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Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis.

Abstract：

OBJECTIVES:This study was designed to assess the safety of arteriotomy closure devices (ACDs) versus mechanical compression by meta-analysis in patients undergoing percutaneous transfemoral coronary procedures. BACKGROUND:Although ACDs are widely applied for hemostasis after percutaneous endovascular procedures, their safety is controversial. METHODS:Randomized, case-control, and cohort studies comparing access-related complications using ACDs versus mechanical compression were analyzed. The primary end point was the cumulative incidence of vascular complications, including pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, femoral artery thrombosis, surgical vascular repair, access site infection, and blood transfusion. RESULTS:A total of 30 studies involving 37,066 patients were identified. No difference in complication incidence between Angio-Seal and mechanical compression was revealed in the diagnostic (Dx) setting (odds ratio [OR] 1.08, 95% confidence interval [CI] 0.11 to 10.0) or percutaneous coronary interventions (PCI) (OR 0.86, 95% CI 0.65 to 1.12). Meta-analysis of randomized trials only showed a trend toward less complications using Angio-Seal in a PCI setting (OR 0.46, 95% CI 0.20 to 1.04; p = 0.062). No differences were observed regarding Perclose in either Dx (OR 1.51, 95% CI 0.24 to 9.47) or PCI (OR 1.21, 95% CI 0.94 to 1.54) setting. An increased risk in complication rates using VasoSeal in the PCI setting (OR 2.25, 95% CI 1.07 to 4.71) was found. The overall analysis favored mechanical compression over ACD (OR 1.34, 95% CI 1.01 to 1.79). CONCLUSIONS:In the setting of Dx angiography, the risk of access-site-related complications was similar for ACD compared with mechanical compression. In the setting of PCI, the rate of complications appeared higher with VasoSeal.

journal_name

J Am Coll Cardiol

journal_title

Journal of the American College of Cardiology

authors

Nikolsky E,Mehran R,Halkin A,Aymong ED,Mintz GS,Lasic Z,Negoita M,Fahy M,Krieger S,Moussa I,Moses JW,Stone GW,Leon MB,Pocock SJ,Dangas G

doi

10.1016/j.jacc.2004.06.048

subject

Has Abstract

pub_date

2004-09-15 00:00:00

pages

1200-9

issue

eissn

0735-1097

issn

1558-3597

pii

S0735-1097(04)01323-3

journal_volume

pub_type

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Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis.