Comparison of the acute outcome of two cryoballoon technologies for pulmonary vein isolation: An updated systematic review and meta-analysis

Assaf, Amira; Bhagwandien, Rohit; Szili-Török, Tamás; Yap, Sing‐Chien

doi:10.1016/j.ijcha.2022.101115

Cited by 10 publications

(10 citation statements)

References 27 publications

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“…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.…”

Section: Introductionmentioning

confidence: 99%

“…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, 13–16 and chronic 1 year outcomes, 17–19 only a few reports of large patient cohorts exist 13,14,18,20,21 …”

Section: Introductionmentioning

confidence: 99%

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

Ellenbogen,

Mittal,

Varma

et al. 2024

Cardiovasc electrophysiol

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IntroductionCryoablation therapy for pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) is well established. A novel 28 mm cryoballoon system designed to operate under low pressure to safely reach a lower nadir temperature and maintain constant balloon size during cooling has not been prospectively studied in a large patient population for safety and efficacy. The FROZEN AF (NCT04133168) trial was an international multicenter, open‐label, prospective, single‐arm study on the safety and performance of a novel cryoballoon system for treatment of PAF.Methods and ResultsThe study enrolled patients at 44 sites in 10 countries across North America, Europe, and Asia. Subjects were indicated for PVI treatment of PAF and had failed or were intolerant of one or more antiarrhythmic drugs. Procedural outcomes were defined based on the 2017 HRS consensus statement. Follow‐up was performed at 7 days, 3, 6, and 12 months. Data are reported as mean ± SD or median (IQR). PVI was performed with a 28 mm cryoballoon in 325 drug refractory PAF patients. Complete PVI was achieved in 95.7% of patients. In cryoablation lesions longer than 60 s, 60.1% of PV isolations required only a single cryoballoon application. Procedure related complications included: phrenic nerve palsy [temporary 4 (1.2%), persistent 0 (0.0%)], cardiac tamponade/perforation 2 (0.6%), and air embolism 1 (0.3%). Freedom from documented atrial arrhythmia recurrence at 12 months was 79.9% (AF 82.7%, AFL 96.5%, AT 98.1%), antiarrhythmic drugs (AAD) were continued or re‐initiated in 26.8% of patients after the 3‐month blanking period. Additionally, an extension arm enrolled 50 pts for treatment with 28/31 mm variable size cryoballoon. A single temporary PNP occurred in this group, which resolved before discharge. Freedom from documented recurrence at 12 months in these pts was 82.0%.ConclusionsThis novel cryoballoon may facilitate PVI to treat PAF, providing more options to address the variety of anatomies present in patients with PAF. This cryoballoon system proved to be safe and effective for treatment of patients with drug refractory or drug intolerant PAF.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Ellenbogen,

Mittal,

Varma

et al. 2024

Cardiovasc electrophysiol

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“…Most available studies comparing the two technologies are retrospective, nonrandomized and often focused on acute procedural success alone. A meta‐analysis of eight studies from 11 European centers comparing PolarX™ system and Arctic front™ Advanced Pro revealed no differences in acute PVI, procedure time, fluoroscopy time, ablation time, minimal esophageal temperature, and risk of phrenic nerve palsy or thromboembolic events 8 . However, this study did not examine long term clinical outcomes of arrhythmia recurrence.…”

Section: Name Trial Design; Technology Number Of Patients Studied Fol...mentioning

confidence: 72%

“…A meta-analysis of eight studies from 11 European centers comparing PolarX™ system and Arctic front™ Advanced Pro revealed no differences in acute PVI, procedure time, fluoroscopy time, ablation time, minimal esophageal temperature, and risk of phrenic nerve palsy or thromboembolic events. 8 However, this study did not examine long term clinical outcomes of arrhythmia recurrence. Results of current randomized studies comparing the two technologies with blinded end point adjudication and rigorous rhythm monitoring including during the blanking period, in addition to data on arrhythmia burden are likely to provide more definitive guidance for clinical practice.…”

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confidence: 98%

Frozen too: Adopt the new or let it go?

Dhande,

Jain

2024

Cardiovasc electrophysiol

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Pulmonary vein isolation (PVI) has been established as the mainstay of interventional management of atrial fibrillation, as has the utility of cryoablation as one of two standard thermal techniques for achieving PVI. 1 The efficacy of cryoballoon ablation is known to be comparable to radiofrequency ablation, however novel technologies within the realm of contemporary cryoablation have yet to be explored. 2,3 Ellenbogen et al. report the results of an international multicenter, open-label, prospective, single-arm study on the safety and performance of PolarX™ (BosSci), a new cryoballoon system for treatment of paroxysmal atrial fibrillation. 3 Compared to the current standard of care Medtronic cryoablation system, the Boston Scientific system differs in its design. The FlexCath™

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“… 2 , 3 Despite different balloon characteristics, overall, most published data have presently shown a similar acute procedural efficacy and safety. 4–9 However, that was retrospective, observational, and limited to high-volume centres’ experience or relatively small populations to assess complications with a low incidence. In this study, we compared the prevalence of phrenic nerve injury (PNI) during pulmonary vein isolation (PVI) between the two different CBs by analysing multi-centre prospective registry data.…”

mentioning

confidence: 99%

Incidence of phrenic nerve injury during pulmonary vein isolation using different cryoballoons: data from a large prospective ablation registry

Tachibana,

Miyazaki,

Nitta

et al. 2024

Europace

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Aims Phrenic nerve injury (PNI) is the most common complication during cryoballoon ablation. Currently, two cryoballoon systems are available, yet the difference is unclear. We sought to compare the acute procedural efficacy and safety of the two cryoballoons. Methods This prospective observational study consisted of 2,555 consecutive atrial fibrillation (AF) patients undergoing pulmonary vein isolation (PVI) using either conventional (Arctic Front Advance) (AFA-CB) or novel cryoballoons (POLARx) (POLARx-CB) at 19 centers between January 2022 and October 2023. Results Among 2,555 patients (68.8 ± 10.9 years, 1,740 men, paroxysmal AF[PAF] 1,670 patients), PVIs were performed by the AFA-CB and POLARx-CB in 1,358 and 1,197 patients, respectively. Touch-up ablation was required in 299(11.7%) patients. The touch-up rate was significantly lower for POLARx-CB than AFA-CB (9.5% vs. 13.6%, p = 0.002), especially for right inferior PVs (RIPVs). The touch-up rate was significantly lower for PAF than non-PAF (8.8% vs. 17.2%, P < 0.001) and was similar between the two cryoballoons in non-PAF patients. Right PNI occurred in 64(2.5%) patients and 22(0.9%) were symptomatic. It occurred during the right superior PV (RSPV) ablation in 39(1.5%) patients. The incidence was significantly higher for POLARx-CB than AFA-CB (3.8% vs. 1.3%, P < 0.001) as was the incidence of symptomatic PNI (1.7% vs. 0.1%, P < 0.001). The difference was significant during RSPV (2.5% vs. 0.7%, P < 0.001) but not RIPV ablation. The PNI recovered more quickly for the AFA-CB than POLARx-CB. Conclusions Our study demonstrated a significantly higher incidence of right PNI and lower touch-up rate for the POLARx-CB than AFA-CB in the real-world clinical practice.

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Comparison of the acute outcome of two cryoballoon technologies for pulmonary vein isolation: An updated systematic review and meta-analysis

Cited by 10 publications

References 27 publications

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

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

Frozen too: Adopt the new or let it go?

Incidence of phrenic nerve injury during pulmonary vein isolation using different cryoballoons: data from a large prospective ablation registry

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