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INTERVENTIONAL CARDIOLOGY

Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures

A meta-analysis

Eugenia Nikolsky, MD, PhD^*, Roxana Mehran, MD, FACC^*, Amir Halkin, MD^*, Eve D. Aymong, MD, FACC^*, Gary S. Mintz, MD, FACC^*, Zoran Lasic, MD, FACC^*, Manuela Negoita, MD^*, Martin Fahy, MSc^*, Shoshana Krieger, BA^*, Issam Moussa, MD, FACC^*, Jeffrey W. Moses, MD, FACC^*, Gregg W. Stone, MD, FACC^*, Martin B. Leon, MD, FACC^*, Stuart J. Pocock, PhD and George Dangas, MD, PhD, FACC^*,*

^* Cardiovascular Research Foundation and the Lenox Hill Heart and Vascular Institute, New York, New York, USA
London School of Hygiene and Tropical Medicine, London, United Kingdom

Manuscript received February 18, 2004; revised manuscript received June 1, 2004, accepted June 9, 2004.

^* Reprint requests and correspondence: Dr. George Dangas, Cardiovascular Research Foundation, 55 East 59th Street, 6th Floor, New York, New York 10022 (Email: gdangas{at}crf.org).

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.

Abbreviations and Acronyms   ACD = arteriotomy closure devices   CI = confidence interval   Dx = diagnostic   OR = odds ratio   PCI = percutaneous coronary intervention   RCT = randomized controlled trial

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