Extravascular closure for patients with high-risk femoral anatomy.
BACKGROUND
Vascular closure devices (VCDs) improve patient comfort and decrease time to ambulation. However, VCD studies have excluded patients with high-risk femoral artery anatomy; we examined the safety and efficacy of clip-based extravascular closure in this high-risk group.


METHODS
We performed a prospective registry enrolling 98 consecutive patients undergoing diagnostic coronary angiography. Inclusion criteria were femoral artery calcification, moderate femoral artery stenosis, or non-femoral arterial sheath insertion. All patients underwent immediate vessel closure with the Starclose device (Abbott Vascular). Patients with severe femoral arterial disease or femoral arterial diameter < or = 4.0 mm were excluded. Hospital outcomes were assessed prospectively and femoral arterial stenosis was determined by quantitative angiography.


RESULTS
Inclusion was mainly related to at least one of 3 main high-risk characteristics: moderate femoral arterial stenosis (30%), femoral arterial calcification (24%) or nonfemoral sheath insertion (46%). The average femoral stenosis was 35.3 +/- 5.1% among patients included for a significant femoral disease. There was a 100% procedural and 94% device success: 1 patient required manual compression for greater than or equal to 30 minutes. The average time from sheath removal to hemostasis was 0.76 +/- 1.3 minutes. Despite the higher-risk anatomy, there were no major vascular complications and only one minor vascular complication. The average time to ambulation was 78.1 +/- 47.3 minutes.


CONCLUSIONS
In this prospective registry, the Starclose VCD was safe and effective for early ambulation of patients despite the presence of high-risk femoral arterial anatomy.
Rashid
Mitchell N
MN
Division of Cardiology, Department of Medicine, University of Vermont College of Medicine, Burlington, VT 05401, USA.
Ahmed
Bina
B
Straight
Faye
F
Bradley
Jason T
JT
Gilbert
Kristin
K
Gogo
Prospero B
PB
Terrien
Edward F
EF
Watkins
Matthew W
MW
Dauerman
Harold L
HL
D000368:Aged; D000792:Angiography; D006328:Cardiac Catheterization; D015331:Cohort Studies; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation; D006801:Humans; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000601:surgery; D010865:Pilot Projects; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D014656:Vascular Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods