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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.
Background: The application of high-frequency ablation is used for the treatment of tachycardia arrhythmias and is a respected method. Ablation with high frequency current leads to the targeted heat destruction of myocardial tissue at specific sites and thus prevents the pathological propagation of excitation through these structures.
Purpose: The aim of this study was to simulate heat propagation during RF ablation with modeled electrodes in different sizes and materials. The simulation was performed on atrioventricular node re-entry tachycardia (AVNRT), atrioventricular re-entry tachycardia (AVRT) and atrial flutter (AFL).
Methods: Using the modeling and simulation software CST, ablation catheters with 4 mm and 8 mm tip electrodes were modeled from gold and platinum for each. The designed catheters correspond to the manufacturer"s specifications of Medtronic, Biotronik and Osypka. The catheters were integrated into the Offenburg heart rhythm model to simulate and compare the heat propagation during an ablation application, which also takes into account the blood flow in the four heart chambers. A power of 5 W - 40 W was simulated for the 4 mm electrodes and a power of 50 W - 80 W for the 8 mm electrodes.
Results: During the simulated HF ablation application, the temperature at the ablation electrode was measured at different powers. This is 40.67°C at 5 W, 44.34°C at 10 W, 51.76°C at 20 W, 59.0°C at 30 W, and 66.33°C at 40 W. The measured temperature during 40 W application is 39.5°C at 0,5 mm depth in the myocardium and 37.5°C at 2 mm depth.
In the simulation, the 8 mm platinum electrode reached an ablation temperature of 72.85°C at its tip during an applied power of 60 W. In contrast, the 8 mm platinum electrode reached a depth of 5 mm at 39.5 C° and at a depth of 2 mm at 37.5 °C. In contrast, the 8 mm gold electrode reached a temperature of 64.66°C with the same performance. This is due to the thermal properties of gold, which has a better thermal conductivity than platinum.
Conclusions: CST offers the possibility to carry out a static and dynamic simulation of a heart model and the ablation electrodes integrated in it during an HF ablation. In variation with different electrode sizes and materials, therapy methods for the treatment of AVNRT, AVRT and AFL can be optimized
Background: Pulmonary vein isolation (PVI) using cryoballoon catheters are a recognized method for the treatment of atrial fibrillation (AF). This method offers shorter treatment duration in contrast to the classical therapy with high-frequency (HF) ablation.
Purpose: The aim of this study was to integrate different cryoballoon catheters and a HF catheter into a heart rhythm model and to compare them by means of static and dynamic electromagnetic and thermal simulation in use under AF.
Methods: The cryoballoon catheters from Medtronic and the HF ablation catheter from Osypka were modelled virtually with the aid of manufacturer specifications and the CST (Computer Simulation Technology, Darmstadt) simulation program. The cryoballoon catheter was located in the lower left pulmonary vein of the virtual heart rhythm model for the realization of pulmonary vein isolation (PVI) by cryoenergy. The simulated temperature at the balloon surface was -50°C during the simulation.
Results: During a simulated 20 second application of a cryoballoon catheter at -50°C, a temperature of -24°C was measured at a depth of 0.5 mm in the myocardium. At a depth of 1 mm the temperature was -3°C, at 2 mm depth 18°C and at 3 mm depth 29°C. Under the 15 second application of a RF catheter with a 8 mm electrode and a power of 5 W at 420 kHz, the temperature at the tip of the electrode was 110°C. At a depth of 0.5 mm in the myocardium, the temperature was 75°C, at a depth of 1 mm 58°C, at 2 mm depth 45°C and at 3 mm depth 38°C.
Conclusions: The simulation of temperature profiles during the virtual application of several catheter models in the heart rhythm model allows the static and dynamic simulation of PVI by cryoballoon ablation and RF ablation. The three-dimensional simulation can be used to improve ablation applications by creating a model in personalized cardiac rhythm therapy from MRI or CT data of a heart and finding a favourable position for ablation of AF.
Background: Transesophageal left atrial (LA) pacing and transesophageal LA ECG recording are semi-invasive techniques for diagnostic and therapy of supraventricular rhythm disturbance. Cardiac resynchronization therapy (CRT) with right atrial (RA) sensed biventricular pacing is an established therapy for heart failure patients with reduced left ventricular (LV) ejection fraction, sinus rhythm and interventricular electrical desynchronization.
Purpose: The aim of the study was to evaluate electromagnetic and voltage pacing fields of the combination of RA pacing, LA pacing and biventricular pacing in patients with long interatrial and interventricular electrical desynchronization.
Methods: The modelling and electromagnetic simulations of transesophageal LA pacing in combination with RA pacing and biventricular pacing would be staged and analyzed with the CST (Computer Simulation Technology) software. Different electrodes were modelled in order to simulate different types of bipolar pacing in the 3D-CAD Offenburg heart rhythm model: The bipolar Solid S (Biotronik) electrode where modelled for RA pacing and right ventricular (RV) pacing, Attain 4194 (Medtronic) for LV pacing and TO8 (Osypka) multipolar esophageal electrode with hemispheric electrodes for LA pacing.
