Figure-of-8 Suture With a 3-Way Tap Versus Manual Compression After Atrial Fibrillation Ablation: The HARNESS Randomized Controlled Trial.

BACKGROUND

Reliable hemostasis is essential to minimize femoral venous access site complications after transcatheter cardiovascular procedures, particularly atrial fibrillation (AF) ablation, which require large-bore sheath insertion and systemic heparinization. A figure-of-8 suture secured with a 3-way tap (Fo8TAP) offers a simple and low-cost alternative to manual compression (MC).

OBJECTIVES

The HARNESS (Haemostasis After Venous Access in Atrial Fibrillation Catheter Ablation) randomized controlled trial evaluated the efficacy of Fo8TAP and its impact on post-procedural bed rest duration.

METHODS

Patients undergoing AF ablation via unilateral femoral venous access were randomized 1:1:1 to: 1) MC with 4-hour bed rest (MC-4), 2) Fo8TAP with 4-hour bed rest (TAP-4), and 3) Fo8TAP with 2-hour bed rest (TAP-2). The primary endpoint of any access site complication before hospital discharge was assessed for superiority (TAP-4 vs MC-4) and noninferiority (TAP-2 vs TAP-4). Bleeding was graded from 1 (minor) to 4 (life-threatening). Secondary endpoints included times to hemostasis, catheter laboratory exit, and mobilization.

RESULTS

A total of 336 patients (median age 64 years, 34.2% female, median body mass index 28.9 kg/m2) were enrolled and randomized to MC-4 (n = 110), TAP-4 (n = 110), and TAP-2 (n = 116). The primary endpoint occurred in 16 patients (14.5%) in the TAP-4 group and 36 patients (32.7%) in the MC-4 group (P = 0.002 for superiority). In the TAP-2 group, the primary endpoint occurred in 36 (31.0%) patients (P = 0.156; which did not meet the prespecified noninferiority margin vs TAP-4). No major vascular complications occurred. Most events were grade 1 bleeding (85/92, 92.4%), with the remainder minor hematomas (7/92, 7.6%). Median time to hemostasis was significantly shorter with Fo8TAP (MC-4: 12 min; TAP-4 and TAP-2: 1 min; P < 0.001). Median time to catheter laboratory exit was shortest with Fo8TAP (MC-4: 16 min; TAP-4: 9 min; TAP-2: 8 min; P < 0.001). Median time to mobilization was shortest with TAP-2 (MC-4: 242 min; TAP-4: 241 min; TAP-2: 122 min; P < 0.001).

CONCLUSIONS

After AF catheter ablation, Fo8TAP was superior to MC in lowering the incidence of access site complications and was associated with health care efficiencies. However, a 2-hour bed rest strategy failed to meet noninferiority criteria versus 4 hours. (Haemostasis After Venous Access in Atrial Fibrillation Catheter Ablation [HARNESS]; NCT06470555).