Table 1

Indications, Contraindications, and Cautions for 3 VCDs

Angio-SealPercloseStarClose
Closure indication
 Diagnostic cath+++
 PCI+++
 5-F sheathNM++
 6-F sheath+++
 7-F sheath++No
 8-F sheath++No
 Ipsilateral access <90 days1 cm higherNo restrictionNot indicated
 MRI safeNMNM+
ContraindicationNoneNoneNone
Warnings: “Do not use if…”
 SFA or Profunda insertion+++
 Bifurcation insertion+++
 Above inguinal ligament+++
 Posterior wall punctureNM++
 Multiple puncturesNM++
Precautions: “Safety and effectiveness of the VCD has not been established if…”
 Patient on warfarin+NMNM
 Inflammatory disease+++
 Morbid obesityNM++
 Thrombolysis+NMNM
 Access via vascular graft+++
 Significant PVD+++
 Uncontrolled HTN+NM+
 Bleeding diathesis+++
 Ipsilateral venous sheathNM++
 Femoral artery calciumNM++
 Small femoral artery size+++
 Iliofemoral stenosis >50%NM++
 Use of GP IIb/IIIa inhibitorNM+NM

cath = catheterization; GP = glycoprotein; HTN = hypertension; MRI = magnetic resonance imaging; NM = not mentioned in instruction for use as indication, warning, or caution; PCI = percutaneous coronary intervention; PVD = peripheral vascular disease; SFA = superficial femoral artery; VCD = vascular closure device; + = explicitly mentioned in instruction for use as indication, warning, or caution.

  • Instructions for Use Angio-Seal VIP; St. Jude Medical February 2006 (www.sjm.com);

  • Instructions for Use Perclose A*T (August 2006) and StarClose (February 2007). Abbott Vascular (www.abbottvascular.com/ifu);

  • no restriction is only for reaccess after prior arteriotomy repaired with Perclose.