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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.
Electrode modelling and simulation of diagnostic and pulmonary vein isolation in atrial fibrillation
(2022)
Transthoracic impedance cardiography (ICG) is a non-invasive method for determination of hemodynamic parameters. The basic principle of transthoracic ICG is the measurement of electrical conductivity of the thorax over the time. The aim of the study was the analysis of hemodynamic parameters from healthy individuals and the evaluation of various hemodynamic monitoring devices. Fourteen men (mean age 25 ± 4.59 years) and twelve women (mean age 24 ± 3.5 years) were measured during the cardiovascular engineering laboratory at Offenburg University of Applied Sciences, Offenburg, Germany. The ICG recordings were measured with the devices CardioScreen 1000, CardioScreen 2000 and TensoScreen with the corresponding Software Cardiovascular Lab 2.5 (Medis Medizinische Messtechnik GmbH, Illmenau, Germany). In order to create identical frame conditions, all measurements were recorded in the same position and for the same duration. Various positions were simulated from horizontal lying position to vertical standing position. Altogether, more than 30 hemodynamic parameters were measured.
In contrast to conventional aortic valve replacement, the Transcatheter Aortic Valve Implantation (TAVI) is a new highly specialist alternative to surgical valve replacement for patients with symptomatic severe aortic stenosis and high operative risk. The procedure was performed in a minimally invasive way and was introduced at the university heart centre, Freiburg – Bad Krozingen in 2008. The results have been getting better and better over the years. The aim of the investigation is the analysis of electrocardiogram conduction time and the electrocardiography changes recorded hours and days after the procedure depending on artificial heart valve models, which may lead to pacemaker implantation, even the analysis of the effectiveness of treatment.
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).
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).
Patients with focal ventricular tachycardia are at risk of hemodynamic failure and if no treatment is provided the mortality rate can exceed 30%. Therefore, medical professionals must be adequately trained in the management of these conditions. To achieve the best treatment, the origin of the abnormality should be known, as well as the course of the disease. This study provides an opportunity to visualize various focal ventricular tachycardias using the Offenburg heart rhythm model. Modeling and simulation of focal ventricular tachycardias in the Offenburg heart rhythm model was performed using CST (Computer Simulation Technology) software from Dessault Systèms. A bundle of nerve tissue in different regions in the left and right ventricle was defined as the focus in the already existing heart rhythm model. This ultimately served as the origin of the focal excitation sites. For the simulations, the heart rhythm model was divided into a mesh consisting of 5354516 tetrahedra, which is required to calculate the electric field lines. The simulations in the Offenburg heart rhythm model were able to successfully represent the progression of focal ventricular tachycardia in the heart using measured electrical field lines. The simulation results were realized as an animated sequence of images running in real time at a frame rate of 20 frames per second. By changing the frame rate, these simulations can additionally be produced at different speeds. The Offenburg heart rhythm model allows visualization of focal ventricular arrhythmias using computer simulations.
Disturbances of the cardiac conduction system causing reentry mechanisms above the atrioventricular (AV) node are induced by at least one accessory pathway with different conducting properties and refractory periods. This work aims to further develop the already existing and continuously expanding Offenburg heart rhythm model to visualise the most common supraventricular reentry tachycardias to provide a better understanding of the cause of the respective reentry mechanism.
Patients with focal ventricular tachycardia are at risk of hemodynamic failure and if no treatment is provided the mortality rate can exceed 30%. Therefore, medical professionals must be adequately trained in the management of these conditions. To achieve the best treatment, the origin of the abnormality should be known, as well as the course of the disease. This study provides an opportunity to visualize various focal ventricular tachycardias using the Offenburg cardiac rhythm model.
Background: A disturbed synchronization of the ventricular contraction can cause a highly developed systolic heart failure in affected patients, which can often be explained by a diseased left bundle branch block (LBBB). If medication remains unresponsive, the concerned patients will be treated with a cardiac resynchronization therapy (CRT) system. The aim of this study was to integrate His bundle pacing into the Offenburg heart rhythm model in order to visualize the electrical pacing field generated by His bundle pacing.
Methods: Modelling and electrical field simulation activities were performed with the software CST (Computer Simulation Technology) from Dessault Systèms. CRT with biventricular pacing is to be achieved by an apical right ventricular electrode and an additional left ventricular electrode, which is floated into the coronary vein sinus. This conventional type of biventricular pacing leads to a reduction of the left ventricular ejection fraction. Furthermore, the non-responder rate of the CRT therapy is about one third of the CRT patients.
Results: His bundle pacing represents a physiological alternative to conventional cardiac pacing and cardiac resynchronization. An electrode implanted in the His bundle emits a stronger electrical pacing field than the electrical pacing field of conventional cardiac pacemakers. The pacing of the His bundle was performed by the Medtronic Select Secure 3830 electrode with pacing voltage amplitudes of 3 V, 2 V and 1.5 V in combination with a pacing pulse duration of 1 ms.
