Introduction
In patients undergoing cardiac procedures, the use of large sheath sizes for venous vascular access is not uncommon. Manual compression is the current standard to achieve post-procedural hemostasis. Although some studies have previously reported favorable outcomes in utilizing arterial vascular closure devices for venous access closure, data on venous vascular closure devices are limited.
Figure-of-8 (F8) suture is an alternative approach for large-bore venous access closure. Prior studies have evaluated the safety and efficacy of the F8 suture technique through venography or vascular ultrasound. (1-3) The first reported use of the F8 suture was done by Bagai and Zhao who used the technique to achieve adult femoral venous access hemostasis and reported success in large caliber sheaths (8 to 21 Fr). As a result, F8 has been used in achieving venous hemostasis with sheaths as large as 24 Fr. (1)
In the F8 suture, a large curved needle with a 0-silk suture is passed through the subcutaneous tissue around 5-10 mm under the access sheath with care taken not to insert the needle deep enough as to ligate the femoral vein or artery. A significant amount of subcutaneous tissue is included to contribute to compression and hemostasis. The needle is then brought cranially to the sheath insertion point and is inserted again in the same initial direction through the subcutaneous tissue, hence a figure of eight stitch is performed [Figure 1]. After the sheaths are removed, the suture is tightened and knotted. The site is observed for a few minutes without utilization of manual compression. A sterile gauze is placed followed by monitoring for any signs of bleeding. Sutures are typically removed the following morning. (4-6)
Our study sought to determine the efficacy, impact and safety of F8 suture in comparison to manual compression for large-bore venous access closure. Nine studies composed of seven observational and two randomized controlled trials (RCTs) have been included in this updated meta-analysis.
Methods2.1 Search Strategy
The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines was used in this meta-analysis. A systematic search was done using PubMed, Google Scholar, EMBASE, SCOPUS and ClinicalTrials.gov without language restriction up until April 15, 2020 by two authors (MM and AA). Studies comparing figure-of-8 suture vs manual compression were compared. The search included the following keywords: manual compression, manual pressure, figure of eight, figure of 8, fellow’s stitch, z-stitch, venous closure, vascular closure.
2.2 Study Selection
The following criteria were used for study selection: [1] The study was performed on adults ≥ 18 years of age. [2] The study compared figure-of-eight suture vs manual compression. [3] The study reported atleast one clinical outcome.
2.3 Data Extraction
Disagreements between the two authors (MM and AA) were resolved through internal discussion. The following details were collected from each study: Author, design, study population, male sex, age, mean CHA₂DS₂VASc score, laboratory parameters such as pre-procedural international normalized ratio (INR) and post-procedural activated clotting time (ACT), type of procedure, location of access sites, number of access sites and procedural success rate.
2.4 Clinical Outcomes
The study collected and evaluated the following clinical outcomes: [1] time to hemostasis [2] access site complications [3] fistula formation [4] pseudoaneurysm formation [5] access site bleeding [6] access site hematoma [7] post-procedural protamine use.
2.5 Statistical Analysis
Review Manager (RevMan), version 5.3 (The Cochrane Collaboration, Copenhagen, Denmark) was used for statistical analysis. The DerSimonian-Laird random-effects model was used to estimate the risk ratios (RR) and mean difference (MD) with the corresponding 95% confidence interval (CI). Two-sided p values <0.05 were considered statistically significant. Higgins and Thompson I2 statistic was used to assess heterogeneity.
Results3.1 Search Results
A PRISMA flow chart has been included [Figure 2]. A total of 121 citations were identified after an intensive search process, 23 articles were assessed for eligibility and 14 were excluded after screening. Nine studies were found to be eligible based on the inclusion criteria.(4-12)
3.2 Study Characteristics
In this meta-analysis, 9 eligible studies were included, composed of 7 observational and 2 RCTs with a total of 2,338 patients. The majority of the study population were males. 1,175 (50.26%) of patients received the F8 suture of which mean ± SD age ranged from 55 ± 12.4 to 63 ± 11 years and baseline INR ± SD ranged from 1.4 ± 0.5 to 2.6 ± 0.6. The majority of the procedures done were AF catheter ablation. Access sites reported were the left and right femoral veins. The success rate of the F8 suture ranged from 91.7% to 100% in the included studies