Author + information
- Arnold Seto1,
- William Rollefson2,
- Mitul Patel3,
- William Suh4,
- Daniel Amador1,
- Omid Behnamfar5,
- Vinisha Garg6 and
- Mauricio Cohen7
- 1Long Beach VA Medical Center, Long Beach, California, United States
- 2Arkansas Heart Hospital, Little Rock, Arkansas, United States
- 3VA San Diego Healthcare System and University of California San Diego, La Jolla, California, United States
- 4UCLA Medical Center, Boston, Massachusetts, United States
- 5UCSD, San Diego, California, United States
- 6UCLA, Los Angeles, California, United States
- 7University of Miami Hospital, Miami, Florida, United States
Radial sheaths are invariably removed following transradial catheterization, however, secure hemostasis of the puncture site remains a limiting factor for discharge after uncomplicated diagnostic or interventional procedures. The potassium ferrate patch (Statseal Advanced, Biolife, Sarasota FL) may serve as an adjunct to the TR band (Terumo, Somerset NJ) and allow expedited deflation and removal of the TR band.
Prospective multicenter randomized controlled trial of transradial catheterization procedures using the TR band with and without the addition of Statseal. Full deflation of the TR band was attempted at 40 minutes with or at 120 minutes without the Statseal. The primary outcome was time to hemostasis as defined as full deflation of the TR band. Secondary outcomes included radial artery patency by plethysmography and hematoma formation.
At four U.S. sites, 158 patients were enrolled, with a minimum of 5000 units of heparin or bivalirudin administration. Interventions occurred in 25% of procedures, with double wall puncture technique used in 40%. Successful TR band deflation occurred at a mean of 55.2 ± 82 minutes with Statseal and 173 ± 93 minutes without Statseal (p<0.001). Hematomas occurred in 10% of TR band patients and 19% of Statseal patients, p=0.18. No radial artery occlusions were detected in either group.
The Statseal hemostatic patch facilitated early deflation of the TR band with a nonsignificant increase in forearm hematomas and with no evidence of radial artery occlusion. Use of the Statseal may improve patient throughput through recovery and allow for early discharge following transradial catheterization.
OTHER: Vascular Access