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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.
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.
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.
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.
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.
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。
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.
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.
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.
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.
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.
Die Pulmonalvenenisolation (PVI) mithilfe von Kryoballonkathetern ist eine anerkannte Methode zur Behandlung von Vorhofflimmern (AF). Diese Methode bietet eine kürzere Behandlungsdauer als die klassische Therapie durch die Hochfrequenz- (HF) Ablation. Ziel dieser Studie war es, verschie-dene Kryoballonkatheter, HF-Ablationskatheter und Ösophaguskatheter in ein Herzrhythmusmodell zu integrieren und mit statischer und dynamischer Simulation elektrische und thermische Felder bei PVI unter Vorhofflimmern zu untersuchen.
Die Katheterablation mit Hochfrequenzstrom (HF) ist der Goldstandard für die Therapie vieler kardi-aler Tachyarrhythmien. Bei der HF-Ablation entstehen Temperaturen zwischen 50 °C und 70 °C, wo-durch bestimmte Strukturen im Herzgewebe gezielt zerstört werden können. Ziel der Studie ist, die HF-Ablation und deren Wärmeausbreitung in Bezug auf die zugeführte Leistung mit unterschiedli-chem Elektrodenmaterial und Elektrodengröße bei supraventrikülären Tachykardien zu simulieren.
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.