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Comparison of the QuickSeal Femoral Arterial Closure System with manual compression following diagnostic and interventional catheterization procedures*

      Hemostasis at the femoral artery access site is typically achieved using manual compression or deployment of a closure device after diagnostic and interventional procedures. Manual compression is usually uncomfortable to the patient and requires significant personnel and facilities to support a successful outcome.
      • Spokojny A.M.
      • Sanborn T.A.
      Management of the arterial puncture site.
      ,
      • Lehmann K.G.
      • Ferris S.T.
      • Heath-Lange S.J.
      Maintenance of hemostasis after invasive cardiac procedures implications for outpatient catheterization.
      ,
      • Semler H.J.
      Transfemoral catheterization mechanical versus manual control of bleeding.
      ,
      • Christenson R.
      • Staab E.V.
      • Burke H.
      • Foster J.
      Pressure dressings and postarteriographic care of the femoral puncture site.
      ,
      • Johnson L.W.
      • Esente P.
      • Giambartolomei A.
      • Grant W.D.
      • Loin M.
      • Reger M.J.
      • Shaw C.
      • Walford G.D.
      Peripheral vascular complications of coronary angioplasty by the femoral and brachial techniques.
      ,
      • Bogart D.B.
      • Bogart M.A.
      • Miller J.T.
      • Farrar M.W.
      • Barr W.K.
      • Montgomery M.A.
      Femoral artery catheterization complications a study of 503 consecutive patients.
      ,
      • Ricci M.A.
      • Trevisani G.T.
      • Pilcher D.B.
      Vascular complications of cardiac catheterization.
      Patients must then remain immobile for approximately 4 to 8 hours to avoid access site bleeding and vascular complications, particularly with the addition of anticoagulation therapy.
      • Spokojny A.M.
      • Sanborn T.A.
      Management of the arterial puncture site.
      ,
      • Johnson L.W.
      • Esente P.
      • Giambartolomei A.
      • Grant W.D.
      • Loin M.
      • Reger M.J.
      • Shaw C.
      • Walford G.D.
      Peripheral vascular complications of coronary angioplasty by the femoral and brachial techniques.
      ,
      • Bogart D.B.
      • Bogart M.A.
      • Miller J.T.
      • Farrar M.W.
      • Barr W.K.
      • Montgomery M.A.
      Femoral artery catheterization complications a study of 503 consecutive patients.
      ,
      • Ricci M.A.
      • Trevisani G.T.
      • Pilcher D.B.
      Vascular complications of cardiac catheterization.
      ,
      • Muller D.W.
      • Shamir K.J.
      • Ellis S.G.
      • Topol E.J.
      Peripheral vascular complications after conventional and complex percutaneous coronary interventional procedures.
      An ideal arterial closure device should be effective, safe, easy to use, and preferably extravascular. QuickSeal (SUB-Q Inc., San Clemente, California) is a porcine gelatin sponge that is placed in the extravascular space at the femoral artery access site using an over-the-wire system. The purpose of this randomized, multicenter controlled clinical investigation was to evaluate the safety and efficacy of the QuickSeal Femoral Arterial Closure System. Time to hemostasis (TTH), time to ambulation (TTA), and rates of major complications were compared with standard manual compression.
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