between earliest onset of QRS in the 12-channel surface ECG and onset of LV deflection in the focused bipolar transesophageal LV electrogram.
Results: There were 50 responders with LVCD of 76.5 ± 20.4 ms, IVCD of 80.5 ± 26.1 ms (P=0.34) and QRSD of 171 ± 37.7 ms. 15 non-responders had longer LVCD of 90 ± 28.5 ms (P = 0.045), shorter IVCD of 50.1 ± 29.1 ms (P < 0.001) and QRSD of 155.3 ± 25 ms (P=0.14). During 21.3 ± 20.3 month BV pacing follow-up, the responder`s NYHA classes improved from 3 ± 0.2 to 2. ± 0.3 (P < 0.001) whereas the non-responders NYHA classes did not improve from 3 ± 0.2 to 2.9 ± 0.3 (P = 0.43) during 15.7 ± 13.9 month BV pacing follow-up (53 Boston, 10 Medtronic and 2 St. Jude CRT devices).
Conclusion: Determination of electrical LVCD and IVCD by focused bipolar transesophageal LV electrogram recording may be an additional useful technique to improve patient selection for CRT.
Cardiac resynchronization therapy (CRT) with biventricular (BV) pacing is an established therapy in approximately two-thirds of symptomatic heart failure (HF) patients (P) with left bundle branch block (LBBB). The aim of this study was to evaluate left atrial (LA) conduction delay (LACD) and left ventricular (LV) conduction delay (LVCD) using pre-implantational transesophageal electrocardiography (ECG) in sinus rhythm (SR) CRT responder (R) and non-responder (NR).
Methods: SR HF P (n=52, age 63.6±10.4 years; 6 females, 46 males) with New York Heart Association (NYHA) class 3.0±0.2, 24.4±7.1 % LV ejection fraction and 171.2±37.6 ms QRS duration (QRSD) were measured by bipolar filtered transesophageal LA and LV ECG recording with hemispherical electrodes (HE) TO catheter (Osypka AG, Rheinfelden, Germany). LACD was measured between onset of P-wave in the surface ECG and onset of LA deflection in the LA ECG. LVCD was measured between onset of QRS in the surface ECG and onset of LV deflection in the LV ECG.
Results: There were 78.8 % SR CRT R (n=41) with 171.2±36.9 ms QRSD, 73.3±25.7 ms LACD, 80.0±24.0 ms LVCD and 2.3±0.5 QRSD-LVCD-ratio. SR CRT R QRSD correlated with LACD (r=0.688, P<0.001) and LVCD (r=0.699, P<0.001). There were 21.2 % SR CRT NR (n=11) with 153.4±22.4 ms QRSD (P=0.133), 69.8±24.8 ms LACD (n=6, P=0.767), 54.2±31.0 ms LVCD (P<0.0046) and 3.9±2.5 QRSD-LVCD-ratio (P<0.001). SR CRT NR QRSD not corre-lated with IACD (r=-0.218, P=0.678) and IVCD (r=0.042, P=0.903). During a 22.8±21.3 month CRT follow-up, the CRT R NYHA class improved from 3.1±0.3 to 1.9±0.3 (P<0.001). In CRT NR, NYHA class not improved (2.9±0.4 to 2.9±0.2, P=1) during 11.2±9.8 months BV pacing.
Conclusions: Transesophageal LA and LV ECG with HE can be utilized to analyse LACD and LVCD in HF P. Pre-implantational LVCD and QRSD-LVCD-ratio may be additional useful parameters to improve P selection for SR CRT.
Capture threshold (CT) for transesophageal left atrial (LA) pacing (TLAP) and transesophageal left ventricular (LV) pacing (TLVP) with conventional cylindrical electrodes (CE) are higher than TLAP feeling threshold (FT). Purpose of the study was to evaluate focused TLAP CT and FT for supraventricular tachycardia (SVT) initiation and focused TLVP CT for cardiac resynchronisation therapy (CRT) simulation.
