Remote Navigation and Contact-Force Control of Radiofrequency Ablation Catheters

Atrial fibrillation (AF), the most common and clinically significant heart rhythm disorder, is characterized by rapid and irregular electrical activity in the upper chambers resulting in abnormal contractions. Radiofrequency (RF) cardiac catheter ablation is a minimally invasive curative treatment that aims to electrically correct signal pathways inside the atria to restore normal sinus rhythm. Successful catheter ablation requires the complete and permanent elimination of arrhythmogenic signals by delivering transmural RF ablation lesions contiguously near and around key cardiac structures. These procedures are complex and technically challenging and, even when performed by the most skilled physician, nearly half of patients undergo repeat procedures due to incomplete elimination of the arrhythmogenic pathways. This thesis aims to incorporate innovative design to improve catheter stability and maneuverability through the development of robotic platforms that enable precise placement of reproducibly durable ablation lesions. The first part of this thesis deals with the challenges to lesion delivery imposed by cardiorespiratory motion. One of the main determinants of the delivery of durable and transmural RF lesions is the ability to define and maintain a constant contact force between the catheter tip electrode and cardiac tissue, which is hampered by the presence of cardiorespiratory motion. To address this need, I developed and evaluated a novel catheter contact-force control device. The compact electromechanical add-on tool monitors catheter-tissue contact force in real-time and simultaneously adjusts the position of a force-sensing ablation catheter within a steerable sheath to compensate for the change in contact force. In a series of in vitro and in vivo experiments, the contact-force control device demonstrated an ability to: a) maintain an average force to within 1 gram of a set level; b) reduce contact-force variation to below 5 grams (2-8-fold improvement over manual catheter intervention); c) ensure the catheter tip never lost contact with the tissue and never approached dangerous force levels; and importantly, d) deliver reproducible RF ablation lesions regardless of cardiac tissue motion, which were of the same depth and volume as lesions delivered in the absence of tissue motion. In the second part of the thesis, I describe a novel steerable sheath and catheter robotic navigation system, which incorporates the catheter contact-force controller. The robotic platform enables precise and accurate manipulation of a remote conventional steerable sheath and permits catheter-tissue contact-force control. The robotic navigation system was evaluated in vitro using a phantom that combines stationary and moving targets within an in vitro model representing a beating heart. An electrophysiologist used the robotic system to remotely navigate the sheath and catheter tip to select targets and compared the accuracy of reaching these targets performing the same tasks manually. Robotic intervention resulted in significantly higher accuracy and significantly improved the contact-force profile between the catheter tip and moving tissue-mimicking material. Our studies demonstrate that using available contact-force information within a robotic system can ensure precise and accurate placement of reliably transmural RF ablation lesions. These robotic systems can be valuable tools used to optimize RF lesion delivery techniques and ultimately improve clinical outcomes for AF ablation therapy

Abbott Lab Instrumentation Validation

Over the past 40 years, since the initial catheter ablation procedure was completed, cardiac mapping has become an essential part of electrophysiological procedures. Cardiac mapping is an electrophysiological study that allows physicians to analyze the electrical activity of the heart in order to diagnose and treat cardiovascular disease. Institutions like Cal Poly can utilize professional instrumentation systems with an appropriate wet lab to develop new devices and study various phenomena in an in-vitro physiological environment. Cardiac mapping systems used in tandem with catheter ablation procedures are essential to ensuring that the trend of deaths due to cardiovascular disease continues to decline. This project thesis will signify the importance of the development of a wet lab integrated with Abbott’s Ensite Precision Cardiac Mapping System for future product development and in-vitro studies

Remote magnetic versus manual catheters: evaluation of ablation effect in atrial fibrillation by myocardial marker levels

