Pulmonary vein isolation by means of a novel cryoballoon technology in paroxysmal atrial fibrillation patients: 1‐year outcome from a large Italian multicenter clinical registry

Abstract

IntroductionRecently, a new cryoballoon (CB) technology (POLARx; Boston Scientific) has come onto the market. Preliminary data have shown that its acute safety and efficacy are similar to those of the first‐generation CB. The aim of this study was to assess the medium‐term outcome of pulmonary vein isolation (PVI) with the POLARxTM CB in a large multicenter registry.MethodsWe prospectively collected data on 125 consecutive patients with paroxysmal atrial fibrillation (AF) who underwent PVI by means of a novel CB system. Two cases of transient phrenic nerve palsy occurred, with full recovery in the 48h post procedure; no major procedure‐related adverse events were reported. During the 90‐day blanking period, 4 (3.2%) patients experienced an early recurrence. After the blanking period, over a mean follow‐up of 411 ± 62 days, 19 patients (15.2%) suffered an AF/atrial tachycardia (AT) recurrence. The 1‐year freedom from AF/AT recurrence was 86.4% (n = 17): 10 (8%) patients had an AF recurrence, 6 (4.8%) had an AT occurrence and 1 (0.8%) suffered both events. Patients with AF/AT recurrences had both a shorter deflation time and total deflation time. Moreover, CB ablations with measured TTI < 90 s and TTI < 60 s were more frequent in patients without AF/AT recurrence (88.5% and 77.4%, respectively) than in those who experienced at least one AF/AT recurrence (67.5% and 55.0%, p = .001 and p = .005, respectively).ConclusionThe novel POLARx cryo‐balloon system is safe and effective for PV isolation, displaying a 1‐year freedom from atrial arrhythmia recurrence of 86.4%, which is in line to that reported with AFA‐Pro CB or RF ablation.Clinical trial registrationCatheter Ablation of Arrhythmias with a High‐Density Mapping System in Real‐World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998. Registration date: January 4, 2019.

One‐year outcomes of pulmonary vein isolation with a novel cryoballoon: Primary results of the FROZEN AF trial

“…12 At present there is limited long-term (1 year) outcome data on this novel cryoballoon, and little data available on the safety or effectiveness of the novel variable size cryoballon. 12 While multiple studies have reported both acute procedural data, [13][14][15][16] and chronic 1 year outcomes, [17][18][19] only a few reports of large patient cohorts exist. 13,14,18,20,21 FROZEN AF is an international multicenter, open-label, prospective, single-arm study to determine the safety and performance of a novel cryoballoon system for treatment of PAF, additionally an extension arm examined the safety and performance of a novel variable size cryoballon.…”

One-year outcomes of Pulmonary Vein Isolation with a novel cryoballoon: Primary results of the FROZEN AF Trial

“…11 Additionally, a second generation of this novel cryoballoon that allows inflation and ablation at 2 sizes, 28mm or 31mm, has also become available. 12 At present there is limited long-term (1yr) outcome data on this novel cryoballoon, and little data available on the safety or effectiveness of the novel variable size cryoballon 12 While multiple studies have reported both acute procedural data, [13][14][15][16] and chronic 1 year outcomes, [17][18][19] only a few reports of large patient cohorts exist. 13,14,18,20,21 FROZEN AF is an international multi-center, open-label, prospective, single-arm study to determine the safety and performance of a novel cryoballoon system for treatment of PAF, and an extension arm which examined the safety and performance of a novel variable size cryoballon.…”