Purse string suture for hemostasis after removal of large-caliber femoral venous delivery sheaths in pediatric transcatheter intervention of atrial septal defect: a single center experience

doi:10.21203/rs.3.rs-3753871/v1

Download PDF

Research Article

Purse string suture for hemostasis after removal of large-caliber femoral venous delivery sheaths in pediatric transcatheter intervention of atrial septal defect: a single center experience

https://doi.org/10.21203/rs.3.rs-3753871/v1

This work is licensed under a CC BY 4.0 License

You are reading this latest preprint version

The objective of this study is to evaluate the efficacy and safety of purse-string suture compared with manual compressing for hemostasis in children with atrial septal defect (ASD) after large-caliber venous delivery sheath removal.

We conducted a retrospective study of 271 children with ASD were treated with transcatheter closure of the large-calibe venous delivery sheath (≥ 8 Fr) at our center from January 2018 to January 2023. The control group (n = 127) underwent manual compression for femoral venous hemostasis after removal sheaths. The purse string suture (PSS) group (n = 144) underwent PSS technique. Contrast clinical data on hemostatic time, limb braking time, bed rest time, hospital stay and complications (rebleeding, hematoma formation, local blood ooze, skin ecchymosis and skin damage) between two groups of patients.

Compared with the control group, the average hemostatic time (4.63 ± 1.95 vs. 19.69 ± 5.64) min, limb bending time (6.83 ± 2.25 vs. 13.45 ± 2.87) h and bed rest time (8.69 ± 1.43 vs. 22.93 ± 2.24) h were significantly shorter in the PSS group, compared to the control group (P < 0.001). The differences regarding hospital stay and complications between the two groups were statistically insignificant (P༞0.05).

Conclusions: The PSS is a straightforward, effective, and secure procedure for attaining rapid hemostasis after removal of large-calibe venous delivery sheath (≥ 8 Fr) for transcatheter closure of ASD in children. The PSS enables pediatric patients to access earlier mobilization and physical activity, a shorter bed rest duration and relief of discomfort when compared to manual compression.

purse string suture

hemostasis

atrial septal defect

venous delivery sheath

children

With the development of transcatheter closure of congenital heart disease (CHD), it has turned into the main treatment option for children with common CHD[1]. For transcatheter closure in children, the standard choice is to establish an occluder delivery track via the femoral vein. With the accumulation of pediatricians' experience, they are constantly challenged by large atrial septal defects (ASD), requiring the utilization of larger calibe venous delivery sheaths for the implantation of bigger occluders[2]. Procedures that involve the use of large-calib venous delivery sheaths and anticoagulant may increase the risk of venous access complications[3]. The use of large-calib venous delivery sheaths could exacerbate the difficulty of hemostasis and increase the chance of venous complications.

Postoperative hemostasis of femoral vein is usually achieved by manual compression for approximately 30 min, and then bed rest is recommended for 12 to 18 hours once hemostasis has been achieved. Manual compressing veins for hemostasis is a simple process and usually has a satisfactory effects. This procedure necessitates a long period of bed rest and limb braking, which can be especially challenging for children. Children are apt to rebel and cry, and after a tough struggle, they may have symptoms like hematoma formation, local blood ooze and skin ecchymosis. Meticulous sterile surgical sutures technique is considered to complete rapid venous hemostasis after remove large-caliber venous sheath in adult patients. Wyss et al. investigated 56 patients who had undergone mitral valve repair via a percutaneous femoral vein approach, and revealed that the use of a revised temporary Figure-of-Eight suture with light bandages and short bed rest time (2–4 hours) was a secure and economical hemostatic option for large femoral vein damage[4]. Multiple studies have confirmed that Figure-of-Eight suture technology can also effectively achieved femoral vein hemostatic in adult patients with atrial fibrillation treated by radiofrequency ablation, significantly reduced the risk of rebleeding, shortened bed rest time, and alleviated the discomfort of patients during the use of large-calib venous delivery sheaths[5–7]. Aytemir et al. used Figure-of-Eight suture in adult patients undergoing cryoablation for hemostasis after removal of 15 Fr right femoral vein sheath, and no vascular access complications such as hematoma formation, rebleeding, fistula formation, or thrombosis were observed at the puncture site[8].

