Background: Hemostasis after venous vascular access following atrial fibrillation (AF) ablation continues to be a challenge. Figure of 8 (FoE) is an alternative to manual pressure (MP), however safety and efficacy remains unknown.
Objective: To study the safety and efficacy of FoE compared with MP to achieve femoral venous hemostasis in patients undergoing AF ablation.
Methods: A comprehensive search in clinicalTrials.gov, PubMed, Web of Science, EBSCO Services, Cochrane Central Register of Controlled Trials, Google Scholar, and various scientific conference sessions from inception to December 1, 2019 was performed. A meta-analysis was performed using random effects model to calculate risk ratio (RR) and mean difference (MD) with 95% confidence interval (CI).
Results: Seven studies (1 randomized trial and 6 observational studies) were eligible and included 1958 patients, of which 957 patients received FoE and 1001 received MP. Mean (SD) number of accesses and catheter size was 2.4 (0.5) and 7.7 (2.7) respectively. Mean (SD) INR was 1.98 (0.5). FoE was associated with significantly lower risk of access site complications (RR: 0.39, 95%CI: 0.23 to 0.65, p=0.0003), access site hematoma (RR: 0.42, 95%CI: 0.25 to 0.69, p= 0.0008) and access site bleeding (RR: 0.30, 95%CI: 0.14 to 0.65; p=0.002) compared with MP. There was no difference in risk of access site pseudoaneurysm between the two groups (RR: 0.62, 95%CI: 0.19 to 2.04, p= 0.43).
Conclusion: Our results demonstrate the efficacy and safety of FoE with lower risk of femoral venous access site complications when compared with MP. in patients undergoing AF ablation. <!--EndFragment-->