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Arterial Closure Devices Versus Manual Compression for Femoral Haemostasis in Interventional Radiological Procedures: A Systematic Review and Meta-Analysis

  • Clinical Investigation
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Abstract

Purpose

The use of arterial closure devices (ACDs) in interventional radiology (IR) procedures has not yet been validated by large-scale randomised controlled trials or meta-analysis. Improved haemostasis and early mobilisation are publicised advantages; however, anecdotal evidence of haemorrhagic and ischaemic complications with ACDs is also apparent. Meta-analysis from interventional cardiology cannot be directly extrapolated for IR patients.

Materials and Methods

Systematic review, performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines was performed to assess four ACDs: Angioseal; StarClose; Perclose; and Duett―in peripheral vascular interventions: uterine artery embolisation, transhepatic chemoembolisation, and cerebral diagnostic and interventional procedures. Procedures requiring cardiac, aortic, or nonfemoral access, as well as those requiring >8F sheath size, were excluded. The outcomes assessed were device deployment failure, haematoma, bleeding, groin pain, retroperitoneal haematoma, arteriovenous fistula, infection, distal ischaemia, need for vascular surgery, need for manual compression, and death.

Results

Search of MEDLINE and other major databases identified 34 studies from 15,805 records. Twenty-one noncomparative studies (3,662 participants) demonstrated total complication rates of 3.1–11.4%. Thirteen comparative studies were analysed separately, and random-effects meta-analysis yielded 10 studies (2,373 participants).

Conclusion

Meta-analyses demonstrated no statistically significant difference, but there were marginally fewer complications with pooled ACDs compared with manual compression (odds ratio [OR] 0.87, 95% confidence interval [CI] 0.52–1.48, p = 0.13). The Angioseal group compared with the manual-compression group (total complication rate: OR 0.84, 95% CI 0.53–1.34, p = 0.49) and the Perclose group compared with the manual-compression group (total complication rate: OR 1.29, 95% CI 0.19–8.96, p = 0.01) each demonstrated trends for and against the specified ACD, respectively. Adequately powered randomised controlled trials are required to further elucidate the efficacy of ACDs.

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Authors and Affiliations

  1. Department of Radiology, St. George’s Hospital, Blackshaw Road, London, SW17 0QT, UK

    Rajib Das, Robert A. Morgan & Anna-Maria Belli

  2. Department of Surgery and Cancer, Imperial College, Praed Street, London, W2 1NY, UK

    Kamran Ahmed & Thanos Athanasiou

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  1. Rajib Das
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Corresponding author

Correspondence to Rajib Das.

Appendix: Search Strategies

Appendix: Search Strategies

Electronic Search Strategy

The full electronic search strategy for MEDLINE is presented below.

The following search combinations were used:

“closure device” AND “puncture”

“closure device” AND “peripheral vascular”

“closure device” AND “pseudoaneurysm”

“closure device” AND “femoral”

“closure device” AND “vascular”

“closure device” AND “ischaemia” OR “ischemia”

“closure device” AND “arterial”

“closure device” AND “lower limb”

“closure device” AND “infection”

“closure device” AND “intervention”

“closure device” AND “complication”

“closure device” AND “mortality”

“closure device” AND “angiography”

“closure device” AND “hemorrhage” OR “haemorrhage”

“closure device” AND “morbidity”

“closure device” AND “angioplasty”

“closure device” AND “hematoma” OR “haematoma”

“closure device” AND “randomised” OR “randomized”

“closure device” AND “stent”

  

“closure device” AND “embolisation” OR “embolization”

  

After this, the first word “closure device” was substituted with “manual compression,” “Angioseal,” “StarClose,” “Perclose,” “Closer,” and “Duett.” Limits of human studies and publications after 1990 were used.

MEDLINE Medical Subject Headings Used in Search Strategy

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Das, R., Ahmed, K., Athanasiou, T. et al. Arterial Closure Devices Versus Manual Compression for Femoral Haemostasis in Interventional Radiological Procedures: A Systematic Review and Meta-Analysis. Cardiovasc Intervent Radiol 34, 723–738 (2011). https://doi.org/10.1007/s00270-010-9981-0

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