A new vascular sealant (Sealgel) to achieve rapid hemostasis after percutaneous angioplasty in anticoagulated patients: clinical feasibility and preliminary results.
The aim of this study was to assess the feasibility of a new vascular sealant (Sealgel) to provide rapid hemostasis in anticoagulated patients after percutaneous transluminal angioplasty (PTA). Sealgel was designed with ancrod (10 mg) and tranexamic acid (80 mg) dissolved in a hyaluronic acid gel (3 ml). Fifty anticoagulated patients (heparin, aspirin, ticlopidin) who underwent PTA of coronary artery were enrolled in the study. Sealgel (3 ml) was delivered under manual compression through a 9-F cannula at the arterial puncture site after the introducer sheath removal at the end of PTA procedure. Hemostasis time as well as complications were recorded. Sealgel was successfully delivered in 98 % of patients. Hemostasis occurred within 15 mn of manual compression in 82 % of patients, within 25 mn in 98 %, and failed in 1 patient (2 %). Hematoma (6-cm diameter) was observed in 1 patient and late bleeding in another one. There were no clinical signs of embolism, inflammatory swelling, local infection, vascular fistula, or pseudoaneurysm. No surgery or blood transfusion was required. Sealgel application after PTA in anticoagulated patient is feasible and secure. Preliminary results suggest that the Sealgel brought about rapid hemostasis; however further studies are needed to determine its clinical efficacy.
Lefebvre
J M
JM
Department of Cardiology, Clinique de la Louvière, Lille, France.
Qanadli
S D
SD
Kacher
S
S
Aberkane
L
L
Rigaud
M
M
Lacombe
P
P
Rocha
P
P
D000368:Aged; D000721:Ancrod / Q000008:administration & dosage*; D000787:Angina Pectoris / Q000628:therapy*; D000789:Angina, Unstable / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary; D000818:Animals; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects*; D001458:Bandages; D001780:Blood Coagulation Tests; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery / Q000187:drug effects; D005782:Gels; D006489:Hemostatic Techniques; D006490:Hemostatics / Q000008:administration & dosage*; D006801:Humans; D006820:Hyaluronic Acid; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D011677:Punctures; D011817:Rabbits; D014148:Tranexamic Acid / Q000008:administration & dosage*
D000925:Anticoagulants; D004338:Drug Combinations; D005782:Gels; D006490:Hemostatics; D014148:Tranexamic Acid; D006820:Hyaluronic Acid; D000721:Ancrod