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PO-07-201 INSIGHTS INTO EARLY ADOPTION AND LEARNING CURVE OF PULSED FIELD ABLATION (PFA) IN THE USA FROM THE MULTI-CENTER, PROSPECTIVE DISRUPT-AF REGISTRY
Abstract   Peer reviewed

PO-07-201 INSIGHTS INTO EARLY ADOPTION AND LEARNING CURVE OF PULSED FIELD ABLATION (PFA) IN THE USA FROM THE MULTI-CENTER, PROSPECTIVE DISRUPT-AF REGISTRY

Amin Al-Ahmad, Andrea Natale, David J. Kessler, Joe Gallinghouse, Weeranun D. Bode, Jose Osorio, Jorge Romero, Jonathan W. Dukes, Robert E. Eckart, Anish K. Amin, …
Heart rhythm, Vol.22(4 Supplement), pp.S789-S789
04/2025
DOI: 10.1016/j.hrthm.2025.03.1898

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Abstract

Introduction Pulsed field ablation (PFA) has been available in Europe for 4 years, with registries describing procedural workflows. In the United States, PFA recently became commercially available, and practice patterns are expected to differ. To date, registries have focused on center-level, retrospective data. DISRUPT-AF is a multi-center, prospective registry capturing patient-level data on the first use of the pentaspline PFA catheter in the US. Methods DISRUPT-AF is a prospective registry enrolling patients undergoing ablation using the pentaspline PFA catheter per physician standard-of-care. Patient demographics and procedural characteristics were collected. Learning curve was assessed by categorizing experience levels as: 0-3, 4-10, and 11+ procedures. Results Data from the first 856 index procedures, performed at 18 sites by 62 operators, are included. Overall, 78% of cases were performed under general anesthesia (GA) and 71% used electroanatomical mapping (EAM). There was an average of 8.0 ± 7.8 minutes of fluoroscopy, with 19% of cases using zero-fluoroscopy, and 25% using less than 2 minutes. Procedural efficiency improved with operator experience, demonstrated by a 22% decrease in average procedure time and a 39% decrease in average fluoroscopy time, despite more complex ablation strategies, including additional ablation (89% in 11+ procedure group) and non-PV applications. The serious adverse event (SAE) rate was low (1.2%) and consistent across experience levels. A total of 11 SAEs were reported in 10 patients which included vascular access site complications (n=4), pericarditis (n=1), stroke (n=1), coronary spasm (n=1), rhabdomyolysis (n=1), urinary retention (n=2), and bilirubin elevation (n=1). Application Initial US experience with the pentaspline PFA catheter demonstrates key differences from European workflows including higher use of GA and EAM. Learning curve analysis suggests rapid adoption, with procedural efficiency improving after just a few cases, reflected by reduced procedure and fluoroscopy times without compromising safety. Next Steps/Future The DISRUPT AF Registry will continue to enroll patients treated with the pentaspline PFA catheter to evaluate workflow and long-term effectiveness in the U.S.

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