Novel Cryoballoon Ablation System for Single Shot Pulmonary Vein Isolation　― The Prospective ICE-AGE-X Study ―

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  • Tilz Roland Richard
    University Heart Center Lübeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck
  • Meyer-Saraei Roza
    University Heart Center Lübeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein
  • Eitel Charlotte
    University Heart Center Lübeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein
  • Fink Thomas
    University Heart Center Lübeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein
  • Sciacca Vanessa
    University Heart Center Lübeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein
  • Lopez Lisbeth Delgado
    University Heart Center Lübeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein
  • Kirstein Bettina
    University Heart Center Lübeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein
  • Schlüter Michael
    LANS Cardio
  • Vogler Julia
    University Heart Center Lübeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein
  • Kuck Karl-Heinz
    University Heart Center Lübeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein LANS Cardio
  • Heeger Christian-H.
    University Heart Center Lübeck, Division of Electrophysiology, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), University Hospital Schleswig-Holstein German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck

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<p>Background:The arctic front cryoballoon (AF-CB) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome. The POLARx cryoballoon incorporates unique features and design changes that may translate into improved efficacy, safety and further simplified balloon-based procedures. Efficacy and safety of the novel POLARx cryoballoon was compared to the fourth generation AF-CB (AF-CB4).</p><p>Methods and Results:Twenty-five consecutive patients with paroxysmal or persistent atrial fibrillation were prospectively enrolled, underwent POLARx-based PVI (POLARx group) and were compared to 25 consecutive patients treated with the AF-CB4 (AF-CB4 group). All PVs were successfully isolated utilizing the POLARx and AF-CB4. A significant difference regarding the mean minimal cryoballoon temperatures reached using the AF-CB4 and POLARx (−50±6℃ vs. −57±7℃, P=0.004) was observed. Real-time PVI was visualized in 81% of POLARx patients and 42% of AF-CB4 patients (P<0.001). Utilizing the POLARx, a trend towards shorter median procedure time (POLARx: 45 [39, 53] min vs. AF-CB4: 55 [50, 60] min; P=0.062) was found. No differences were observed between AF-CB4 and POLARx concerning catheter maneuverability, catheter stability and periprocedural complications.</p><p>Conclusions:The novel POLARx showed similar safety and efficacy compared to the AF-CB4. A higher rate of real-time PV recordings and significantly lower minimal balloon temperatures were observed using the POLARx.</p>

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  • Circulation Journal

    Circulation Journal 85 (8), 1296-1304, 2021-07-21

    一般社団法人 日本循環器学会

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