Safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent AF in a real‐world global setting: Results from the Cryo AF Global Registry

Chun, K.R. Julian; Okumura, Ken; Scazzuso, Fernando; On, Young Keun; Kueffer, Fred; Braegelmann, Kendra M.; Khelae, Surinder Kaur; Al‐Kandari, Fawzia; Földesi, Csaba; Investigators, Cryo Global Registry

doi:10.1002/joa3.12504

Cited by 28 publications

(38 citation statements)

References 25 publications

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“…While the safety and efficacy of AF ablation has been established, it was only until recently that outcomes of AF ablation were examined within large, prospectively enrolled cohorts of patients with AF. The recent report from the Cryo AF Global Registry described primary outcomes of cryoablation used according to local practice around the world 4 . Country specific evaluations such as the GWTG-AFIB study, the FREEZE Cohort, and the 1STOP registry describe outcomes of cryoablation in the USA, Germany, and Italy, which have had many years of experience with the cryoablation catheter 5 – 7 .…”

Section: Introductionmentioning

confidence: 99%

Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study

Ferrero-de-Loma-Osorio

León

García‐Alberola

et al. 2021

Sci Rep

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Cryoablation is safe and effective for the treatment of atrial fibrillation (AF) in controlled clinical trials, but contemporary real-world usage and outcomes are limited. The Report of the Spanish Cryoballoon Ablation Registry (RECABA) was designed to evaluate acute and 12-month outcomes of cryoballoon ablation for the treatment of AF in Spain. Patients from 27 Spanish centers were prospectively enrolled. Patients were treated with cryoballoon ablation and managed according to standard of care protocols at each center. The primary endpoint was ≥ 30 s freedom from AF at 12-month after a 3-month blanking period. Secondary endpoints included a description of patient characteristics, cryoablation procedural strategy and safety, and predictors of efficacy. In total, 1742 patients (71.4% PAF, 68.8% male, mean age 58.02 ± 10.40 years, 76.1% overweight or obese, CHA2DS2-VASc index 1.40 ± 1.28) were enrolled. Patients received 7.2 ± 2.67 cryo-applications. PV potentials could be detected in 61% of the PVs during ablation, with a mean time to block of 52.9 ± 37.02 s. Acute PVI was observed in 97% of PVs with 75.8% isolated with the first cryo-application. Mean procedural time was 113 ± 41 min. Acute complications occurred in 4.4% of the cases. With follow-up in 1628 patients, AF-free survival was 78.5% (PAF: 80.6% vs PersAF 73.3%; p < 0.001). Left atrium enlargement, female sex, non-PAF, and early recurrence were independent predictors of AF recurrence (p < 0.05). RECABA provides detailed insight into current dosing practices and demonstrates cryoablation is safe and effective in real-world use.ClinicalTrials.gov number: NCT02785991.

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Section: Introductionmentioning

confidence: 99%

Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study

Ferrero-de-Loma-Osorio

León

García‐Alberola

et al. 2021

Sci Rep

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“…The Cryo AF Global Registry reported a procedure time of 82 ± 34 min and Sawhney et al. reported a procedure time of 95 ± 65 min [ 23 , 24 ]. In addition, the fluoroscopy times in this study compared to previous studies using electrical mapping is more favourable.…”

Section: Discussionmentioning

confidence: 99%

The long-term effect of thermal-guided second-generation cryoablation in paroxysmal and persistent atrial fibrillation

