Direct Comparison of Two Commercially Available Pulsed Field Ablation Systems for Atrial Fibrillation; Procedure Characteristics and Acute Outcomes.

Background: There are few comparative studies on the everyday clinical outcomes of commercially available pulsed field ablation (PFA) systems for atrial fibrillation (AF). Objective: This study evaluates the acute efficacy and safety outcomes of the FARAPULSE™ (pentaspline catheter) and PulseSelect™...

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Publicado en:Journal of Cardiovascular Electrophysiology Vol. 36; no. 8; pp. 1957 - 1966
Autores principales: Abeln, Bob G. S., van der Graaf, Marisa, Musat, Dan L., Gunawardene, Melanie A., Nair, Devi G., Knight, Bradley P., Wilsmore, Bradley, Liebregts, Max, van Dijk, Vincent F., Wijffels, Maurits C. E. F., Balt, Jippe C., Mittal, Suneet, Willems, Stephan, Verma, Nishant, Peigh, Graham, Malaty, Michael M., Boersma, Lucas V. A.
Formato: research tables/charts Journal Article
Publicado: Wiley-Blackwell Aug2025
Acceso en línea:Ver este registro en EBSCOhost
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        10.1111/jce.16761
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        atl: Direct Comparison of Two Commercially Available Pulsed Field Ablation Systems for Atrial Fibrillation; Procedure Characteristics and Acute Outcomes.
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          Abeln, Bob G. S.
          van der Graaf, Marisa
          Musat, Dan L.
          Gunawardene, Melanie A.
          Nair, Devi G.
          Knight, Bradley P.
          Wilsmore, Bradley
          Liebregts, Max
          van Dijk, Vincent F.
          Wijffels, Maurits C. E. F.
          Balt, Jippe C.
          Mittal, Suneet
          Willems, Stephan
          Verma, Nishant
          Peigh, Graham
          Malaty, Michael M.
          Boersma, Lucas V. A.
        affil: Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands
      sug:
        subj:
          Atrial Fibrillation Surgery
          Catheter Ablation Methods
          Ablation Techniques Equipment and Supplies
          Treatment Outcomes
          Equipment Reliability
          Equipment Safety
          Treatment Duration
          Catheter Ablation Adverse Effects
          Postoperative Complications
          Human
          Male
          Female
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          Netherlands
          United States
          Germany
          Australia
          Multicenter Studies
          Prospective Studies
          Nonexperimental Studies
          Retrospective Design
          Record Review
          Comparative Studies
          Fluoroscopy
          Echocardiography
          Descriptive Statistics
          Data Analysis Software
          T-Tests
          Mann-Whitney U Test
          Chi Square Test
          Middle Aged: 45-64 years
          Aged: 65+ years
          Male
          Female
      ab: Background: There are few comparative studies on the everyday clinical outcomes of commercially available pulsed field ablation (PFA) systems for atrial fibrillation (AF). Objective: This study evaluates the acute efficacy and safety outcomes of the FARAPULSE™ (pentaspline catheter) and PulseSelect™ (circular catheter) system. Methods: International, multicenter, registry on patients with paroxysmal or persistent AF, undergoing a first ablation using either PFA system between January 29th, 2024 and September 1st, 2024. Primary endpoints were electrical isolation of ablation targets, procedural characteristics and freedom from major adverse events within 30 days postprocedure. Results: A total of 402 patients were enrolled at the six participating centers, of whom 56.5% were treated with the pentaspline ablation‐catheter. Acute procedural efficacy was 100% for both groups. Use of the pentaspline ablation‐catheter was associated with significantly shorter procedural times (36.0 min [IQR 31.0; 44.0] vs. 49.0 min [IQR 41.5;76.0]) compared to the circular ablation‐catheter (p < 0.001). Major adverse events were scarce and not different between cohorts. Two patients (0.5%) experienced a stroke and one patient (0.2%) had a serious vascular access site complication. One patient had a transient ischemic attack (0.2%). Minor vascular access site complications were more common in the pentaspline catheter group (11.9% vs. 1.1%, p < 0.001). Conclusions: This study showed excellent acute efficacy and safety for both PFA‐systems. Our findings reveal shorter procedural times with the pentaspline catheter, less minor access site complications with the circular catheter, and several procedural differences between the ablation systems, often driven by operator choice.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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