Background A remote magnetic navigation (MN) system is available for radiofrequency ablation of atrial fibrillation (AF), challenging the conventional manual ablation technique. The myocardial markers were measured to compare the effects of the two types of MN catheters with those of a manual-irrigated catheter in AF ablation. Methods AF patients underwent an ablation procedure using either a conventional manual-irrigated catheter (CIR, n=65) or an MN system utilizing either an irrigated (RMI, n=23) or non-irrigated catheter (RMN, n=26). Levels of troponin T (TnT) and the cardiac isoform of creatin kinase (CKMB) were measured before and after ablation. Results Mean procedure times and total ablation times were longer employing the remote magnetic system. In all groups, there were pronounced increases in markers of myocardial injury after ablation, demonstrating a significant correlation between total ablation time and post-ablation levels of TnT and CKMB (CIR r=0.61 and 0.53, p<0.001; RMI r=0.74 and 0.73, p<0.001; and RMN r=0.51 and 0.59, p<0.01). Time-corrected release of TnT was significantly higher in the CIR group than in the other groups. Of the patients, 59.6% were free from AF at follow-up (12.2± 5.4 months) and there were no differences in success rate between the three groups. Conclusions Remote magnetic catheters may create more discrete and predictable ablation lesions measured by myocardial enzymes and may require longer total ablation time to reach the procedural endpoints. Remote magnetic non-irrigated catheters do not appear to be inferior to magnetic irrigated catheters in terms of myocardial enzyme release and clinical outcome

Modeling and Control of Steerable Ablation Catheters

Catheters are long, flexible tubes that are extensively used in vascular and cardiac interventions, e.g., cardiac ablation, coronary angiography and mitral valve annuloplasty. Catheter-based cardiac ablation is a well-accepted treatment for atrial fibrillation, a common type of cardiac arrhythmia. During this procedure, a steerable ablation catheter is guided through the vasculature to the left atrium to correct the signal pathways inside the heart and restore normal heart rhythm. The outcome of the ablation procedure depends mainly on the correct positioning of the catheter tip at the target location inside the heart and also on maintaining a consistent contact between the catheter tip and cardiac tissue. In the presence of cardiac and respiratory motions, achieving these goals during the ablation procedure is very challenging without proper 3D visualization, dexterous control of the flexible catheter and an estimate of the catheter tip/tissue contact force. This research project provides the required basis for developing a robotics-assisted catheter manipulation system with contact force control for use in cardiac ablation procedures. The behavior of the catheter is studied in free space as well in contact with the environment to develop mathematical models of the catheter tip that are well suited for developing control systems. The validity of the proposed modeling approaches and the performance of the suggested control techniques are evaluated experimentally. As the first step, the static force-deflection relationship for ablation catheters is described with a large-deflection beam model and an optimized pseudo-rigid-body 3R model. The proposed static model is then used in developing a control system for controlling the contact force when the catheter tip is interacting with a static environment. Our studies also showed that it is possible to estimate the tip/tissue contact force by analyzing the shape of the catheter without installing a force sensor on the catheter. During cardiac ablation, the catheter tip is in contact with a relatively fast moving environment (cardiac tissue). Robotic manipulation of the catheter has the potential to improve the quality of contact between the catheter tip and cardiac tissue. To this end, the frequency response of the catheter is investigated and a control technique is proposed to compensate for the cardiac motion and to maintain a constant tip/tissue contact force. Our study on developing a motion compensated robotics-assisted catheter manipulation system suggests that redesigning the actuation mechanism of current ablation catheters would provide a major improvement in using these catheters in robotics-assisted cardiac ablation procedures

Signal quality of endovascular electroencephalography

Objective, Approach. A growing number of prototypes for diagnosing and treating neurological and psychiatric diseases are predicated on access to high-quality brain signals, which typically requires surgically opening the skull. Where endovascular navigation previously transformed the treatment of cerebral vascular malformations, we now show that it can provide access to brain signals with substantially higher signal quality than scalp recordings. Main results. While endovascular signals were known to be larger in amplitude than scalp signals, our analysis in rabbits borrows a standard technique from communication theory to show endovascular signals also have up to 100× better signal-to-noise ratio. Significance. With a viable minimally-invasive path to high-quality brain signals, patients with brain diseases could one day receive potent electroceuticals through the bloodstream, in the course of a brief outpatient procedure

Study of slow conduction zones and comparison of the information extracted from isochronal late activation maps (ILAMs) with the one extracted from MRI

Treballs Finals de Grau d'Enginyeria Biomèdica. Facultat de Medicina i Ciències de la Salut. Universitat de Barcelona. Curs: 2021-2022. Director: Ivo RocaOne of the hardest and most important things regarding to ventricular tachycardia (VT) ablation is the determination of critical sites. They can be determined by using navigation systems, which allow the generation of isochronal late activation maps (ILAMs). ILAMs are mainly used to determine deceleration zones, since one of the mechanisms of VT and the one studied, is re-entry, which is caused by the presence of a channel with slow conduction zones. However, the main problem with this technology is that the late activation time of most electric signals is not recorded properly, so a post signal filtering is required to accurately determine the critical sites. Understanding the above, this projected analysed ILAMs from 43 cases and 107 deceleration zones ablated during 2019-2021 to study the behaviour of slow conduction zones and compare the information extracted with the one extracted from MRI. After filtering all the signals and analysing the results with the statistical software SPSS, we found that..

