Figure-of-eight suture secured with a three-way tap following atrial fibrillation catheter ablation: results of the HARNESS randomised controlled trial
M T Mills, P Calvert, L Tidbury, K Wilson, R Snowdon, Z Borbas, J Waktare, S N Mahida, N Denham, R Ashrafi, D Todd, S Modi, V Luther, D GuptaAbstract
Background
Effective haemostasis is critical to minimise vascular complications following atrial fibrillation (AF) catheter ablation as it involves large-bore femoral venous access and systemic anticoagulation. The figure-of-eight suture secured with a three-way tap (Fo8TAP) [Figure 1] represents a simple, low-cost technique that may improve post-procedural outcomes compared with manual compression (MC). The HARNESS (Haemostasis AfteR veNous accESS) randomised controlled trial investigated the efficacy and safety of Fo8TAP, as well as its influence on bed rest duration following AF ablation.
Purpose
To compare access-site complication rates between Fo8TAP and manual compression, and to assess whether a shorter post-procedural bed rest duration following Fo8TAP maintains safety.
Methods
Patients undergoing AF ablation requiring unilateral, large-bore (≥11 French external diameter) femoral venous access were randomised 1:1:1 to: (1) manual compression with 4-hour bed rest (MC-4); (2) Fo8TAP with 4-hour bed rest (TAP-4); or (3) Fo8TAP with 2-hour bed rest (TAP-2). The primary endpoint was the occurrence of any access-site complication prior to hospital discharge, assessed for superiority (TAP-4 vs MC-4) and non-inferiority (TAP-2 vs TAP-4). Bleeding was graded on a 4-point scale (1 = minor, 4 = life-threatening). Secondary endpoints included time to haemostasis, time to catheter laboratory exit and time to mobilisation.
Results
A total of 336 patients were enrolled (median age 64 years; 34.2% female; median body mass index 28.9 kg/m²) and randomised to MC-4 (n=110), TAP-4 (n=110), or TAP-2 (n=116). The primary endpoint occurred in 14.5% of TAP-4 patients versus 32.7% in the MC-4 group (p=0.002 for superiority). In the TAP-2 group, 31.0% experienced the primary endpoint (p=0.156), not meeting the pre-specified non-inferiority margin versus TAP-4 [Figure 2]. No major vascular complications were observed. Most events were grade 1 bleeding (85/92, 92.4%), with the remainder consisting of grade 1 haematomas (7/92, 7.6%). Time to haemostasis was significantly shorter with Fo8TAP (median: MC-4, 12 min; TAP-4 and TAP-2, 1 min; p<0.001). Median time to catheter laboratory exit was reduced with Fo8TAP (MC-4, 16 min; TAP-4, 9 min; TAP-2, 8 min; p<0.001). Mobilisation occurred earliest with TAP-2 (MC-4, 242 min; TAP-4, 241 min; TAP-2, 122 min; p<0.001).
Conclusion
Following AF catheter ablation, haemostasis with Fo8TAP was superior to manual compression in reducing access-site complications and enhanced procedural efficiency. However, reducing post-procedural bed rest from four to two hours did not meet non-inferiority criteria, indicating that a 4-hour period remains the safer standard following Fo8TAP closure.Figure 1Figure 2