Jackson et al. performed the first randomized controlled trial of femoral vein hemostasis after cardiac radiofrequency ablation therapy in adult patients using purse string suture (PSS) technique. PSS is able to achieve hemostasis within 10 minutes, which is more comfortable and rapid for patients than manual compression[9]. The minimal amount of sutures needed to close skin injuries with PSS may be more ideal for pediatric clinical purposes, however there are few associated reports. This study was conducted to evaluate the performance of PSS method in achieving hemostasis of femoral vein during transcatheter closure in pediatric patients with ASD.

The single-center study aimed to assess efficacy and safety of the PSS technique for hemostasis in children with ASD after large-caliber venous delivery sheath (≥ 8 Fr) removal. We performed transcatheter closure for ASD in 271 patients between January 2018 to January 2023 at Heart Center, Women and Children's Hospital, Qingdao University in China. All children met the criteria of interventional treatment of common congenital heart disease: the common view of Chinese medical experts in 2011[10]. We won't performed the PSS technique before large-caliber venous delivery sheath removal in the femoral puncture site until 2021. Thus, the first 127 consecutive patients with femoral venous delivery sheaths ≥ 8 Fr were treated with the manual compression approach for femoral venous hemostasis (as the control group), whereas the subsequent 144 consecutive cases were treated with the PSS technique for femoral venous hemostasis (as the PSS group). The study protocol was approved by our hospital ethics committee (No. FELL-YX-2018-004) and followed the Declaration of Helsinki. Before the operation, all patients and their families signed an informed consent form for the interventional treatment and the use of their clinical data in a retrospective study.

Pediatric patients were denied food and water for four to six hours before their intervention and were given the appropriate intravenous fluid-supplement therapy. Based on the size of the ASD defect, select the suitable model of occluder to acquire the relevant atrial septal occluder delivery sheath. The operators were educated strict training and have rich experience in the femoral vein puncture, and pay full attention to avoid arteriovenous fistula and retroperitoneal hemorrhage caused by inadvertent punctures. Detailed transcatheter closure methods was as follows. The right femoral vein access was selected in all children under general anesthesia, and was anticoagulated with low molecular weight heparin at a dosage of 100 IU/kg during the operation. The activated clotting time (ACT) should be maintained at about 220 to 280 s. During the operational process, it is necessary to determine the size of the heart defect by multi angle echocardiography view, select the appropriate occluder, send it to the exact position along the delivery sheath, and complete the release of the occluder.

A 5 − 0 surgical sutures on a curved cutting needle was passed little distal 5 mm to 10 mm to entry point of the sheath into skin below the sheath and advanced through the subcutaneous tissue holding its generous amount but without going too deep to damage the femoral vein. The needle is continuously sutured within 5 mm to 10 mm around the sheath. When the venous sheath was removed, the suture is tightened on the skin in the shape of a "purse", so that subcutaneous tissue was bunched up for hemostasis (Fig. 1). After the operation, apply light pressure on the knot and cover with sterile gauzes.

All the children underwent general anesthesia and needed enough time to wake up. In the control group, the puncture point usually needs manual compression for 20 min to 30 min, with limb braking time for 8 h to12 h and bed rest 18 h to 24 h. Manual compression was administered to children in the PSS group for a period of 5 min to 10 min following operation, and they usually stayed in bed for 8 h to12 h. The hemostatic time, limb braking time and bed rest time can be extended in accordance with the patient's bleeding situation.

During the period of bed rest, we kept watch for any complications such as rebleeding, vascular murmurs, hematoma formation, local blood ooze, skin ecchymosis and skin damage. Aspirin (3 to 5mg·kg^− 1) should be taken to prevent thrombus after occlusion. All patients were hospitalized for at least 72 h and followed up after transcatheter closure to check for any complications.