Conclusions: Compared to conventional cardiac pacemaker pacing, His bundle pacing is capable of bridging LBBB conduction disorders in the left ventricle. The His bundle pacing electrical field is able to spread via the physiological pathway in the right and left ventricles for CRT with a narrow QRS-complex in the surface ECG.
A disturbed synchronization of the ventricular contraction can cause a highly developed systolic heart failure in affected patients with reduction of the left ventricular ejection fraction, which can often be explained by a diseased left bundle branch block (LBBB). If medication remains unresponsive, the concerned patients will be treated with a cardiac resynchronization therapy (CRT) system. The aim of this study was to integrate His-bundle pacing into the Offenburg heart rhythm model in order to visualize the electrical pacing field generated by His-Bundle-Pacing. Modelling and electrical field simulation activities were performed with the software CST (Computer Simulation Technology) from Dessault Systèms. CRT with biventricular pacing is to be achieved by an apical right ventricular electrode and an additional left ventricular electrode, which is floated into the coronary vein sinus. The non-responder rate of the CRT therapy is about one third of the CRT patients. His- Bundle-Pacing represents a physiological alternative to conventional cardiac pacing and cardiac resynchronization. An electrode implanted in the His-bundle emits a stronger electrical pacing field than the electrical pacing field of conventional cardiac pacemakers. The pacing of the Hisbundle was performed by the Medtronic Select Secure 3830 electrode with pacing voltage amplitudes of 3 V, 2 V and 1,5 V in combination with a pacing pulse duration of 1 ms. Compared to conventional pacemaker pacing, His-bundle pacing is capable of bridging LBBB conduction disorders in the left ventricle. The His-bundle pacing electrical field is able to spread via the physiological pathway in the right and left ventricles for CRT with a narrow QRS-complex in the surface ECG.
The visualization of heart rhythm disturbance and atrial fibrillation therapy allow the optimization of new cardiac catheter ablations. With the simulation software CST (Computer Simulation Technology, Darmstadt) electromagnetic and thermal simulations can be carried out to analyze and optimize different heart rhythm disturbance and cardiac catheters for pulmonary vein isolation. Another form of visualization is provided by haptic, three-dimensional print models. These models can be produced using an additive manufacturing method, such as a 3D printer. The aim of the study was to produce a 3D print of the Offenburg heart rhythm model with a representation of an atrial fibrillation ablation procedure to improve the visualization of simulation of cardiac catheter ablation.
The basis of 3D printing was the Offenburg heart rhythm model and the associated simulation of cryoablation of the pulmonary vein. The thermal simulation shows the pulmonary vein isolation of the left inferior pulmonary vein with the cryoballoon catheter Arctic Front AdvanceTM from Medtronic. After running through the simulation, the thermal propagation during the procedure was shown in the form of different colors. The three-dimensional print models were constructed on the base of the described simulation in a CAD program. Four different 3D printers are available for this purpose in a rapid prototyping laboratory at the University of Applied Science Offenburg. Two different printing processes were used: 1. a binder jetting printer with polymer gypsum and 2. a multi-material printer with photopolymer. A final print model with additional representation of the esophagus and internal esophagus catheter was also prepared for printing.
With the help of the thermal simulation results and the subsequent evaluation, it was possible to make a conclusion about the propagation of the cold emanating from the catheter in the myocardium and the surrounding tissue. It could be measured that already 3 mm from the balloon surface into the myocardium the temperature drops to 25 °C. The simulation model was printed using two 3D printing methods. Both methods as well as the different printing materials offer different advantages and disadvantages. While the first model made of polymer gypsum can be produced quickly and cheaply, the second model made of photopolymer takes five times longer and was twice as expensive. On the other hand, the second model offers significantly better properties and was more durable overall. All relevant parts, especially the balloon catheter and the conduction, are realistically represented. Only the thermal propagation in the form of different colors is not shown on this model.
Three-dimensional heart rhythm models as well as virtual simulations allow a very good visualization of complex cardiac rhythm therapy and atrial fibrillation treatment methods. The printed models can be used for optimization and demonstration of cryoballoon catheter ablation in patients with atrial fibrillation.
