Safety and Efficacy of Arterial Closure Devices in an Office-Based Angiosuite

Abstract

We aimed to compare the safety and efficacy of 5 arterial closure devices in an outpatient endovascular surgery center. We retrospectively reviewed all cases using femoral arterial access performed between January 2012 and December 2013. Five different arterial closure devices (AngioSeal, Perclose, StarClose, ExoSeal, and Mynx) were used by 7 endovascular surgeons. All femoral arteries were accessed with 6F sheaths under ultrasound guidance. All patients received systemic anticoagulation with sodium heparin (70 IU/kg). Sheath-shot angiograms of all arterial punctures were taken before deploying closure devices. Device failure was defined as any partial or complete failure requiring additional closure assistance. Minor complication was defined as any event that occurred because of incomplete hemostasis but did not result in hospitalization, including hematoma, hypotension, bleeding, arterial dissection, or extended recovery. Major complication was defined as any event that occurred because of incomplete hemostasis requiring inpatient management. Any device failure was identified per device and per surgeon. Device safety, efficacy, and relationships between other variables were analyzed using a binomial logistic regression. Results with P values<0.05 were considered to be statistically significant. During the study period, there were a total of 3142 endovascular procedures, including 1976 arterial cases (62.9%). Out of 1898 femoral artery punctures, closure devices were used in 1810 (95.4%), which forms the basis of this report. Device failure occurred in 151 cases (8.34%), and minor complications occurred in 53 cases (2.93%). There were 11 hospitalizations (0.61%). AngioSeal had both the lowest device failure rate (3.5%) and minor complication rate (1.3%). Our data showed a significant difference between the respective arterial closure devices for device failure rate (P=0.007) and minor complication rate (P=0.049), but not for major complication rate (P=0.199). No significant difference was observed between surgeons for device failure (P=0.798), minor complication (P=0.218), or major complication rate (P=0.899). With the lowest device failure and minor complication rate, AngioSeal is a consistently well-performing arterial closure device in the office surgical suite setting.