External Suture‐Retention Device Versus Manual Compression for Venous Access‐Site Closure Post‐Ablation: The LockeT II Study

Introduction The LockeT external suture retention device addresses the shortcomings of manual compression (MC), and other vascular closure devices—namely, prolonged immobilization, resource utilization, and costs. Objective In this study, we compare the safety and effectiveness of LockeT to that of MC. Methods We performed a prospective, single‐center study of patients (N) undergoing atrial fibrillation ablation, randomized 1:1 to MC or LockeT. Each vascular access site (n) was included for analysis. Assessments included hemostasis at two hours (HA2H), time to ambulation (TTA), time to (TTD) and same‐day discharge (SDD), groin complications, and a patient comfort assessment. Cost analysis was also performed. Results Patients were randomized to MC ( N = 49; n = 98) or LockeT ( N = 52; n = 102). Procedural times (119 [IQR 91−155] vs. 106 [IQR 84−127], p = 0.104) and maximum sheath size (8.5 [IQR 8.5−11] vs. 8.5 [IQR 8.5−11], p = 0.730) were no different. Neither HA2H (95.5% vs. 99%, p = 0.129) nor SDD rates (23.5% vs. 36.0%, p = 0.06) differed. However, TTA was significantly less (5.1 [IQR 3.9−6.5] vs. 4.4 [IQR 3.4−5.3], p = 0.017) in those with LockeT. In patients with SSD, the TTD was significantly shorter (6.0 [IQR 4.8−6.5] vs. 4.6 [IQR 4.3−4.9], p < 0.001). The cumulative complications were also significantly less (11.2% vs. 2.9%, p < 0.001) with LockeT. Conclusion The LockeT is associated with lower TTA, without major complications, and with effective hemostasis. It also limits post‐procedural time for groin management. However, further evaluation of the device is needed.