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

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 stud...

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Publicado en:Journal of Cardiovascular Electrophysiology Vol. 32; no. 11; pp. 2915 - 2923
Autores principales: Al‐Ahmad, Amin, Knight, Bradley, Tzou, Wendy, Schaller, Robert, Yasin, Omar, Padmanabhan, Deepak, Zagrodzky, Jason, Bassiouny, Mohammed, Burkhardt, J. David, Gallinghouse, G. Joseph, Mansour, Moussa, McLeod, Christopher, Natale, Andrea
Formato: research tables/charts tracings randomized controlled trial Journal Article
Publicado: Wiley-Blackwell Nov2021
Acceso en línea:Ver este registro en EBSCOhost
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      jtl: Journal of Cardiovascular Electrophysiology
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      dt: Nov2021
      vid: 32
      iid: 11
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        10.1111/jce.15250
        153434875
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        atl: Evaluation of a novel cardiac signal processing system for electrophysiology procedures: The PURE EP 2.0 study.
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        au:
          Al‐Ahmad, Amin
          Knight, Bradley
          Tzou, Wendy
          Schaller, Robert
          Yasin, Omar
          Padmanabhan, Deepak
          Zagrodzky, Jason
          Bassiouny, Mohammed
          Burkhardt, J. David
          Gallinghouse, G. Joseph
          Mansour, Moussa
          McLeod, Christopher
          Natale, Andrea
        affil: Texas Cardiac Arrhythmia Institute, Austin Texas,, USA
      sug:
        subj:
          Signal Processing, Computer Assisted
          Electrophysiology Methods
          Outcome Assessment
          Electrocardiography Methods
          Human
          Randomized Controlled Trials
          Catheter Ablation
          Multicenter Studies
          Prospective Studies
          Random Assignment
      ab: 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.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        tracings
        randomized controlled trial
        Journal Article
      ougenre: Article
    language: English
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