Outcomes of vascular closure devices for femoral venous hemostasis following catheter ablation of atrial fibrillation

Abstract

IntroductionAccess site complications remain common following atrial fibrillation (AF) catheter ablation. Femoral vascular closure devices (VCDs) reduce time to hemostasis compared with manual compression, although large‐scale data comparing clinical outcomes between the two approaches are lacking.MethodsTwo cohorts of patients undergoing AF ablation were identified from 36 healthcare organizations using a global federated research network (TriNetX): those receiving a VCD for femoral hemostasis, and those not receiving a VCD. A 1:1 propensity score matching (PSM) model based on baseline characteristics was used to create two comparable cohorts. The primary outcome was a composite of all‐cause mortality, vascular complications, bleeding events, and need for blood transfusion. Outcomes were assessed during early (within 7 days of ablation) and extended follow‐up (within 8–30 days of ablation).ResultsAfter PSM, 28 872 patients were included (14 436 in each cohort). The primary composite outcome occurred less frequently in the VCD cohort during early (1.97% vs. 2.60%, odds ratio (OR) 0.76, 95% confidence interval (CI) 0.65–0.88; p < .001) and extended follow‐up (1.15% vs. 1.43%, OR 0.80, 95% CI 0.65–0.98; p = .032). This was driven by a lower rate of vascular complications during early follow‐up in the VCD cohort (0.83% vs. 1.26%, OR 0.66, 95% CI 0.52–0.83; p < .001), and fewer bleeding events during early (0.90% vs. 1.23%, OR 0.73, 95% CI 0.58–0.92; p = .007) and extended follow‐up (0.36% vs. 0.59%, OR 0.61, 95% CI 0.43–0.86; p = .005).ConclusionFollowing AF ablation, femoral venous hemostasis with a VCD was associated with reduced complications compared with hemostasis without a VCD.

Bringing big data to vascular complications during atrial fibrillation ablation

“…7 In this issue of the Journal, Mills and colleagues from Liverpool, in the UK, take a novel approach to this problem by utilizing a commercial database from the United States to support the idea that vascular close your devices reduce AF ablation related complications. 8 The TriNetX database has been used by this group, and others, to assess the association between AF ablation and outcomes such as dementia but has not been used previously to assess the impact of an intervention on ablation safety. 9 The study is, by its nature, observational and non-randomized and therefore is limited by the inherent uncontrollable biases of non-randomized data.…”