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Cryoballoon atrial fibrillation ablation: Single-center safety and efficacy data using a novel cryoballoon technology compared to a historical balloon platform.
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  • Adriano Kochi,
  • Massimo Moltrasio,
  • Fabrizio Tundo,
  • Sfefania Isabella Riva,
  • Ciro Ascione,
  • Maria Antonietta Dessanai,
  • Francesca Pizzamiglio,
  • Giulia Vettor,
  • Selene Cellucci,
  • Alessio Gasperetti,
  • Claudio Tondo,
  • Gaetano Fassini
Adriano Kochi
Centro Cardiologico Monzino IRCCS
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Massimo Moltrasio
Centro Cardiologico Monzino Istituto di Ricovero e Cura a Carattere Scientifico
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Fabrizio Tundo
Centro Cardiologico Monzino Istituto di Ricovero e Cura a Carattere Scientifico
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Sfefania Isabella Riva
Centro Cardiologico Monzino Istituto di Ricovero e Cura a Carattere Scientifico
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Ciro Ascione
Centro Cardiologico Monzino IRCCS
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Maria Antonietta Dessanai
Centro Cardiologico Monzino Istituto di Ricovero e Cura a Carattere Scientifico
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Francesca Pizzamiglio
Centro Cardiologico Monzino IRCCS
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Giulia Vettor
Centro Cardiologico Monzino Istituto di Ricovero e Cura a Carattere Scientifico
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Selene Cellucci
Centro Cardiologico Monzino IRCCS
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Alessio Gasperetti
IRCCS Centro Cardiologico Monzino
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Claudio Tondo
Centro Cardiologico Monzino IRCCS
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Gaetano Fassini
IRCCS Centro Cardiologico Monzino
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Abstract

Introduction: Catheter ablation is superior to drugs regarding atrial fibrillation (AF) recurrence, symptoms improvement, and mortality reduction in heart failure. POLARx™ is a novel cryoballoon, with technical improvements seeking to improve outcomes. So far, its clinical evidence is restricted to a case report. Methods: To compare the POLARx™ cryoballoon procedural safety and efficacy to the already established Arctic Front Advance PRO™ (AFAP) in a single-center cohort study, consecutive patients undergoing AF cryoablation with the POLARx™ were enrolled. Data were prospectively gathered. POLARx™ patients were compared to a historical cohort of patients submitted to AF cryoablation with the AFAP. Results: Seventy patients were analyzed, 20 in POLARx™, and 50 in the AFAP group. They all underwent first-time pulmonary vein isolation, 77% were male, 94% had paroxysmal AF, median age was 62.5 years, median CHA2DS2-VASc 1, left-atrium size 34ml/m², and 65% were receiving anticoagulation. The primary end-point, all pulmonary veins isolation, was 100% in both groups. The complication rate was similar (0% POLARx™ vs. 5.7% AFAP, p=0.39). The median total procedural time was longer in the POLARx™ group (90min vs. 60min, p<0.001), but the overall time-to-isolation (TTI) (44.8sec vs. 39sec, p=0.253) and ablation time (15min vs. 13.7min, p=0.122) was similar between POLARx™ and AFAP groups, respectively. Despite equal TTI, the POLARx™ had a lower minimal temperature reached (-57ºC vs -47ºC, p<0.001). Conclusion: The novel POLARx™ cryoballoon had similar efficacy and safety compared to the AFAP. It was also associated with longer procedural times, similar TTI, and lower minimum temperature reached.

Peer review status:ACCEPTED

22 Nov 2020Submitted to Journal of Cardiovascular Electrophysiology
26 Nov 2020Submission Checks Completed
26 Nov 2020Assigned to Editor
26 Nov 2020Reviewer(s) Assigned
14 Dec 2020Review(s) Completed, Editorial Evaluation Pending
14 Dec 2020Editorial Decision: Revise Minor
14 Dec 20201st Revision Received
19 Dec 2020Submission Checks Completed
19 Dec 2020Assigned to Editor
19 Dec 2020Reviewer(s) Assigned
01 Jan 2021Review(s) Completed, Editorial Evaluation Pending
02 Jan 2021Editorial Decision: Accept