We retrospectively reviewed clinical data of 271 pediatric patients with ASDs who underwent transcatheter ASD closure using large-caliber venous delivery sheath (≥ 8 Fr) between January 2018 and January 2023 at our institution. We did not use the PSS technique for femoral venous hemostasis prior to the removal of large-caliber venous delivery sheaths at the femoral puncture site until 2021. Consequently, the first 127 consecutive patients with femoral venous delivery sheaths of ≥ 8 Fr underwent hemostasis through manual compression (the control group), while the subsequent 144 consecutive patients received hemostasis using the PSS technique (the PSS group). The comparison evaluated hemostatic time, limb immobilization duration, bed rest time, hospital stay, and vascular access complications, including re-bleeding, vascular murmurs, hematoma, local blood ooze, skin ecchymosis, and skin damage. All data were collected from medical and nursing records. The study protocol was approved by our hospital ethics committee (No. FELL-YX-2018-004) and adhered to the Declaration of Helsinki. Prior to the procedure, all patients and their legal guardians provided informed consent for the interventional treatment and for the use of their clinical data in a retrospective study.

Pediatric patients were withheld food and water for four to six hours prior to their intervention and were provided with the appropriate intravenous fluid supplementation. The operators received rigorous training and had extensive experience with obtaining femoral vein access using short introducers, with careful attention to avoiding arteriovenous fistula and retroperitoneal hemorrhage from inadvertent punctures.

All interventions were performed under general anesthesia, with anticoagulation provided by 100 IU/kg of low molecular weight heparin, maintaining the activated clotting time (ACT) between 220 and 280 s. During the procedure, multi-angle echocardiography was used to assess the ASD size, select the appropriate occluder, deliver it accurately along the corresponding delivery sheath, to implant it.

To obtain access hemostasis with purse-string sutures, a 5 − 0 surgical suture on a curved cutting needle was placed 5–10 mm distal to the sheath entry point, advanced through the subcutaneous tissue without damaging the femoral vein, and sutured continuously around the sheath (Vid. 1). Once the venous sheath was removed, the suture was tightened in a “purse” shape to bunch up the subcutaneous tissue for hemostasis (Fig. 1). After the procedure, light pressure was applied to the knot and covered with sterile gauze.

The procedure of “purse string suture”. 1) A 5 − 0 surgical sutures on a curved cutting needle was passed little distal (5 to 10 mm) to entry point of the sheath into skin below the sheath. 2) The needle is continuously sutured within 5 to 10 mm around the sheath. 3) When the venous sheath was pulled out, the suture was tightened on the skin in the shape of a “purse”. 4) Demonstration of “purse-string sutures” suture

In the control group, manual compression at the puncture site typically lasted 20 to 30 min, with a recommended limb braking for 8 to 12 h and bed rest for 18 to 24 h. In the PSS group, manual compression was applied for 5 to 10 min post-operation, and bed rest was generally recommended for 8 to 12 h. Hemostatic time, limb braking, and bed rest time may be extended based on the patient’s bleeding situation. In both groups, heparin was not reversed using protamine.

Post-procedure, patients received 24 h of anticoagulation and antibioprophylaxis. General and vascular access complications were monitored. Patients were prescribed daily oral aspirin (3 to 5 mg/kg) for 6 months to prevent thrombo-embolic events. Two days post-catheterization, the sutures were taken out and a vascular ultrasound found the evidence of thrombosis, embolism, or venous narrowing. All patients were hospitalized for at least 72 h post-procedure and followed-up in outpatient setting to check for complications.

The primary endpoints of the study were major vascular complications, including arteriovenous fistula or pseudoaneurysm formation, a hemoglobin decrease of ≥ 2.0 g/dL requiring transfusion, or puncture site issues needing surgical, radiological intervention, or hospitalization [14].

Statistical analyses were performed using the SPSS 24.0. Normally distributed continuous variables are presented as the mean ± standard deviation (SD), and the Student T-Test was used for analyzing the difference between two independent samples. Categorical variables are presented as frequency and percentage, and the chi-square test was used for comparison between categorical values. A two-sided test with P < 0.05 was considered statistically significant.