Novel cryoballoon ablation system for single shot pulmonary vein isolation - The prospective ICE-AGE-X study

Roland Richard Tilz*, Roza Meyer-Saraei, Charlotte Eitel, Thomas Fink, Vanessa Sciacca, Lisbeth Delgado Lopez, Bettina Kirstein, Michael Schlüter, Julia Vogler, Karl Heinz Kuck, Christian H. Heeger*

*Corresponding author for this work
24 Citations (Scopus)

Abstract

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). 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°C vs. -57±7°C, 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. 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.

Original languageEnglish
JournalCirculation Journal
Volume85
Issue number8
Pages (from-to)1296-1304
Number of pages9
ISSN1346-9843
DOIs
Publication statusPublished - 2021

Research Areas and Centers

  • Centers: Cardiological Center Luebeck (UHZL)

DFG Research Classification Scheme

  • 205-12 Cardiology, Angiology

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