Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis.
OBJECTIVE
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.
Nikolsky
Eugenia
E
Cardiovascular Research Foundation and the Lenox Hill Heart and Vascular Institute, New York, New York 10022, USA.
Mehran
Roxana
R
Halkin
Amir
A
Aymong
Eve D
ED
Mintz
Gary S
GS
Lasic
Zoran
Z
Negoita
Manuela
M
Fahy
Martin
M
Krieger
Shoshana
S
Moussa
Issam
I
Moses
Jeffrey W
JW
Stone
Gregg W
GW
Leon
Martin B
MB
Pocock
Stuart J
SJ
Dangas
George
G
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000295:instrumentation*; D001458:Bandages; D016022:Case-Control Studies; D015331:Cohort Studies; D004868:Equipment Failure; D005263:Femoral Artery / Q000601:surgery*; D006801:Humans; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000627:therapeutic use; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology*; D016032:Randomized Controlled Trials as Topic; D013223:Statistics as Topic; D014652:Vascular Diseases / Q000453:epidemiology / Q000209:etiology*
D019039:Platelet Glycoprotein GPIIb-IIIa Complex