A second cryoballoon system—New and improved?

Su, Wilber

doi:10.1111/jce.14953

Cited by 5 publications

(7 citation statements)

References 6 publications

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“…All studies published to date, including ours (Table 5), agree that the POLARx catheter achieves significantly lower minimal freezing temperatures [15,[17][18][19][20]23]. In summary, the optimal minimum temperature for the POLARx system seems to be about −5 to −10 • C lower compared to the AFA system [15,[17][18][19][20]23].…”

Section: Minimal Freezing Temperaturesupporting

confidence: 64%

“…All PVs could be reached and isolated (Table 4). Other studies have come to comparable conclusions [15,[17][18][19][20]23].…”

Section: Acute Procedural Successmentioning

confidence: 61%

“…Meanwhile, a second CB-system (POLARx, Boston Scientific) became available. First clinical experiences with this novel system reported comparable efficacy and safety, but differences in terms of biophysiological parameters [14][15][16][17][18][19][20][21][22][23].…”

Section: Introductionmentioning

confidence: 97%

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News from the Cold Chamber: Clinical Experiences of POLARx versus Arctic Front Advance for Single-Shot Pulmonary Vein Isolation

Guckel

Lucas

Isgandarova

et al. 2022

JCDD

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Cryoballoon (CB)-guided pulmonary vein isolation (PVI) represents a cornerstone in the treatment of atrial fibrillation (AF). Recently, a novel balloon-guided single shot device (POLARx, Boston Scientific) was designed. Our study aimed to compare the efficacy, safety and characteristics of the novel CB system with the established one (Arctic Front Advance (Pro), AFA, Medtronic). A total number of 596 patients undergoing CB-guided ablation for AF were included. 65 patients (65.0 ± 11.6, 31% female) undergoing PVI with the POLARx were compared to a cohort of 531 consecutive patients (63.0 ± 27.9, 25% female) treated with AFA. Acute PVI was achieved in all patients (n = 596, 100%). Total procedure duration (POLARx 113.3 ± 23.2 min, AFA 100.9 ± 21.3 min; p < 0.001) and fluoroscopy time (POLARx 10.5 ± 5.9 min, AFA 4.8 ± 3.6 min; p < 0.001) were significantly longer in the POLARx group. The POLARx balloon achieved significantly lower nadir temperatures (POLARx −57.7 ± 0.9 °C, AFA −45.1 ± 2.6 °C; p < 0.001) and a significantly higher percentage of pulmonary veins successfully isolated with the first freeze (p = 0.027 *). One major complication occurred in the POLARx (2%) and three (1%) in the AFA group. Both ablation systems are comparably safe and effective. AF ablation utilizing the POLARx system is associated with longer procedure and fluoroscopy times as well as lower nadir temperatures.

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Section: Minimal Freezing Temperaturesupporting

confidence: 64%

“…All PVs could be reached and isolated (Table 4). Other studies have come to comparable conclusions [15,[17][18][19][20]23].…”

Section: Acute Procedural Successmentioning

confidence: 61%

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News from the Cold Chamber: Clinical Experiences of POLARx versus Arctic Front Advance for Single-Shot Pulmonary Vein Isolation

Guckel

Lucas

Isgandarova

et al. 2022

JCDD

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“…This new CB ablation system, compared to previous system, includes a more compliant 28 mm balloon catheter, designed to maintain the same volume during application of cryoenergy. Moreover, a difference can be found in the gas pressure, that is kept stable and lower in POLARx system (2.5 psi), while it increases to higher values during cryoenergy applications with previous system ( 3 – 7 ).…”

Section: Introductionmentioning

confidence: 91%

Ultra-high-resolution assessment of lesion extension after cryoballoon ablation for pulmonary vein isolation

Spera

Narducci²,

Bencardino³

et al. 2022

Front. Cardiovasc. Med.

