[Table 1].
3.3.1 Time to Hemostasis
Time to achieve hemostasis was significantly reduced in the F8 arm [MD
-21.04 mins (95% CI: -35.66 to -6.42; p=.005)] [Figure
3.1] .
3.3.2 Overall Access Site Complications
Overall access site complications were lower in the F8 arm [RR 0.38
(95% CI:0.26 to 0.55; p<0.00001)] [Figure
3.2] .
3.3.3 Access Site Complications for Sheaths ≥ 10 Fr
Access site complications for sheaths ≥10 Fr were lower in the F8 arm
[RR 0.33 (95% CI: 0.18 to 0.60; p=0.0003)] [Figure
3.3].
3.3.4 Fistula Formation
There was no significant difference in the rate of fistula formation
[RR 0.67 (95% CI: 0.18 to 2.41; p=0.54)] between the two groups[Figure 3.4] .
3.3.5 Pseudoaneurysm Formation
There was no significant difference in the occurrence of pseudoaneurysm
[RR 0.47 (95% CI 0.16 to 1.42; p=0.18)] [Figure 3.5] .
3.3.6 Access site Hematoma
Access site hematoma formation was lower in the F8 arm [RR 0.42 (95%
CI: 0.26 to 0.67; p=0.0003)] [Figure 3.6] .
3.3.7 Access Site Bleeding
Access site bleeding was significantly lower in the F8 group [RR 0.35
(95% CI: 0.18 to 0.66; p=0.001)] [Figure 3.7] .
3.3.8 Post-Procedural Protamine Use
Use of protamine after the procedure was significantly lower in the F8
arm [RR 0.07 (95% CI:0.01 to 0.36; p=0.001)] [Figure
3.8] .
Test of heterogeneity was low for rates of fistula, hematoma and
pseudoaneurysm formation, and access site complications. Test of
heterogeneity was moderate for access site bleeding and was high for
time to achieve hemostasis and post-procedural protamine use.
The main findings of our study are the following: [1] Time to
achieve hemostasis was significantly shorter in the F8 group. [2]
There is no difference between F8 and MC in pseudoaneurysm or fistula
formation. [3] Access site hematoma and access site bleeding were
lower in the F8 group . [4] Overall access site complications were
lower in the F8 group with a more pronounced effect seen in sheaths ≥ 10
Fr. [5] Post-procedural protamine use was higher in the manual
compression group.
Vascular access site complications are known to occur in cardiac
procedures and are associated with increased morbidity and prolonged
hospital stay. (13, 14) The use of large venous sheaths, periprocedural
anticoagulation and multiple sites of puncture contribute to these
complications. A demographic shift towards elderly patients receiving
cardiac procedures can contribute to an increase in complication rates.
Techniques to achieve effective hemostatic control are thus of paramount
importance to prevent these complications. Manual compression is the
current standard for venous access closure and has been demonstrated to
be effective in achieving post-procedural hemostasis; however, its use
is associated with patient discomfort, need for additional staff and a
longer patient stay in the procedural lab. (15) A period of absolute bed
rest with limited limb movement is required to achieve hemostasis
through MC. Various techniques such as pressure dressing and closure
devices have been utilized for venous vascular hemostasis and have been
reported to be efficacious. These techniques are associated with
increased cost, risk of device failure and reported complications such
as infections and thromboembolism.(16-22)
The F8 suture has been branded as the “Fellow’s Stitch ” due to
its simple technique compared to other suture delivery systems.(2) F8
can be performed in a very short duration (30-60s), and its failure has
been attributed to inadequate knot tie or suture break.(4, 6) Our study
demonstrated on average a 21 minute reduction in the time needed to
achieve satisfactory hemostasis when utilizing the F8 suture compared to
traditional MC. Pracon et al., using doppler-duplex assessment of the
groins, reported a slightly compressed mean vein diameter with the F8
stitch in place. This gives insight to the stitch’s mechanism of action
of utilizing the subcutaneous tissue pad to exert pressure on the
puncture site. The pressure exerted by the compression is sufficient for
hemostasis but maintains the vein’s lumen dimensions. Venous thrombosis
is a possible concern with a compressed vein diameter. Cilingiroglu et
al demonstrated vasoconstriction at the sheath entry point through
venography after F8 closure but vascular ultrasound following suture
removal demonstrated resolution of the vasoconstriction along with
femoral vein compressibility and the absence of thrombus. (1) Our study
sought to determine and compare thromboembolic rates. Five of eight
studies included thromboembolism as an outcome but no thromboembolic
complications were observed aside from 2 events in the Issa 2015 MC arm,
both of which were transient ischemic attacks.(4-6)
The use of F8 resulted in a 62% reduction in overall access site
complications. The size of the sheaths used in the included studies
varied widely, with reported sizes of up to 22 Fr, demonstrating safety
and efficacy across a wide range of large venous sheath sizes. The
reduction in access site complications may be explained by a shorter
time to hemostasis in comparison to the MC group.
Although there were differences in procedural protocols in the included
studies, we found a lower need for post-procedural protamine use in the
F8 arm. This can lead to lower rates of thromboembolic complications and
prevention of other commonly-reported side effects of protamine use such
as anaphylaxis, hypotension and bradycardia.(23) Additional cost for
suture material are lower in comparison to the amount saved from the use
of protamine sulfate ($1.53 vs $7.60) (8)
Aside from outcomes reported in this study, Payne et al reported a
reduced time to extubation and a reduced recovery time in the
electrophysiology lab in their study with the use of F8 suture in
comparison to MC. A subgroup analysis done in the study conducted by
Jensen et al. showed a significantly higher rate of vascular
complications in the manual compression arm (9.4% vs 0%; p= 0.045) in
patients with obesity (body mass index ≥30 kg/m2), a
factor which should be considered in the decision to use MC. Of note,
most of the studies included patients who underwent ablation for atrial
fibrillation. The efficacy and safety of the F8 suture may possibly be
greater in patients undergoing procedures which do not require continued
anticoagulation.
The following limitations should be considered in the interpretation of
the results of this meta-analysis.
Most of the studies included were observational. Some included studies
were nonrandomized and retrospective in nature which may potentially
have selection bias. A wide variety of venous sheaths sizes were used in
the different studies. Although some studies reported utilizing sheaths
< 8 Fr, procedural review showed that they were closed
concomitantly with a bigger sheath size utilizing a single F8 suture. 4
studies did not monitor or report post-procedural thromboembolic
complications. Included studies had variations in ablation protocols,
protamine administration and timing of sheath removal. Publication bias
is an inherent characteristic of any meta-analysis.
F8 is a safe and efficacious alternative to MC in large-bore venous
access closure and its use results in a shortened time to hemostasis
with a lower overall risk of access site complications and
post-procedural protamine use. Further RCTs are needed to confirm these
results.