The Angio-Seal Evolution registry: outcomes of a novel automated Angio-Seal vascular closure device.
OBJECTIVE
The objective of the study was to assess the efficacy and safety of a novel vascular closure device, the Angio-Seal Evolution (EVCD), in patients undergoing routine cardiac catheterization (CATH) and intervention (PCI) via a retrograde femoral artery access.


BACKGROUND
Successful use of current-generation vascular closure devices is highly dependent on operator methodology. To reduce dependence on operator technique, the EVCD was modified to automate the closure process, specifically the compaction of the extravascular collagen sponge that creates a sandwich under pressure against the intra-arterial anchor.


METHODS
This was a prospective ten-site registry including 1,004 patients undergoing 1,010 procedures with in-laboratory closure using the EVCD after CATH and PCI. The primary outcome measure was the rate of major vascular complications, and secondary outcomes were deployment success, time to hemostasis and in-hospital rates of minor vascular complications through 30 days. Clinical trial identifier NCT 00817349.


RESULTS
There were 575 CATH (56.9%) and 435 PCI (43.1%) closures. Overall deployment success was 99.7%; 99.8% for CATH and 99.5% for PCI. Major vascular complications occurred in 0.4% including 0.2% in CATH and 0.7% in PCI. Minor vascular complications occurred in 2.4%, with 0.5% for CATH and 4.9% for PCI.


CONCLUSIONS
Automation of the anchor-collagen closure of femoral artery access sites with the Angio-Seal ECVD resulted in excellent efficacy and safety after routine cardiac catheterization and intervention.
Applegate
Robert J
RJ
Wake Forest University School of Medicine, Section of Cardiology, Medical Center Boulevard, Winston-Salem, NC 27157-1045, USA. bapplega@wfubmc.edu
Turi
Zoltan
Z
Sachdev
Naveen
N
Ahmed
Abdel
A
Szyniszewski
Arthur
A
Foster
Malcolm
M
Pratsos
Antonis
A
Shapiro
Timothy
T
Yakubov
Steven
S
Shavelle
David
D
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000706:statistics & numerical data; D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000706:statistics & numerical data; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003324:Coronary Artery Disease / Q000453:epidemiology / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery; D006470:Hemorrhage / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation* / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data; D015999:Multivariate Analysis; D012042:Registries / Q000592:standards / Q000706:statistics & numerical data*; D012307:Risk Factors; D016896:Treatment Outcome