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Background: The electrical field (E-field) of the biventricular (BV) stimulation is important for the success of cardiac resynchronization therapy (CRT) in patients with cardiac insufficiency and widened QRS complex. The 3D modeling allows the simulation of CRT and high frequency (HF) ablation.
Purpose: The aim of the study was to model different pacing and ablation electrodes and to integrate them into a heart model for the static and dynamic simulation of atrial and BV stimulation and high frequency (HF) ablation in atrial fibrillation (AF).
Methods: The modeling and simulation was carried out using the electromagnetic simulation software CST (CST Darmstadt). Five multipolar left ventricular (LV) electrodes, one epicardial LV electrode, four bipolar right atrial (RA) electrodes, two right ventricular (RV) electrodes and one HF ablation catheter were modeled. Selected electrodes were integrated into the Offenburg heart rhythm model for the electrical field simulation. The simulation of an AV node ablation at CRT was performed with RA, RV and LV electrodes and integrated ablation catheter with an 8 mm gold tip.
Results: The right atrial stimulation was performed with an amplitude of 1.5 V with a pulse width of 0.5. The far-field potentials generated by the atrial stimulation were perceived by the right and left ventricular electrode. The far-field potential at a distance of 1 mm from the right ventricular electrode tip was 36.1 mV. The far-field potential at a distance of 1 mm from the left ventricular electrode tip was measured with 37.1 mV. The RV and LV stimulation were performed simultaneously at amplitude of 3 V at the LV electrode and 1 V at the RV electrode with a pulse width of 0.5 ms each. The far-field potentials generated by the BV stimulations could be perceived by the RA electrode. The far-field potential at the RA electrode tip was 32.86 mV. AV node ablation was simulated with an applied power of 5 W at 420 kHz and 10 W at 500 kHz at the distal 8 mm ablation electrode.
Conclusions: Virtual heart and electrode models as well as the simulations of electrical fields and temperature profiles allow the static and dynamic simulation of atrial synchronous BV stimulation and HF ablation at AF. The 3D simulation of the electrical field and temperature profile may be used to optimize the CRT and AF ablation.
Die vorliegende Erfindung betrifft Steuer- und Regeleinheiten für eine extrakorporale Kreislaufunterstützung sowie Systeme, umfassend eine solche Steuer- und Regeleinheit und entsprechende Verfahren. Entsprechend wird eine Steuer- und Regeleinheit Steuer- und Regeleinheit (10) für eine extrakorporale Kreislaufunterstützung vorgeschlagen, welche dazu eingerichtet ist eine Messung eines EKG-Signals (12) eines unterstützten Patienten über einen vorgegebenen Zeitraum zu empfangen, wobei das EKG-Signal (12) für jeden Zeitpunkt innerhalb eines Herzzyklus mehrere Datenpunkte umfasst. Die Steuer- und Regeleinheit (10) umfasst eine Auswerteeinheit (100), welche dazu eingerichtet ist, die Datenpunkte für mindestens einen Zeitpunkt räumlich und/oder zeitlich auszuwerten und aus den ausgewerteten Datenpunkten mindestens eine Amplitudenänderung (14) innerhalb des Herzzyklus zu bestimmen. Die Steuer- und Regeleinheit (10) ist weiterhin dazu eingerichtet, ein Steuer- und/oder Regelsignal (16) für die extrakorporale Kreislaufunterstützung an einem vorgegebenen Zeitpunkt nach der mindestens einen Amplitudenänderung (14) auszugeben.
The present invention relates to open-loop and closed-loop control units for extracorporeal circulatory support, to systems comprising such an open-loop and closed-loop control unit, and to corresponding methods. An open-loop and closed-loop control unit (10) for extracorporeal circulatory support is proposed, which is configured to receive a measurement of an ECG signal (12) of a supported patient over a predefined period of time, wherein the ECG signal (12) comprises multiple data points for each time point within a heart cycle. The open-loop and closed-loop control unit (10) comprises an evaluation unit (100) which is configured to evaluate the data points for at least one time point in a spatial and/or temporal manner and to determine at least one amplitude change (14) within the heart cycle based on the evaluated data points. The open-loop and closed-loop control unit (10) is further configured to output an open-loop and/or closed-loop signal (16) for extracorporeal circulatory support at a predefined point in time after the at least one amplitude change (14).
Die vorliegende Erfindung betrifft Steuer- und Regeleinheiten für eine extrakorporale Kreislaufunterstützung sowie Systeme, umfassend eine solche Steuer- und Regeleinheit und entsprechende Verfahren. Entsprechend wird eine Steuer- und Regeleinheit (10) für eine extrakorporale Kreislaufunterstützung vorgeschlagen, welche dazu eingerichtet ist eine Messung eines EKG-Signals (12) eines unterstützten Patienten über einen vorgegebenen Zeitraum zu empfangen und für die extrakorporale Kreislaufunterstützung bereitzustellen, wobei das EKG-Signal (12) für jeden Zeitpunkt innerhalb eines Herzzyklus eine Signalhöhe aus mindestens einer EKG-Ableitung (14A, 14B) umfasst. Die Steuer- und Regeleinheit (10) umfasst eine Auswerteeinheit (16), welche dazu eingerichtet ist, eine Signaldifferenz (18) einer Signalhöhe eines aktuellen Zeitpunkts (12A) und einer Signalhöhe des vorhergehenden Zeitpunkts (12B) zu bestimmen und die Signaldifferenz (18) mit einem vorgegebenen Schwellenwert (20) zu vergleichen. Die Steuer- und Regeleinheit (10) ist weiterhin dazu eingerichtet, das EKG-Signal (22) beim Überschreiten des Schwellenwerts (20) für den aktuellen Zeitpunkt und eine vorgegebene Anzahl von nachfolgenden Zeitpunkten (28) mit einer vorgegebenen Signalhöhe (30) bereitzustellen.
