Background: Catheter ablation of atrial fibrillation (AF) is a commonly performed procedure. However, it is associated with potentially significant complications. Reported procedure-related complication rates are highly variable, depending in part on study design.
Objectives: The purpose of this systematic review and pooled analysis was to determine the rate of procedure-related complications associated with catheter ablation of AF using data from randomized control trials and to assess temporal trends.
Methods: MEDLINE and EMBASE databases were searched from January 2013 to September 2022 for randomized control trials that included patients undergoing a first ablation procedure of AF using either radiofrequency or cryoballoon (PROSPERO, CRD42022370273).
Results: A total of 1,468 references were retrieved, of which 89 studies met inclusion criteria. A total of 15,701 patients were included in the current analysis. Overall and severe procedure-related complication rates were 4.51% (95% CI: 3.76%-5.32%) and 2.44% (95% CI: 1.98%-2.93%), respectively. Vascular complications were the most frequent type of complication (1.31%). The next most common complications were pericardial effusion/tamponade (0.78%) and stroke/transient ischemic attack (0.17%). The procedure-related complication rate during the most recent 5-year period of publication was significantly lower than during the earlier 5-year period (3.77% vs 5.31%; P = 0.043). The pooled mortality rate was stable over the 2 time periods (0.06% vs 0.05%; P = 0.892). There was no significant difference in complication rate according to pattern of AF, ablation modality, or ablation strategies beyond pulmonary vein isolation.
Conclusions: Procedure-related complications and mortality rates associated with catheter ablation of AF are low and have declined in the past decade.
Keywords: adverse event; atrial fibrillation; catheter ablation; complication; meta-analysis; mortality; randomized trials; trend.
Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.