Practices and Complications of Vascular Closure Devices and
Manual Compression in Patients Undergoing Elective Transfemoral
Coronary Procedures
Nathaniel R. Smilowitz, MD, Ajay J. Kirtane, MD, Michael Guiry, RPA-C, MBA,
William A. Gray, MD, Pilar Dolcimascolo, RPA-C, Michael Querijero, RPA-C,
Claudia Echeverry, RCIS, Nellie Kalcheva, MD, Braulio Flores, MD, Varinder P. Singh, MD,
LeRoy Rabbani, MD, Susheel Kodali, MD, Michael B. Collins, MD, Martin B. Leon, MD,
Jeffrey W. Moses, MD, and Giora Weisz, MD*
Femoral arterial puncture is the most common access method for coronary angiography
and percutaneous coronary interventions (PCIs). Access complications, although infre-
quent, affect morbidity, mortality, costs, and length of hospital stay. Vascular closure
devices (VCDs) are used for rapid hemostasis and early ambulation, but there is no
consensus on whether VCDs are superior to manual compression (MC). A retrospective
review and nested case– control study of consecutive patients undergoing elective trans-
femoral coronary angiography and PCI over 3 years was performed. Hemostasis strategy
was performed according to the operators’ discretion. Vascular complications were defined
as groin bleeding (hematoma, hemoglobin decrease >3 g/dl, transfusion, retroperitoneal
bleeding, or arterial perforation), pseudoaneurysm, arteriovenous fistula formation, ob-
struction, or infection. Patients with postprocedure femoral vascular access complications
were compared to randomly selected patients without complication. Data were available
for 9,108 procedures, of which PCI was performed in 3,172 (34.8%). MC was performed in
2,581 (28.3%) and VCDs (4 different types) were deployed in 6,527 procedures (71.7%).
Significant complications occurred in 74 procedures (0.81%), with 32 (1.24%) complications
with MC and 42 (0.64%) with VCD (p ؍ 0.004). VCD deployment failed in 80 procedures
(1.23%), of which 8 (10%) had vascular complications. VCD use was a predictor of fewer
complications (odds ratio 0.52, 95% confidence interval 0.33 to 0.83). In the case– control
analysis, older age and use of large (7Fr to 8Fr) femoral sheaths were independent
predictors of complications. In conclusion, the retrospective analysis of contemporary
hemostasis strategies and outcomes in elective coronary procedures identified a low rate of
complications (0.81%), with superior results after VCD deployment. Careful selection of
hemostasis strategy and closure device may further decrease complication rates. © 2012
Published by Elsevier Inc. (Am J Cardiol 2012;110:177–182)
Femoral arterial puncture is the most commonly used
arterial access method for diagnostic and interventional cor-
onary procedures. Manual compression (MC) with pro-
longed bedrest to achieve hemostasis has been increasingly
replaced by the use of vascular closure devices (VCDs). The
use of VCDs enables rapid postprocedure hemostasis, a
shorter duration of bedrest with sooner ambulation, and
earlier discharge.
1
Different of VCDs have been approved
for use in the United States including suture-based, sealant-
based, and collagen-plug based devices. With improved
operator experience and the development of newer genera-
tions of closure devices, complication rates have de-
creased.
2,3
Even with these improvements, complications of
vascular access continue to affect procedure-related mor-
bidity and mortality, hospital length of stay, and health care
costs. Despite the potential benefits and improvements with
VCDs, there is still no consensus on whether they are
superior to MC.
4–6
Few large studies have compared vas-
cular access strategies in patients undergoing elective cor-
onary procedures.
7,8
We performed a retrospective review
of consecutive patients who underwent elective coronary
angiography or intervention with femoral arterial access to
evaluate patterns of use and outcomes associated with var-
ious vascular closure strategies in the modern era of elective
angiography.
Methods
This is a retrospective evaluation of consecutive patients
undergoing ambulatory elective transfemoral coronary an-
Center for Interventional Vascular Therapy, New York-Presbyterian
Hospital, Columbia University Medical Center, New York, New York.
Manuscript received January 25, 2012; revised manuscript received and
accepted February 28, 2012.
Dr. Gray is a consultant to and has received research support from
Abbott Vascular, Redwood City, California and has minor equity in
AccessClosure, Mountain View, California. Dr. Moses is a consultant to
Abbott Vascular.
*Corresponding author: Tel: 212-305-7060; fax: 212-342-3680.
E-mail address: gw2128@columbia.edu (G. Weisz).
0002-9149/12/$ – see front matter © 2012 Published by Elsevier Inc. www.ajconline.org
doi:10.1016/j.amjcard.2012.02.065