Methods: SVT initiation in patients (P) with palpitations (n=49, age 47 ± 17 years) was analysed during spontaneous rhythm and during focused bipolar TLAP with atrial constant current stimulus output, distal CE and three or seven 6 mm hemispherical electrodes (HE) (TO, Osypka AG, Rheinfelden, Germany). CRT simulation in heart failure P (n=75, age 62 ± 11 years) was evaluated by focused bipolar TLAP and/or TLVP with ventricular constant voltage stimulus output and different pacing mode.
Results: Focused electrical pacing field between CE and HE (n=28) allowed low threshold TLAP with 8.0 ± 2.6 mA CT at 9.9 ms stimulus duration (SD) which was lower than 9.2 ± 4.5 mA FT at 9.9 ms SD. Focused electrical pacing field between HE and HE (n=21) allowed low threshold TLAP with 8.1 ± 2.2 mA CT at 9.9 ms SD which was lower than 9.8 ± 5.0 mA FT at 9.9 ms SD. SVT initiation by programmed AAI TLAP was possible in 23 P and not possible in 26 P. CRT simulation was evaluated with TLAP and TLVP with VAT, D00 and V00 pacing mode and 95.5 ± 10.9 V TLVP CT at 4.0 ms SD.
Conclusions: Programmed focused AAI TLAP allowed initiation of SVT with very low CT and high FT and focused electrical pacing field between CE-HE and HE-HE.CRT simulation with focused TLAP and/or TLVP with VAT, D00 and V00 pacing mode may be a useful technique to detect responders to CRT.
Introduction: Cardiac resynchronisation therapy (CRT) with atrioventricular (AV) and interventricular (VV) optimized biventricular pacing (BV) is an established therapy for heart failure (HF) patients. The aim of the study was to compare AV and VV delay optimization with cardiac output (CO), cardiac index (CI), contractility index (IC) and acceleration index (ACI) impedance cardiographic (ICG) methods in CRT.
Methods: 15 HF patients (age 66 ± 10 years; 2 females, 13 males) in New York Heart Association (NYHA) class 3.1 ± 0.4, left ventricular (LV) ejection fraction 21.3 ± 7.8 % and QRS duration 176.1 ± 31.7 ms underwent AV and VV delay optimization with CO, CI, IC and ACI (Cardioscreen ®, Medis GmbH, Ilmenau, Germany) at different AV and VV delay BV pacing settings versus right ventricular (RV) pacing one day after implantation of a CRT device.
Results: Optimal AV delay after atrial sensing was 108.6 ± 20.3 ms (n=14) and optimal AV delay after atrial pacing 190 ± 14.1 ms (n=2) with AV delay range from 80 ms to 200 ms. Optimal VV delay was -12.3 ± 25.9 ms left ventricular before RV pacing. RV versus BV pacing mode resulted in improvement of CO from 3.4 ± 1.2 l/min to 4.4 ± 1.4 l/min (p<0.001), CI from 1.8 ± 0.64 l/min/m² to 2.4 ± 0.78 l/min/m² (p<0.001), IC from 0.028 ± 0.011 1/s to 0.036 ± 0.013 1/s (p<0.001) and ACI from 0.667 ± 0.227 1/s² to 0.834 ± 0.282 1/s² (p<0.002). During 34 ± 26 month BV pacing, the NYHA class improved from 3.1 ± 0.4 to 2.1 ± 0.4 (p<0.001).
Conclusion: AV and VV delay optimized BV pacing acutely improve hemodynamic parameters of transthoracic ICG and their NYHA class during long-term follow-up. ICG may be a simple and useful technique to optimize AV and VV delay in CRT.
Introduction: Cardiac resynchronisation therapy (CRT) with atrioventricular (AV) and interventricular (VV) optimized biventricular pacing (BV) is an established therapy for heart failure (HF) patients with electrical interventricular conduction delay (IVCD). The aim of the study was to compare AV and VV delay optimization with cardiac output (CO) and acceleration index (ACI) impedance cardiographic (ICG) methods.
Methods: HF patients with IVCD 86.8 ± 33 ms (n=15, age 66 ± 10 years; 2 females, 13 males), New York Heart Association (NYHA) functional class 3.1 ± 0.4, left ventricular (LV) ejection fraction 21.3 ± 7.8 % and QRS duration 176.1 ± 31.7 ms underwent AV and VV delay optimization with CO and ACI methods (Cardioscreen, Medis GmbH, Ilmenau, Germany). After evaluation of optimal AV delay, we evaluated optimal VV delay during simultaneous LV and right ventricular (RV) pacing (LV=RV), LV before RV pacing (LV-RV) and RV before LV pacing (RV-LV).
