Safety and Efficacy of LockeT Suture Retention Device for Large-Bore Venous Access Closure.

BACKGROUND: Electrophysiology (EP) procedures increasingly require large-bore venous access (LBVA), which is associated with a higher risk of vascular complications. While vascular closure devices (VCDs) are well established for arterial access, data on venous closure-particularly for LBVA-remain limited. The LockeT device is a suture-mediated venous closure system designed to achieve rapid hemostasis without intravascular components, but its performance in LBVA has not been well characterized.

METHODS: We conducted a single-center, retrospective observational study of patients undergoing EP procedures requiring LBVA (> 14 French) between June 2023 and October 2024. Patients undergoing left atrial appendage occlusion (LAAO) or leadless pacemaker (LPM) implantation with LockeT venous closure were included. Primary endpoints were effectiveness, assessed by hemostasis at 2 h (HA2H) and time to hemostasis (TTH), and safety, assessed by major and minor vascular complications. Secondary outcomes included time to ambulation (TTA) and same-day discharge (SDD).

RESULTS: A total of 139 patients were included (median age 76.0 years; 55.4% male). LockeT deployment was successful in 97.0% of cases. HA2H was achieved in 100% of successfully deployed cases. Median TTH was 12 s (IQR: 0.0-78.0), and median TTA was 4.1 h (IQR: 3.0-5.1). Same-day discharge occurred in 91.4% of patients. No major vascular complications were observed. Minor complications occurred in 3.6% of patients and included oozing and mild hematoma. Device failure occurred in 2.8% of cases, all during early adoption, and was managed successfully with manual compression. Outcomes did not differ by procedure type or baseline oral anticoagulation status.

CONCLUSIONS: In this single-center experience, LockeT demonstrated high procedural success, rapid hemostasis, early ambulation, and low complication rates for venous closure following EP procedures requiring LBVA. These findings support LockeT as a feasible and effective venous closure strategy in contemporary EP practice, though prospective studies with comparator groups and longer follow-up are warranted.