Combined Use of a High-Density Multi-electrode Mapping Catheter and a Magnetically Navigated Ablation Catheter for Atrial Fibrillation Procedures - A Feasibility Study
At a Glance
Section titled âAt a Glanceâ| Metadata | Details |
|---|---|
| Publication Date | 2016-07-20 |
| Journal | Journal of Innovations in Cardiac Rhythm Management |
| Authors | Burkhard HĂŒgl, Bjoern Buchter, Zdravena Doneva, Arne G. A. Geissler, Leilani Sell |
| Institutions | Marienhaus Klinikum Hetzelstift Neustadt, Stereotaxis (United States) |
| Citations | 3 |
| Analysis | Full AI Review Included |
6CCVD Technical Documentation & Analysis
Section titled â6CCVD Technical Documentation & AnalysisâAdvanced Material Requirements for High-Density Electrophysiology Catheters
Section titled âAdvanced Material Requirements for High-Density Electrophysiology CathetersâThis document analyzes the technical requirements of high-density mapping and remote magnetic navigation (RMN) as described in the research paper, focusing on how 6CCVDâs specialized CVD diamond materials can enhance the performance and longevity of next-generation catheter components, particularly sensing and ablation electrodes.
Executive Summary
Section titled âExecutive SummaryâThe combination of high-density multi-electrode mapping and Remote Magnetic Navigation (RMN) sets a demanding standard for material performance in cardiac electrophysiology tools.
- Application Success: The study demonstrated 100% successful Pulmonary Vein Isolation (PVI) using a high-density mapping catheter (PentaRayÂź) and an RMN-guided RF ablation catheter (ThermoCool RMTÂź).
- Material Challenge: Achieving high-resolution electroanatomical mapping requires ultra-stable, dimensionally precise, and highly conductive electrode materials, especially when targeting critical Low-Voltage Areas (LVAs) defined by narrow voltage windows (0.25-0.5 mV).
- 6CCVD Solution: Boron-Doped Diamond (BDD) produced by 6CCVD offers unmatched stability, biocompatibility, and controlled electrical properties, making it the ideal material for high-density, stable sensing electrodes and robust RF ablation tips.
- Precision Manufacturing: The study utilized 1-mm electrodes with specific inter-electrode spacing (4-4-4 mm). 6CCVD delivers custom-sized SCD and PCD plates up to 125mm, capable of being post-processed into intricate electrode arrays with precision metalization.
- Enhanced Performance: Utilizing 6CCVD BDD electrodes ensures consistent, long-term performance across complex RF delivery parameters (35 W RF power, 43 °C maximum temperature), reducing the risk of signal drift and improving map accuracy.
Technical Specifications
Section titled âTechnical SpecificationsâThe following hard data points extracted from the study illustrate the operational demands placed on the catheter systems and material stability.
| Parameter | Value | Unit | Context |
|---|---|---|---|
| PVI Success Rate | 100 | % | Complete PVI achieved in all 21 patients |
| LVA Voltage Range (Target) | 0.25-0.5 | mV | Bipolar voltage range used to define Low-Voltage Areas (LVAs) |
| Standard RF Power Setting | 35 | W | Power delivery during ablation (ThermoCool RMTÂź) |
| Upper Temperature Limit | 43 | °C | Maximum allowed temperature at ablation tip |
| Ablation Duration (Average) | 131.0 ± 17.1 | min | Total time RF energy was delivered |
| Initial Map Points (Average) | 1726.2 ± 475.6 | n | High-density mapping points acquired in 12.4 min |
| Electrode Spacing (PentaRayÂź) | 4-4-4 | mm | Configuration of inter-electrode distance |
| Catheter Electrode Size | 1 | mm | Nominal size of mapping electrodes |
Key Methodologies
Section titled âKey MethodologiesâThe experimental workflow employed advanced electrophysiological techniques demanding precision, stability, and high data throughput from material components.
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High-Density Electroanatomical Mapping:
- A detailed bipolar Left Atrium (LA) voltage map was acquired during sinus rhythm using the PentaRayÂź (20 electrodes, 1-mm size, 4-4-4 mm spacing).
- Electrograms were filtered between 30 and 500 Hz.
- Low-Voltage Areas (LVAs) were identified for substrate modification, defined as bipolar voltages within 0.25-0.5 mV.
-
Remote Magnetic Navigation (RMN) Ablation:
- Ablation was performed using the ThermoCool RMTÂź catheter, controlled remotely via the Niobe ESâą system.
- Standard ablation parameters included a 43 °C upper temperature limit, 35 W RF power, 30 ml/s flow rate, and a 30 s maximum duration per ablation point.
- The goal was circumferential PVI with bidirectional conduction block.
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Procedural Verification:
- The Navigant Ablation History module was used to visualize connected ablation lines (tracking material stability).