Results: Optimal VV delay was -12.3 ± 25.9 ms LV-RV pacing with VV delay range from -80 ms LV-RV pacing to +20 ms RV-LV pacing and RV=LV pacing. Optimal AV delay after atrial sensing was 108.6 ± 20.3 ms (n=14) and optimal AV delay after atrial pacing 190 ± 14.1 ms (n=2) with AV delay range from 80 ms to 200 ms. RV versus BV pacing mode resulted in improvement of CO from 3.4 ± 1.2 l/min to 4.4 ± 1.4 l/min (p<0.001) and ACI from 0.667 ± 0.227 1/s² to 0.834 ± 0.282 1/s² (p<0.002). During 34 ± 26 month BV pacing, the NYHA class improved from 3.1 ± 0.4 to 2.1 ± 0.4 (p<0.001).
Conclusion: AV and VV delay optimized BV pacing acutely improve ICG CO and ACI and their NYHA class during long-term follow-up. ICG may be a simple and useful technique to optimize AV and VV delay in CRT.
Introduction: Cardiac resynchronization therapy (CRT) with left ventricular (LV) pacing is an established therapy for heart failure (HF) patients (P) with ventricular desynchronisation and reduced LV ejection fraction (EF). The aim of this study was to test the utilization of the transesophageal approach to measure arterial pulse pressure (PP) during LV pacing and electrical interventricular conduction delay (IVCD), to better select patients for CRT.
Methods: 32 HF patients (age 64 ± 10 years; 5 females, 27 males) with New York Heart Association (NYHA) class 2.8 ± 0.6, 27 ± 11 % LV EF and 155 ± 35 ms QRS duration were analysed with semi-invasive left cardiac pacing and electrocardiography. Esophageal TO8 Osypka catheter of 10.5 F diameter was perorally applied to the esophagus and placed in the position of maximum left atrial (LA) deflection and maximum LV deflection to measure PP with VAT or D00 pacing modes.
Results: Temporary transesophageal LV pacing was possible with VAT mode (n=16) and D00 mode (n=16) in all patients. In 15 Δ-PP-responders, PP was higher during LV pacing on than LV pacing off (78.3 ± 26.6 versus 65.9 ± 23.7 mmHg, P < 0.001) and NYHA class improved from 3.1 ± 0.35 to 2.1 ± 0.35 (P < 0.001) during 29 ± 26 month biventricular (BV) pacing follow-up (6 Medtronic and 9 Boston BV pacing devices). In 17 Δ-PP-non-responders, PP was not higher during LV pacing on than LV pacing off (61.5 ± 23.9 versus 60.9 ± 23.5 mmHg, P = 0.066). IVCD was significant longer in Δ-PP-responders than in Δ-PP-non-responders (87 ± 33 ms versus 37± 29 ms, P < 0.001).
Conclusion: Semi-invasive transesophageale LA and LV pacing with D00 and VAT mode and LV electrogram recording may be useful techniques to predict CRT improvement.
Background: Cardiac resynchronization therapy (CRT) is an established therapy for heart failure (HF) patients (P) with reduced left ventricular (LV) ejection fraction and electrical interventricular desynchronization, but not all P improved clinically. The aim of the study was to evaluate electrical interventricular delay (IVD) to LV delay (LVD) ratio in atrial fibrillation (AF) CRT responder (R) and non-responder (NR).
Methods: AF P (n = 18, age 60.6 ± 11.4 years, 1 female, 17 males) with HF New York Heart Association (NYHA) class 3.0 ± 0.2, 25.3 ± 5.9 % LV ejection fraction and 157.8 ± 24.4 ms QRS duration (QRSD) were measured by surface ECG and focused transesophageal bipolar LV ECG before implantation of CRT pacemaker (n = 2) or CRT defibrillator (n = 16). IVD was measured between onset of QRS in the surface ECG and onset of LV signal in the LV ECG. LVD was measured between onset and offset of LV signal in the LV ECG.