Results: The pacemaker amplitudes for the electromagnetic pacing simulations were performed with 3 V for RA pacing, 1.5 V for RV pacing, 50 V for LA pacing and 3V for LV pacing with pacing impulse duration of 0.5 ms for RA, RV and LV pacing and 10 ms for LA pacing. The atrioventricular pacing delay after RA pacing was 140 ms. The different pacing modes AAI, VVI, DDD, DDD0V and DDD0D were evaluated for the analysis of the electric pacing field propagation of pacemaker, CRT and LA pacing. The pacing results were compared at minimum (LOW) and maximum (HIGH) parameter settings. While the LOW setting produced fewer tetrahedral and more inaccurate results, the HIGH setting produced many tetrahedral and therefore more accurate results.
Conclusions: The simulation of the combination of transesophageal LA pacing with RA sensed biventricular pacing is possible with the Offenburg heart rhythm model. The new temporary 4-chamber pacing method may be additional useful method in CRT non-responders with long interatrial electrical delay.
Cardiac resynchronization therapy (CRT) with hemodynamic optimized biventricular pacing is an established therapy for heart failure patients with sinus rhythm, reduced left ventricular ejection fraction and wide QRS complex. The aim of the study was to evaluate electrical right and left cardiac atrioventricular delay and left atrial delay in CRT responder and non-responder with sinus rhythm.
Methods: Heart failure patients with New York Heart Association class 3.0 ± 0.3, sinus rhythm and 27.7 ± 6.1% left ventricular ejection fraction were measured by surface ECG and transesophageal bipolar left atrial and left ventricular ECG before implantation of CRT devices. Electrical right cardiac atrioventricular delay was measured between onset of P wave and onset of QRS complex in the surface ECG, left cardiac atrioventricular delay between onset of left atrial signal and onset of left ventricular signal in the transesophageal ECG and left atrial delay between onset and offset of left atrial signal in the transesophageal ECG.
Results: Electrical atrioventricular and left atrial delay were 196.9 ± 38.7 ms right and 194.5 ± 44.9 ms left cardiac atrioventricular delay, and 47.7 ± 13.9 ms left atrial delay. There were positive correlation between right and left cardiac atrioventricular delay (r = 0.803 P < 0.001) and negative correlation between left atrial delay and left ventricular ejection fraction (r = −0.694 P = 0.026) with 67% CRT responder.
Conclusions: Transesophageal electrical left cardiac atrioventricular delay and left atrial delay may be useful preoperative atrial desynchronization parameters to improve CRT optimization.
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.
Background: The electrical field (E-field) of the biventricular (BV) stimulation is essential for the success of cardiac resynchronization therapy (CRT) in patients with cardiac insufficiency and widened QRS complex. 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 BV stimulation and HF ablation in atrial fibrillation (AF).
Methods: The modeling and simulation was carried out using the electromagnetic simulation software. 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. Different models of electrodes were integrated into a heart rhythm model for the electrical field simulation (fig.1). 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 RV and LV stimulation were performed simultaneously at amplitude of 3 V at the LV electrode and 1 V at the RV electrode, each with a pulse width of 0.5 ms. The far-field potentials generated by the BV stimulations were perceived by the RA electrode. The far-field potential at the RA electrode tip was 32.86 mV. A far-field potential of 185.97 mV resulted at a distance of 1 mm from the RA electrode tip. AV node ablation was simulated with an applied power of 5 W at 420 kHz at the distal 8 mm ablation electrode. The temperature at the catheter tip was 103.87 ° C after 5 s ablation time, 44.17 ° C from the catheter tip in the myocardium and 37.61 ° C at a distance of 2 mm. After 10 s, the temperature at the three measuring points described above was 107.33 ° C, 50.87 ° C, 40.05 ° C and after 15 seconds 118.42 ° C, 55.75 ° C and 42.13 ° C.
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.
Heart rhythm model and simulation of electrophysiological studies and high-frequency ablations
(2017)
Background: The simulation of complex cardiologic structures has the potential to replace clinical studies due to its high efficiency regarding time and costs. Furthermore, the method is more careful for the patients’ health than the conventional ways. The aim of the study was to create an anatomic CAD heart rhythm model (HRM) as accurate as possible, and to show its usefulness for cardiac electrophysiological studies (EPS) and high-frequency (HF) ablations.
Methods: All natural heart components of the new HRM were based on MRI records, which guaranteed electronic functionality. The software CST (Computer Simulation Technology, Darmstadt) was used for the construction, while CST’s material library assured genuine tissue properties. It should be applicable to simulate different heart rhythm diseases as well as various diffusions of electromagnetic fields, caused by electrophysiological conduction, inside the heart tissue.
Results: It was achievable to simulate normal sinus rhythm and fourteen different heart rhythm disturbance with different atrial and ventricular conduction delays. The simulated biological excitation of healthy and sick HRM were plotted by simulated electrodes of four polar right atrial catheter, six polar His bundle catheter, ten polar coronary sinus catheter, four polar ablation catheter and eight polar transesophageal left cardiac catheter (Fig.). Accordingly, six variables were rebuilt and inserted into the anatomic HRM in order to establish heart catheters for ECG monitoring and HF ablation. The HF ablation catheters made it possible to simulate various types of heart rhythm disturbance ablations with different HF ablation catheters and also showed a functional visualisation of tissue heating. The use of tetrahedral meshing HRM made it attainable to store the results faster accompanied by a higher degree of space saving. The smart meshing function reduced unnecessary high resolutions for coarse structures.
Conclusions: The new HRM for EPS simulation may be additional useful for simulation of heart rhythm disturbance, cardiac pacing, HF ablation and for locating and identification of complex fractioned signals within the atrium during atrial fibrillation HF ablation.
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 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.