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 with 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 CHA2 DS2 -VASc 1, left-atrium size 34ml/m, 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=.39). The median total procedural time was longer in the POLARx group (90min vs. 60min, p<.001), but the overall time-to-isolation (TTI; 44.8s vs. 39s, p=.253) and ablation time (15min vs. 13.7min, p=.122) was similar between POLARx and AFAP groups, respectively. Despite equal TTI, the POLARx had a lower minimal temperature reached (-57°C vs -47°C, p<.001).CONCLUSION: The novel POLARx cryoballoon had similar efficacy and safety compared with the AFAP. It was also associated with longer procedural times, similar TTI, and lower minimum temperature reached.

Cryoballoon atrial fibrillation ablation: Single-center safety and efficacy data using a novel cryoballoon technology compared to a historical balloon platform / A.N. Kochi, M. Moltrasio, F. Tundo, S. Riva, C. Ascione, M.A. Dessanai, F. Pizzamiglio, G. Vettor, S. Cellucci, A. Gasperetti, C. Tondo, G. Fassini. - In: JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. - ISSN 1045-3873. - 32:3(2021), pp. 588-594.

Cryoballoon atrial fibrillation ablation: Single-center safety and efficacy data using a novel cryoballoon technology compared to a historical balloon platform

F. Tundo;C. Ascione;F. Pizzamiglio;A. Gasperetti;C. Tondo;
2021

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 with 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 CHA2 DS2 -VASc 1, left-atrium size 34ml/m, 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=.39). The median total procedural time was longer in the POLARx group (90min vs. 60min, p<.001), but the overall time-to-isolation (TTI; 44.8s vs. 39s, p=.253) and ablation time (15min vs. 13.7min, p=.122) was similar between POLARx and AFAP groups, respectively. Despite equal TTI, the POLARx had a lower minimal temperature reached (-57°C vs -47°C, p<.001).CONCLUSION: The novel POLARx cryoballoon had similar efficacy and safety compared with the AFAP. It was also associated with longer procedural times, similar TTI, and lower minimum temperature reached.
Arctic Front Advance PRO; POLARx; ablation; arrhythmias; atrial fibrillation; cryoablation; cryoballoon
Settore MED/11 - Malattie dell'Apparato Cardiovascolare
Article (author)
File in questo prodotto:
File Dimensione Formato  
jce.14930.pdf

accesso aperto

Tipologia: Publisher's version/PDF
Dimensione 1.36 MB
Formato Adobe PDF
1.36 MB Adobe PDF Visualizza/Apri
Pubblicazioni consigliate

Caricamento pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/817016
Citazioni
  • ???jsp.display-item.citation.pmc??? 9
  • Scopus 14
  • ???jsp.display-item.citation.isi??? 13
social impact