Spinal cord stimulation (SCS) is the most commonly used technique of neurostimulation. It involves the stimulation of the spinal cord and is therefore used to treat chronic pain. The existing esophageal catheters are used for temperature monitoring during an electrophysiology study with ablation and transesophageal echocardiography. The aim of the study was to model the spine and new esophageal electrodes for the transesophageal electrical pacing of the spinal cord, and to integrate them in the Offenburg heart rhythm model for the static and dynamic simulation of transesophageal neurostimulation. The modeling and simulation were both performed with the electromagnetic and thermal simulation software CST (Computer Simulation Technology, Darmstadt). Two new esophageal catheters were modelled as well as a thoracic spine based on the dimensions of a human skeleton. The simulation of directed transesophageal neurostimulation is performed using the esophageal balloon catheter with an electric pacing potential of 5 V and a trapezoidal signal. A potential of 4.33 V can be measured directly at the electrode, 3.71 V in the myocardium at a depth of 2 mm, 2.68 V in the thoracic vertebra at a depth of 10 mm, 2.1 V in the thoracic vertebra at a depth of 50 mm and 2.09 V in the spinal cord at a depth of 70 mm. The relation between the voltage delivered to the electrodes and the voltage applied to the spinal cord is linear. Virtual heart rhythm and catheter models as well as the simulation of electrical pacing fields and electrical sensing fields allow the static and dynamic simulation of directed transesophageal electrical pacing of the spinal cord. The 3D simulation of the electrical sensing and pacing fields may be used to optimize transesophageal neurostimulation.
The visualization of heart rhythm disturbance and atrial fibrillation therapy allows the optimization of new cardiac catheter ablations. With the simulation software CST (Computer Simulation Technology, Darmstadt) electromagnetic and thermal simulations can be carried out to analyze and optimize different heart rhythm disturbance and cardiac catheters for pulmonary vein isolation. Another form of visualization is provided by haptic, three-dimensional print models. These models can be produced using an additive manufacturing method, such as a 3d printer. The aim of the study was to produce a 3d print of the Offenburg heart rhythm model with a representation of an atrial fibrillation ablation procedure to improve the visualization of simulation of cardiac catheter ablation. The basis of 3d printing was the Offenburg heart rhythm model and the associated simulation of cryoablation of the pulmonary vein. The thermal simulation shows the pulmonary vein isolation of the left inferior pulmonary vein with the cryoballoon catheter Arctic Front Advance™ from Medtronic. After running through the simulation, the thermal propagation during the procedure was shown in the form of different colors. The three-dimensional print models were constructed on the base of the described simulation in a CAD program. Four different 3d printers are available for this purpose in a rapid prototyping laboratory at the University of Applied Science Offenburg. Two different printing processes were used and a final print model with additional representation of the esophagus and internal esophagus catheter was also prepared for printing. With the help of the thermal simulation results and the subsequent evaluation, it was possible to draw a conclusion about the propagation of the cold emanating from the catheter in the myocardium and the surrounding tissue. It was measured that just 3 mm from the balloon surface into the myocardium the temperature dropped to 25 °C. The simulation model was printed using two 3d printing methods. Both methods, as well as the different printing materials offer different advantages and disadvantages. All relevant parts, especially the balloon catheter and the conduction, are realistically represented. Only the thermal propagation in the form of different colors is not shown on this model. Three-dimensional heart rhythm models as well as virtual simulations allow very clear visualization of complex cardiac rhythm therapy and atrial fibrillation treatment methods. The printed models can be used for optimization and demonstration of cryoballoon catheter ablation in patients with atrial fibrillation.
Spinal cord stimulation (SCS) is the most commonly used technique of neurostimulation. It involves the stimulation of the spinal cord and is therefore used to treat chronic pain. The existing esophageal catheters are used for temperature monitoring during an electrophysiology study with ablation and transesophageal echocardiography. The aim of the study was to model the spine and new esophageal electrodes for the transesophageal electrical pacing of the spinal cord, and to integrate them in the Offenburg heart rhythm model for the static and dynamic simulation of transesophageal neurostimulation. The modeling and simulation were both performed with the electromagnetic and thermal simulation software CST (Computer Simulation Technology, Darmstadt). Two new esophageal catheters were modelled as well as a thoracic spine based on the dimensions of a human skeleton. The simulation of directed transesophageal neurostimulation is performed using the esophageal balloon catheter with an electric pacing potential of 5 V and a trapezoidal signal. A potential of 4.33 V can be measured directly at the electrode, 3.71 V in the myocardium at a depth of 2 mm, 2.68 V in the thoracic vertebra at a depth of 10 mm, 2.1 V in the thoracic vertebra at a depth of 50 mm and 2.09 V in the spinal cord at a depth of 70 mm. The relation between the voltage delivered to the electrodes and the voltage applied to the spinal cord is linear. Virtual heart rhythm and catheter models as well as the simulation of electrical pacing fields and electrical sensing fields allow the static and dynamic simulation of directed transesophageal electrical pacing of the spinal cord. The 3D simulation of the electrical sensing and pacing fields may be used to optimize transesophageal neurostimulation.