- Following ablation, a detailed post-PVI bipolar voltage map (remap) was created to assess for potential gaps or reconnection sites.
6CCVD Solutions & Capabilities
Section titled â6CCVD Solutions & CapabilitiesâThe requirement for high stability, precision geometry, and specialized metal contacts in high-density cardiac mapping and RMN ablation systems is perfectly addressed by 6CCVDâs material expertise.
Applicable Materials for Electrophysiology
Section titled âApplicable Materials for ElectrophysiologyâTo replicate or extend this research with enhanced electrode performance, 6CCVD recommends materials optimized for biomedical conductivity and long-term stability under continuous RF application.
| Material | Description | Core Advantage for EP Catheters |
|---|---|---|
| Boron-Doped Diamond (BDD) | Custom-doped Polycrystalline (PCD) or Single Crystal (SCD) diamond. | Extreme electrochemical stability, corrosion resistance, superior biocompatibility, and electrically consistent performance necessary for accurate LVA (0.25-0.5 mV) demarcation. |
| Thermal Grade SCD or PCD | SCD or PCD substrates and plates up to 500 ”m thick. | Used as heat spreaders or insulating structural components near the ablation tip, managing thermal stress resulting from 35 W RF delivery. |
| Optical Grade SCD | Highly polished, ultra-pure diamond substrates. | Ideal for potential integration into future systems requiring in situ optical sensing or high-power laser delivery (e.g., LVA visualization or pulsed field ablation support). |
Customization Potential for High-Density Arrays
Section titled âCustomization Potential for High-Density ArraysâThe studyâs use of 1-mm electrodes in intricate, spline-based arrangements necessitates materials that can be custom-processed to exacting standards.
- Precision Dimensions: 6CCVD routinely produces SCD and PCD wafers/plates with custom geometries and thicknesses (SCD: 0.1 ”m - 500 ”m; PCD up to 500 ”m), suitable for fabrication into the precise 1-mm electrode geometry required by high-density mapping catheters like the PentaRayŸ.
- Surface Finish: Achieving stable, low-noise signal acquisition, crucial for differentiating voltages in the 0.25-0.5 mV range, requires superior surface quality. 6CCVD guarantees ultra-smooth finishes: Ra < 1nm for SCD and Ra < 5nm for inch-size PCD substrates.
- Metalization Solutions: For optimal signal transduction and adhesion, 6CCVD provides in-house metalization services, including common stacks required for biomedical electronics and sensor contacts (e.g., Ti/Pt/Au, Ti/W/Cu). This ensures robust electrical connection to the highly stable BDD sensing elements.
- Large Format Manufacturing: We offer large format PCD plates up to 125 mm in diameter, supporting high-throughput manufacturing of multi-electrode components for commercial EP device scaling.
Engineering Support & Logistics
Section titled âEngineering Support & Logisticsâ6CCVDâs in-house PhD team can assist with material selection, doping concentration, and custom geometries required for similar Cardiac Electrophysiology, RF Ablation, or High-Density Mapping projects. We ensure seamless material integration from research phase to clinical device production.
We offer global shipping with DDU default terms and DDP available upon request, guaranteeing timely delivery for time-sensitive R&D and manufacturing programs worldwide.
For custom specifications or material consultation, visit 6ccvd.com or contact our engineering team directly.
View Original Abstract
PentaRay s catheters (Biosense Webster, Diamond Bar, CA) create high-density electroanatomical maps, and remote magnetic navigation (RMN) (Niobe Epocht, Stereotaxis Inc., St. Louis, MO) enables intricate manipulation of magnetic ablation catheters.The purpose of this study was to assess the feasibility of PentaRay s used in combination with RMN ablation for pulmonary vein isolation (PVI).In 21 paroxysmal atrial fibrillation (AF) patients undergoing PVI, a PentaRay s catheter was used to map the left atrium in sinus rhythm at baseline and post PVI.The Navigant Ablation History module (Stereotaxis Inc., St. Louis, MO) was used to help create connected ablation lines, pacing from the ablation catheter (ThermoCool RMT, Biosense Webster, Diamond Bar, CA) was performed to examine the presence of exit block, and voltage maps from the PentaRay s were used to demarcate low-voltage areas where bipolar voltages were within 0.25-0.5 mV.This information was assessed to identify potential PVI gaps, and additional ablation points were delivered as necessary.Complete PVI was achieved in 21 out of 21 patients (100%).The average initial mapping time was 12.4 ± 2.7 min spanning 1,726 ± 476 points.Similarly, the average remap time was 14 ± 4.3 min spanning 1,928 ± 842 points.There were no procedural complications associated with this study.This study demonstrates the feasibility of this clinical workflow using both a high-density multi-electrode mapping catheter and an RMN ablation catheter for PVI.The combination might be a useful strategic choice for treatment of AF.