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

Figures

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  FIGURE 1. Patient Flow. Subject enrollment and criteria for the Procedure Analysis Cohort and Efficacy Analysis Cohort. Efficacy analyses were completed on the subset of subjects who were a minimum of 12 months post cryoablation at the time of the analysis

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  FIGURE 2. Monitoring Methods for Atrial Arrhythmia Recurrence. The proportion of the Efficacy Analysis Cohort to be monitored for atrial arrhythmia recurrence during the 12 month follow‐up period with one (blue), two (yellow), or three or more (green) ECGs, ≥24 hour Holter Monitors, and all combined methods for arrhythmia monitoring is depicted. Patients who were evaluated with continuous monitoring methods (black) are also presented. In total, 79.9% of patients underwent monitoring for atrial arrhythmia recurrence at least once during the follow‐up period

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  FIGURE 3. Rate of Serious Adverse Events. Serious device‐related and serious procedure‐related adverse events rates for subjects with paroxysmal (green) and persistent AF (blue). Fisher's exact tests identified no difference in the serious device‐related adverse event rates (1.3% vs 1.8%; P = .57) or the serious procedure‐related adverse event rates (3.4% vs 3.5%; P = .80) between paroxysmal and persistent AF cohorts, respectively

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  FIGURE 4. Freedom from Atrial Arrhythmia Recurrence. (A) Kaplan‐Meier 12 month estimate of freedom from ≥30 second recurrences of AF/AFL/AT in paroxysmal (green) and persistent AF (blue) after a 90 day blanking period. The 12 month freedom from arrhythmia recurrence was significantly higher in the paroxysmal AF cohort (86.4% [95% CI: 84.3%‐88.3%]) than the persistent AF cohort (70.9% (95% CI: 64.6%‐76.4%); P < .01) (B) Kaplan‐Meier estimate of freedom from ≥30 second recurrences of AF/AFL/AT at 12 months after a 90 day blanking period in patients with paroxysmal AF (green lines) and persistent AF (blue lines) who were drug refractory (solid lines) or treated with first‐line cryoballoon ablation (dashed lines). Cox regression model identified that patients who were drug refractory prior to cryoballoon ablation had lower rates of freedom from atrial arrhythmia recurrence than first‐line cryoablation patients (P = .02). *A total of 46 patients were missing baseline AAD information; therefore, 1394/1440 patients were included in the drug refractory vs first‐line Kaplan‐Meier estimates of freedom from atrial arrhythmia recurrence.