Key result
The PURE EP intracardiac signal processing system was rated as superior to conventional systems in 75.2% of evaluated signal samples (p < 0.001).
Why the study?
Intracardiac electrogram data guide complex ablation procedures, but technology to collect, process, and display these signals has known shortcomings and has not advanced in decades.
Does the PURE EP system improve intracardiac signal quality compared to conventional systems in patients undergoing elective ablation procedures?
Observational (n=51)
Blinded reviewers
Sample randomization for blinded review
Yes
Does the PURE EP system improve intracardiac signal quality compared to conventional systems in patients undergoing elective ablation procedures?
The PURE EP system provides superior intracardiac signal quality and better differentiation of near-field from far-field signals compared to conventional systems during ablation procedures.
Answers are grounded in this paper and cite their sources.
PURE EP may enhance intracardiac signal quality in ablation procedures; leaves open whether it improves outcomes in randomized trials.
BACKGROUND: Intracardiac electrogram data remain one of the primary diagnostic inputs guiding complex ablation procedures. However, the technology to collect, process, and display intracardiac signals has known shortcomings and has not advanced in several decades. OBJECTIVE: The purpose of this study was to evaluate a new signal processing platform, the PURE EP™ system (PURE), in a multi-center, prospective study. METHODS: Intracardiac signal data of clinical interest were collected from 51 patients undergoing ablation procedures with PURE, the signal recording system, and the 3D mapping system at the same time stamps. The samples were randomized and subjected to blinded, controlled evaluation by three independent electrophysiologists to determine the overall quality and clinical utility of PURE signals when compared to conventional sources. Each reviewer assessed the same (92) signal sample sets and responded to (235) questions using a 10-point rating scale. If two or more reviewers rated the PURE signal higher than the control, it was deemed superior. RESULTS: A total of 93% of question responses showed consensus amongst the blinded reviewers. Based on the ratings for each pair of signals, a cumulative total of 164 PURE signals out of 218 (75.2%) were statistically rated as Superior for this data set (p < .001). Only 14 PURE signals out of 218 were rated as Inferior (6.4%). CONCLUSION: The PURE intracardiac signals were statistically rated as superior when compared to conventional systems.
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Al‐Ahmad et al. (2021) conducted an observational in Arrhythmias requiring elective ablation procedures (n=51). PURE EP system vs. Conventional signal recording and 3D mapping systems was evaluated on Overall quality and clinical utility of signals (rated as Superior, Equivalent, or Inferior) (p=<0.001). The PURE EP intracardiac signal processing system was rated as superior to conventional systems in 75.2% of evaluated signal samples (p < 0.001).
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