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Publications

Journal Article Ahead of print

PubMed: 42667242 DOI: 10.1093/europace/euag238

Safety and Effectiveness of a Novel Dual-Energy Radiofrequency/Pulsed Field Ablation Catheter: 12 Month Results of the FlexPulse Study.

Europace

Authors: Ayman A Hussein, Gediminas Rackauskas, Sri Sundaram, Jonathan P Piccini, Franz Xaver Roithinger, Patricia Tung, Jose Osorio, B Judson Colley, Usman R Siddiqui, Dhanunjaya R Lakkireddy, Larry A Chinitz, Matthew C Hyman, Laura Zitella Verbick, Nick Dirckx, Virginia Woods, Monica Lo

Affiliations

  • Cleveland Clinic, Cleveland, Ohio, United States.
  • Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
  • South Denver Cardiology, Denver, Colorado, United States.
  • Duke University, Durham, North Carolina, United States.
  • NO Landesgesundheitsagentur, Il. Internal Medicine Department, Wiener Neustadt, Austria.
  • Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States.
  • HCA Florida, Miami, Florida, United States.
  • The Heart Rhythm Center of Mississippi, Gulfport, Mississippi, United States.
  • Advent Health Orlando, Orlando, Florida, United States.
  • Kansas City Heart Rhythm Institute, Overland Park, Kansas, United States.
  • NYU Langone Health, New York, New York, United States.
  • Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States.
  • Abbott, Plymouth, Minnesota, United States.
  • CardioVascular Health Clinic, Oklahoma City, Oklahoma, United States.

Abstract

BACKGROUND AND AIMS

Pulsed field (PF) ablation is increasingly used to treat paroxysmal atrial fibrillation (PAF). FlexPulse (NCT06676072) was conducted to evaluate safety and effectiveness of a novel dual-energy, flexible-tip focal ablation catheter with radiofrequency and PF for treatment of symptomatic, drug-refractory PAF.

METHODS

FlexPulse was a global, prospective, single arm, multicentre study. The ablation procedures targeted pulmonary vein isolation (PVI) and adjunctive ablation at operators' discretion. The primary safety endpoint was occurrence of pre-defined safety events within 7-days of any ablation procedure. The primary effectiveness endpoint was freedom from a composite of recurrent AF/atrial tachycardia/atrial flutter, repeat procedure, new use or escalation of class I/III AAD, and/or cardioversion through 12-months.

RESULTS

Overall, 180 subjects underwent PAF ablation. Successful PVI was achieved in all participants. Additional non-PV ablations were performed in 37.2% (67/180) of subjects. The primary safety endpoint event rate was 1.7%. The primary effectiveness endpoint was 74.6% at 12-months, and freedom from documented AF/AFL/AT recurrence was 77.4% (92.6% without weekly transtelephonic monitoring). In 15 subjects who underwent repeat ablation after the blanking period, remapping indicated that 79.7% (47/59) of the PVs were durably isolated from the index procedures. Retrospective analysis found that workflows with PFA Index (PI) ≥30 and AutoMark distance up to 6 mm target had a 12-month freedom from AF/AFL/AT of 84.6%.

CONCLUSIONS

In this trial, ablation with TactiFlex Duo in patients with symptomatic, drug-refractory PAF was safe and effective.

MeSH

Safety, Pharmaceutical Preparations, Atrial Fibrillation, Catheter Ablation, Catheters, Pulsed Field Ablation