Dataset Information

Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation in relation to the Patients' Age: Results from a Large Real-World Multicenter Observational Project.

ABSTRACT:

Background

The real-world efficacy and safety of atrial fibrillation (AF) ablation in particularly young and elderly patients are still under debate. The aim of the analysis was to investigate the effect of age on the efficacy and safety of cryoballoon ablation (CBA).

Methods

2,534 patients underwent pulmonary vein isolation (PVI) by way of CBA for paroxysmal or persistent drug-resistant and symptomatic AF. The population was divided into age quartiles for evaluation, including (1) <53 years, (2) ≥53 and <61 years, (3) ≥61 and <67 years, and (4) ≥67 years. Furthermore, outcomes were analyzed in patients <41 years, ≥41 and ≤74, and >74 years old. Procedural data and complications were collected, and atrial fibrillation recurrences were evaluated during follow-up.

Results

Procedural-related complications (4.1%) were similar in the four subgroups according to age. At the 12-month follow-up, freedom from AF recurrence was 79.2%, 77.4%, 76.8%, and 75.2% (p=0.21), respectively (with increasing age). At 24-month follow-up, similar incidences of AF recurrence were observed in the four subgroups. When the sample was arbitrarily divided into the three age groups, a higher rate of recurrence was observed in older patients with regard to long-term follow-up (freedom from AF recurrence was 71.8% and 40.9%, respectively, at 12 and 24-month follow-up). In the univariate and multivariate analysis, age did not result in a significant predictor of AF recurrence during follow-up; however, a trend toward higher AF recurrences rates in patients ≥67 years was observed.

Conclusion

The data demonstrated a high degree of safety during CBA across all patient ages. Procedural performance and complications were similar between different ages; AF recurrences seem to be more frequent in patients over 74 years.

SUBMITTER: Sciarra L

PROVIDER: S-EPMC8727157 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionAblation Index, also known as VISITAG SURPOINT™, is a novel lesion-quality marker that improves outcomes in radiofrequency (RF) catheter ablation of atrial fibrillation (AF). There is no direct evidence on the comparative effectiveness of RF ablation with Ablation Index and cryoballoon (CB). The objective of the present study was to conduct a matching-adjusted indirect comparison (MAIC) using individual patient-level data (IPD) to compare the effectiveness of RF ablation with Ablation Index to that of CB on recurrence of atrial arrhythmias 12 months after catheter ablation in patients with paroxysmal AF (PAF).MethodsIndividual patient-level data for RF ablation with Ablation Index were obtained from two studies: Solimene et al. [J Interv Card Electrophysiol 54(1):9-15, 2019] and Hussein et al. [J Cardiovasc Electrophysiol 28(9):1037-1047, 2017]. Comparable CB studies identified from a systematic literature review were pooled. Prognostic variables for adjustment were ranked a priori by several practicing electrophysiologists. In the absence of a common treatment arm between the Ablation Index and CB studies, an unanchored MAIC was conducted. Primary analysis compared the Solimene et al. study to pooled CB studies. A secondary analysis compared pooled RF ablation with Ablation Index studies to pooled CB studies. Several scenario and sensitivity analyses were conducted.ResultsPrimary analyses showed statistically significant reductions in the rate of arrhythmia recurrence with RF ablation with Ablation Index compared to CB in unmatched, unadjusted (HR 0.50, 95% CI 0.27-0.95) and matched (0.42, 0.21-0.86) analyses. Greater reductions in the rate of arrhythmia recurrence that favored RF ablation with Ablation Index were observed after matching and adjusting for age (0.41, 0.20-0.85), age and left ventricular ejection fraction (0.37, 0.16-0.88), and age, sex, and left ventricular ejection fraction (0.30, 0.13-0.71). Secondary and sensitivity analyses showed similar reductions.ConclusionsRadiofrequency ablation with Ablation Index was associated with reductions in recurrence of atrial arrhythmias at 12 months compared to CB in unmatched and unadjusted, matched, and matched and adjusted comparisons.