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

• Published in: Journal of the American College of Cardiology 2004-09, Vol.44 (6), p.1200-1209
• Main Authors: NIKOLSKY, Eugenia, MEHRAN, Roxana, MOSES, Jeffrey W, STONE, Gregg W, LEON, Martin B, POCOCK, Stuart J, DANGAS, T. George, HALKIN, Amir, AYMONG, Eve D, MINTZ, Gary S, LASIC, Zoran, NEGOITA, Manuela, FAHY, Martin, KRIEGER, Shoshana, MOUSSA, Issam
• Format: Article
• Language: English
• Subjects: Angioplasty, Balloon, Coronary - adverse effects; Angioplasty, Balloon, Coronary - instrumentation; Bandages; Biological and medical sciences; Blood transfusions; Cardiology; Case-Control Studies; Cohort Studies; Confidence intervals; Diseases of the cardiovascular system; Equipment Failure; Femoral Artery - surgery; Hospitalization; Humans; Intubation; Medical sciences; Meta-analysis; Patient satisfaction; Platelet Glycoprotein GPIIb-IIIa Complex - therapeutic use; Postoperative Complications - epidemiology; Postoperative Complications - etiology; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Randomized Controlled Trials as Topic; Statistics as Topic; Studies; Ultrasonic imaging; Vascular Diseases - epidemiology; Vascular Diseases - etiology
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2004.06.048

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. Although ACDs are widely applied for hemostasis after percutaneous endovascular procedures, their safety is controversial. 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. 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). 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.