Pulmonary Vein Stenosis After Catheter Ablation of Atrial Fibrillation Using a Cryoballoon, Hot Balloon, or Laser Balloon

Tokuda, Michifumi; Yamashita, Seigo; Shiomi, Satoko; Sakurai, Ryutaro; Sato, Hidenori; Oseto, Hirotsuna; Yokoyama, Masaaki; Tokutake, Kenichi; Kato, Mika; Narui, Ryohsuke; Tanigawa, Shin‐ichi; Yoshimura, Michihiro; Yamane, Teiichi

doi:10.1253/circj.cj-23-0048

Cited by 4 publications

(2 citation statements)

References 23 publications

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“…4 Despite over a decade of use the safety profile of cryoablation remains relatively unchanged. [5][6][7][8][9][10] Recently a novel 28 mm cryoballoon system that operates under markedly lower pressure and maintains constant balloon size during cooling has become available for clinical studies. 11 Additionally, a second generation of this novel cryoballoon that allows inflation and ablation at 2 sizes, 28 or 31 mm, has also become available.…”

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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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.

show abstract

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

View full text Add to dashboard Cite

show abstract

“…4 Despite over a decade of use the safety profile of cryoablation remains relatively unchanged. [5][6][7][8][9][10] Recently a novel 28 mm cryoballoon system that operates under markedly lower pressure and maintains constant balloon size during cooling became available for clinical studies. 11 Additionally, a second generation of this novel cryoballoon that allows inflation and ablation at 2 sizes, 28mm or 31mm, has also become available.…”

Section: Introductionmentioning

confidence: 99%

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

KA,

Varma

et al. 2024

Preprint

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Introduction: Cryoablation 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 multi-center, open-label, prospective, single-arm study on the safety and performance of a novel cryoballoon system for treatment of PAF. Methods and Results: The 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 1 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 28mm cryoballoon in 325 drug refractory PAF patients. Complete PVI was achieved in 95.7% of patients. In cryoablation lesions longer than 60s, 60.1% of PV isolations required only a single cryoballoon application. Procedure related complications included: phrenic nerve palsy [transient 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 28/31mm variable size cryoballoon. A single temporary PNP occurred in this group, which resolved prior to discharge. Freedom from documented recurrence at 12 months in these pts was 82.0%. Conclusions: This novel cryoballoon may facilitate PVI to treat PAF, providing more options to address the variety of anatomy present in patients with PAF. This cryoballoon system was safe and effective for treatment of patients with drug refractory or drug intolerant PAF.

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Comprehensive review of pulmonary vein stenosis post-atrial fibrillation ablation: diagnosis, management, and prognosis

Tokuda,

Ogawa,

Tokutake

et al. 2024

Cardiovasc Interv and Ther

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Pulmonary Vein Stenosis After Catheter Ablation of Atrial Fibrillation Using a Cryoballoon, Hot Balloon, or Laser Balloon

Cited by 4 publications

References 23 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

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

Comprehensive review of pulmonary vein stenosis post-atrial fibrillation ablation: diagnosis, management, and prognosis

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