Universal Method of Compatibility Assessment for Novel Ablation Technologies With Different 3D Navigation Systems

Abstract

BackgroundNew technologies for ablation procedures are often produced by different companies with no cross-compatibility out of the box. This is not a negligible clinical problem since those separately developed devices are often used together. The aim of this study was to develop a bench-testing method to assess compatibility between the DiamondTemp ablation system (DTA) and the Rhythmia electroanatomic mapping system (EAM).MethodsDifferent setups were tested. DTA was connected to the Rhythmia EAM using the following configurations: 3.1. An Ensite EPT GenConnect box (GCB) and Rhythmia Maestro GCB (Maestro GCB, native Rhythmia setup); 3.2. The Medtronic GCB-E and Maestro GCB; 3.3. The Medtronic GCB-E out via the Medtronic GCB-E directly to the Rhythmia at box 1 (pin A61 to A64).ResultsThe DTA location was represented in real-time on the Rhythmia EAM. A proper tracking of the DTA was observed in all setups tested by visual comparison of physical catheter movements and its representation on EAM. In configuration 3.1, a significant shift was observed after the first radio frequency (RF) application; however, further applications caused no further shift. In setup 3.2, no significant shift was observed. The setup 3.3 showed a massive shift in the catheter position before ablation compared to baseline points acquired using the Orion catheter as a reference.ConclusionsA universal and reproducible solution for compatibility testing between the various mapping systems and the ablation catheters has been described. DTA has been demonstrated as compatible with Rhythmia EAM with satisfactory results if a specific setup is used.

Compatibility assessment of a temperature-controlled radiofrequency catheter with a novel electroanatomical mapping system

“…Four different configurations have been tested. Reproducibility of results, in comparison with earlier testing according to the described compatibility assessment method ( 1 ). The DTA can be connected to the navigation system either by using electrogram (EGM) out cables from RF generator or from dedicated GenConnect interface to be able to filter out RF energy so it does not affect localization.…”

“…Reproducibility of results, in comparison with earlier testing according to the described compatibility assessment method ( 1 ).…”

“…In these configurations no significant shift has been observed. All points were taken within the EnSiteX accuracy specifications ( 1 ), Table 2 and Supplementary Table S2 .…”

“…Our group has previously developed a novel universal compatibility assessment method to evaluate the safety and accuracy of a new temperature-controlled radiofrequency (RF) catheter ablation system with 3rd party electro anatomical mapping systems ( 1 ).…”

“…The DTA has been validated by its manufacturer only in combination with previous version of EnSite System—EnSite Precision TM System (Abbott, St. Paul, MN) ( 5 ). The aim of this study was to evaluate compatibility between DTA and EnSiteX with a previously developed protocol ( 1 ). Furthermore, different configurations have been tested to ensure accuracy of DTA visualization in the novel mapping system.…”