Computer-Assisted Electroanatomical Guidance for Cardiac Electrophysiology Procedures

Cardiac arrhythmias are serious life-threatening episodes affecting both the aging population and younger patients with pre-existing heart conditions. One of the most effective therapeutic procedures is the minimally-invasive catheter-driven endovascular electrophysiology study, whereby electrical potentials and activation patterns in the affected cardiac chambers are measured and subsequent ablation of arrhythmogenic tissue is performed. Despite emerging technologies such as electroanatomical mapping and remote intraoperative navigation systems for improved catheter manipulation and stability, successful ablation of arrhythmias is still highly-dependent on the operator’s skills and experience. This thesis proposes a framework towards standardisation in the electroanatomical mapping and ablation planning by merging knowledge transfer from previous cases and patient-specific data. In particular, contributions towards four different procedural aspects were made: optimal electroanatomical mapping, arrhythmia path computation, catheter tip stability analysis, and ablation simulation and optimisation. In order to improve the intraoperative electroanatomical map, anatomical areas of high mapping interest were proposed, as learned from previous electrophysiology studies. Subsequently, the arrhythmic wave propagation on the endocardial surface and potential ablation points were computed. The ablation planning is further enhanced, firstly by the analysis of the catheter tip stability and the probability of slippage at sparse locations on the endocardium and, secondly, by the simulation of the ablation result from the computation of convolutional matrices which model mathematically the ablation process. The methods proposed by this thesis were validated on data from patients with complex congenital heart disease, who present unusual cardiac anatomy and consequently atypical arrhythmias. The proposed methods also build a generic framework for computer guidance of electrophysiology, with results showing complementary information that can be easily integrated into the clinical workflow.Open Acces

Principles of Electroanatomic Mapping

Electrophysiologic testing and radiofrequency ablation have evolved as curative measures for a variety of rhythm disturbances. As experience in this field has grown, ablation is progressively being used to address more complex rhythm disturbances. Paralleling this trend are technological advancements to facilitate these efforts, including electroanatomic mapping (EAM). At present, several different EAM systems utilizing various technologies are available to facilitate mapping and ablation. Use of these systems has been shown to reduce fluoroscopic exposure and radiation dose, with less significant effects on procedural duration and success rates. Among the data provided by EAM are chamber reconstruction, tagging of important anatomic landmarks and ablation lesions, display of diagnostic and mapping catheters without using fluoroscopy, activation mapping, and voltage (or scar) mapping. Several EAM systems have specialized features, such as enhanced ability to map non-sustained or hemodynamically unstable arrhythmias, ability to display diagnostic as well as mapping catheter positions, and wide compatibility with a variety of catheters. Each EAM system has its strengths and weaknesses, and the system chosen must depend upon what data is required for procedural success (activation mapping, substrate mapping, cardiac geometry), the anticipated arrhythmia, the compatibility of the system with adjunctive tools (i.e. diagnostic and ablation catheters), and the operator's familiarity with the selected system. While EAM can offer significant assistance during an EP procedure, their incorrect or inappropriate application can substantially hamper mapping efforts and procedural success, and should not replace careful interpretation of data and strict adherence to electrophysiologic principles

Novel Strategies in the Ablation of Typical Atrial Flutter: Role of Intracardiac Echocardiography

Radiofrequency ablation (RFA) of the cavo-tricuspid isthmus (CTI) is one of the most frequently performed procedures in electrophysiology. Despite a high success rate, ablation of the CTI can be unusually difficult in some cases. Multiple tools like angiography, 3D mapping, remote navigation and intracardiac echocardiography (ICE) have been introduced to facilitate typical flutter ablation. This review article summarizes the clinical value of different strategies and tools used for CTI ablation focusing on the importance of approaches utilizing ICE