The primary endpoints of the study were defined as major vascular complications, including arteriovenous fistula or pseudoaneurysm formation, a decrease in hemoglobin of ≥ 2.0 g·dl^− 1 necessitating a blood transfusion, or puncture site issues calling for surgical or radiological intervention or hospitalization[11].

Data analysis was retrospective based on medical records. 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 of two independent samples. Categorical variables are presented as frequency and percentage(%), and the chi-square test was used for comparison be-tween categorical values. A two-sided test with P < 0.05 was considered statistically significance.

The transcatheter closure procedural success was achieved in all patients. The mean age of 271 patients who were enrolled was 4.43 ± 1.96 years where male (n = 121, 44.6%) and female (n = 150, 55.4%). The basic clinical characteristics of the two patient groups are comparable as shown in Table 1.

Table 1

Baseline characteristics of patients
Variables	The purse string suture group	The control group	χ² / t	P
Age (year)	5.29 ± 3.30	5.40 ± 3.35	0.285	0.776
Weight (kg)	16.74 ± 6.01	17.06 ± 6.54	0.417	0.677
delivery sheath size			3.396	0.183
8 Fr	83	60
9 Fr	40	40
10 Fr	21	27
ACT (s)	259.26 ± 28.52	256.06 ± 24.44	-0.983	0.326
ACT, activated clotting time

The PSS group had a noticeably shorter hemostatic time, limb braking time and bed rest time compared to the control group. There were no significant differences in hospital stay and complications, such as rebleeding, hematoma formation, local blood ooze, skin ecchymosis and skin damage in the control group and the PSS group. As shown in Table 2.

Table 2

Procedural outcome of patients
Variables	The purse string suture group	The control group	χ² / t	P
Hemostatic time (min)	4.63 ± 1.95	19.69 ± 5.64	30.055	0.000
Limb braking time (h)	6.83 ± 2.25	13.45 ± 2.87	21.178	0.000
Bed rest time (h)	8.69 ± 1.43	22.93 ± 2.24	62.877	0.000
Hospital stay (d)	3.13 ± 0.50	3.30 ± 0.73	2.292	0.230
Complications (n)	12	20	3.563	0.059

Manual compression with pressure dressing was the commonly used technique for femoral venous hemostasis. We demonstrated the efficacy and safety of using the PSS technique to achieve hemostasis after the removal of femoral large-calibe venous delivery sheaths (≥ 8 Fr) in pediatric patients undergone transcatheter closure for ASD in real-world clinical practice. The deployment technique is quite easy to learn and can be performed in 5 min. As it allows hemostasis to be achieved rapidly, decreasing the duration of bed rest.

During the initial postoperative period, manual compression requires medical staff to spend approximately 30 min, while children must stay in bed for at least 18 h, making it a difficult task for them. Activity is typically accompanied by irritation, crying and struggle, as well as recurrent bleeding. Suturing is a surgical technique for closing skin wounds. Previous studies evaluating the suturing technique have been reported that it can be used for hemostasis after removal of large-caliber femoral venous sheaths in adults.

Bagai and Zhao first reported suturing methods, also known as "FoE" or "FoZ," to achieve hemostasis in adult femoral veins[10]. Mehmet et al. found that the suturing technique was effective in compressing the external soft tissue at the puncture site, causing the constriction of the injured blood vessel and the achievement of venous hemostasis[12]. Due to the brevity of hemostasis, the compression is usually momentary. Two days post-operation, the stitches were taken out and a vascular ultrasound found no evidence of thrombosis, embolism, or venous narrowing.

Subsequently, this method was commonly employed for hemostasis after taking out large-caliber sheath after radiofrequency ablation of adult arrhythmia. The technique is safe and feasible, with an overall success rate of 92%. There are a few reports of surgical suture hemostasis after the removal of femoral venous sheaths in children, and the overall success rate is 98.7%[4–8]. It has been demonstrated that 89.3% of children cease bleeding quickly after ligation, 10.7% of them managing to stop the flow within two minutes, which indicates that the technique is highly effective in achieving rapid hemostasis in this demographic and can significantly reduce the time spent in hospital[13]. In our study, this technique is safe and feasible among the ASD pediatric population as well, which is quite similar to the study reported by Zhou et al. among a larger population group (104 patients). In their study, the success rate of the FoE technique was 98.1%, venous sheath sizes ranged from 7 Fr to 14 Fr, and no puncture site hematoma was reported[14].

