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

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 (Fo8_TAP) offers a simple and low-cost alternative to manual compression (MC).

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.

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) Fo8_TAP with 4-hour bed rest (TAP-4), and 3) Fo8_TAP 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.

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 Fo8_TAP (MC-4: 12 min; TAP-4 and TAP-2: 1 min; P < 0.001). Median time to catheter laboratory exit was shortest with Fo8_TAP (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).

After AF catheter ablation, Fo8_TAP 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).