Off-label use of the Angioseal vascular closure device for femoral arteriotomy: retrospective analysis of safety and efficacy.
BACKGROUND
Angioseal, an arteriotomy closure device (ACD), functions as a collagen plug that physically closes arteriotomy sites and can simultaneously induce platelet activation and aggregation. When used 'on-label', the safety and efficacy profile of Angioseal is superior compared with those of other ACDs. However, Angioseal is sometimes deployed in less than ideal situations. Therefore, we sought to assess the safety and efficacy of 'off-label' Angioseal use in patients undergoing femoral arteriotomies.


METHODS
We performed a retrospective review of all femoral arterial angiograms executed at our institution between 2008 and 2014. Patients whose femoral punctures did not fit the criteria for on-label Angioseal use were included, and were dichotomized based on vascular closure (off-label Angioseal vs manual compression).


RESULTS
Of the 521 patients (1023 angiograms) reviewed, 303 (58.2%) patients had off-label Angioseal groin punctures. Mean patient age was 46.2±14.0 years, and 113 were men. 234 patients (77%) had off-label Angioseal deployment while 69 (22%) individuals received manual pressure, serving as controls. Demographic and procedural variables were nearly identical between the two groups but the Angioseal group comprised mostly patients that underwent neurointerventional procedures and thus received intraprocedural heparinization (41%) more often than the manual compression group (19%). The overall rate of major complications associated with off-label Angioseal deployment was low (<0.85%), and clinical complications were not independently associated with Angioseal use (OR 0.76 (95% CI 0.06 to 8.86); p=0.69).


CONCLUSIONS
Off-label use of Angioseal was found to be safe and was not associated with an increased complication rate in our cohort.
Department of Neurosurgery, University of Miami Miller School of Medicine, Miami, Florida, USA.
Sumedh S
SS
Shah
Department of Neurosurgery, University of Miami Miller School of Medicine, Miami, Florida, USA.
Giancarlo
G
Perez
Department of Neurosurgery, University of Miami Miller School of Medicine, Miami, Florida, USA.
Brian M
BM
Snelling
Department of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA.
Diogo C
DC
Haussen
Department of Neurosurgery, University of Miami Miller School of Medicine, Miami, Florida, USA.
Samir
S
Sur
Department of Neurosurgery, University of Miami Miller School of Medicine, Miami, Florida, USA.
Ishna
I
Sharma
Department of Neurology, University of Miami Miller School of Medicine, Miami, Florida, USA.
Dileep R
DR
Yavagal
Department of Neurosurgery, University of Miami Miller School of Medicine, Miami, Florida, USA.
Mohamed Samy
MS
Elhammady
Department of Neurosurgery, University of Miami Miller School of Medicine, Miami, Florida, USA.
Eric C
EC
Peterson
D000328:Adult; D000368:Aged; D000792:Angiography / Q000379:methods; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging* / Q000601:surgery*; D006489:Hemostatic Techniques / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use; D011677:Punctures; D012189:Retrospective Studies; D016896:Treatment Outcome; D065506:Vascular Closure Devices / Q000009:adverse effects / Q000706:statistics & numerical data*; D014656:Vascular Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods
Angiography; Artery; Standards; Technique