Safety of cryoballoon ablation for the treatment of atrial fibrillation: First European results from the cryo AF Global Registry

Abstract

Background Cryoballoon ablation for the treatment of patients with atrial fibrillation (AF) has been utilized in Europe for >15 years. Objectives Report patient and procedural characteristics that influence the safety of cryoablation for the treatment of AF. Methods Patients enrolled in the prospective, multicenter Cryo AF Global Registry were treated at 38 European centers. Freedom from a ≥30s episode of AF/atrial flutter (AFL)/atrial tachycardia (AT) at 12‐months and serious complications were analyzed. Univariate and multivariable models identified baseline patient and procedural characteristics that predicted a procedure‐related complication. Results Of the 1418 subjects who completed an index procedure, the cohort was 62 ± 11 years of age, 37.7% female, and 72.2% paroxysmal AF (PAF). The mean procedure, left atrial dwell, and fluoroscopy times were 81 ± 34, 54 ± 25, and 14 ± 13 min, respectively. Among the 766 patients with 12‐month follow‐up, freedom from a ≥30 s AF/AFL/AT recurrence was 83.3% (95% CI: 79.8%–86.3%) and 71.6% (95% CI: 64.6%–77.4%) in patients with PAF and persistent AF. The serious procedure‐ and device‐related adverse event rates were 4.7% and 2.0%. No baseline patient characteristic independently predicted a procedure‐related adverse event; however, prolonged procedure duration (OR = 1.01 [95% CI: 1.00–1.01]), use of general anesthesia (OR = 1.71 [95% CI: 1.01–2.92]), and delivery of a cavotricuspid isthmus line (OR = 3.04 [95% CI: 1.01–9.20]) were each independently associated with the occurrence of a serious procedural safety event (all p < .05). Conclusions Cryoballoon ablation is safe and effective in real‐world use across a broad cohort of patients with AF.

Incremental value of left atrial strain to predict atrial fibrillation recurrence after cryoballoon ablation

“…Recent reports have shown a recurrence rate of AF after CBA up to 20-30%, which is in line with the results of the present study, where AF recurrence rate was 29% [19]. In order to increase the success rate, re-do ablation might be performed, but repeated procedures are usually more extensive and prone to higher risks of complications [20,21].…”

Association of left atrial enlargement and increased left ventricular wall thickness with arrhythmia recurrence after cryoballoon ablation for atrial fibrillation

“…The procedural safety of CB in our experience is in line with large-scale real-life observational studies [18]. In our study, there was only one serious potentially procedure-related adverse event -stroke -manifesting early (within hours) post-procedure, which occurred despite anticoagulation and exclusion of LA thrombus by TEE index.…”

Pulmonary Vein Isolation with a Novel Size-Adjustable Cryo-Balloon Catheter: A Tailored Ablation Protocol

“…The total left-atrial dwell time with the novel size-adjustable CB system was numerically shorter than in other PVI studies with a non-size-adjustable CB system [9,14]. Furthermore, in our study, the total PV isolation rate was relatively high, compared to the non-size-adjustable CB systems [9,10,12,14,15].…”

“…The fluoroscopy time was slightly longer than in other studies performed with standard non-size-adjustable CB systems [9,10,12,14,15]. An explanation for the difference could be that, in the case of non-optimal PV occlusion with the small balloon configuration, it was possible to switch to the larger balloon configuration.…”