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The use of vascular closure devices (VCDs) following transfemoral procedures reduces recovery time and may reduce bleeding. Transradial (TR) access is associated with fewer adverse events (AEs). The frequency of real-world AEs with VCDs and the effect of increasing TR access are unknown.
The FDA Manufacturer and User Facility Device Experience (MAUDE) database was queried for the years 2007-2011. Specific VCDs queried included Angioeal (St. Jude Medical, Saint Paul MN), StarClose and Perclose (Abbott Vascular, Santa Clara CA) and Mynx (Access Closure Inc, Mountain View CA). Data was analyzed on a per device and per year basis.
b The annual number of reported AEs increased from 2007 to 2010 and declined slightly in 2011 (Figure). There is substantial variation between VCDs in AEs or malfunctions reported. Angioseal has the fewest entries (Table). The significance of these differences is unclear due to the voluntary and incomplete nature of the MAUDE database.
Over a 5 year period, the number of AE reports for common VCDs increased by more than two-fold. Increased use of TR access has not decreased reported AEs with VCDs.
- 2013 American College of Cardiology Foundation