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IntroductionUnrecognized incomplete pulmonary vein (PV) isolation during the index procedure, can be a major cause of clinical recurrences of atrial fibrillation (AF) after cryoballoon (CB) ablation. We aimed to characterize the extension of the lesions produced by CB ablation and to assess the value of using an ultra-high resolution electroanatomic mapping (UHDM) system to detect incomplete CB lesions.Materials and methodsTwenty-nine consecutive patients from the CHARISMA registry undergoing AF ablation at four Italian centers were prospectively evaluated. The Rhythmia™ mapping system and the Orion™ (Boston Scientific) mapping catheter were used to systematically map the left atrium and PVs before and after cryoablation.ResultsA total of 116 PVs were targeted and isolated. Quantitative assessment of the lesions revealed a significant reduction of the antral surface area of the PV, resulting in an ablated area of 5.7 ± 0.7 cm2 and 5.1 ± 0.8 cm2 for the left PV pair and right PV pair, respectively (p = 0.0068). The mean posterior wall (PW) area was 22.9 ± 2 cm2 and, following PV isolation, 44.8 ± 6% of the PW area was ablated. After CB ablation, complete isolation of each PV was documented by the POLARMap™ catheter in all patients. By contrast, confirmatory UHDM and the Lumipoint™ tool unveiled PV signals in 1 out of 114 of the PVs (0.9%). Over 30-day follow-up, no major procedure-related adverse events were reported. After a mean follow-up of 333 days, 89.7% of patients were free from arrhythmia recurrence.ConclusionThe lesion extension achieved by the new CB ablation system involved the PV antrum, with less than 50% of the PW remaining untouched. The new system, with short tip and circular mapping catheter, failed to achieve PV isolation in only 0.9% of all PVs treated.Clinical trial registration[http://clinicaltrials.gov/], identifier [NCT03793998].

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“…Unlike the existing commercially available system (Arctic Front, Medtronic), the POLARx cryoballoon maintains uniform pressure and size throughout the freeze cycle. However, given this cryoballoon is more compliant, there have been concerns raised regarding the stability of balloon placement, with potential for more ostial lesion formation, and resultant issues for procedure safety and subsequent long-term outcomes [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

Novel cryoballoon to isolate pulmonary veins in patients with paroxysmal atrial fibrillation: long-term outcomes in a multicentre clinical study

Martin

Fowler

Brešković

et al. 2022

J Interv Card Electrophysiol

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Background Recently, a novel cryoballoon ablation catheter has demonstrated acute safety and efficacy in de novo pulmonary vein isolation (PVI) procedures in patients with paroxysmal atrial fibrillation (PAF). However, there are limited studies demonstrating the long-term efficacy. The aim of this study was to evaluate the long-term safety and efficacy of this novel cryoballoon in treating PAF. Methods This was a non-randomized, prospective, multicentre study enrolling 58 consecutive patients. Cryoablation was delivered for 180 s if time to isolation was ≤ 60 s. Otherwise a 240-s cryoablation was performed. One centre performed pre- and post-ablation high-density mapping (n = 9) to characterize lesion formation. After a 3-month blanking period, recurrence was defined as having any documented, symptomatic episode(s) of AF or atrial tachycardia. All patients were followed for 1 year. Results Acute PVI was achieved in 230 of 231 pulmonary veins (99.6%) with 5.3 ± 1.6 cryoablations per patient (1.3 ± 0.7 cryoablations per vein). Forty-three (77%) patients remained arrhythmia-free at 1-year follow-up. Four patients (6.9%) experienced phrenic nerve injury (3 resolved during the index procedure; 1 resolved at 6 months). One serious adverse device event was reported: femoral arterial embolism event occurring 2 weeks post-index procedure. For patients who underwent high-density mapping, cryoablation was antral with 50% of the posterior wall ablated. Conclusions Initial multicentre clinical experience with a novel cryoballoon has demonstrated safety and efficacy of PVI in patients with PAF. Ablation with this cryoballoon provides a wide, antral lesion set with significant debulking of the posterior wall of the left atrium.

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A second cryoballoon system—New and improved?

Cited by 5 publications

References 6 publications

News from the Cold Chamber: Clinical Experiences of POLARx versus Arctic Front Advance for Single-Shot Pulmonary Vein Isolation

News from the Cold Chamber: Clinical Experiences of POLARx versus Arctic Front Advance for Single-Shot Pulmonary Vein Isolation

Ultra-high-resolution assessment of lesion extension after cryoballoon ablation for pulmonary vein isolation

Novel cryoballoon to isolate pulmonary veins in patients with paroxysmal atrial fibrillation: long-term outcomes in a multicentre clinical study

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