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

Area of Science:

• Cardiology
• Vascular Surgery
• Interventional Cardiology

Background:

• Reliable hemostasis is critical after transcatheter cardiovascular procedures, especially atrial fibrillation (AF) ablation, due to large sheath use and anticoagulation.
• A figure-of-8 suture with a 3-way tap (Fo8_TAP) presents a cost-effective alternative to manual compression (MC) for achieving hemostasis.

Purpose of the Study:

• The HARNESS randomized controlled trial evaluated the efficacy of Fo8_TAP in reducing access site complications post-AF ablation.
• This study also assessed the impact of Fo8_TAP on post-procedural bed rest duration.

Main Methods:

• Patients undergoing AF ablation were randomized into three groups: manual compression with 4-hour bed rest (MC-4), Fo8_TAP with 4-hour bed rest (TAP-4), and Fo8_TAP with 2-hour bed rest (TAP-2).
• The primary endpoint was any access site complication before discharge, assessed for superiority (TAP-4 vs. MC-4) and noninferiority (TAP-2 vs. TAP-4).
• Bleeding was graded, and secondary endpoints included time to hemostasis, catheter laboratory exit, and mobilization.

Main Results:

• Fo8_TAP (14.5%) demonstrated superiority over MC (32.7%) in reducing access site complications (P=0.002).
• The TAP-2 group did not meet noninferiority criteria compared to TAP-4 (31.0% vs. 14.5%, P=0.156).
• Fo8_TAP significantly reduced time to hemostasis (1 min vs. 12 min) and catheter laboratory exit (8-9 min vs. 16 min) compared to MC.

Conclusions:

• Fo8_TAP is superior to manual compression for minimizing access site complications after AF ablation and offers healthcare efficiencies.
• While Fo8_TAP is effective, a 2-hour bed rest protocol following its use did not meet noninferiority standards compared to a 4-hour protocol.