Background. There are little comparative data on catheter ablation of paroxysmal atrial fibrillation (AF) using the contact force radiofrequency (CF-RF) catheter versus the second-generation cryoballoon (CB2). Methods and results. This is a single center, retrospective, nonrandomized study of 98 patients with symptomatic, drug-refractory paroxysmal AF who underwent their first PVI ablation using either the CB2 (n = 40) or CF-RF (n = 58). The mean age was 60 years with 63% men, a mean LA size of 42 mm. The procedure duration (74 ± 17 versus 120 ± 49 minutes p < 0.05) was shorter for CB2 group; the fluoroscopy time (14 ± 17 versus 16 ± 5 minutes, p = 0.45) was similar. Complete PVI was achieved in 96% of patients with RF-CF and 98% with CB2. Phrenic nerve palsies (2 transient and 1 persistent) occurred exclusively in the CB2 group and 1 severe, nonlethal complication (pericardial tamponade) occurred in the CF-RF group. At 24-month follow-up, the success rate, defined as freedom from AF/atrial tachycardia (AT) after a single procedure without antiarrhythmic drug, was comparable in CF-RF group and CB2 group (65.5% versus 67%, resp., log rank p = 0.54). Conclusion. Both the CB2 and the RF-CF ablation appeared safe; the success rate at 2 years was comparable between both technologies.
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.
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.
BackgroundRadiofrequency catheter ablation of atrial fibrillation (AF) has been proved to be effective and to prevent progressive left atrial (LA) remodeling. Cryoballoon catheter ablation (CCA), using a different energy source, was developed to simplify the ablation procedure. Our hypothesis was that successful CCA can also prevent progressive LA remodeling.Methods36 patients selected for their first CCA because of nonvalvular paroxysmal AF had echocardiography before and 3, 6 and 12 months after CCA. LA diameters, volumes (LAV) and LA volume index (LAVI) were evaluated. LA function was assessed by: early diastolic velocities of the mitral annulus (Aasept, Aalat), LA filling fraction (LAFF), LA emptying fraction (LAEF) and the systolic fraction of pulmonary venous flow (PVSF). Detailed left ventricular diastolic function assessment was also performed.ResultsExcluding recurrences in the first 3-month blanking period, the clinical success rate was 64%. During one-year of follow-up, recurrent atrial arrhythmia was found in 21 patients (58%). In the recurrent group at 12 months after ablation, minimal LAV (38 ± 19 to 44 ± 20 ml; p < 0.05), maximal LAV (73 ± 23 to 81 ± 24 ml; p < 0.05), LAVI (35 ± 10 to 39 ± 11 ml/m2; p = 0.01) and the maximal LA longitudinal diameter (55 ± 5 to 59 ± 6 mm; p < 0.01) had all increased. PVSF (58 ± 9 to 50 ± 10%; p = 0.01) and LAFF (36 ± 7 to 33 ± 8%; p = 0.03) had decreased. In contrast, after successful cryoballoon ablation LA size had not increased and LA function had not declined. In the recurrent group LAEF was significantly lower at baseline and at follow-up visits.ConclusionsIn patients whose paroxysmal atrial fibrillation recurred within one year after cryoballoon catheter ablation left atrial size had increased and left atrial function had declined. In contrast, successful cryoballoon catheter ablation prevented progressive left atrial remodeling.
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.
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