Manual compression versus modified figure-of-8 stitch after left atrial ablations: a comparative randomized trial

Abstract Background The figure-of-eight suture (Fo8) has emerged as an alternative to the standard manual compression (MC) technique for achieving venous hemostasis following catheter ablation. A three-way stopcock can be employed to secure the suture, allowing for adjustable tension to optimize hemostasis. The tensionable-locked Fo8 suture (Fo8-TL) has shown reduced access site complications compared to MC and the traditional Fo8, particularly in ablation procedures requiring periprocedural anticoagulation (1). Purpose This study aimed to evaluate the efficacy, safety, and patient comfort of the Fo8-TL versus MC for hemostasis after left atrial (LA) ablation in an inclusive randomized design. Methods Patients undergoing LA ablation, involving heparin to maintain ACT > 300, were randomly allocated to one of two hemostasis methods. A single 8.5F sheath was used for pulmonary vein isolation, with an additional 6F sheath for repeat ablations and LA flutter. MC patients had a compressive bandage applied after 10 minutes of compression, while Fo8-TL was performed as shown in Figure 1. No protamine was given post-procedure. Both closure systems were removed after 6 hours, with Fo8-TL patients mobilizing at 4 hours. All patients stayed overnight as per standard of care. Fo8-TL feasibility was defined by acute hemostasis success and cross-over rate. Safety was assessed through acute (<24h) and subacute (1–30 days) complications, while patient comfort and satisfaction were evaluated using a pre-discharge questionnaire (Figure 2). Results A total of 164 consecutive patients were included (MC = 82, Fo8-TL = 82), without exclusion criteria. Baseline characteristics were similar between groups (average age 64 ±12, average BMI 27.4 ±4). Echo-guided puncture was performed at operator’s discretion, with slightly higher rates in the Fo8-TL group (78% vs. 62.2%, p=0.027). Acute complications were minimal, with a crossover rate of 6% (n=5) due to wire rupture (n=4) and lidocaine allergy (n=1). Subacute vascular complications were comparable between groups, as were patient comfort and satisfaction levels (Figure 2). Conclusion These findings support Fo8-TL as a feasible alternative to traditional compressive bandage techniques, achieving high acute hemostasis rates and potential for early mobilization. Although patient comfort and satisfaction with Fo8-TL were not significantly better, a limitation of our study was the lack of a dedicated nurse training program for early mobilization, which may have impacted these outcomes. Enhanced training could improve mobilization rates and patient comfort. Further studies are needed to confirm these findings and assess the benefits of early mobilization post-ablation.Tensionable-locked Fo8 suture (Fo8-TL) Tables