Key result
Ultra-high density mapping for catheter ablation achieved an 83.3% acute procedural success rate (95% CI: 79.8-86.5%) with a low 0.57% rate of complications attributed to the mapping catheter.
Why the study?
Does an ultra-high density mapping system safely and effectively guide catheter ablation in patients with cardiac arrhythmias?
Observational (n=519)
Does an ultra-high density mapping system safely and effectively guide catheter ablation in patients with cardiac arrhythmias?
Ultra-high density mapping for cardiac arrhythmia ablation demonstrates high acute success rates and low mapping-related complication rates in a real-world setting.
Supports ultra-high density mapping for ablation; extends real-world data but leaves open randomized confirmation.
AIMS: The objective of this study was to verify acute safety, performance, and usage of a novel ultra-high density mapping system in patients undergoing ablation procedure in a real-world clinical setting. METHODS AND RESULTS: The TRUE HD study enrolled patients undergoing catheter ablation with mapping for all arrhythmias (excluding de novo atrial fibrillation) who were followed for 1 month. Safety was determined by collecting all serious adverse events and adverse events associated with the study devices. Performance was determined as the composite of: ability to map the arrhythmia/substrate, complete the ablation applications, arrhythmia termination (where applicable), and ablation validation. Use of mapping system in the ablation validation workflow was also evaluated. Among the 519 patients who underwent a complete (504) or attempted (15) procedure, 21 (4%) serious ablation-related complications were collected, with 3 (0.57%) potentially related to the mapping catheter. Four hundred and twenty treated patients resulted in a successful procedure confirmed by arrhythmia-specific validation techniques (83.3%; 95% confidence interval: 79.8-86.5%). A total of 1419 electroanatomical maps were created with a median acquisition time of 9:23 min per map. Of these, 372 maps in 222 (44%) patients were collected for ablation validation purposes. Following validation mapping, 162/222 (73%) patients required additional ablation. CONCLUSION: In the TRUE HD study mapping was associated with rates of acute success and complications consistent with previously published reports. Importantly, a low percentage of events (0.57%) was attributed to the mapping catheter. When performed, validation mapping was useful for identifying additional targets for ablation in the majority of patients.
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Hindricks et al. (2018) conducted an observational in Cardiac arrhythmias (excluding de novo atrial fibrillation) (n=519). Ultra-high density mapping system was evaluated on Successful procedure confirmed by arrhythmia-specific validation techniques (95% CI 79.8-86.5). Ultra-high density mapping for catheter ablation achieved an 83.3% acute procedural success rate (95% CI: 79.8-86.5%) with a low 0.57% rate of complications attributed to the mapping catheter.
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