Results: Electrical ventricular desynchronization in AF CRT P were 61.9 ± 26.9ms IVD, 80.6 ± 24.3ms LVD, 0.85 ± 0.41 IVD-LVD-ratio (Figure), 3.12 ± 1.89 QRSD-IVD-ratio and 2.07 ± 0.47 QRSD-LVD-ratio. There were 72.2 % AF CRT R (n = 13) with 64.2 ± 24.6ms IVD and 77.8 ± 21.6ms LVD with Pearson correlation to 0.89 ± 0.39 IVD-LVD-ratio (r = 0.87, P < 0.01; r = -0.69, P < 0.01), 2.82 ± 1.32 QRSD-IVD-ratio (r = -0.76, P < 0.01; r = 0.67, P = 0.011) and 2.13 ± 0.46 QRSD-LVD-ratio (r = 0.57, P = 0.041; r = -0.85, P < 0.01). There were 27.8% AF CRT NR (n = 5) with 56.0 ± 34.5ms IVD and 87.8 ± 31.9ms LVD without correlation to 0.74 ± 0.48 IVD-LVD-ratio, 3.88 ± 2.98 QRSD-IVD-ratio and 1.90 ± 0.48 QRSD-LVD-ratio. During 15.3 ± 13.1 month CRT follow-up, the AF CRT R NYHA class improved from 3.0 ± 0.2 to 2.2 ± 0.3 (P < 0.001). During 18.8 ± 20.7 month CRT follow-up, the AF CRT NR NYHA class not improved from 3 to 3.3 ± 0.97.
Cardiac resynchronization therapy (CRT) is an established biventricular pacing therapy in heart failure patients with left bundle branch block and reduced left ventricular ejection fraction, but not all patients improved clinically as CRT responder. Purpose of the study was to evaluate electrical left atrial conduction delay (LACD) with focused transesophageal electrocardiography in CRT responder and CRT non-responder.
Methods: Twenty heart failure patients (age 66.6±8.2 years; 2 females, 18 males) with New York Heart Association functional class 3.0±0.3 and 174.2±40.2ms QRS duration were analysed using posterior left atrial transesophageal electrocardiography with hemispherical electrodes. Electrical LACD was measured between onset and offset of transesophageal left atrial signal before implantation of CRT devices.
Results: Electrical LACD could be evaluated by bipolar transesophageal left atrial electrocardiography using TO Osypka electrode in all heart failure patients with negative correlation between 54.7±18.1ms LACD and 24.9±6.4% left ventricular ejection fraction (r=-0.65, P=0.002). There were 16 CRT responders with reduction of New York Heart Association functional class from 3.0±0.29 to 2.1±0.2 (r=0.522, P=0.038) during 9.41±10.96 month biventricular pacing and negative correlation between 49.6±14.2ms LACD and 26.0±6.2% left ventricular ejection fraction (r=-0.533, P=0.034). There were 4 CRT non-responders with no reduction of New York Heart Association functional class from 3.0±0.4 to 2.8±0.5 (r=0.816, P=0.184) during with 13.88±16.39 month biventricular pacing and no correlation between 75.25±19.17ms LACD and 20.75±6.4% left ventricular ejection fraction (r=-0.831, P=0.169).
Conclusions: Focused transesophageal left atrial electrocardiography can be utilized to analyse electrical LACD in heart failure patients. LACD correlated negative with left ventricular ejection fraction in CRT responders. LACD may be a useful parameter to evaluate electrical left atrial desynchronization in heart failure patients.
Cardiac resynchronization therapy is an established therapy for heart failure patients. The aim of the study was to evaluate electrical left cardiac atrioventricular delay and interventricular desynchronization in sinus rhythm cardiac resynchronization therapy responder and non-responder. Cardiac electrical desynchronization were measured by surface ECG and focused transesophageal bipolar left atrial and left ventricular ECG before implantation of cardiac resynchronization therapy defibrillators. Preoperative electrical cardiac desynchronization was 195.7 ± 46.7 ms left cardiac atrioventricular delay and 74.8 ± 24.5 ms interventricular delay in cardiac resynchronization therapy responder. Cardiac resynchronization therapy responder New York Heart Association class improved during long term biventricular pacing. Transesophageal left cardiac atrioventricular delay and interventricular delay may be additional useful parameters to improve patient selection for cardiac resynchronization therapy.
