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.
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.
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.
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.
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