[Table 1].
3.3 Outcomes
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.
Discussion
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.
5. Study Limitations
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.
6. Conclusion
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.