Accuracy and clinical outcomes of CARTOSOUND compared to electro-anatomical mapping for atrial fibrillation ablation: A randomised controlled study.

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In the last decade, catheter ablation procedures for atrial fibrillation (AF) have increased dramatically and this therapy is now a well entrenched treatment option for drug-refractory AF. The technology associated with mapping the atrial anatomy and localization of catheters within the heart has concurrently evolved to meet the demands of pulmonary vein isolation procedures for paroxysmal AF and a variety of adjunctive substrate ablation approaches for non-paroxysmal AF. Navigation technologies aim to improve clinical outcome, increase safety, reduce procedure times and reduce X-ray exposure for AF ablation procedures. Compared to fluoroscopy led ablation, early randomized trials reported shorter procedure times and reduced X-ray for adjunctive virtual 3D mapping. Non-randomized trials/registries have suggested that adding CT/MRI merge capabilities to 3D mapping provides incremental benefit over 3D mapping alone; however, randomized trials have proven that the addition of CT/MRI merge capabilities to 3D mapping systems may be associated with negligible impact on clinical results and/or X-ray use. Furthermore, randomized evidence for new radiographic mapping technologies (3D rotational angiography) and early data on robotic sheath navigation also result in equivalence compared to standard 3D guided procedures. Prior studies have demonstrated the efficacy of intracardiac echocardiography (ICE) for guiding ablation at the pulmonary vein ostia, within the cavotricuspid isthmus and for detection of left atrial thrombus and assessment of left atrial appendage mechanical function. In addition, one recent case series has reported ‘flouro-less’ AF ablation procedures with ICE as an adjunct to 3D mapping. CARTOSOUND integrates ICE into a 3D mapping system, such that the CARTO system can visualize the location and orientation of a specialized ICE catheter to enable the construction of a 3D geometry from a series of 2D ultrasound slices. CARTOSOUND has been validated in an animal model, tested in several clinical patient series and its unique utility is described in case reports. However, there have been no studies that have assessed the impact of CARTOSOUND mapping/navigation on AF ablation outcomes as compared to conventional EAM. We sought to compare clinical parameters and mapping accuracy between CARTOSOUND and EAM mapping/navigation for AF ablation procedures via a randomized controlled trial.