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Fulltext 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 KRJ, Okumura K, Scazzuso F, Keun On Y, Kueffer FJ, Braegelmann KM, et al.

J Arrhythm, 2021 Apr;37(2):356-367.
PMID: 33850577 DOI: 10.1002/joa3.12504

BACKGROUND: Cryoballoon ablation is a commonly used approach to treat patients with atrial fibrillation (AF).
OBJECTIVES: Report on the safety and efficacy of cryoballoon ablation for the treatment of AF in the largest global cohort of cryoablated patients prospectively studied within a single registry.
METHODS: The Cryo AF Global Registry is a prospective, multi-center registry. Patients with paroxysmal AF (PAF) or persistent AF (PsAF) were treated with the cryoballoon catheter according to routine practices at 93 sites across 36 countries. Primary efficacy endpoints included freedom from AF and freedom from AF/atrial flutter (AFL)/atrial tachycardia (AT) ≥30 seconds. The primary safety endpoint was serious device- or procedure-related adverse events over 12 month follow-up.
RESULTS: During this evaluation window, 2922 subjects completed an index cryoballoon procedure, and 1440 completed 12 month follow-up. The cohort was 61 ± 12 years of age, 36.3% female, and 78.7% PAF. Serious device- and procedure-related adverse event rates were 1.5% and 3.4%, respectively. Freedom from AF/AFL/AT after the 90 day blanking period was 86.4% (95% CI: 84.3%-88.3%) in patients with PAF and 70.9% (95% CI: 64.6%-76.4%) in patients with PsAF. Freedom from AF/AFL/AT in first-line PAF and PsAF was 90.0% (95% CI: 86.4%-92.7%) and 72.9% (95% CI: 58.6%-83.0%) at 12 months, respectively.
CONCLUSIONS: The Cryo Global AF Registry is the largest evaluation to demonstrate cryoablation is an efficient, safe, and effective treatment for patients with AF worldwide. Cryoablation was commonly used to treat patients prior to an AAD failure and may facilitate earlier therapy for patients on the AF disease continuum.
Fulltext Cryoballoon Ablation for the Treatment of Atrial Fibrillation in Patients With Concomitant Heart Failure and Either Reduced or Preserved Left Ventricular Ejection Fraction: Results From the Cryo AF Global Registry

Rordorf R, Scazzuso F, Chun KRJ, Khelae SK, Kueffer FJ, Braegelmann KM, et al.

J Am Heart Assoc, 2021 Dec 21;10(24):e021323.
PMID: 34889108 DOI: 10.1161/JAHA.121.021323

Background Heart failure (HF) and atrial fibrillation (AF) often coexist; yet, outcomes of ablation in patients with AF and concomitant HF are limited. This analysis assessed outcomes of cryoablation in patients with AF and HF. Methods and Results The Cryo AF Global Registry is a prospective, multicenter registry of patients with AF who were treated with cryoballoon ablation according to routine practice at 56 sites in 26 countries. Patients with baseline New York Heart Association class I to III (HF cohort) were compared with patients without HF. Freedom from atrial arrhythmia recurrence ≥30 seconds, safety, and health care utilization over 12-month follow-up were analyzed. A total of 1303 patients (318 HF) were included. Patients with HF commonly had preserved left ventricular ejection fraction (81.6%), were more often women (45.6% versus 33.6%) with persistent AF (25.8% versus 14.3%), and had a larger left atrial diameter (4.4±0.9 versus 4.0±0.7 cm). Serious procedure-related complications occurred in 4.1% of patients with HF and 2.6% of patients without HF (P=0.188). Freedom from atrial arrhythmia recurrence was not different between cohorts with either paroxysmal AF (84.2% [95% CI, 78.6-88.4] versus 86.8% [95% CI, 84.2-89.0]) or persistent AF (69.6% [95% CI, 58.1-78.5] versus 71.8% [95% CI, 63.2-78.7]) (P=0.319). After ablation, a reduction in AF-related symptoms and antiarrhythmic drug use was observed in both cohorts (HF and no-HF), and freedom from repeat ablation was not different between cohorts. Persistent AF and HF predicted a post-ablation cardiovascular rehospitalization (P=0.032 and P=0.001, respectively). Conclusions Cryoablation to treat patients with AF is similarly effective at 12 months in patients with and without HF. Registration URL: https://www.clinicaltrials.gov; Unique Identifier: NCT02752737.
Impact of first-line cryoablation for atrial fibrillation on healthcare utilization, arrhythmia disease burden and efficacy outcomes: real-world evidence from the Cryo Global Registry

Zucchelli G, Chun KRJ, Khelae SK, Földesi C, Kueffer FJ, van Bragt KA, et al.

J Interv Card Electrophysiol, 2023 Apr;66(3):711-722.
PMID: 36331681 DOI: 10.1007/s10840-022-01388-6

BACKGROUND: Cryoballoon ablation (CBA) is an effective first-line treatment for symptomatic atrial fibrillation (AF), as recently demonstrated by three randomized trials. This sub-analysis of the Cryo Global Registry aims to examine current clinical practices of first-line CBA.
METHODS: AF patients treated with first-line CBA were compared to CBA in antiarrhythmic drug (AAD)-refractory patients at 12 months. Efficacy was examined using time-to-first atrial arrhythmia recurrence following a 90-day blanking period. Healthcare utilization was evaluated by repeat ablations and hospitalizations. Disease burden was examined by assessing quality of life (QOL) and patients' reporting of symptoms.
RESULTS: Of 1394 patients, 433 (31.1%) were treated with first-line CBA, which was more frequent in high-volume centers. Serious procedure-related adverse event rates were similar. Efficacy at 12 months was higher in the first-line group (87.8 vs. 81.6%, HRunadj 0.64 (95% CI 0.47-0.88); p
Fulltext Regional variations in patient selection and procedural characteristics for cryoballoon ablation of atrial fibrillation in the cryo global registry

Scazzuso F, Ptaszyński P, Kaczmarek K, Chun KRJ, Khelae SK, Földesi C, et al.

J Interv Card Electrophysiol, 2024 Apr;67(3):493-501.
PMID: 37505337 DOI: 10.1007/s10840-023-01582-0

BACKGROUND: Cryoballoon ablation is a well-established anatomical approach for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Although widely adopted, regional variations in standards of care have not been well characterized.
METHODS: Patients with AF were enrolled in the Cryo Global Registry (NCT02752737) from May 2016 to Sept 2021 at 128 sites in 37 countries and treated with cryoballoon ablation according to local clinical practice. Baseline patient and procedural characteristics were summarized for 8 regions (Central Asia & Russia, East Asia, Europe, Middle East, North America, South Africa, South America, and Southeast Asia). Serious procedure-related adverse events (SAEs) were evaluated in a subset of patients with ≥ 7 days of follow-up.
RESULTS: A total of 3,680 patients undergoing initial PVI for AF were included. Cryoballoon ablation was commonly performed in patients with paroxysmal AF. Mean age ranged from 47 ± 12 years in the Middle East to 64 ± 11 years in East Asia. Mean procedure time was ≤ 95 min in all regions. Average freeze duration ranged from 153 ± 41 s in Southeast Asia to 230 ± 29 s in Central Asia & Russia. Acute procedural success was ≥ 94.7% in all geographies. In 3,126 subjects with ≥ 7 days of follow-up, 122 procedure-related SAEs were reported in 111 patients (3.6%) and remained low in all regions. One procedure-related death was reported during data collection.
CONCLUSIONS: Despite regional variations in patient selection and procedural characteristics, PVI using cryoballoon ablation was performed with high acute success and short procedural times around the world.
CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02752737.