The incidence of vascular complications in FoE has been reported to range from 3–9.8%[5–7, 13, 15]. In this study, no patient had PSS procedure-related major complications, which provided evidence to support the safety of the technique. More importantly, compared with manual compression, PSS technique has faster hemostasis and shorter bed rest time, which reduces the time of medical staff and makes children feel more comfortable.

The suturing process can be quickly mastered by personnel and requires no extended training. Compared with FoE, the PSS method is more appropriate for the extraction of single sheath tubes from ASD patients who require fewer sutures. Suture failure was reported in 5 patients (1.3%) due to suture breakage during knot tying[16]. As far, all reports on the applications of the PSS technique have been successful. The technique is to achieve hemostasis by compressing subcutaneous soft tissue with suture to cause vasoconstriction of different degrees. Therefore, it is not suitable for children who are very thin and lack subcutaneous tissue to have sutured hemostasis. For obese children, even a large curved needle may not grasp enough subcutaneous tissue to compress the femoral vein, resulting in the risk of compression deviation and rebleeding. If the suture is too tight, the skin tension is very heavy, which can cause discomfort in children. Compared with pressure closure devices, PSS technology is unrestricted by the age and vessel diameter, and offers significant economic advantages.

This study was mainly constrained by the retrospective non-randomized observation method. We compiled consecutive data on transcatheter closure over a relatively brief timeframe, with a modest sample size in the PSS group. Compared with our single center experience, multi-center clinical studies need to be evaluated. According to previous experience, the incidence of severe vascular complications at the puncture site is low in children, and vascular complications are the result of femoral venipuncture, not the complication of suture technique. Furthermore, the best of bed rest time and limb braking time has not been determined. The ideal time point of suture removal is not clear, and long-term use may lead to adhesion of subcutaneous tissue. However, the PSS technique was used in all successive children (≥ 8 Fr) by the operator, without any excluding factors.

Based on this retrospective data, the PSS technique is a safe and effective method of providing rapid hemostasis for removal of large-caliber femoral delivery venous sheaths following occlusion in children. This technique provides significantly shorter hemostatic time and bed rest time, as compared to manual compression, along with potential cost savings. The PSS technique is considerably faster to perform and is more comfortable for children than manual compression.

CHD Congenital heart disease

ASD Atrial septal defects

PSS Purse string suture

ACT Activated clotting time

Ethics approval and consent to participate: Women and Children's Hospital, Qingdao University ethics committee, No. FELL-YX-2018-004

Consent for publication: All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Availability of data and materials: The datasets generated and/or analysed during the current study are not publicly available due the data being stored in the hospital's electronic medical record management system but are available from the corresponding author on reasonable request.

Competing interests: The authors have no relevant financial or non-financial interests to disclose.

Funding: The authors declare that no funding was received during the preparation of this manuscript.

Authors' contributions：All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Zhixian Ji, Bei Zhang and Yueyi Ren. The first draft of the manuscript was written by Gang Luo and Silin Pan.

