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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.
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.
Introduction: Patient selection for cardiac resynchronization therapy (CRT) requires quantification of left ventricular conduction delay (LVCD). After implantation of biventricular pacing systems, individual AV delay (AVD) programming is essential to ensure hemodynamic response. To exclude adverse effects, AVD should exceed individual implant-related interatrial conduction times (IACT). As result of a pilot study, we proposed the development of a programmer-based transoesophageal left heart electrogram (LHE) recording to simplify both, LVCD and IACT measurement. This feature was implemented into the Biotronik ICS3000 programmer simultaneously with 3-channel surface ECG.
Methods: A 5F oesophageal electrode was perorally applied in 44 heart failure CRT-D patients (34m, 10f, 65±8 yrs., QRS=162±21ms). In position of maximum left ventricular deflection, oesophageal LVCD was measured between onsets of QRS in surface ECG and oesophageal left ventricular deflection. Then, in position of maximum left atrial deflection (LA), IACT in VDD operation (As-LA) was calculated by difference between programmed AV delay and the measured interval from onset of left atrial deflection to ventricular stimulus in the oesophageal electrogram. IACT in DDD operation (Ap-LA) was measured between atrial stimulus and LA..
Results: LVCD of the CRT patients was characterized by a minimum of 47ms with mean of 69±23ms. As-LA and Ap-LA were found to be 41±23ms and 125±25ms, resp., at mean. In 7 patients (15,9%), IACT measurement in DDD operation uncovered adverse AVD if left in factory settings. In this cases, Ap-LA exceeded the factory AVD. In 6 patients (13,6%), IACT in VDD operation was less than or equal 10ms indicating the need for short AVD.
Conclusion: Response to CRT requires distinct LVCD and AVD optimization. The ICS3000 oesophageal LHE feature can be utilized to measure LVCD in order to justify selection for CRT. IACT measurement simplifies AV delay optimization in patients with CRT systems irrespective of their make and model.
Introduction: To simplify AV delay (AVD) optimization in cardiac resynchronization therapy (CRT), we reported that the hemodynamically optimal AVD for VDD and DDD mode CRT pacing can be approximated by individually measuring implant-related interatrial conduction intervals (IACT) in oesophageal electrogram (LAE) and adding about 50ms. The programmer-based St Jude QuickOpt algorithm is utilizing this finding. By automatically measuring IACT in VDD operation, it predicts the sensed AVD by adding either 30ms or 60ms. Paced AVD is strictly 50ms longer than sensed AVD. As consequence of those variations, several studies identified distinct inaccuracies of QuickOpt. Therefore, we aimed to seek for better approaches to automate AVD optimization.
Methods: In a study of 35 heart failure patients (27m, 8f, age: 67±8y) with Insync III Marquis CRT-D systems we recorded telemetric electrograms between left ventricular electrode and superior vena cava shock coil (LVtip/SVC = LVCE) simultaneously with LAE. By LVCE we measured intervals As-Pe in VDD and Ap-Pe in DDD operation between right atrial sense-event (As) or atrial stimulus (Ap), resp., and end of the atrial activity (Pe). As-Pe and Ap-Pe were compared with As-LA an Ap-LA in LAE, respectively.
Results: End of the left atrial activity in LVCE could clearly be recognized in 35/35 patients in VDD and 29/35 patients in DDD operation. We found mean intervals As-LA of 40.2±24.5ms and Ap-LA of 124.3±20.6ms. As-Pe was 94.8±24.1ms and Ap-Pe was 181.1±17.8ms. Analyzing the sums of As-LA + 50ms with duration of As-Pe and Ap-LA + 50ms with duration of Ap-Pe, the differences were 4.7±9.2ms and 4.2±8.6ms, resp., only. Thus, hemodynamically optimal timing of the ventricular stimulus can be triggered by automatically detecting Pe in LVCE.
Conclusion: Based on minimal deviations between LAE and LVCE approach, we proposed companies to utilize the LVCE in order to automate individual AVD optimization in CRT pacing.
