Author + information
- Received February 18, 2004
- Revision received June 1, 2004
- Accepted June 9, 2004
- Published online September 15, 2004.
- 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*,* ()
- ↵*Reprint requests and correspondence:
Dr. George Dangas, Cardiovascular Research Foundation, 55 East 59th Street, 6th Floor, New York, New York 10022
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.
The research fellowship program of the Cardiovascular Research Foundation is a recipient of an educational grant from St. Jude Medical Inc.
- Received February 18, 2004.
- Revision received June 1, 2004.
- Accepted June 9, 2004.
- American College of Cardiology Foundation