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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.
Heinke, Matthias ; Ismer, Bruno ; Heinke, Tobias ; Surber, Ralf ; Haltenberger, Anna ; Kühnert, Helmut ; Eisenträger, Daniela ; Lorenz, Martin ; Prochnau, Dirk ; Dannberg, Gudrun ; Figulla, Hans Reiner
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.
Heinke, Matthias ; Ismer, Bruno ; Heinke, Tobias ; Kühnert, Helmut ; Surber, Ralf ; Prochnau, Dirk ; Haltenberger, Anna ; Dannberg, Gudrun ; Figulla, Hans Reiner
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.
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.
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.
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 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).
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.
Cardiac resynchronization therapy with atrioventricular and interventricular pacing delay optimized biventricular pacing is an established therapy for heart failure patients with sinus rhythm and reduced left ventricular ejection fraction. The aim of the study was to evaluate atrioventricular and interventricular pacing delay optimization in cardiac resynchroniza-tion therapy by transthoracic impedance cardiography in biventricular pacing with different left ventricular electrode po-sition. In biventricular pacing heart failure patients with lateral, posterolateral and anterolateral left ventricular electrode position, the mean optimal atrioventricular sening delay was 108.6 ± 20.3 ms and the mean optimal interventricular pac-ing delay -12.3 ± 25.9 ms. Transthoracic impedance cardiography may be a useful technique to optimize atrioventricular and interventricular pacing delay in biventricular pacing with different left ventricular electrode position.
Hintergrund: Das elektrische interventrikuläre Delay (IVD) und die Lage der linksventrikulären (LV) Elektrode zum Ort der spätesten LV Erregung sind bei Patienten (P) mit Herzinsuffizienz (HF), reduzierter LV Funktion und breiter QRS Dauer (QRSD) von Bedeutung für den Erfolg der kardialen Resynchronisationstherapie (CRT). Die LV Elektrokardiographie ermöglicht eine Abschätzung des elektrischen IVD. Ziel der Studie besteht in der nicht-invasiven Evaluierung des elektrischen IVD bei Patienten (P) mit Vorhofflimmern (AFib) mit und ohne CRT mit biventrikulärer (BV) Stimulation.
Methoden: Bei 49 HF P mit AFib (Alter 63,9 ± 10,8 Jahre; 43 Männer und 6 Frauen) mit New York Heart Association (NYHA) Klasse 2,9 ± 0,4, LV Ejektionsfraktion 26,03 ± 7,99 % und QRS-Dauer (QRSD) 143,69 ± 35,62 ms wurde das elektrische IVD als Intervall zwischen Beginn des QRS-Komplexes im Oberflächen EKG und Beginn des LV Signals im transösophagealen LV EKG bei 31 HF P mit AFib und bei 18 HF P mit AFib und CRT präoperativ bestimmt. Das fokussierte bipolare LV EKG wurde mittels Osypka TO Sonde mit halbkugelförmigen Elektroden in Höhe des maximalen LV Signals registriert.
Ergebnisse: Bei 31 HF P mit AFib betrugen QRSD 135,48 ± 38,78 ms, IVD 49,55 ± 26,38 ms, QRSD-IVD-Verhältnis 3,12 ± 1,11 und das IVD korrelierte mit der QRSD (r=0,75, P<0,001) und dem QRSD-IVD-Verhältnis (r=-0,67, P<0,001) (Fig.). Bei 18 HF P mit AFib und CRT Defibrillator betrugen QRSD 157,83 ± 24,38 ms, IVD 61,94 ± 26,88 ms, QRSD-IVD-Verhältnis 3,12 ± 1,89 und das IVD korrelierte mit der QRSD (r=0,47, P=0,049) und dem QRSD-IVD-Verhältnis (r=-0,73, P<0,001). Bei 72,2 % CRT Responder (R) (n=13) betrugen QRSD 158,15 ± 22,4 ms, IVD 64,23 ± 24,62 ms, QRSD-IVD-Verhältnis 2,82 ± 1,32 und das IVD korrelierte mit der QRSD (r=0,57, P=0,043) und dem QRSD-IVD-Verhältnis (r=-0,76, P=0,0024). Bei 27,8 % CRT Non-Responder (NR) (n=5) betrugen QRSD 157 ± 31,94 ms, IVD 56 ± 34,52 ms, QRSD-IVD-Verhältnis 3,88 ± 2,98 und das IVD korrelierte nicht mit der QRSD (r=0,33, P=0,591) und dem QRSD-IVD-Verhältnis (r=-0,732, P=0,159). Die CRT R verbesserten sich in der NYHA Klasse von 3 ± 0,2 auf 2,2 ± 0,3 (P<0,001) während 15,3 ± 13,1 Monaten BV Stimulation. Bei 15 CRT NR kam es zu keiner Verbesserung der NYHA Klasse von 3 auf 3,3 ± 0,97 (P=0,529) während 18,8 ± 20,7 Monaten BV Stimulation.
Schlussfolgerungen: Das transösophageale LV EKG ermöglicht bei HF-P mit AFib die nichtinvasive Messung des elektrischen IVD präoperativ vor CRT. IVD und QRSD-IVD-Verhältnis sind möglicherweise einfach anwendbare Parameter zur Vorhersage von CRT R und CRT NR bei P mit AFib.
