title: Efficacy and safety of closing postcatheterisation pseudoaneurysms with ultrasound-guided thrombin injections using two approaches: bolus versus slow injection. A prospective randomised trial.
abstract: BACKGROUND
  Thrombin injection is a widely accepted treatment of an iatrogenic arterial pseudoaneurysm. However, the optimal mode of injection and type of pseudoaneurysm amenable to this therapy have yet been established.
  
  
  OBJECTIVE
  To compare efficacy and safety of two approaches to ultrasound-guided thrombin injections into a femoral artery pseudoaneurysm with or without long neck that developed as an iatrogenic complication of cardiac catheterisation.
  
  
  METHODS
  Patients were randomised to thrombin administration in a bolus or slow injection. The length and width of aneurysm neck and blood flow velocity in the neck were measured with color Doppler ultrasonography before the closure procedure. Thrombin dose, time to thrombotic occlusion, blood oxygen saturation in a toe of the extremity with the pseudoaneurysm (a marker of silent microembolisation), and clinical signs of distal embolisation were recorded. Between 2006 and 2009, 73 consecutive patients (33 males; mean age 67.8 ± 11.9 years) with femoral pseudoaneurysms complicating cardiac catheterisation were randomised into two groups that were treated with thrombin bolus (n = 40) or slow injection (n = 33).
  
  
  RESULTS
  The efficacy of aneurysm closure with either method was similarly high (100% vs 96.8%, NS, respectively) and did not depend on the length and width of the aneurysm neck. Independent risk factors for distal embolisation were: thrombin dose (OR 4.2; 95% CI 0.92-19.3), the length of aneurysm neck (OR 4.66; 95% CI 1.1-19.9), age above 80 years (OR 10.9; 95% CI 1.0-116.8), and bolus treatment (OR 7.6; 95% CI 1.3-44.9). We observed silent microembolisation phenomenon that was common (occurring in 38% of patients in the bolus group vs 33% of patients in the slow injection group) but in most cases asymptomatic.
  
  
  CONCLUSIONS
  Femoral pseudoaneurysm closure with a low dose of thrombin is a valid and beneficial treatment. Either method (bolus or slow injection) was similarly efficacious and safe even in the subgroup of patients with neckless aneurysms. We observed and confirmed silent microembolisation phenomenon during thrombin injections.
authors.affiliation: Department of Cardiology, Medical Centre for Postgraduate Education, Grochowski Hospital, Warsaw, Poland. p.lewandowski@vita-medica.pl
authors.forename: Paweł
authors.initials: P
authors.lastname: Lewandowski
authors.forename: Paweł
authors.initials: P
authors.lastname: Maciejewski
authors.forename: Wojciech
authors.initials: W
authors.lastname: Wąsek
authors.forename: Tomasz
authors.initials: T
authors.lastname: Pasierski
authors.forename: Andrzej
authors.initials: A
authors.lastname: Budaj
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017541:Aneurysm, False / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000209:etiology; D006328:Cardiac Catheterization / Q000009:adverse effects*; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D006490:Hemostatics / Q000008:administration & dosage*; D006801:Humans; D007267:Injections / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D013917:Thrombin / Q000008:administration & dosage*; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional / Q000379:methods
chemical_list: D006490:Hemostatics; D013917:Thrombin