Cardiac contractility modulation (CCM) is a device-based therapy for the treatment of systolic left ventricular chronic heart failure. Unlike other device-based therapies for heart failure, CCM delivers non-excitatory pacing signals to the myocardium. This leads to an extension of the action potential and to an improved contractility of the heart. The modeling and simulation was done with the electromagnetic simulation software CST. Three CCM electrodes were inserted into the Offenburg heart rhythm model and subsequently simulated the electric field propagation in CCM therapy.
In addition, simulations of CCM have been performed with electrodes from other device-based therapies, such as cardiac resynchronization therapy (CRT) and implantable cardioverter / defibrillator (ICD) therapy. At the same distance to the simulation electrode, the electric field is slightly stronger in CCM therapy than in CCM therapy with additionally implanted CRT or ICD electrodes. In addition, there is a change in the electric field propagation at the electrodes of the CRT and the shock electrode of the ICD.
By simulating several different therapy procedures on the heart, it is possible to check how they affect their behavior during normal operation. CCM heart rhythm model simulation allows the evaluation the individual electrical pacing and sensing field during CCM.
Abstract: Electric field of biventricular (BV) pacing, left ventricular (LV) electrode position and electrical interventricular desynchronization are important parameters for successful cardiac resynchronization therapy (CRT) in patients with heart failure, sinus rhythm and reduced LV ejection fraction. The aim of the study was to evaluate electric pacing field of transesophageal left atrial (LA) pacing and BV pacing with 3D heart rhythm simulation. Bipolar right atrial (RA), right ventricular (RV), LV electrodes and multipolar hemispherical esophageal LA electrodes were modeled with CST (Computer Simulation Technology, Darmstadt). Electric pacing field were simulated with bipolar RA and RV pacing with Solid S (Biotronik) electrode, bipolar LV pacing with Attain 4194 (Medtronic) electrode and bipolar LA pacing with TO8 (Osypka) esophageal electrode. 3D heart rhythm model with esophagus allowed electric pacing field simulation of 4-chamber pacing with bipolar intracardiac RA, RV, LV pacing and bipolar transesophageal LA pacing. The pacing amplitudes were 3V RA pacing amplitude, 50V LA pacing amplitude, 1.5V RV pacing amplitude and 3V LV pacing amplitude with 0.5ms pacing pulse duration. The atrioventricular delay between RA pacing and BV pacing was 140ms atrioventricular pacing delay and simultaneous RV and LV pacing. Electric pacing fields were simulated during the different pacing modes AAI, VVI, DDD and DDD0V. The intracardiac far-field pacing potentials were evaluated with intracardiac electrodes and a distance of 1mm from the electrodes with RA electrode 1.104V, RV electrode 0.703V and LV electrode 1.32V. The transesophageal far-field pacing potential was evaluated with transesophageal electrode and a distance of 10mm from the elelctrode with LA electrode 6.076V. Heart rhythm model simulation with esophagus allows evaluation of electric pacing fields in AAI, VVI, DDD, DDD0V and DDD0D pacing modes. Electric pacing field of RA, RV and LV pacing in combination with LA pacing may additional useful pacing mode in CRT non-responders.
Pulmonary vein isolation (PVI) is a common therapy in atrial fibrillation (AF). The cryoballoon was invented to isolate the pulmonary vein in one step and in a shorter time than a point-by-point radiofrequency (RF) ablation. The aim of the study was to model two cryoballoon catheters, one RF catheter and to integrate them into a heart rhythm model for the static and dynamic simulation of PVI by cryoablation and RF ablation in AF. The modeling and simulation were carried out using the electromagnetic and thermal simulation software CST (CST, Darmstadt). Two cryoballons and one RF ablation catheter were modeled based on the technical manuals of the manufacturers Medtronic and Osypka. The PVI especially the isolation of the left inferior pulmonary vein using a cryoballoon catheter was performed with a -50 °C heatsource and an exponential signal. The temperature at the balloon surface was -50 °C after 20 s ablation time, -24 °C from the balloon 0,5 mm in the myocardium, at a distance of 1 mm -3 °C, at 2 mm 18 °C and at a distance of 3mm 29 °C. PVI with RF energy was simulated with an applied power of 5 W at 420 kHz at the distal 8 mm ablation electrode. The temperature at the tip electrode was 110 °C after 15 s ablation time, 75 °C from the balloon at 0,5 mm in the myocardium, at a distance of 1 mm 58 °C, at 2 mm 45 °C and at a distance of 3 mm 38 °C. Virtual heart rhythm and catheter models as well as the simulation of the temperature allow the simulation of PVI in AF by cryo ablation and RF ablation. The 3D simulation of the temperature profile may be used to optimize RF and cryo ablation.