Committee on Congenital Heart Diseases., Internal Medicine Branch of Cadiovascular Diseases, Chinese Physicians' Association. Interventional treatment of common congenital heart disease: the common view of Chinese medical experts (2011) Part one: Interventional treatment of atrial septal defect. J Intervent Radiol 20:3–9.
Inoue K, Murakawa Y, Nogami A, et al. Current status of catheter ablation of atrial fibrillation in Japan: Summary of the 4th survey of the Japanese Catheter Ablation Registry of Atrial Fibrillation (J-CARAF). J Cardiol. 2016;68:83–8.
Geis NA, Pleger ST, Chorianopoulos E, et al. Feasibility and clinical benefit of a suture-mediated closure device for femoral vein access after percutaneous edge-to-edge mitral valve repair. EuroIntervention. 2015;10:1346–53.
Wyss CA, Anliker O, Gämperli O, et al. Closure of Large Percutaneous Femoral Venous Access Using a Modified Figure-of-Eight Suture. Innovations (Phila). 2018;13:147–51.
Okada M, Inoue K, Tanaka K, et al. Efficacy and Safety of Figure-of-Eight Suture for Hemostasis After Radiofrequency Catheter Ablation for Atrial Fibrillation. Circ J. 2018;82:956–64.
Traullé S, Kubala M, Doucy A, et al. Feasibility and safety of temporary subcutaneous venous figure-of-eight suture to achieve haemostasis after ablation of atrial fibrillation. Europace. 2016;18:815–9.
Payne J, Bickel T, Gautam S. Figure-of-eight sutures for hemostasis result in shorter lab recovery time after ablation for atrial fibrillation. Pacing Clin Electrophysiol. 2018. 10.1111/pace.13405.
Aytemir K, Canpolat U, Yorgun H, et al. Usefulness of 'figure-of-eight' suture to achieve haemostasis after removal of 15-French calibre femoral venous sheath in patients undergoing cryoablation. Europace. 2016;18:1545–50.
Jackson N, McGee M, Ahmed W, et al. Groin Haemostasis With a Purse String Suture for Patients Following Catheter Ablation Procedures (GITAR Study). Heart Lung Circ. 2019;28:777–83.
Cilingiroglu M, Salinger M, Zhao D, et al. Technique of temporary subcutaneous Figure-of-Eight sutures to achieve hemostasis after removal of large-caliber femoral venous sheaths. Catheter Cardiovasc Interv. 2011;78:155–60.
Schulman S, Kearon C, Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005;3:692–4.
Cilingiroglu M, Salinger M, Zhao D, et al. Technique of temporary subcutaneous Figure-of-Eight sutures to achieve hemostasis after removal of large-caliber femoral venous sheaths. Catheter Cardiovasc Interv. 2011;78:155–60.
Dönmez YN, Aykan HH, Sel K, et al. Femoral venous haemostasis in children and young adults using the 'figure-of-eight' suture technique. Acta Cardiol. 2022;77:626–31.
Pracon R, Bangalore S, Henzel J, et al. A randomized comparison of modified subcutaneous Z-stitch versus manual compression to achieve hemostasis after large caliber femoral venous sheath removal. Catheter Cardiovasc Interv. 2018;91:105–12.
Lakshmanadoss U, Wong WS, Kutinsky I, et al. Figure-of-eight suture for venous hemostasis in fully anticoagulated patients after atrial fibrillation catheter ablation. Indian Pacing Electrophysiol J. 2017;17:134–9.
Kumar P, Aggarwaal P, Sinha SK, et al. Efficacy and Safety of Subcutaneous Fellow's Stitch Using Fisherman's Knot Technique to Achieve Large Caliber (> 10 French) Venous Hemostasis. Cardiol Res. 2019;10:303–8.

No competing interests reported.

Download PDF

Editorial decision: Revision requested
22 Aug, 2024
Reviews received at journal
17 Aug, 2024
Reviewers agreed at journal
13 Aug, 2024
Reviews received at journal
12 Aug, 2024
Reviewers agreed at journal
12 Aug, 2024
Reviewers agreed at journal
08 Aug, 2024
Reviewers invited by journal
24 Apr, 2024
Editor assigned by journal
12 Apr, 2024
Editor invited by journal
16 Dec, 2023
Submission checks completed at journal
16 Dec, 2023
First submitted to journal
14 Dec, 2023

You are reading this latest preprint version

Purse string suture for hemostasis after removal of large-caliber femoral venous delivery sheaths in pediatric transcatheter intervention of atrial septal defect: a single center experience

Status:

Version 1

Abstract

Figures

Introduction

Materials and methods

Results

Discssion

Abbreviations

Declarations

References

Additional Declarations

Status:

Version 1