Key result
The Figure-of-8-Suture significantly reduced the incidence of vascular complications (1.3% vs. 6.8%, p=0.01) and turnaround time (58.6 vs. 77 minutes, p=0.004) compared to manual compression.
Why the study?
Unlike arterial access, no dedicated closure devices exist for large-sheath femoral venous access in interventional electrophysiology, prompting evaluation of the Figure-of-8-Suture as a feasible closure approach.
Does the Figure-of-8-Suture reduce vascular complications and turnaround time compared to manual compression in patients undergoing interventional electrophysiology procedures?
Observational (n=290)
Open-label
No
Does the Figure-of-8-Suture reduce vascular complications and turnaround time compared to manual compression in patients undergoing interventional electrophysiology procedures?
Absolute Event Rate: 1.3% vs 6.8%
p-value: p=0.01
The Figure-of-8-Suture is a feasible and safer alternative to manual compression for venous closure in electrophysiology procedures, significantly reducing vascular complications, especially in obese patients.
May inform venous closure choices in EP procedures; extends observational data but leaves open need for RCTs.
Background: Venous vascular access with higher sheath size is common in interventional electrophysiology. In contrast to arterial vascular access, no dedicated closure devices exist for closure after venous access with higher sheath sizes. The Figure-of-8-Suture, an easy to apply suture, may be as a feasible approach for closure venous puncture. Our aim was to evaluate the feasibility of closure of femoral venous access. Methods: From November 2016 to February 2018, patients undergoing electrophysiological procedures, closure of left atrial appendage or patent foramen ovale were included. Until May 2017, manual compression was performed to achieve haemostasis at venous access site (control group). From May 2017, patients were treated with a Figure-of-8-Suture (treatment group, Figure Turnaround time and incidence of vascular complications were compared between the two groups. Results: In total, 290 patients were included, 132 in the control group and 158 in the Figure-of-8-Suture group. Hemostasis after sheath removal was achieved in 100% of the cases in the control group by manual compression and in 98.7% of the cases with the Figure-of-8-Suture (p=0.2). Vascular complications were more common in the control group (6.8 vs. 1.3 %, p=0.01). Turnaround time was significantly lower in the Figure In a sub-analysis in obese patients with body mass index (BMI) 30 kg/m 2 (Figure-of-8 n=45, controls n=35), vascular complications were significantly more common in the control group (9.4 vs 0%, p=0.045).
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Jensen et al. (2020) conducted an observational in Patients undergoing electrophysiological procedures, closure of left atrial appendage or patent foramen ovale (n=290). Figure-of-8-Suture vs. Manual compression was evaluated on Incidence of vascular complications (p=0.01). The Figure-of-8-Suture significantly reduced the incidence of vascular complications (1.3% vs. 6.8%, p=0.01) and turnaround time (58.6 vs. 77 minutes, p=0.004) compared to manual compression.
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