A Proposal for 3D Electro-Anatomical Mapping Software Based on Benchmark Analysis of Current Clinical Systems: Technical Specifications and Functional Requirements for Electrophysiological Mapping
Cardiac arrhythmias constitute a substantial global health burden, affecting tens of millions of individuals worldwide. The disorders, characterized by deviations from the normal cardiac rhythm, can markedly impair quality of life, manifesting as syncope, dizziness, chest discomfort, and palpitations. While certain arrhythmias remain clinically subtle, more complex forms are associated with considerable challenges in early detection. Delayed diagnosis and intervention significantly increase the risk of adverse outcomes, including sudden cardiac death. Consequently, complex cardiac arrhythmias represent a critical and ongoing challenge in clinical practice. Hence, catheter ablation has become a cornerstone of cardiac electrophysiology (EP), providing diagnosis and treatment for a broad range of cardiac arrhythmias. The procedure is minimally invasive and performed using catheters with varying numbers of electrodes, which are inserted via the vascular system into the heart chambers. Three-dimensional electro-anatomical mapping systems (3D EAMs) are the primary technological platforms used worldwide to guide catheter ablation procedures for the diagnosis and treatment of cardiac arrhythmias. By integrating catheter localization, chamber geometry reconstruction, and intracardiac electrograms (EGMs) analysis, these systems have significantly improved procedural safety, mapping accuracy, and clinical outcomes in EP studies and cardiac ablation procedures. Despite their clinical effectiveness, currently available 3D EAMs are proprietary, associated with high acquisition and maintenance costs, limiting accessibility in public healthcare systems and restricting open-source and research-driven innovation. This dissertation presents a requirements-driven study aimed at defining the core software components of a low-cost 3D EAM system to be applied for the Brazilian Unified Health System (Sistema Único de Saúde – SUS). The study does not involve software implementation and algorithm development. Instead, it focuses on the systematic analysis and synthesis of technical and workflow-related requirements derived from existing commercial 3D EAMs. Firstly, a structured benchmarking analysis is conducted on four widely used commercial 3D EAMs: Carto (Biosense Webster, Johnson \& Johnson, CARTO 3), EnSite (Abbott, Ensite Precision and Ensite X), Rhythmia (Boston Scientific, RHYTHMIA HDx), and AcQMap (Acutus Medical, 900100 AcQMap). The analysis is based on multiple complementary data sources, including user manuals and technical tutorials, peer-reviewed literature, and assistance in around 60 catheter ablation procedures at Hospital do Coração (Hcor), where some of these systems were used to guide ablation in patients with atrial and ventricular arrhythmias. These sources are used to characterize processing workflows, catheter localization technologies, EGMs acquisition, filtering types and ranges, mapping modalities, and annotation strategies. Based on the comparative analysis, conceptual and functional software requirements for a 3D EAM system are proposed. The proposed software supports hybrid catheter localization strategies and accommodates unipolar and bipolar intracardiac EGMs, as well as standard 12-lead surface electrocardiogram (ECG) signals. Signal pre-processing requirements include configurable band-pass filtering, high-pass filter (HPF) range: 0.05–40 Hz; low-pass filter (LPF) range: 10–500 Hz, and power-line notch filtering at 60 Hz, applicable to all ECG and EGM signals. Core mapping functionalities include voltage and local activation time (LAT) mapping, which represent the fundamental modalities for substrate characterization and activation sequence reconstruction.
The inclusion of these modalities reflects a shift from purely descriptive mapping toward more functional and mechanism-oriented analysis within 3D EAMs. Furthermore, beyond the definition of technical and functional software requirements, this study addresses a critical translational gap between EP research and clinical practice. Currently, a substantial disconnect exists between algorithmic developments reported in the literature and their integration into clinically usable systems. By systematically consolidating heterogeneous sources of knowledge, this work aims to transform fragmented information into a structured framework that is directly applicable within EP laboratories. In particular, the study seeks to support research environments such as HEartLab by enabling the development of clinically grounded, application-oriented tools, thereby facilitating the translation of research innovations into practical solutions for cardiac mapping and ablation. By consolidating fragmented technical knowledge into a unified comparative framework and proposing a scalable and modular conceptual software design, this study demonstrates the feasibility of defining 3D EAM requirements tailored to resource-constrained public healthcare environments. The findings are intended to support future research, promote standardization, and enable the subsequent development of an affordable and more accessible 3D EAM system for the treatment of cardiac arrhythmias.