Comparative effectiveness and safety of Angio-Seal and StarClose vascular closure devices: a systematic review and meta-analysis

Study protocol and registration

The systematic review and meta-analysis protocol presented in this article was prepared based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Further registration takes place with the International Prospective Register of Systematic Reviews (PROSPERO CRD42024529705).

Literature search strategy

We identified studies by searching the literature in the PubMed, EMBASE, Cochrane Library and Web of Science without any language or publication status restrictions. This search strategy specifically included the search terms for vascular closure devices used, namely: “Angio-Seal” “StarClose” and “hemostasis” combined with Boolean operators to expand the sensitivity of the search. Additional studies were further sought by manually searching the reference lists of identified studies and relevant reviews.

Eligibility criteria

We will include randomized controlled trials (RCTs) in adult patients comparing Angio-Seal with StarClose for vascular closure after intervention, as well as observational studies (Lucatelli et al., 2017; Deuling et al., 2008; Engelbert et al., 2010; Elmasri et al., 2017; Veasey et al., 2019; Engelbert et al., 2013; Rastan et al., 2015; Ierardi et al., 2023; Gonen, Hakyemez & Erdogan, 2021). We exclude non-comparative studies and case reports, editorials, or commentaries that do not report interesting results.

Data extraction

The two reviewers Jingquan Chen and Qiang Tan independently performed data extraction using a standardized form that included the characteristics of the included studies, outcomes, details of the intervention. Any disagreements between reviewers were resolved by consensus or decision by a third reviewer, Lan Luo.

Statistical analysis

The data was synthesized and analyzed using Review Manager Version 5.4. Risk ratio (RR) and the 95% confidence intervals (CI) were calculated to express the effect size for dichotomous data. To assess heterogeneity among included trials, we used Chi-squared and Higgins I² tests. If significant heterogeneity was obtained (p ≤ 0.05 for Chi-squared test results or I² ≥ 50%), we used a random-effects model; otherwise, a fixed-effects model was used. Statistical significance was indicated by a p value < 0.05. In our meta-analysis, we employed both fixed-effects and random-effects models depending on the characteristics of the included studies. The choice between these models was determined not only by the heterogeneity in the results (measured using I² statistics) but also by potential differences in the study designs. These differences include: Endpoint definitions: Variations in how the studies defined clinical outcomes (e.g., hemostasis success, complication rates).

When significant variability in these factors was present, we utilized a random-effects model, as it allows for more generalized conclusions across studies with diverse clinical settings. Conversely, when the included studies were consistent in their design, a fixed-effects model was used to provide a more precise estimate of the effect size.

Study selection

The initial search strategy yielded a total of 163 records, of which 96 remained after duplicate removal. Upon reviewing the titles and abstracts, 73 records were excluded from the research scope due to irrelevant titles or abstracts. The full texts of 21 articles were reviewed, of which nine qualified for the systematic review and meta-analysis. The study selection process is illustrated in the PRISMA flowchart below (Fig. 1).

Study characteristics

The current meta-analysis includes a number of studies published between 2007 and 2023, which were rigorously selected based on their focus on the efficacy and safety of different vascular closure devices. The collective dataset comes from nine different studies, as summarised in Table 1, covering a range of sample sizes from 166 to 1,672 participants per study, for a total of 5,466 individuals.

Efficacy of vascular closure

The pooled analysis of the success rate of vascular closure indicated a slight advantage for Angio-Seal (RR 1.05, 95% CI [1.00–1.09], p = 0.03). The forest plot for the success rate of vascular closure demonstrates the individual and pooled estimates (Fig. 2).

Complication rates

On the other hand, the overall complication rates between these two devices did not reach statistical significance (RR 0.61; 95% CI [0.29–1.29], p = 0.20) (Fig. 3).

Hematomas

The more common complication was hematoma formation, with no statistically significant difference between Angio-Seal and StarClose (RR 0.75, 95% CI [0.46–1.22], p = 0.24) (Fig. 4).

Incidence of pseudoaneurysm

Postprocedure pseudoaneurysm formation is a relatively feared complication. The pooled data for the studies revealed no difference in the incidence of pseudoaneurysms between Angio-Seal and StarClose, with a risk ratio (RR) of 0.52 (95% CI [0.18–1.48], p = 0.22) (Fig. 4).

Arterial occlusion rates

Arterial occlusion is an adverse event, the severity of which can easily lead to harm to the patient. Based on our analysis, it was found that the prevalence of arterial occlusion rates was quite low and the difference between the two groups was not statistically significant, with a relative risk of 1.86 (95% CI [0.24–14.33], p = 0.55) (Fig. 4).

Surgical intervention requirement

It probed into the need for surgical intervention as an adjunct to severe complications related to devices. There was no significant difference in the need for surgical intervention, RR = 1.17 (95% CI [0.13–10.77], p = 0.89), in their comparison of the Angio-Seal-treated group and patients treated with StarClose (Fig. 5).

Complications associated with VCDs

There was no significant difference in the incidence of pseudoaneurysm and arterial occlusion between the devices (Auer et al., 2023). This observation is consistent with literature indicating that VCDs have improved post-catheterization management but have not eliminated the risk of such complications entirely (Mohammed & Tamimi, 2017). These rare complications have significant impacts on patient morbidity, emphasizing the need for vigilant monitoring (Rastogi et al., 2016).

Hematoma formation, a frequent complication, occurred at similar rates between the devices, indicating no distinct advantage for either in reducing this risk. This underscores the importance of skilled technique and careful patient selection in the use of VCDs (Goldsweig & Secemsky, 2020).

The mechanistic differences between Angio-Seal and StarClose have significant clinical implications. Angio-Seal’s bioabsorbable anchor promotes rapid hemostasis by creating a mechanical and biological seal, which may explain its slightly higher success rate in achieving immediate vessel closure. This is particularly advantageous in patients requiring early ambulation or those at higher risk for bleeding. On the other hand, StarClose’s nitinol clip provides a mechanical closure that might be more effective in patients with complex vascular anatomies, where a more rigid support structure is needed to ensure closure (Lucatelli et al., 2017). Selecting the appropriate device is essential for achieving successful outcomes and minimizing complications. The choice directly influences procedural success and patient recovery.

Surgical interventions

The rarity of surgical intervention following the use of VCDs and the lack of significant differences between the two devices support the use of VCDs as the primary method of vascular closure following interventional procedures. This is consistent with the primary goal of minimising patient trauma and promoting rapid recovery.

Limitations

Our study has limitations, including the heterogeneity of the studies, variations in operator expertise, and differences in patient populations, all of which could affect the outcomes.

Future research

Future research should aim to address several critical gaps in the current literature regarding vascular closure devices. First, large-scale, multicenter randomized controlled trials are needed to evaluate the long-term outcomes of Angio-Seal and StarClose in diverse patient populations. These studies should focus on specific subgroups, such as those with complex vascular anatomies or high bleeding risks, to determine the most effective device for varying clinical scenarios. Additionally, there is a need for research that investigates the economic implications of using different vascular closure devices. Understanding the cost-effectiveness and impact on healthcare resource utilization will help inform clinical decision-making.