Vascular Closure Devices After Femoral Access in Adult EP Procedures: Updated Systematic Review and Meta-Analysis.
Abstract
Background
Femoral vascular access is integral to diagnostic and therapeutic electrophysiology (EP) procedures but is associated with bleeding and access-site complications. Manual compression and figure-of-eight sutures remain widely used for hemostasis; however, they are resource intensive and delay ambulation. Vascular closure devices (VCDs) have been introduced to facilitate rapid hemostasis and improve procedural efficiency, yet evidence specific to adult EP procedures remain conflicting.
Objectives
To systematically evaluate the safety and efficacy of vascular closure devices compared with manual compression or figure-of-eight sutures for femoral access-site closure in adult electrophysiology procedures.
Methods
A systematic review and meta-analysis were conducted in accordance with PRISMA 2020 guidelines. PubMed/MEDLINE, Embase, Cochrane CENTRAL, and Scopus were searched from inception through January 2026. Randomized controlled trials and observational studies enrolling adults (≥ 18 years) undergoing diagnostic electrophysiology studies or catheter ablation with femoral access were included. Structural and valvular interventions were excluded. Random-effects meta-analyses were performed. Safety outcomes were summarized using risk ratios (RRs), and efficiency outcomes using standardized mean differences (SMDs) with 95% confidence intervals (CIs).
Results
Eighteen studies (10 randomized controlled trials and 8 observational studies) involving 40,632 patients were included. Compared with manual compression, VCD was associated with significantly lower risks of access-site hematoma (RR, 0.59; 95% CI, 0.46-0.71), major bleeding (RR, 0.72; 95% CI, 0.55-0.88), minor bleeding (RR, 0.55; 95% CI, 0.17-0.93), and pseudoaneurysm formation (RR, 0.69; 95% CI, 0.54-0.83), with minimal heterogeneity for these outcomes. Absolute risk reductions were modest (number needed to treat: 90 for hematoma; 430 for pseudoaneurysm). VCDs significantly reduced time to hemostasis (SMD, -2.90; 95% CI, -3.71 to -2.08), time to ambulation (SMD, -1.84; 95% CI, -2.45 to -1.24), and time to hospital discharge (SMD, -1.12; 95% CI, -1.66 to -0.58), although heterogeneity for time-based outcomes was high. No significant differences were observed in infection or hospital readmission rates.
Conclusions
In adult electrophysiology procedures, vascular closure devices are associated with modest reductions in access-site complications and substantial improvements in procedural efficiency. These findings support selective adoption of VCDs to optimize patient recovery and workflow, particularly in high-volume EP centers.