Background: Cardiac resynchronization therapy (CRT) with biventricular (BV) pacing is an established therapy for heart failure (HF) patients (P) with sinus rhythm, reduced left ventricular (LV) ejection fraction (EF) and electrical ventricular desynchronization. The aim of the study was to evaluate electrical interventricular delay (IVD) and left ventricular delay (LVD) in right ventricular (RV) pacemaker pacing before upgrading to CRT BV pacing.
Methods: HF P (n=11, age 69.0 ± 7.9 years, 1 female, 10 males) with DDD pacemaker (n=10), DDD defibrillator (n=1), RV pacing, New York Heart Association (NYHA) class 3.0 ± 0.2 and 24.5 ± 4.9 % LVEF were measured by surface ECG and transesophageal bipolar LV ECG before upgrading to CRT defibrillator (n=8) and CRT pacemaker (n=3). IVD was measured between onset of QRS in the surface ECG and onset of LV signal in the transesophageal ECG. LVD was measured between onset and offset of LV signal in the transesophageal ECG. CRT atrioventricular (AV) and BV pacing delay were optimized by impedance cardiography.
Results: Interventricular and intraventricular desynchronization in RV pacemaker pacing were 228.2 ± 44.8 ms QRS duration, 86.5 ± 32.8ms IVD, 94.4 ± 23.8ms LVD, 2.6 ± 0.8 QRS-IVD-ratio with correlation between IVD and QRS-IVD-ratio (r=-0.668 P=0.0248) and 2.3 ± 0.7 QRS-LVD-ratio. The LVEF-IVD-ratio was 0.3 ± 0.1 with correlation between IVD and LVEF-IVD-ratio (r=-0.8063 P=0.00272) and with correlation between QRS duration and LVEF-IVD-ratio (r=-0.7251 P=0.01157). Optimal sensing and pacing AV delay were 128.3 ± 24.8 ms AV delay after atrial sensing (n=6) and 173.3 ± 40.4 ms AV delay after atrial pacing (n=3). Optimal BV pacing delay was -4.3 ± 11.3 ms between LV and RV pacing (n=7). During 30.4 ± 29.6 month CRT follow-up, the NYHA class improved from 3.1 ± 0.2 to 2.2 ± 0.3.
Conclusions: Transesophageal electrical IVD and LVD in RV pacemaker pacing may be additional useful ventricular desynchronization parameters to improve P selection for upgrading RV pacemaker pacing to CRT BV pacing.
Cardiac resynchronization therapy is an established therapy for heart failure patients with sinus rhythm, reduced left ventricular ejection fraction and prolongation of QRS duration. The aim of the study was to evaluate ventricular desynchronization with electrical interventricular delay (IVD) to left ventricular delay (LVD) ratio in atrial fibrillation heart failure patients. IVD and LVD were measured by transesophageal posterior left ventricular ECG recording. In atrial fibrillation heart failure patients with prolonged QRS duration, the mean IVD-to-LVD-ratio was 0.84 +/- 0.42 with a range from 0.17 to 2.2 IVD-to-LVD-ratio. IVD-to-LVD-ratio correlated with QRS duration. IVD-to-LVD-ratio may be a useful parameter to evaluate electrical ventricular desynchronization in atrial fibrillation heart failure patients.
Heinke, Matthias ; Dannberg, Gudrun ; Heinke, Tobias ; Ismer, Bruno ; Haber, Tobias ; Tumampos, Jonas ; Kühnert, Helmut
Cardiac resynchronization therapy (CRT) is an established class I level A biventricular pacing therapy in chronic heart failure patients with left bundle branch block and reduced left ventricular ejection fraction, but not all patients improved clinically. Purpose of the study was to evaluate electrical interatrial conduction delay (IACD) to interventricular conduction delay (IVCD) ratio with focused transesophageal left atrial and left ventricular electrocardiography.
Methods: Thirty eight chronic heart failure patients (age 63.4±10.2 years; 3 females, 35 males) with New York Heart Association (NYHA) functional class 3.0±0.2 and 171.71±36.17ms QRS duration were analysed using posterior left atrial and left ventricular transesophageal electrocardiography with hemispherical electrodes before CRT. Electrical IACD was measured between onset of P-wave in the surface ECG and onset of left atrial signal. Electrical IVCD was measured between onset of QRS complex in the surface ECG and onset of left ventricular signal.
Results: Electrical IACD and IVCD could be evaluated by transesophageal left atrial and left ventricular electrocardiography in all heart failure patients with correlation to 1.18±0.92 IACD-IVCD-ratio (r=-0.57, P<0.001; r=0.66, P<0.001). There were 32 CRT responder with reduction of NYHA class from 3.0±0.22 to 1.97±0.31 (P<0.001) during 16.5±18.9 month CRT with 75.19±33.49ms IACD, 78.91±24.73ms IVCD, 1.04±0.66 IACD-IVCD-ratio and correlation between IACD and IACDIVCD- ratio (r=0.84, P<0.001). There were 6 CRT nonresponder with no reduction of NYHA class from 3.0±0.3 to 2.9±0.5 during 14.3±13.7 month biventricular pacing, 50.0±28.26ms IVCD (P=0.014), 1.92±1.65 IACD-IVCD-ratio (P=0,029) and correlation between 67.0±24.9ms IACD and IACD-IVCD-ratio (r=0.85, P=0.031).
Conclusions: Focused transesophageal left atrial and left ventricular electrocardiography can be utilized to analyse electrical IACD and IVCD in heart failure patients. IACDIVDC- ratio may be a useful parameter to evaluate electrical left cardiac desynchronization in heart failure patients.