A poly-N-acetyl glucosamine hemostatic dressing for femoral artery access site hemostasis after percutaneous coronary intervention: a pilot study.
BACKGROUND
Arterial puncture closure devices have improved time to hemostasis and ambulation after percutaneous coronary intervention (PCI) relative to traditional manual compression, though complication rates for both methods leave room for improvement. In a pilot registry, the authors evaluated a topical hemostatic dressing containing poly-N-acetyl glucosamine (p-GlcNAc) post PCI in fully anticoagulated patients.


RESULTS
In 100 patients undergoing PCI via the common femoral artery in the short-stay unit, the p-GlcNAc hemostatic dressing was applied with 15 minutes of manual compression at arterial access sites after arterial sheath removal. Procedural antiplatelet and anticoagulation therapies were aspirin, clopidogrel and bivalirudin. Patients were observed during 2 hours of bed rest and attempted to ambulate 2 hours post hemostasis. Effectiveness was assessed based on times to hemostasis and ambulation. Data were stratified by time elapsed since bivalirudin bolus or discontinuation of infusion (30 minutes, > 30-60 minutes, > 60 minutes). Mean time to hemostasis was 15.5 minutes. Mean time from hemostasis to ambulation was 2.08 hours; 87% of patients ambulated at 2 hours. Sheaths were removed at a mean 40.38 minutes after discontinuing bivalirudin. Anticoagulation status (as assessed by time since discontinuation of bivalirudin) did not influence time to hemostasis or ambulation. There was a single major complication (pseudoaneurysm), two minor rebleeds requiring additional manual compression, and 1 hematoma > 5 cm.


CONCLUSIONS
This p-GlcNAc topical hemostatic dressing safely achieved hemostasis at arterial access sites and early ambulation, even with nearly immediate sheath removal after PCI with systemic anticoagulation using bivalirudin.
Mego
David
D
Arkansas Heart Hospital, 1701 South Shackleford Road, Little Rock, AR 72211, USA. dmmego@gmail.com
Thomas
Melody
M
Stewart
Jeff
J
Rollefson
William
W
Flaherty
Patrick
P
Murphy
Bruce
B
Ribeiro
Paul
P
D000117:Acetylglucosamine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000287:Administration, Topical; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000925:Anticoagulants / Q000627:therapeutic use; D001684:Biological Dressings; D005260:Female; D005263:Femoral Artery / Q000502:physiology*; D006487:Hemostasis / Q000502:physiology*; D006490:Hemostatics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006629:Hirudins; D006801:Humans; D008297:Male; D010446:Peptide Fragments / Q000627:therapeutic use; D010865:Pilot Projects; D011994:Recombinant Proteins / Q000627:therapeutic use; D012039:Regional Blood Flow / Q000502:physiology*; D012189:Retrospective Studies; D013927:Thrombosis / Q000517:prevention & control; D013997:Time Factors; D016138:Walking
D000925:Anticoagulants; D006490:Hemostatics; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; C113831:poly-N-acetyl glucosamine; C074619:bivalirudin; D000117:Acetylglucosamine