本发明涉及一种用于生物阻抗测量和/或用于神经刺激的食道电极探针(10);用于经食道心脏病治疗和/或心脏病诊断的设备(100);以及一种用于控制或调节用于心脏导管消融装置和/或心脏、循环和/或肺支持装置的方法。食道电极探针包括生物阻抗测量装置,用于测量围绕食道电极探针的组织中的至少一部分组织的生物阻抗。生物阻抗装置包括至少一个第一电极和至少一个第二电极,其中至少一个第一电极(12A)布置在食道电极探针的面向心脏的一侧(14)上,并且至少一个第二电极(12B)布置在食道电极探针背离心脏的一侧(16)上。装置(100)包括食道电极探针(10)和控制和/或评估装置(30),其被配置用于从至少一个第一电极(12A)接收第一生物阻抗测量信号并从至少一个第二电极(12B)接收第二生物阻抗测量信号,并对这些信号进行比较,并且在比较的基础上产生控制信号。该控制信号可以是用于控制或调节心脏导管消融装置和/或心脏、循环和/或肺支持装置的信号。
Die transösophageale Neurostimulation ist eine neue Therapieform und könnte unter anderem zur Schmerzlinderung während einer transösophagealen Linksherzstimulation angewendet werden. Sie ist in die Kategorie der Rückenmarksstimulation (SCS) einzuordnen, die die meist verwendete Technik der Neurostimulation ist. Die derzeit auf dem Markt vorhandenen Ösophaguskatheter werden bei einer elektrophysiologischen Untersuchung mit Ablation und transösophagealer Echokardiographie zur Temperaturüberwachung eingesetzt. Das Ziel dieser Arbeit war, das vorhandene Offenburger Herzrhythmusmodell, um die Wirbelsäule zu erweitern, einen neuen Ösophagus-Elektroden- Katheter für die transösophageale elektrische Stimulation des Rückenmarks zu modellieren und mittels 3D-Computer-Simulationen auf Ihre Wirksamkeit zu untersuchen.
Um medizinische Behandlungsverfahren in der Praxis besser verstehen und anwenden zu können, gewinnt die Visualisierung der Prozesse an immer größerer Bedeutung. Durch Anwendung der Computer-Simulationssoftware CST können elektromagnetische und thermische Simulationen zur Analyse verschiedener Herzrhythmusstörungen durchgeführt werden. Eine weitere Form der Visualisierung erfolgt durch haptische, dreidimensionale Druckmodelle. Diese Modelle können mit einem generativen Herstellungsverfahren, wie z. B. einem 3D-Drucker, in kürzester Zeit hergestellt werden.
In-vivo and in-vitro comparison of implant-based CRT optimization - What provide new algorithms?
(2011)
Introduction: In cardiac resynchronization therapy (CRT), individual AV delay (AVD) optimization can effectively increase hemodynamics and reduce non-responder rate. Accurate, automatic and easily comprehensible algorithms for the follow-up are desirable. QuickOpt is the first attempt of a semi-automatic intracardiac electrogram (IEGM) based AVD algorithm. We aimed to compare its accuracy and usefulness by in-vitro and in-vivo studies.
Methods: Using the programmable ARSI-4 four-chamber heart rhythm and IEGM simulator (HKP, Germany), the QuickOpt feature of an Epic HF system (St. Jude, USA) was tested in-vitro by simulated atrial IEGM amplitudes between 0.3 and 3.5mV during both, manual and automatic atrial sensing between 0.2 and 1.0mV. Subsequently, in 21 heart failure patients with implanted biventricular defibrillators, QuickOpt was performed in-vivo. Results of the algorithm for VDD and DDD stimulation were compared with echo AV delay optimization.
Results: In-vitro simulations demonstrated a QuickOpt measuring accuracy of ± 8ms. Depending on atrial IEGM amplitude, the algorithm proposed optimal AVD between 90 and 150ms for VDD and between 140 and 200ms for DDD operation, respectively. In-vivo, QuickOpt difference between individual AVD in DDD and VDD mode was either 50ms (20pts) or 40ms (1pt). QuickOpt and echo AVD differed by 41 ± 25ms (7 – 90ms) in VDD and by 18 ± 24ms (17-50ms) in DDD operation. Individual echo AVD difference between both modes was 73 ± 20ms (30-100ms).
Conclusion: The study demonstrates the value of in-vitro studies. It predicted QuickOpt deficiencies regarding IEGM amplitude dependent AVD proposals constrained to fixed individual differences between DDD and VDD mode. Consequently, in-vivo, the algorithm provided AVD of predominantly longer duration than echo in both modes. Accepting echo individualization as gold standard, QuickOpt should not be used alone to optimize AVD in CRT patients.
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.