The present invention relates to open-loop and closed-loop control units for extracorporeal circulatory support, to systems comprising such an open-loop and closed-loop control unit, and to corresponding methods. An open-loop and closed-loop control unit (10) for extracorporeal circulatory support is proposed, which is configured to receive a measurement of an ECG signal (12) of a supported patient over a predefined period of time, wherein the ECG signal (12) comprises multiple data points for each time point within a heart cycle. The open-loop and closed-loop control unit (10) comprises an evaluation unit (100) which is configured to evaluate the data points for at least one time point in a spatial and/or temporal manner and to determine at least one amplitude change (14) within the heart cycle based on the evaluated data points. The open-loop and closed-loop control unit (10) is further configured to output an open-loop and/or closed-loop signal (16) for extracorporeal circulatory support at a predefined point in time after the at least one amplitude change (14).
Die vorliegende Erfindung betrifft Vorrichtungen zum Überwachen und Optimieren einer zeitlichen Triggerstabilität einer extrakorporalen Kreislaufunterstützung sowie Steuer- und Regeleinheiten zur extrakorporalen Kreislaufunterstützung, umfassend eine solche Vorrichtung und entsprechende Verfahren. Entsprechend wird eine Vorrichtung (10) zum Überwachen einer zeitlichen Triggerstabilität einer extrakorporalen Kreislaufunterstützung vorgeschlagen, welche dazu eingerichtet ist, einen ersten Datensatz (14) einer Messung eines EKG-Signals eines unterstützten Patienten über einen vorgegebenen Zeitraum zu empfangen. Die Vorrichtung (10) umfasst eine Auswerteeinheit (16), welche dazu eingerichtet ist, mehrere R-Trigger (26) aus dem ersten Datensatz (14) zu bestimmen oder zu identifizieren, wobei die Auswerteeinheit (16) weiterhin dazu eingerichtet ist, einen zweiten Datensatz (20) mit ausgewerteten EKG-Signalen und mehreren R-Triggern (28) zu empfangen oder bereitzustellen und den zweiten Datensatz (20) selektiv auf dem ersten Datensatz (14) abzubilden. Die Vorrichtung ist weiterhin dazu eingerichtet, ein Signal (22) auszugeben, welches kennzeichnend für einen zeitlichen Abstand sukzessiver R-Trigger (26) aus dem ersten Datensatz (14) und darauf abgebildeten sukzessiven R-Trigger (28) aus dem zweiten Datensatz (20) ist.
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.
Das Ausmaß der elektrischen ventrikulären Desynchronisation bei reduzierter linksventrikulärer Funktion ist von Bedeutung für den Erfolg der Resynchronisationstherapie der Herzinsuffizienz mit biventrikulärer Stimulation. Das Ziel der Untersuchung besteht in der nichtinvasiven Messung der elektrischen inter-ventrikulären Desynchronisation mit und ohne ischämische Herzerkrankung bei kardialen Resynchronisationstherapie Respondern. Bei Patienten mit 25,3 ± 7,3 % reduzierter linksventrikulärer Ejektionsfraktion und 166,9 ± 38,5 ms QRS-Dauer wurde das transösophageale linksventrikuläre EKG abgeleitet. Die QRS-Dauer korrelierte mit dem interventrikulären und links-ventrikulären Delay bei Resynchronisationstherapie Respondern mit nicht-ischämischer Herzerkrankung.
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.
Transösophageales interventrikuläres Delay bei Vorhofflimmern und kardialer Resynchronisation
(2013)
Die transösophageale linksventrikuläre Elektrokardiographie ermöglicht die Evaluierung der elektrischen ventrikulären Desynchronisation im Rahmen der kardialen Resynchronisationstherapie der Herzinsuffizienz. Das Ziel der Untersuchung besteht in der präoperativen Abschätzung des transösophagealen interventrikulären Delays bei Vorhofflimmern und kardialer Resynchronisationstherapie. Bei Patienten mit Vorhofflimmern, Herzinsuffizienz New York Heart Association Klasse 3,0 ± 0,2 und QRS-Dauer 159,6 ± 23,9 ms wurde das fokusierte transösophageale linksventrikuläre EKG abgeleitet. Die kardiale Resynchronisationstherapie Responder QRS-Dauer korrelierte mit dem transösophagealen interventrikulären Delay bei Vorhofflimmern.
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.