Evaluation of a novel cardiac signal processing system for electrophysiology procedures: The PURE EP 2.0 study

Amin Al-Ahmad, Bradley Knight, Wendy Tzou, Robert Schaller, Omar Yasin, Deepak Padmanabhan, Jason Zagrodzky, Mohammed Bassiouny, J David Burkhardt, G Joseph Gallinghouse, Moussa Mansour, Christopher McLeod, Andrea Natale, Amin Al-Ahmad, Bradley Knight, Wendy Tzou, Robert Schaller, Omar Yasin, Deepak Padmanabhan, Jason Zagrodzky, Mohammed Bassiouny, J David Burkhardt, G Joseph Gallinghouse, Moussa Mansour, Christopher McLeod, Andrea Natale

Abstract

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.

Keywords: intracardiac signals; signal acquisition; signal processing; signals.

© 2021 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.

Figures

Figure 1
Figure 1
Signal sample collection process
Figure 2
Figure 2
Core lab signal categories, assigned color for notation, and associated assessment question
Figure 3
Figure 3
(A) 76‐year‐old man, Persistent AF—PURE shows less noise on ABL d channel and sharper NF signals on Ls channels. (B) 66‐year‐old man, PVC ablation—ABL p shows clearer His and early potential on PURE. (C) 72‐year‐old woman, nonischemic VT ablation—ABL channels show sharper and larger near‐field signals on PURE. PVC, premature ventricular contractions
Figure 4
Figure 4
# of samples reviewed and randomized
Figure 5
Figure 5
Results of the PURE EP study
Figure 6
Figure 6
PURE signals were rated statistically better in (3) signal categories: overall signal quality, ability to discern near‐field from far‐field signal components, and clinical value of small/fractionated signals
Figure 7
Figure 7
PURE signals were rated statistically better regardless of the type of ablation procedure

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