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Extravascular closure for patients with high-risk femoral anatomy
Mitchell N Rashid1, Bina Ahmed, Faye Straight
1Division of Cardiology, Department of Medicine, University of Vermont College of Medicine, Burlington, VT 05401, USA.
Insights
Clip-based extravascular closure using the Starclose device is safe and effective for patients with high-risk femoral artery anatomy, enabling early ambulation after diagnostic coronary angiography.
Area of Science:
- Interventional Cardiology
- Vascular Surgery
- Medical Devices
Background:
- Vascular closure devices (VCDs) enhance patient comfort and reduce time to ambulation.
- Previous VCD studies often excluded patients with high-risk femoral artery anatomy.
- This study investigated clip-based extravascular closure in this specific high-risk population.
Purpose of the Study:
- To evaluate the safety and efficacy of the Starclose device for extravascular closure.
- To assess its use in patients with high-risk femoral artery anatomy undergoing diagnostic coronary angiography.
- To determine the impact on patient ambulation time and vascular complications.
Main Methods:
- Prospective registry of 98 consecutive patients undergoing diagnostic coronary angiography.
- Inclusion criteria: femoral artery calcification, moderate stenosis, or non-femoral sheath insertion.
- Exclusion criteria: severe femoral arterial disease or diameter < 4.0 mm. Closure with Starclose device.
Main Results:
- High-risk characteristics included moderate stenosis (30%), calcification (24%), and non-femoral sheath insertion (46%).
- 100% procedural success and 94% device success; minimal need for manual compression.
- Average time to hemostasis was 0.76 minutes; average ambulation time was 78.1 minutes.
- No major vascular complications and only one minor complication observed.
Conclusions:
- The Starclose VCD demonstrated safety and effectiveness in patients with high-risk femoral artery anatomy.
- Early ambulation was achieved despite challenging anatomical factors.
- This approach offers a viable solution for closure in this previously excluded patient group.
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.