Oesophageal Electrode Probe and Device for Cardiological Treatment and/or Diagnosis (US20200261024)
(2020)
An oesophageal electrode probe for bioimpedance measurement and/or for neurostimulation is provided; a device for transoesophageal cardiological treatment and/or cardiological diagnosis is also provided; a method for the open-loop or closed-loop control of a cardiological catheter ablation device and/or a cardiological, circulatory and/or respiratory support device is also provided. The oesophageal electrode probe comprises a bioimpedance measuring device for measuring the bioimpedance of at least one part of tissue surrounding the oesophageal electrode probe. The bioimpedance device comprises at least one first and one second electrode. The at least one first electrode is arranged on a side of the oesophageal electrode probe facing towards the heart. The at least one second electrode is arranged on a side of the oesophageal electrode probe facing away from the heart. The device comprises the oesophageal electrode probe and a control and/or evaluation device.
Oesophageal Electrode Probe and Device for Cardiological Treatment and/or Diagnosis (EP3706626A1)
(2020)
The invention relates to an oesophageal electrode probe (10) for bioimpedance measurement and/or for neurostimulation; a device (100) for transoesophageal cardiological treatment and/or cardiological diagnosis; and a method for the open-loop or closed-loop control of a cardiac catheter ablation device and/or a cardiac, circulatory and/or respiratory support device. The oesophageal electrode probe comprises a bioimpedance measuring device for measuring the bioimpedance of at least one part of the tissue surrounding the oesophageal electrode probe. The bioimpedance device comprises at least one first and one second electrode, wherein the at least one first electrode (12A) is arranged on a side (14) of the oesophageal electrode probe facing towards the heart and the at least one second electrode (12B) is arranged on a side (16) of the oesophageal electrode probe facing away from the heart. The device (100) comprises the oesophageal electrode probe (10) and a control and/or evaluation device (30), which is configured for receiving a first bioimpedance measurement signal from the at least one first electrode (12A) and a second bioimpedance measurement signal from the at least one second electrode (12B), and comparing same, and generating a control signal on the basis of the comparison. The control signal can be a signal for the open-loop or closed-loop control of a cardiac catheter ablation device and/or a cardiac, circulatory and/or respiratory support device.
Targeting complex fractionated atrial electrocardiograms by automated algorithms during ablation of persistent atrial fibrillation has produced conflicting outcomes in previous electrophysiological studies and catheter ablation of atrial fibrillation and ventricular tachycardia. The aim of the investigation was to evaluate atrial and ventricular high frequency fractionated electrical signals with signal averaging technique.
Methods: Signal averaging electrocardigraphy allows high resolution ECG technique to eliminate interference noise signals in the recorded ECG. The algorithm use automatic ECG trigger function for signal averaged transthoracic, transesophageal and intra-cardiac ECG signals with novel LabVIEW software.
Results: The analysis in the time domain evaluated fractionated atrial signals at the end of the signal averaged P-wave and fractionated ventricular signals at the end of the QRS complex. We evaluated atrial flutter in the time domain with two-to-one atrioventricular conduction, 212.0 ± 4.1 ms atrial cycle length, 426.0 ± 8.2 ms ventricular cycle length, 58.2 ± 1.8 ms P-wave duration, 119.6 ± 6.4 ms PQ duration, 103.0 ± 2.4 ms QRS duration and 296.4 ± 6.8 ms QT duration. The analysis in the frequency domain evaluated high frequency fractionated atrial signals during the P-wave and high frequency fractionated ventricular signals during QRS complex.
Conclusions: Spectral analysis of signal averaging electrocardiography with novel LabVIEW software can be utilized to evaluate atrial and ventricular conduction delays in patients with atrial fibrillation and ventricular tachycardia. Complex fractionated atrial and ventricular electrocardiograms may be useful parameters to evaluate electrical cardiac bradycardia and tachycardia signals in atrial fibrillation and ventricular tachycardia ablation.