Key result
The MediGuide 3D catheter tracking system was safe and feasible for typical atrial flutter ablation, achieving complete isthmus block in all 10 patients with a mean fluoroscopy time of 2.5 minutes.
Why the study?
Is the novel MediGuide 3D catheter tracking system safe and feasible for ablation of typical atrial flutter?
Observational (n=10)
Is the novel MediGuide 3D catheter tracking system safe and feasible for ablation of typical atrial flutter?
The novel MediGuide 3D catheter tracking system is safe and feasible for typical atrial flutter ablation, enabling successful procedures with short fluoroscopy times.
Supports progression to efficacy trials of MediGuide; leaves open comparative performance versus standard mapping in atrial flutter.
AIMS: Three-dimensional (3D) mapping has been established for clinical routine in an interventional electrophysiology (EP). Recently, a novel sensor-based 3D catheter tracking system has been introduced integrating 3D non-fluoroscopic catheter navigation into the environment of pre-recorded 2D fluoroscopy [MediGuide™ Technology (MG)]. We are reporting on the first clinical experience for ablation of typical atrial flutter. First we aimed to demonstrate safety and feasibility of this new technique. Secondly, procedural aspects such as effectiveness, procedure, and fluoroscopy time should be evaluated. METHODS AND RESULTS: Ten consecutive patients (100% male, age 68 ± 8 years) were ablated using MG technology. Two steerable diagnostic EP catheters (MediGuide Enabled Livewire™ Catheter, SJM) were used for coronary sinus cannulation and anatomical cavo-tricuspidal isthmus (CTI) reconstruction within the EnSite NavX™ System (NavX). Ablation was performed with a conventional 8 mm tip ablation catheter (IBI, SJM). In all 10 patients both sensor-equipped MG catheters could be tracked non-fluoroscopically. Successful anatomical CTI reconstruction was performed and complete isthmus block was documented after the ablation. Total procedure duration was comparable with conventional procedures (55 ± 8 min). Usage of the MG tracking system resulted in a fluoroscopy time of 2.5 ± 2 min. No adverse events occurred during the procedures. CONCLUSIONS: For the first clinical application of the MG technology in an interventional electrophysiology we found a stable system enabling excellent 3D orientation for spatial catheter positioning on the basis of underlying pre-recorded cine loops. Clinically, the MG technology allowed successful procedures with short fluoroscopy times, even though a sensor-equipped ablation catheter was not yet available for use in the study.
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Sommer et al. (2012) conducted an observational in Typical atrial flutter (n=10). MediGuide 3D catheter tracking system was evaluated on Safety, feasibility, effectiveness, procedure time, and fluoroscopy time. The MediGuide 3D catheter tracking system was safe and feasible for typical atrial flutter ablation, achieving complete isthmus block in all 10 patients with a mean fluoroscopy time of 2.5 minutes.
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