Dulai

Kassir

et al. 2021

Indian Pacing and Electrophysiology Journal

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Background Second-generation cryoballoon ablation is safe and effective in patients with paroxysmal (PAF) and persistent atrial fibrillation (AF). Objective This study aimed to assess the long-term clinical outcomes and freedom from AF in patients undergoing thermal-guided cryoablation without the use of an electrical mapping catheter. Methods All patients who had undergone thermal-guided second-generation cryoablation without electrical mapping between January 2015 and April 2018 at Eastbourne District General Hospital were retrospectively analysed. Success was defined as freedom from atrial arrhythmia lasting >30 s during the follow up period. Results The study included 234 patients with a mean age of 65.3 ± 10.6 years. There were 134 (57.0%) and 100 (42.7%) patients who had PAF and persistent AF respectively. Arrhythmia recurrence occurred in 38 of 134 (28.4%) PAF and 42 of 100 (42.0%) persistent AF patients after mean follow up of 40 ± 9.2 months. The patients with PAF had a significantly greater freedom from arrhythmia than patients with persistent AF (p = .040). The mean procedure time was 55.5 ± 12.2 min and the mean fluoroscopy time was 10.9 ± 4.8 min 73.5% of patients were discharged on the same day. Conclusion Thermal-guided cryoablation is feasible, safe and results in freedom from arrhythmia in the majority of paroxysmal and persistent AF patients in the long term. Randomised controlled trials are required to confirm the findings of this study.

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“…The primary endpoint of the study was AF free survival at the 12-month follow-up. Secondary endpoints included the following: (1) a description of baseline characteristics of subjects who underwent CBA, (2) the acute e cacy, safety (the rate of all procedure-related adverse events), and e ciency of the procedure (e.g. electrical PVI, PV potential monitoring, cryoapplications analysis, related complications, and procedural related times), (3) description of the dosing strategies utilized, and (4) identi cation of the factors that predicted AF recurrence during follow-up.…”

Section: Objective and Endpointsmentioning

confidence: 99%

“…The recent report from the Cryo AF Global Registry described primary outcomes of cryoablation used according to local practice around the world. 2 Country speci c evaluations such as the GWTG-AFIB study, the FREEZE Cohort, and the 1STOP registry describe outcomes of cryoablation in the USA, Germany, and Italy, which have had many years of experience with the cryoablation catheter. [3][4][5] Uniquely, a recent report from Miyazaki et al described the rst safety experience with cryoablation in Japan.…”

Section: Introductionmentioning

confidence: 99%

Acute and Long-term Outcomes of Cryoballoon Ablation in Patients with Atrial Fibrillation. Primary Results of the Spanish Cryoballoon Ablation Registry (RECABA)

Loma-Osorio

León

García‐Alberola

et al. 2021

Preprint

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Background Cryoablation is safe and effective for the treatment of atrial fibrillation (AF) in controlled clinical trials, but contemporary real-world usage and outcomes are limited. Objectives The Report of the Spanish Cryoballoon Ablation Registry (RECABA) was designed to evaluate acute and 12-month outcomes of cryoballoon ablation for the treatment of AF in Spain. Methods Patients from 27 Spanish centers were prospectively enrolled. Patients were treated with cryoballoon ablation and managed according to standard of care protocols at each center. Theprimary endpoint was ≥ 30 sec freedom from AF at 12-mo after a 3-mo blanking period. Secondary endpoints included a description of patient characteristics, cryoablation procedural strategy and safety, and predictors of efficacy. Results In total, 1742 patients (71.4% PAF, 68.8% male, mean age 58.02 ± 10.40 years, 76.1% overweight or obese, CHA2DS2-VASc index 1.40 ± 1.28) were enrolled. Patients received 7.2 ± 2.67 cryoapplications. PV potentials could be detected in 61% of the PVs during ablation, with a mean time to block of 52.9 ± 37.02 seconds. Acute PVI was observed in 97% of PVs with 75.8% isolated with the first cryoapplication. Mean procedural time was 113 ± 41 minutes. Acute complications occurred in 4.4% of the cases21. With follow-up in 1628 patients, AF-free survival was 78.5% (PAF: 80.6% vs PersAF 73.3%; p < 0.001). Left atrium enlargement, female sex, non-PAF, and early recurrence were independent predictors of AF recurrence (p < 0.05). Conclusions RECABA provides detailed insight into current dosing practices and demonstrates cryoablation is safe and effective in real-world use.

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Safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent AF in a real‐world global setting: Results from the Cryo AF Global Registry

Cited by 28 publications

References 25 publications

Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study

Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study

The long-term effect of thermal-guided second-generation cryoablation in paroxysmal and persistent atrial fibrillation

Acute and Long-term Outcomes of Cryoballoon Ablation in Patients with Atrial Fibrillation. Primary Results of the Spanish Cryoballoon Ablation Registry (RECABA)

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