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.